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Regulatory Submissions, Information, and Document Management Forum

DIA Your Way! Join us live in-person or live from the comfort of your home/office. This event offers two learning avenues depending on your preference!


Speakers

  • Venkatraman  Balasubramanian, PhD, MBA

    Venkatraman Balasubramanian, PhD, MBA

    • Senior Vice President and Global Head, Healthcare and Life Sciences
    • Orion Innovation, United States

    V. “Bala” Balasubramanian is Senior Vice President and Global Head for Healthcare and Life Sciences at Orion, a global digital transformation products, solutions and services company. With over three decades of IT experience, Bala is a thought leader on digital transformation. Prior to Orion, Bala was the President and CEO of Cabeus, a niche Life Sciences services firm where he was responsible for strategy, leadership and vision for a cloud platform called ReALM® to transform the regulatory value chain for Life Sciences. Bala developed IT strategies and capabilities for Bristol-Myers Squibb, Roche, Aventis, Merrill Lynch, AT&T, Bell Atlantic and IBM. Bala has his PhD and MBA from Rutgers University and MS in Computer Science from NJIT.

  • Karen  McCarthy Schau

    Karen McCarthy Schau

    • Director, Global Clinical Operations
    • Vertex Pharmaceuticals, United States

    Clinical Research/Clinical Management Professional with 23 years diversified experience across functional areas and global regions with current focus in Clinical Operations Risk-based Quality Management business process improvement and eClinical Systems deployment. Career includes greater than 9 years specializing in process reengineering and eClinical system implementation for a large global CRO and 6 years helping companies deploy solutions to streamline processes, improve productivity and operational efficiency, and better manage information across CTMS, eTMF, Risk-Based Quality Management (RBQM), Investigator Portal, CRO Engagement and Clinical Architecture.

  • Peter  Terbeek, MBA

    Peter Terbeek, MBA

    • Senior Director, Regulatory Operations
    • Astellas, United States

    Peter is the Sr. Director of Publishing & Submissions for Astellas. This global group has responsibility for compiling, dispatching and archiving submissions and ensuring those activities are captured in the appropriate systems. Peter has been involved in multiple global programs targeting process improvements around product change control, document management and submission management. Prior to moving into Regulatory Operations, Peter worked in IT at Astellas focusing on informatics in the areas RA, QA and document management. Peter has a Bachelor’s degree in Mathematics from Austin College in Sherman, TX, and an MBA from the Lake Forest Graduate School of Management.

  • Jake  Doran

    Jake Doran

    • Head of Global R&D IT
    • Bausch Health, United States

    Jake Doran is the Head of Global R&D IT @ Bausch Health. In this role, Jake is responsible for establishing the strategic direction and defining the digital solutions across Bausch's R&D portfolio. Prior to joining Bausch Health, Jake was with Genpact, as the Chief Technology Officer focusing on the life sciences vertical. Jake prides himself in being a biologist by study and a technologist by trade and throughout his career has positioned himself at the intersection of science and technology. Earlier in his career, Jake held positions of increasing responsibility at Janssen Pharmaceuticals and Schering Plough. Jake has a Bachelor’s Degree from Fairleigh Dickinson University where his area of specialization was Biological Sciences.

  • Jo  English

    Jo English

    • Vice President, Regulatory Information Management
    • Calyx, United Kingdom

    An established Regulatory Information Management expert with extensive skills and experience in life sciences. As the VP of Regulatory Information Management at Calyx Jo is the operations lead and the business owner for the Calyx RIM suite. The operations team are responsible for strategic consultancy and delivery of services and solutions to facilitate our clients’ business using the Calyx RIM suite and other RIM technologies. The operations team remit is to ensure that the Calyx RIM suite aligns with the changing regulatory landscape and client needs and to provide strategic regulatory input into the software development lifecycle. As the business owner Jo is responsible for the overall budget to align with Calyx fiscal requirements.

  • Michiel  Stam

    Michiel Stam

    • Head of Data Management and Regulatory Information Scientist
    • Qdossier, Netherlands

    Michiel Stam is heading the Data Management group at Qdossier and works as a Regulatory Information Scientist. He is a specialist in electronic submissions and regulatory information management and worked for various Pharma and Biotech companies in the past 10 years. Michiel has a strong focus on product and registration data management, master data management and IDMP.

  • Danielle  Beaulieu, PhD

    Danielle Beaulieu, PhD

    • Senior Director, Global Regulatory Business Capabilities
    • Bristol-Myers Squibb, United States

    Danielle Beaulieu, PhD Danielle obtained her PhD in Biochemistry from Laval University Canada. After a 13 years career in Microbiology Drug Discovery, she moved into regulatory operations where she managed several drugs at different stages of development in the US/EU. In 2012, she began managing BMS’s home grown RIM Solution. She also envisioned, helped develop and instituted a Data Quality program. In 2014 BMS began the work to replace their older RIM solution with a new authoritative source for RIM. Danielle was been the Business lead for that effort, from process definition and simplification to configuration and roll out, and she is now the head of the Business Capabilities group for regulatory at BMS.

  • Kristen  Sauter, MBA

    Kristen Sauter, MBA

    • Director, Global Regulatory Informatics & Analytics
    • Takeda Pharmaceuticals, United States

    Kristen has 20 years of experience helping life sciences clients create modern and innovative regulatory practices and processes that leverage cutting-edge technology to satisfy both FDA requirements and their bottom line. She has built and led global regulatory operations and project management teams for top industry organizations using forward-facing strategy and business systems. Her experience includes comprehensive knowledge of electronic submissions requirements, connections into e-subs group, strong experience in pharmaceutical process and submission preparation through pre-market and NDA stages of development, and strong exposure and awareness of post-marketing and international filings.

  • Vahe  Ghahraman, PhD

    Vahe Ghahraman, PhD

    • Senior Director, Global Regulatory Operations Head
    • Apellis Pharmaceuticals, Inc. , United States

    Vahé has about 20 years of global regulatory operations, project management and regulatory technology experience, with special focus on regulatory information management, data governance, publishing and global submissions strategy. Vahé has had various roles at Alexion, Takeda, Dyax, Millennium, Parexel, and Datafarm, and has also been involved in consulting activities. He is currently heading the Global Regulatory Operation at Apellis. Vahé is a member of the DIA-RIMWG sub-team on RIM Reference Model.

  • Cindy  Chiu

    Cindy Chiu

    • Senior Director, Regulatory Affairs Operations and Quality Management
    • Merck & Co., Inc., United States

    Cindy Chiu is a Senior Director in Global Regulatory Affairs and Clinical Safety group at Merck & Co. She has over 20 years of experience in the pharmaceutical and energy industries, focusing on post-merger process integration and operations excellence. She has served in various leadership roles overseeing project management, business process improvement and change management initiatives. In her current role at Merck & Co., she is the Lead of the Regulatory Content Authoring and Archiving Management group. Prior to Merck, she worked as a management consultant, where she assisted clients with change management and business process redesign as a result of merger activity or technology integrations.

  • Joanne  Malia, MS, MSc

    Joanne Malia, MS, MSc

    • Director, Clinical Documentation Management
    • Regeneron Pharmaceuticals, United States

    Joanne Malia is Director, Clinical Documentation Management at Regeneron Pharmaceuticals and responsible for the TMF group and Clinical Archives and is the Business Process Owner for the eTMF. Throughout her 25+ year career in life sciences she has worked for diagnostic, biotech, pharmaceutical companies and CROs. She serves as co-lead of the Change Control Board for the TMF Reference Model group, on the organizing committee for DIA’s Regulatory Information Document Submission Meeting and presents frequently at industry conferences.

  • Jamie  O'Keefe

    Jamie O'Keefe

    • VP, Business & Technology Consulting
    • Just in Time GCP, United States

    Mr. O’Keefe has over 15 years of R&D management and IT consulting expertise, working with both top tier pharmaceutical firms, and early stage biotechs. Prior to joining Just in Time GCP as Vice President of Business & Technology Consulting, he established and led the R&D Consulting Solutions practice for Paragon Solutions/CGI Life Sciences, where he focused on helping drive adoption of business capabilities such as: submissions management and archiving; IDMP; electronic management of Trial Master Files and investigator interactions; and defining and implementing risk-based monitoring programs. He has over 20 years of business and IT consulting experience, with the past 15 years focused in life sciences clinical and R&D.

  • Stacy  Tegan

    Stacy Tegan

    • Associate Director, Program Management
    • Transcelerate Biopharma Inc., United States

    Stacy Tegan is a Program Director at TransCelerate Biopharma, Inc., a non-profit organization with a mission to collaborate across the biopharmaceutical R&D community. In her current role she oversees projects to enable information sharing and harmonization across the clinical development process. She has expertise in Regulatory Operations, Clinical Development processes, and Project Management gain through 20+ years of experience working for sponsor, consulting, technology, and nonprofit organizations in the pharmaceutical industry.

  • Divya  Gangaramani, PhD, RAC

    Divya Gangaramani, PhD, RAC

    • Senior Regulatory Specialist
    • VIR Biotech, United States

    I am a bench scientist (Virologist) with about 10 years of research experience who recently transitioned into the field of regulatory affairs. Currently, I am a Senior Regulatory Specialist working on exciting products in the field of infectious diseases. I am excited to be a part of a DIA event for the very first time and look forward to meeting some of the best regulatory professionals in the field.

  • Rob  Labriola, MS

    Rob Labriola, MS

    • Sr. Director, Regulatory Operations
    • Synchrogenix, United States

    Rob oversees the Regulatory Operations services group at Synchrogenix, a Certara Company. His over 35 years-experience in leadership positions of increasing responsibility managing high technology programs and initiatives, include over 25 years expertise in Regulatory Operations. He was an early planner and adopter for the electronic Common Technical Document (eCTD), having previously serving on Bio and PhRMA working groups for eCTD and electronic submissions. Rob is a builder and leader of teams of all sizes, including past roles at Janssen, Millennium, Sunovion, and Alexion. His submissions experience includes coordinating submissions for investigational and marketing programs, and has been an operator, planner, gatekeeper and champion.

  • Sandra  Krogulski, MA

    Sandra Krogulski, MA

    • Associate Director, Submission Management
    • Bristol-Myers Squibb Company, United States

    Sandy Krogulski is a Regulatory Submission Manager with 10 years of experience and this is her sixth RSIDM. She has experience managing and reviewing submissions to the US, Health Canada, Swissmedic, Australia and other Rest of World countries. In addition to submissions, Sandy has a background in training/developing teams, SOP writing and change initiatives. Currently in her third year with BMS, Sandy has previous vendor experience supporting submissions to numerous health authorities.

  • Demetra  Macheras, MBA

    Demetra Macheras, MBA

    • Director, Regulatory Policy and Intelligence - Regulatory Affairs
    • AbbVie, Inc., United States

    Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S. and Canada regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and final regulatory policies. She also provides regulatory and strategic support to global project teams. Demetra has over 25 years of industry experience and has held positions in Regulatory Affairs, QA, Compliance, and Operations. Demetra is also active in a number of external trade associations.

  • Ethan  Chen, MBA

    Ethan Chen, MBA

    • Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
    • FDA, United States

    Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining the FDA in 2012, Mr. Chen has led several critical initiatives as the CDER Informatics Architect, including Data Management and Business Intelligence programs. While leading the CDER Division of Data Management Service and Solution, Ethan had successfully implemented the eCTD electronic submission mandate in 2017 for NDAs, BLAs and ANDAs, and again in 2018 for Commercial INDs and DMFs (excluding DMF Type III). Ethan has over 20-years’ experience in Data Management, Enterprise Architecture, Solution Development and System Integration.

  • Jonathan  Resnick, PMP

    Jonathan Resnick, PMP

    • Project Management Officer, OBI, OSP, CDER
    • FDA, United States

    Jonathan Resnick is a member of CDER’s Division of Data Management Services and Solutions, with a focus on eCTD and has been with FDA for 11 years. Prior to joining FDA, Jonathan spent 18 years working in IT project management supporting federal and private sector clients.

  • Representative Invited

    Representative Invited

    • United States
  • Kyle A. Fliszar, PhD

    Kyle A. Fliszar, PhD

    • Vice President, Regulatory Transformation
    • Genpact, United States

    Kyle is a life sciences professional with over 20 years of experience working in the pharmaceutical industry holding roles across a range of functions including analytical research, regulatory affairs, manufacturing, and commercial at Merck and Organon. Ultimately, he became headed the group responsible for overseeing all aspects of incoming and outgoing partnerships as they related to regulatory affairs and clinical safety.    Kyle has an undergraduate degree in Chemistry from Villanova University, and a MS & PHD in Pharmaceutical Chemistry from Lehigh University. He recently completed the Regulatory Excellence Leadership Academy through McKinsey and held the position of Adjunct Professor of Chemistry at Lehigh University for 10 years.

  • Mark A. Gray

    Mark A. Gray

    • Senior Project Manager, DSS, CBER
    • FDA, United States

    Mark has over 30 years’ experience in Information Technology & Management. Mark began his career developing commercial applications and has been working for FDA for over 30 years. Mark’s FDA responsibilities have included; software development and project management in CBER; Director of Applications Development & Services in CDER; PDUFA IT Program Director; and Director, Division of Data Management Services & Solutions managing CDER’s electronic submission program. Mark’s current responsibilities include representing CBER in the development of international electronic submission standards, with a focus on the ICH electronic Common Technical Document (eCTD).

  • Hans  van Bruggen, MSc

    Hans van Bruggen, MSc

    • CEO and Senior RA Consultant
    • Qdossier, Netherlands

    Hans van Bruggen has been involved in the transition form paper to digitalized paper to data exchange to data sharing. Key areas of expertise: lean regulatory documents, data capture right-first-time, and reuse rather then recreate or copy. Hans has an MSc in Pharmaceutical Medicine from the University of Surrey and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European Headquarters. Using that scientific background he brings together people, processes and tools, leading to lean interdisciplinary and international processes.

  • Gautam  Gulati, MD, MBA, MPH

    Gautam Gulati, MD, MBA, MPH

    • Co-Founder and CEO
    • Well Played, United States

    “Dr. G” Gulati is a sought-after expert on health, trends, and innovation. Radical leaders looking to transform organizations into innovative powerhouses call on Dr. G to help think differently, escape the trap of mediocrity, and unleash creativity. Dr. G is the Founder of The Well Home, an interior wellness design clinic; and also the founder of Well Played, a non-boring storytelling studio. He has over 20 years of hands-on experience as an award-winning innovation executive for a number of globally recognized brands and products - both inside and out of healthcare. Dr. G received his MD and MPH from The George Washington University, and MBA from Johns Hopkins University.

  • Kate  Wilber

    Kate Wilber

    • Director, Regulatory Information Management
    • Vertex Pharmaceuticals, United States

    Kate has experience partnering with life science companies of all sizes to implement innovative software solutions that keep pace with regulatory, technology and industry rates of change. Kate has an extensive background in content management, submission compilation, and registration tracking. Her experience has given her unique insights into the problems and pressures facing life sciences companies as they look to get new treatments onto the global marketplace. With more than twenty years experience in electronic document management and global regulatory submissions, Kate is a credible subject expert skilled at helping companies find the most efficient way to leverage people, processes and technology in a changing landscape.

  • Jan  Benedictus, MS, MSc

    Jan Benedictus, MS, MSc

    • CEO
    • Fonto, Netherlands

    Jan Benedictus is founder of Fonto - a user friendly authoring tool for structured content. Fonto is widely used in content-intense industries such as Publishing, Aviation, Technical Documentation, and increasinlgy in Pharma. Jan is actively involved in programmes that are rolling out structured content management and authoring at various top 10 Pharma companies. He will be sharing his experiences on use-cases and key challenges that arise when implementing structured content.

  • Betsy  Fallen, RN

    Betsy Fallen, RN

    • Consultant
    • BAFallen Consulting LLC, United States

    Ms. Fallen is an authority on the business processes and associated use of information technology in drug development with a focus on regulatory and clinical. A passionate advocate for moving life sciences business on-line, Betsy is an expert on regulatory and clinical operations. Over the two decades of outstanding contributions at Merck, she was recognized for her leadership and excellent representation of the organization on internal transformational teams and in many industry initiatives. Now consulting, she continues to be recognized for her knowledge in technical innovation, process efficiency and ability to assess and assure compliance in documentation, execution and oversight.

  • Daniel  Orfe, MS

    Daniel Orfe, MS

    • President and CEO
    • Regulatory eSubmissions, LLC, United States

    Dan is a Leadership professional with 20+ years experience in Regulatory Submission production. A subject matter expert for eCTD & EDMS solutions. A business process analyst for submission assembly and eCTD publishing. He’s been a key member of several industry/agency initiatives for electronic submission standardization & efficiency. Dan has presented or chaired sessions at DIA Annual Meeting & DIA RSIDM/EDM Conferences. He's a DIA RSIDM Conference Program committee member. Dan established/directed eCTD publishing groups at Merck & Co., Inc. & Datafarm Inc. (leading eCTD software & services provider). At Teva, Dan led a initiative to harmonize the publishing environment into a single tool set (EDMS, eCTD Publishing etc.).

  • Heather  Crandall, MA

    Heather Crandall, MA

    • Operations Research Analyst, OBI, OSP, CDER
    • FDA, United States

    Heather Crandall has been with the FDA since 2012, working in CDER’s Office of Business Informatics. She currently focuses on standards and processes around electronic submissions.

  • Karen  Harry

    Karen Harry

    • Director, Regulatory Information Management
    • Calyx, United Kingdom

    Extensive industry experience in Regulatory Operations and Regulatory Information Management with proven success in the implementation of Regulatory processes and compliance with regulations. In Karen's current role as Director of Regulatory Information Management at Calyx she leads a team of Regulatory Consultants who provide strategic regulatory input into the software development lifecycle and support clients with their subject matter expertise to effectively manage complex regulatory processes, to align with the changing regulatory landscape.

  • Michael  Agard, MS, RPh

    Michael Agard, MS, RPh

    • Team Leader, Clinical Consulting US
    • NNIT, United States

    Michael joined NNIT in 2021 and is managing the US clinical consultants at NNIT. Michael works with clients to improve their clinical operations compliance and operational efficiency. He is working to increase the agility and automation of clinical processes with several clients. Michael has worked at CGI, Paragon Solutions and Sanofi-Aventis prior to joining NNIT. He has experience in Clinical Operations, Data Management, and Clinical Supply Operations. Michael has a Masters in Leadership Development and a BS in Pharmacy.

  • Manuela  Bernhardt, MS

    Manuela Bernhardt, MS

    • Business Unit Director - Technology Services
    • Fme US, LLC, United States

    Graduating in 2003 from Braunschweig, Germany with a Master’s Degree in „Computer Science in Economics“, Manuela directly joined fme AG as an Associate Consultant, working primarily with Documentum implementation projects. Over the years she developed to the role of a Senior Consultant for Documentum and Deputy Business Manager for the Munich department. In 2010 Manuela moved to Connecticut USA to join the newly formed fme US as Senior Consultant providing Documentum and Migration services primarily for the Life Sciences industry. Currently she is the Business Unit Director - Technology Services and Deputy of Operations overlooking the Delivery team servicing a wide range of Life Sciences clients in Implementation and Integration projects.

  • Stephen  Blanchard, MS

    Stephen Blanchard, MS

    • IDMP Programme Lead
    • Johnson & Johnson Consumer Health, United Kingdom

    Steve is Head of IDMP at J&J Consumer Health and is leading a cross-functional team for digital transformation to deliver IDMP compliance. He has 27 years’ R&D experience with J&J spanning product development and Regulatory Affairs leading multiple global projects across different categories including medicinal products, medical devices, engineered and formulated products. He has worked in Germany, USA and UK. Steve’s interests include delivering new solutions, data and technology strategy, working across functional areas.

  • D. Vanessa  Brewer-Yizar

    D. Vanessa Brewer-Yizar

    • Sr. Manager, Regulatory Affairs Consultant
    • Ipharmaquest Inc., United States

    For over 15 years’ I have been in Regulatory Affairs for large and small pharmaceutical and Medical Device companies. I am currently a Regulatory Affairs Manager for SG Research International a Pharmaceutical Quality Assurance Consulting Firm. During my years in the industry, I have contributed to the production, manufacturing, registration, and marketing of medical products, that include biopharmaceuticals, Oligonucleotides, and orphan-drugs designated for specified rare diseases or conditions.

  • Jillian E. Carinci, MS

    Jillian E. Carinci, MS

    • Director, Submission Sciences
    • Biogen, United States

    Jillian Carinci is Director in the Submission Sciences group at Biogen. Jillian leads Biogen’s Global Delivery Managers and is responsible for overseeing global submissions, establishing processes, ensuring compliance, robust submission planning, tracking metrics, high quality submission delivery and process improvements. Jillian began her career at Octagon Research Solutions before transitioning to Accenture. During her tenure at Accenture Jillian partnered with sponsors to manage numerous regulatory submission projects, ensuring compliance with global regulatory requirements, delivering within scope, on time, and with the highest quality.

  • Scott  Cleve

    Scott Cleve

    • Vice President Regulatory Operations and Compliance
    • Bluebird Bio, United States

    Scott Cleve is currently the Vice president of Regulatory Operations and Compliance at bluebird bio where he leads a team responsible for building and executing publishing, project management, RIM, and compliance activities to support the regulatory organization. In his career he previously led Regulatory Operations teams at Boehringer Ingelheim, AbbVie and Astellas. Scott’s focus is on developing his team, investigating technology to improve process and compliance, and partnering within industry and vendors to improve standards, process and technology.

  • Donna  Dorozinsky, BSN, MSN

    Donna Dorozinsky, BSN, MSN

    • President/CEO
    • Just in Time GCP, United States

    Donna is a business consultant who has over 30 years of experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management. She encourages strategic thinking and implementation of solutions not only for today, but for the future. Her vast experiences dealing with a broad range of research organizations provides her with the knowledge to assist research organizations in all areas of clinical compliance. .

  • Matthew  Eisenberg

    Matthew Eisenberg

    • Chief, Business Process and Information Management Branch
    • NIH, United States

    Matt Eisenberg joined the National Institute of Allergy and Infectious Diseases in 2011. As the Chief of the Business Process and Information Management Branch (BPIMB), Mr. Eisenberg is responsible for the Institute's electronic document management, process automation systems, and collaborative technologies. BPIMB also manages NIAID's clinical and regulatory systems, including the Institute's Clinical Quality Management System. Prior to joining NIAID, Mr. Eisenberg was the Application Development and Support Branch Chief at the United States Peace Corps. He has 25 years of experience in Software Development and Project Management in a variety of settings. Mr. Eisenberg holds a B.A. in Government and Politics.

  • Joel  Finkle

    Joel Finkle

    • Associate Director, Regulatory Information Management
    • BeiGene, United States

    Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our reports into WordPerfect format for the FDA reviewer?" -- and he didn't say "no." Since then, he's been involved with content management, custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard both as a vendor/consultant and within biopharma companies.

  • Richard F Fredericks

    Richard F Fredericks

    • Director, Regulatory Operations and Technology
    • Black Diamond Therapeutics, United States

    I have been in the life sciences industry for close to fifteen years functioning entirely in the Regulatory Operations space. My career began as a publisher and over the past decade has gravitated towards the technology and process side of the business. I currently lead the RegOps group at Black Diamond Therapeutics where I am responsible for the creation of a Regulatory Operations business unit, RIM ecosystem and associated operating procedures. Prior to Black Diamond I have worked at several other pharmaceutical/biotech companies including GSK/Tesaro, Shire, Sunovion, Ariad, Ironwood, Pfizer, Regeneron, Ipsen and Genzyme.

  • Steve  Gens, MS

    Steve Gens, MS

    • Managing Partner
    • Gens & Associates Inc., United States

    Steve Gens (MSOD) is the Managing Partner of Gens & Associates Inc., a global Life Science benchmarking and advisory firm specializing in performance improvement, strategy, industry analysis, and organizational transition. His early career was spent at Johnson & Johnson in a variety of management positions and then transitioned to consulting where he lead global Life Science consulting practices for First Consulting Group and Booz Allen Hamilton. His organization is well known for their insightful industry benchmarks and World Class RIM thought leadership. Steve has a Bachelor’s of Science in Business Computer Science and a Master in Organizational Development and Performance.

  • Dominik  Gigli

    Dominik Gigli

    • Principal Consultant
    • Main5 GmbH & Co. KGaA, Germany

    Senior expert in Regulatory Information Management and IDMP with 10+ years in the pharmaceutical industry. Successfully implemented Veeva Vault RIM replacing Regulatory processes, RIMS, eDMS and Publishing system driving Digital Transformation in Regulatory Affairs. Experienced in leading teams of internal and external employees in a matrix organization, accountable for all Data related topics in the Veeva Vault RIM implementation covering Data and Documents migration including Submission Archive and Publishing, Data Governance, Master Data Management, IDMP PMS Iteration 1 readiness, Data Quality, Reporting and Analytics for Vault RIM and realizing process requirements with best practice data management.

  • Virginia  Hussong

    Virginia Hussong

    • Chief, Data Standards Program, CBER
    • FDA, United States

    Ginny serves as Chief of CBER's Data Standards Program, where she leads a multidisciplinary team that advances standards such as eCTD, SDTM, ADaM, SEND, ICSR, IDMP, SPL and related terminologies. In addition, the team leads reviewer training and support related to the review of study data. She serves as co-Chair of the FDA Data Standards Advisory Board and is FDA Topic Lead for the ICH M2 Electronic Standards EWG. Ginny has worked in informatics at FDA since 2004, previously serving as Director, Data Management Services and Solutions in OBI/CDER. She developed CDER’s electronic submissions and reviewer training program, encompassing eCTD and CDISC Standards and well as contributing to the 745A binding guidances.

  • Ram  Iyer, MS

    Ram Iyer, MS

    • Chief Data Officer
    • FDA, United States

    As the Chief Data Officer of the FDA, Ram C Iyer has the accountability to develop and execute an agency wide data modernization strategy, building robust central functions that can be leveraged by the centers and the agency for high value decisions. The scope spans the entire stack from data identification to actionable decision, including data policies and governance. Ram is an industry and peer recognized data and technology professional with experience in the Pharma, Consulting, Telecom and International Government organizations. His expertise includes Data and Decision Sciences, Digital and Technology Architecture, and Talent Development with a focus on building collaborative partnerships and Ecosystems.

  • Dominique  Lagrave, PharmD

    Dominique Lagrave, PharmD

    • Head of Regulatory Innovation
    • Accumulus Synergy, United States

    Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel, Dendreon and TCS. Dominique joined Amgen in 2015 as the Head of Global Regulatory Operations, and has recently, under a secondment, joined Accumulus Synergy as Head of Regulatory Innovation and Product Owner for Accumulus initial platform supporting Submission Review Collaboration. Dominique is also a Board Member of IRISS Forum since 2021 Dominique holds a Pharm D and a master’s in International Regulatory Affairs from the University of Paris.

  • Rodrigo  Palacios, MBA

    Rodrigo Palacios, MBA

    • Regulatory Policy Lead
    • F. Hoffmann-La Roche, Switzerland

    Rodrigo Palacios is an Associate Director in Regulatory Policy at Roche. He is responsible for advancing global policy on data and technology in the regulatory domain. These topics include Cloud Submissions, Data Standardisation (e.g. IDMP), structured data submissions, eCTD and Regulatory Information Management. Rodrigo represents Roche in EFPIA and PhRMA in Regulatory Technology expert groups. He is a member of the Accumulus Consortium Leadership Team and co-chairs its EU subcommittee. He has over 25 years of experience in data and technology strategy, Information Technology management, software development and consulting.

  • Adam  Price

    Adam Price

    • Director of Product
    • Rimsys, United States

    Adam Price has over 17 years of medical device industry experience as a quality assurance and regulatory affairs professional. He currently serves as Director of Product, Post-Market at Rimsys, where he is responsible for the strategy and implementation of all post-market surveillance activities within the Rimsys platform, which enable medical device manufacturers to efficiently gather and evaluate data to monitor device performance in the field, assure product safety and efficacy, and maintain compliance with new and changing global regulations. Adam holds a Bachelor of Science in mechanical engineering as well as a Master of Business Administration (MBA) from the University of Pittsburgh.

  • Evan  Richardson, RAC

    Evan Richardson, RAC

    • Director, Regulatory Services
    • Certara Synchrogenix, United States

  • Olaf  Schoepke, PhD

    Olaf Schoepke, PhD

    • Vice President, Regulatory Solutions
    • Instem, United Kingdom

    Dr. Olaf Schoepke studied Computing Sciences in Germany and holds a PhD in Computer Architecture from Bath University (UK). He is now the Director of Strategic Development at Samarind Ltd., having worked for PricewaterhouseCoopers, advising pharmaceutical companies worldwide on document and submission management.

  • Meredith K Sewell

    Meredith K Sewell

    • Executive Director, Head of Global Regulatory Operations
    • Sarepta Therapeutics, United States

    Meredith Sewell is Sarepta’s Executive Director of Global Regulatory Operations, heading up the RIM and Submissions space. Meredith joined the company in 2019, and is enjoying working at a smaller, rare disease, gene therapy company after 14 years in Reg Ops at Allergan, and prior to that, Amgen Inc.

  • Kimberly  Sivananthan, MPH

    Kimberly Sivananthan, MPH

    • Quality Management Analyst
    • NIAID, United States

    Kimberly Sivananthan joined the National Institute of Allergy and Infectious Diseases during the summer of 2020 as a Quality Management Analyst. A life sciences professional with ten years of experience in the field, she brought experience with quality system digital transformation. Over the past 18 months, she has assisted NIAID research divisions with making the jump from paper to computers, the first step toward digitalization of quality management systems across the institute.

  • Cary  Smithson, MBA

    Cary Smithson, MBA

    • Director, Regulatory Solutions
    • Phlexglobal, United States

    Cary Smithson is the Director of Regulatory Solutions at Phlexglobal and has over 25 years of experience helping life science Regulatory, Clinical and Quality organizations drive increased productivity, streamline information management and enhance regulatory compliance. Her areas of expertise include regulated content and information management, regulatory information management, eTMF, GxP quality / compliance, IT strategy, business process optimization, Agile and project / program management. Cary leads the DIA RIM Intelligent Automation Topic Team, contributes to the RIM and EDM Reference Models and led the development of the DIA GMP Quality Systems Reference Model.

  • Cham  Williams, MS

    Cham Williams, MS

    • Associate Director, Business Systems
    • IQVIA, United States

    Cham Williams is an Associate Director of Business Systems at IQVIA, responsible for designing products that help shape the next generation of RIM solutions. He has more than 20 years’ experience in the life sciences industry working globally for pharmaceutical, consulting and technology solutions companies. His expertise includes managing regulatory technology, business process optimization and systems planning and implementation.

  • Jenny Shu-Hui Chang, MS

    Jenny Shu-Hui Chang, MS

    • Director, Labeling Digital Enablement & Innovation Management
    • Merck Sharp & Dohme, Taiwan

    Jenny Chang is currently the Labeling Digital Enablement & Innovation Management Director for Global Labeling Group in MSD, Leading the e-Labeling initiative to develop the strategy & governance structure, support country pilot, vision/roadmap development and interact with Authority. Prior to current assignment, Jenny Chang is the Regulatory Affairs Director as the sub-regional Lead for HK & Taiwan.   Prior to joining MSD Taiwan, Jenny worked for Pfizer Taiwan as Clinical Research Associate, 3M Pharmaceuticals as Regulatory Affairs Specialist in China region, Sanofi Taiwan as Director of Regulatory Affairs & Quality Assurance. Jenny holds a Master of Pharmaceutical Science from National Taiwan University and is a Pharmacist in Taiwan

  • Thomas  Denaro

    Thomas Denaro

    • Senior Business Analyst
    • Orion Innovation, United States

    Thomas Denaro has over 30 years of Medical Device and Pharmaceutical industry experience in the areas of compliance, business process, implementation of global systems. Tom’s background includes successful remediation of critical non-conformances that were under FDA consent decree agreements with two drug-makers. His quality experience provided an opportunity to become Management Representative for a Medical Device company located in both Israel and US. Currently, Tom supports the regulatory organization at BMS by providing regulatory business analysis, interaction with multiple functional areas, and developing document support for the implementation for the IDMP initiative. Thomas holds a BS in business management from Nyack College.

  • Frank  Dickert

    Frank Dickert

    • Senior Business Consultant
    • EXTEDO Gmbh, Germany

  • Ron  Fitzmartin, PhD, MBA

    Ron Fitzmartin, PhD, MBA

    • Senior Informatics Advisor, Office of the Director, CBER
    • FDA, United States

    Ron Fitzmartin is Senior Informatics Advisor, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions and standardized data. Some of Ron’s activities include: chair of the PDUFA VI information technology committee, Regulatory Chair of the ICH M11 Expert Working Group on the standardized clinical protocol template, and chair of the IDMP Working Group under the International Pharmaceutical Regulators Programme. Ron received a PhD in statistics from the University of Maryland and MBA from University of New Haven.

  • Tracy  Hernandez

    Tracy Hernandez

    • Global Risk Management Lead, Publishing and Support
    • Bristol-Myers Squibb, United States

    Tracy Hernandez is a Senior Director in Global Risk Management and heads Publishing and Support for RMP submissions and monitors the implementation of additional risk minimization measures for Brystal Meyers Squibb assets. She has been in the pharmaceutical industry for over 20 years with a primary focus in risk management. She has experience with leading US REMS programs such as Thalomid REMS, Revlimid REMS and Pomalyst REMS within BMS for over 10 years and has managed the development of Risk Management Plans for submissions to Health Authorities worldwide. Tracy has her Bachelor of Arts degree in psychology from Rutgers University.

  • Paul Richard Ireland

    Paul Richard Ireland

    • VP Life Sciences
    • DocShifter, Belgium

    Currently the VP of Life Sciences and Product Owner at DocShifter, Paul has over 20 years of experience in helping to provide regulatory software and service solutions to Life Sciences organisations globally. Paul has practical industry and commercial experience in delivering content authoring & rendering, Regulatory Information Management, submission and report-level publishing, and electronic Document Management solutions.

  • Susant  Mallick, MBA

    Susant Mallick, MBA

    • Leader and Evangelist, Healthcare and Life Sciences,
    • Amazon Web Services, Netherlands

    Susant Mallick is leading Amazon AWS HCLS professional services for EMEA region. He comes up with 21+yrs of Pharma and IT background on building disruptive solutions/products in Clinical and Regulatory space. He is technology evangelist on cutting edge technology like (Artificial Intelligence, Machine Learning, IoT, Cloud etc) and an industry leading speakers across geographies. He has been working with various customers & partners in pharma & healthcare to drive digital transformation in Clinical & Regulatory landscape. He was instrumental in implementing/building many Regulatory solutions using advanced technology. Innovation & Digital Transformation in Healthcare & Life Sciences are two key focus areas for him in AWS.

  • Matt  Neal, MA

    Matt Neal, MA

    • Senior Director, Regulatory Affairs Operations
    • Atara Biotherapuetics, United States

    Matt Neal is an author and frequent keynote speaker. He joined Atara Biotherapeutics in 2019 as the Head of Regulatory Operations. Prior to that, Matt was the Head of Product Management for the InSight Suite of Regulatory Information Management Solutions at Parexel, Inc. and partnered with Microsoft. Before joining PAREXEL, Matt was a Director of Regulatory & Safety Operations at Amgen, Inc. (2003-2016) and was one of the pioneering members of the Regulatory Submissions Department for GlaxoSmithKline (1996-2003). Matt has been publishing and submitting electronic dossiers to the FDA since 1996, and submitted the very first fully electronic NDA for GSK in 1999.

  • Mckenzie  Orchowski, MS

    Mckenzie Orchowski, MS

    • Associate Director of Regulatory Operations
    • Biologics Consulting, United States

    Mckenzie Orchowski serves as the Associate Director of Regulatory Operations at Biologics Consulting and has 10 years of regulatory submission experience. She is proficient in managing the assembly of complex clinical trial authorizations and marketing applications for submission to the FDA for drugs, biologics, and medical devices. Mckenzie previously worked for Translational Drug Development (TD2), Arivis (formerly known as Mission3), and as a Senior Publishing Specialist at Medicis Pharmaceuticals. She received her B.S. in Molecular Bioscience and Biotechnology from Arizona State University in 2007 and her M.S. in Biotechnology Management from Southern Illinois University Edwardsville in 2010.

  • Donald  Palmer, MA

    Donald Palmer, MA

    • Senior Regulatory Affairs Director; Business & Technology Transformation
    • IQVIA, Inc., United States

    As the Senior Regulatory Affairs Director for Business & Technology Transformation, Donald works with the Global Regulatory Affairs (GRA) team at IQVIA to add and update technology solutions to the business processes. His experience bridges the business and technology divide that spans Regulatory submissions, document management, and Regulatory Information Management, especially as they integrate with other departments and systems. Having worked in several organizations of different sizes, he provides perspectives from sponsors, vendors and now CROs. He is a strong proponent of standards and data governance. With a BA and MA in Mathematics, Donald has over 20 years experience in the industry.

  • Vada A. Perkins, DrSc, MSc

    Vada A. Perkins, DrSc, MSc

    • Executive Director, Regulatory Policy and Intelligence
    • Bayer Pharmaceuticals, United States

    Vada A. Perkins, Bayer Pharmaceuticals, Executive Director, Regulatory Policy & Intelligence, Head Regulatory Intelligence- Vada A. Perkins, CAPT (ret) is a former FDA Senior Advisor for Regulatory Science and a recognized global regulatory policy & intelligence expert with regulatory thought leadership in the application of data governance, technology, data standards throughout the product lifecycle . He is active in interactions with national and international stakeholders in promoting technology and innovation (e.g., RWD/RWE) to support international regulatory convergence for medicinal product regulation. He received his degrees from The Johns Hopkins University, University of Southern California, and the University of Maryland.

  • Nichelle Ann Sage

    Nichelle Ann Sage

    • Associate Director
    • Bristol-Myers Squibb, United States

    Nichelle Sage is Associate Director of Global Submission Management at Bristol Myers Squibb in Lawrenceville New Jersey. With 12 years of pharmaceutical experience, she has vast knowledge of both planning and electronically publishing high quality and timely global submissions in oncology. She also leads cross functional initiatives on process improvements looking to enhance the speed and efficiency of global submissions. Prior to her current role at BMS, Nichelle also worked in the Clinical space, assisting with the management of global trials. She holds a Bachelor's of Science degree from The College of New Jersey in Biology.

  • Gary  Saner

    Gary Saner

    • Senior Manager, Information Solutions - Life Sciences
    • Reed Technology and Information Services Inc., United States

    Gary Saner, Sr. Manager of Information Solutions in the Reed Tech Life Sciences group, is a subject matter expert on Drug Labeling, Medical Device UDI, and other structured content submissions to health authorities including U.S. FDA, Health Canada, and EMA. He has over 38 years of experience in software development, process management, and data administration with over 18 years focused on the Life Sciences industry. With an understanding of regulations, business requirements, and systems, he has helped shape and implement successful Reed Tech solutions for data management, validation, and processing of Drug Labeling and Medical Device UDI content. He serves as chair of the industry’s Structured Product Labeling (SPL) Technical Team.

  • Seyoum  Senay, MS

    Seyoum Senay, MS

    • Supervisory Operations Research Analyst, CDER/OBI
    • FDA, United States

    Mr. Senay is leading the FDA CDER mission-critical Informatics initiatives in support of human drug regulatory review process with a customer focus through analysis and pragmatic solutions that work to advance CDER’s public health mission. He represents CDER in the FDA cloud strategy working group for decision making, collaboration, coordination, and execution of programs. Mr. Senay earned a reputation among many clients for ensuring customer satisfaction and delivering desired outcomes. Currently, Mr. Senay is leading innovative cloud transformation effort to enable collaboration and improve operational efficiency. This capability continues to reduce regulatory overhead for sponsors, research institute, academia, and small businesses.

  • Samuel  Thompson

    Samuel Thompson

    • Managing Consultant
    • NNIT, United States

  • Jaclyn  Verrow

    Jaclyn Verrow

    • Director, Clinical Quality Management
    • Vertex Pharmaceuticals, United States

    Scope of responsibilities at Vertex for the past 16 years has been focused on Clinical Operations. Leading the Trial Master File group for the past three years. Have been participating in GCP inspections under various roles for the past six years. My current role is within Clinical Quality Management using my experience with process, compliance, and inspection readiness while maintaining oversight of the Trial Master Files.

  • Brian  Williams

    Brian Williams

    • Managing Director, Life Sciences Consulting
    • KPMG, United States

    Brian is a leader in KPMG’s Life Sciences Consulting practice, with a focus on Regulatory Affairs. He has extensive experience helping clients improve efficiency and enable compliance by implementing process and technology changes. His experience includes leading programs related to global RIM deployments, RA operating model and process redesign, IDMP preparation, data cleansing/harmonization and adoption of emerging digital technologies.

  • Donna  Yosua

    Donna Yosua

    • Master Data Management & Data Governance
    • Merck & Co., Inc, United States

    Donna Yosua is a business architect and strategist and an expert in regulatory information management with more than twenty years of experience guiding organizations toward improved business performance by leading the development and deployment of new strategies, processes, and enabling technologies. She has global experience in the pharmaceutical, technology development and consulting industries and leads Regulatory Data Harmonization and Interoperability, Master Data Management and Data Governance within Global Regulatory Affairs and Clinical Safety at Merck.

  • Mitzi  Allred, PhD

    Mitzi Allred, PhD

    • Director, Clinical Operations
    • United States

    Mitzi Allred is a Director at MSD where her focus is on Structured Content Management. She has over 20 years of experience in the biopharmaceutical industry in Regulatory & Clinical Operations. Mitzi uses process improvement through information design and structured content reuse to leverage time. quality and efficiency for content within documents . Over the last fifteen years, she has led improvements in electronic documents, structured content management reuse implementations. Mitzi participates in the TransCelerate Clinical Content & Reuse workstream and ICH M11 Working group. Additionally, Mitzi has PhD in engineering and 15 years of experience in Aerospace.

  • Jennifer  Arters

    Jennifer Arters

    • Associate Director eClinical Operations
    • CSL Behring, United States

    Jennifer Arters is an ambitious educated professional offering technical innovation to marry business processes by developing new strategies and deploying system agnostic technologies. With over twenty years in information management supporting life science and manufacturing industries she is an expert in product life cycle. Jennifer is a strategic leader with patient focus for successful deployments in the pharmaceutical industry, that produce a global knowledge across multiple functional areas. Currently Jennifer is an eClinical Manager with CSL Behring and has been with the organization for 5 years. She is responsible for a portfolio of clinical applications supporting CSL Behring’s global clinical organization.

  • Eric  Cardwell, MBA

    Eric Cardwell, MBA

    • Director, Regulatory Information Management
    • Abbvie, United States

    Eric Cardwell is the Director of Regulatory Information Management at AbbVie. Prior to joining AbbVie in 2014, he was the Director of Quality and Regulatory Affairs for Cardinal Health with oversight of three manufacturing sites. Eric has held several positions at Hospira, including Sr. Manager Commercial Quality and Device On-Market Support. Before Hospira, Eric was the Continuous Improvement Lead for the medical device division of Rexam. Eric earned his MBA from Roosevelt University and graduated University of Illinois at Chicago with bachelor’s in Biology. Eric holds professional certifications including two Six Sigma certifications (ASQ & TQM), his Six Sigma Master Black Belt (Stat-A-Matrix) and his Certified Quality Engineer (ASQ).

  • Daniel  Chen, PhD

    Daniel Chen, PhD

    • Senior Consultant
    • Veeva Systems, Canada

    Daniel Chen is a Senior Consultant with Veeva's RIM Process Development Group. He was previously a Principal Product Manager at OpenText Life Sciences managing the company's EDMS and RIM products. Prior to becoming a technologist, he spent close to a decade in immune-oncology product development, using machine learning and robotics to automate and scale personalized biologics manufacturing. Daniel is RAC-certified and holds a Ph.D. in computational biology.

  • Isabel  Esteve Garcia, MSc

    Isabel Esteve Garcia, MSc

    • Associate Director, Global Regulatory Business Capabilities Strategist
    • Bristol-Myers Squibb, United States

    After graduating from Universidad de Valencia School of Pharmacy with a Masters in Pharmacy in 2007, I then attended Centro Superior de Estudios de la Industria Farmacéutica de Barcelona and obtained a Master’s degree in Pharmaceutical Industry in 2008. I started my professional career working at EMA as a Scientific administrator in H-Quality of Medicines for two years. After my experience at the EMA, I joined BMS in 2012 as part of the European Regulatory Procedure Management (ERPM) team, working on Virology, Immunology and Oncology portfolio and early development projects; In June 2019, I relocated to the United States and joined the Global Regulatory Business Capabilities group (my current role).

  • Daniil  Graborov, MS, PMP

    Daniil Graborov, MS, PMP

    • Computer Scientist, CDER/OBI
    • FDA, United States

    Daniil Graborov has been working in FDA CDER Office of Business Informatics since 2014. Prior to joining FDA, he had extensive project management and system implementation experience supporting a wide range of federal agencies and commercial customers.

  • Karen  Jones

    Karen Jones

    • Head of Regulatory Innovation
    • Accumulus Synergy , United States

    Karen Jones is the Head of Regulatory Innovation at the non-profit, Health-tech company, Accumulus Synergy. Her tenure started in June 2021, providing strategic vision, leadership, and regulatory expertise to the organization as they developed their future roadmap. She has over 27 years of global regulatory therapeutic experience and has led future-forward global transformational and digital modernization initiatives. She has worked for both large pharma and small biotech and held positions in both N. America and Europe. Karen actively seeks to leverage her business acumen, regulatory expertise and her passion for innovation and corporate sustainability to deliver improved social outcomes through the life science sector.

  • Qian  Liu, MSc

    Qian Liu, MSc

    • Regulatory Submission Manager
    • Bayer Healthcare Company Ltd., China

    Qian had been working in Bayer from 2019 as Regulatory Submission Manager, mainly supporting the submission projects in APAC region. Qian has various knowledge on eCTD guidelines, publishing operational process, and submission project management experiences worldwide. Before joining Bayer, Qian had worked in different GRA operational functions of multinational companies. During 2018, Qian had joined the eCTD System Construction Project in China CDE. Qian holds a Master degree in Analytical and Pharmaceutical Science from Loughborough University, UK and a Bachelor degree in Pharmacy from School of Pharmaceutical Science, Peking University.

  • Sri  Mantha, MBA, MS

    Sri Mantha, MBA, MS

    • Director, Office of Business Informatics, CDER
    • FDA, United States

  • Raghu  Nandan

    Raghu Nandan

    • Director, Global Delivery, R&D and Quality Domain Architect
    • Bristol-Myers Squibb, United States

    Senior Technology and Management professional and Thought Leader with varied experience and expertise spanning 24+ years in Information Technology. Currently specializing in Pharma and Health sciences domain with additional experience across Financial Services, Banking, Insurance, Securities and Capital markets domains. Accountable for Technology, Strategy, Architecture and Delivery of ~$100 million portfolio. Extensive experience conceptualizing, developing and implementing enterprise solutions across multiple geographies (US, Europe & APAC). Specialties: Management Consulting, Business and IT Transformation, IT strategy & business solutions development leveraging Enterprise architecture frameworks (Zachmann, TOGAF), SOA,

  • James  Nichols

    James Nichols

    • Chief Product Officer
    • Phlexglobal, United States

    Jim has nearly 30 years of experience with compliant software solutions for regulated processes in both the insurance and life sciences industries. He has held senior management positions at Intracorp (a CIGNA company), Liquent, Thomson Reuters, ePharmaSolutions, DitaExchange and Cunesoft. Following the merger of Cunesoft into Phlexglobal, Jim is now the Chief Product Officer at Phlexglobal. Jim holds a Bachelor of Science in Mathematics from The Pennsylvania State University.

  • Katherine  Novak, MS

    Katherine Novak, MS

    • Senior Advisory Consultant, Regulatory Affairs
    • NNIT, United States

    Katherine Novak provides experience as a Business Analyst across the full drug product lifecycle, including Clinical Research, Regulatory Operations, Regulatory Information Management, Pharmacovigilance, and large-scale Manufacturing. She obtained her MS degree from Georgetown University in Clinical and Translational Research, where she focused on large-scale meta-analyses as a basis for clinical trials. With over four years of experience in the life science industry, Katherine supports clients in system implementation, process development, and data quality. Her passion is in data standard harmonization, specifically Regulatory data and optimization for Regulatory decision-making.

  • Nirjhar  Sarkar, MS

    Nirjhar Sarkar, MS

    • Associate Director, Technology Transformation
    • Novartis, India

    Nirjhar is part of the Technology Transformation group at Novartis and is passionate about developing solutions that will reduce drug development time so that medicines can reach patients faster. He brings in extensive operational acumen, process improvement experience and effective leadership skills. He did his MS in Regulatory Affairs and Health Policy at Massachusetts College of Pharmacy and Health Sciences. Analytical by nature, he maintains strong interpersonal skills, an adaptive work method, a robust understanding of the industry and a commitment to organizational integrity.

  • Karin  Schneider, MLIS, MS

    Karin Schneider, MLIS, MS

    • Document Management Enablement Head
    • Janssen Pharmaceuticals, Inc., United States

    German citizen, who worked in Switzerland and now lives in the US. I have been in the Pharmaceutical Industry for my entire career. I looked at Content Management from many different angles: Information broker, information architect, solution engineer and end user in various business domains and regions. The time is now to prepare for fundamental change in RIM. We have done Document and Data Management in silos for decades. The past couple of years AI dominated the solution space with various success. It is time to fundamentally rethink how we work with content and design business centric solutions that actually deliver desired results. I love conversations with disruptive thinkers, walking my dog and training in the local circus schoo

  • Daniel  Smith

    Daniel Smith

    • Regulatory Information Management Consultant
    • Calyx, United Kingdom

    Extensive industry experience in Regulatory Operations and Regulatory Information Management with proven success in the implementation of Regulatory processes, with emphasis on the creation and embedding of bespoke reporting solutions. In Daniel's current role as Regulatory Information Management Consultant at Calyx he has supported a variety of clients to effectively manage complex end-to-end regulatory processes, using the power of reporting to drive better business decision-making.

  • Gabriela  Stanescu, RN

    Gabriela Stanescu, RN

    • Lead Clinical Project Manager
    • Chiesi Canada Corporation, Canada

    Gabriela is currently a Lead Clinical Project Manager in Global Rare Diseases Unit of Chiesi. She also manages the CTA team, putting her in the position to oversee TMF and inspection readiness activities. With over 20 years of experience in the pharmaceutical industry, mostly in clinical operations, Gabriela also has previous experience in QA and IRB services. A highly motivated professional, she is always looking for ways to improve processes by challenging the status quo. A nurse by training, Gabriela is very passionate about bringing new treatment options to people living with rare diseases.

  • David  Wilson

    David Wilson

    • Pharma Team Lead
    • Reed Tech, United States

    David Wilson is a subject-matter expert in the pharmaceutical industry, Global Health Authorities and structured product labeling. For the past decade, He has been assisting pharmaceutical and medical device companies to achieve compliance through innovative technologies. David is an expert on upcoming deadlines and expanded regulations. Reed Tech serves customers with the expertise required in the Life Sciences industry and has assisted over 1,000 pharma companies in complying with complex FDA Electronic Drug Listing/Labeling and Registration requirements.

  • Christopher  Joneckis, PhD

    Christopher Joneckis, PhD

    • Associate Director for Review Management, CBER
    • FDA, United States

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  • Mary Lynn  Mercado, PhD

    Mary Lynn Mercado, PhD

    • Senior Group Head Regulatory Writing
    • Novartis Pharmaceuticals Corporation, United States

    Mary Lynn Mercado is a US Group Head of Regulatory Medical Writing, Pharma at Novartis Pharmaceuticals Corporation. She has over 10 years of experience in the biopharmaceutical industry in Medical Writing, during which she has supported submissions across multiple therapeutic areas. On the Clinical electronic Structured Harmonised Protocol (CeSHarP) M11 EWG, Mary Lynn is the Deputy Topic Lead for PhRMA. She participates in the TransCelerate Clinical Content & Reuse (CC&R) workstream, where she is the lead for Strategic Engagement. Additionally, Mary Lynn has a PhD in Pharmacology and over 10 years of experience in Neuroscience research and drug discovery.

  • Jean M. Mulinde, MD

    Jean M. Mulinde, MD

    • Medical Officer, Policy Advisor, Division of Clinical Compliance Evaluation, OSI
    • FDA, United States

    Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products in OND. She received her M.D. and completed a residency in Internal Medicine at the University Of South Alabama School Of Medicine, and then completed a fellowship in Infectious Diseases at the University Of Maryland School Of Medicine.

  • Sarah  Pope Miksinski, PhD

    Sarah Pope Miksinski, PhD

    • Senior Director, Global Regulatory Affairs
    • AstraZeneca, United States

    Sarah Pope Miksinski has been with AstraZeneca since February 2018 and is currently a Senior Director in Regulatory CMC, AstraZeneca. Her duties include leadership of a global team covering CMC regulatory strategy for development and pre-approval health authority submissions, as well as serving as a key contributor to several ongoing initiatives including continuous manufacturing and Q12 implementation. She represents AstraZeneca in various external capacities – including serving on PhRMA’s Global Quality and Manufacturing Committee, serving as chair of ISPE’s Regulatory Steering Council, and supporting multiple other advocacy efforts (review/inspection standards, nitrosamines, and KASA/M4Q).

  • Keith  Schlaudecker

    Keith Schlaudecker

    • Associate Director, Information Integration and Label Management
    • Merck & Co., Inc., United States

    Keith Schlaudecker is an Associate Director in Global Regulatory Affairs and Clinical Safety group at Merck & Co. He has over 18 years of experience in the pharmaceutical industry focusing on the Labeling Management process, systems integration and operational excellence. He has served in various leadership roles overseeing business process development and improvements, project management, and systems development to deployment supporting change management initiatives in the Labeling Management and Artwork Development areas. In his current role at Merck & Co., he is a Lead for Label Management Systems Capability Team.

  • Norman Robert Schmuff, PhD

    Norman Robert Schmuff, PhD

    • Associate Director for Science, OPMA, OPQ
    • FDA, United States

    Norman R. Schmuff joined the FDA in 1990. For more than 20 years, he has participated in ICH as a member of several Expert Working Groups. He was the Rapporteur for the M4 CTD (eCTD) – Quality Implementation Working Group. He is involved in many FDA electronic submission initiatives, including the Pharmaceutical Quality/Chemistry, Manufacturing, and Controls structured data project. He is also serves as a delegate to the International Organization for Standardization's (ISO) Technical Committee (TC 215) on health informatics which deals with the IDMP standards. Currently he is Associate Director in FDA’s Office of Process and Facilities in CDER. He has never served time in prison.

  • Jamie  Toth, MS

    Jamie Toth, MS

    • Global Head, TMF Management & Records
    • Beigene, United States

    Jamie has over 18 years of IT experience in the pharmaceutical industry. She has been with BeiGene since January 2022 as the Global Head of Trial Master Management & Records. Prior to that she was with Daiichi Sankyo, Inc., for over 5 1/2 years. She is a Steering Committee member of the DIA TMF Reference Model Working Group and on the Operations Committee and a Director for the Health Sciences Records and Archives Association (HSRAA). She also serves on the AVOCA Safety Leadership Advisory Board. Jamie is a Certified Project Manager (CPM), a trained Six Sigma Green Belt, and is PROSCI certified.

  • Vaishali  Popat, MD, MPH

    Vaishali Popat, MD, MPH

    • Associate Director, Biomedical Informatics and Reg Review Science, OND, CDER
    • FDA, United States

    Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as safety analytics, staff training on the use of new review tools to make the evaluation of pre-marketing data more efficient and consistent, data standards, as well as leveraging data from internal and external sources to make regulatory decisions.

  • Patterson  Shafer

    Patterson Shafer

    • Managing Director
    • FTI Consulting, Inc., United States

    Pat Shafer is a Managing Director at FTI Consulting. He is responsible for delivering services, solutions and thought leadership for pharmaceutical, biotech and medical device clients. He has over 30 years of experience solving complex global challenges and helping clients achieve their strategic and operational objectives in the areas of regulatory affairs and operations, quality, compliance, clinical operations, safety and surveillance, manufacturing, supply chain, medical affairs and commercial compliance.

  • Jennifer  Wemstrom

    Jennifer Wemstrom

    • Life Sciences Cloud Strategist
    • Google, United States

    As a Life Sciences solution strategist within Google, Jennifer Wemstrom brings a customer centric and business driver focus to solution development. Ms. Wemstrom has over 25 years of content management experience, with specific areas of expertise in Life Sciences Regulatory, Clinical, and Quality and Manufacturing processes. During her tenure at Google, Ms. Wemstrom spearheaded the strategic visions for digital transformation for key consortiums and customers within the Pharmaceutical space. Prior to joining Google. Ms. Wemstrom was head of Life Sciences Product Management and Engineering at OpenText, where she oversaw the strategy and development of a product portfolio across content management and business process engineering.

  • Panagiotis  Telonis

    Panagiotis Telonis

    • Scientific Administrator, Data Standardisation and Analytics Department
    • European Medicines Agency, Netherlands