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Bethesda North Marriott Hotel and Conference Center

Feb 14, 2022 8:30 AM - Feb 16, 2022 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum


Venkatraman  Balasubramanian, PhD, MBA

Venkatraman Balasubramanian, PhD, MBA

SVP and Global Head, Industry Solutions - Healthcare and Life Sciences , Orion Innovation, United States

V. “Bala” Balasubramanian is Senior Vice President and Global Head, Industry Solutions Group for Healthcare and Life Sciences at Orion, a global digital transformation products, solutions and services firm. Bala has over three decades of IT and digital transformation experience. Prior to Orion, Bala was the President and CEO of Cabeus, a niche Life Sciences services firm where he was also responsible for vision and strategy 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, Risk-based Study Management, Vertex Pharmaceuticals, United States

Clinical Research/Clinical Management Professional with 24 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, 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 Digital, Lykos Therapeutics, United States

Jake Doran is currently the Head of Digital @ MAPS Public Benefit Corporation. In this role, Jake is responsible for overseeing the development and implementation of the digital and IT strategy as the MPBC organization transitions from a clinical research startup to a commercial entity and industry pioneer. Prior to joining MPBC, Jake was the Head of Global R&D IT at Bausch Health. 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 Genpact, Janssen Pharmaceuticals and Schering Plough.

Jo  English

Jo English

Chief Strategy Officer, Ennov, United Kingdom

An established Regulatory Information Management expert with extensive skills and experience in life sciences. As the VP and GM of Enterprise Technology at Calyx Jo is responsible for the Commercial and SME functions. Our expert team are responsible for strategic consultancy and delivery of services and solutions to facilitate our clients’ business using the Calyx RIM, Calyx CTMS and Calyx EDC technologies. With a remit to ensure that the our suite of technologies aligns with the changing regulatory landscape and client needs and to provide strategic regulatory input into the software development lifecycle, Jo is responsible for the overall budget to align with Calyx fiscal requirements.

Michiel  Stam

Michiel Stam

Management Consultant, MAIN5 Gmbh & Co. Kgaa, Germany

Michiel has 15 years of experience in Regulatory Affairs and Information Management. He provides strategic direction and subject matter expertise for implementation of Regulatory Information Management (RIM) solutions. His focus goes beyond compliance, Michiel specializes in unlocking the true value of an organization’s data – whilst taking advantage of initiatives such as XEVMPD, IDMP and SPOR. Through the alignment of people, cross-functional processes, and tools, he has enabled efficient and sustainable data quality for a wide range of customers.

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

Senior Director, Head, Global RIM, Analytics & Digital Innovation, 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 over 20 years of global regulatory operations, project management and regulatory technology experience, with special focus on regulatory information management, data governance, business process optimization, regulatory intelligence, medical imaging, publishing and global submissions strategy. Vahé has had various leading 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 an active 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, Development Records Management, Regeneron Pharmaceuticals, United States

Joanne Malia is Director, Development Records 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 on the CDISC TMF Reference Model Steering Committee, on the organizing committee for DIA’s Regulatory Information Document Submission Meeting and presents frequently at industry conferences.

Jamie  O'Keefe

Jamie O'Keefe

Head, Clinical & Regulatory Consulting, Astrix, United States

Mr. O’Keefe has over 18 years of R&D management and IT consulting expertise, working with both top tier pharmaceutical firms, and early stage biotechs. Prior to joining Astrix, he led Business & Technology Consulting at Just in Time GCP; 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

Program Director, 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

Exec. Director, Regulatory Operations, Garuda Therapeutics, United States

Rob is a seasoned Regulatory Affairs Operations professional with over 30 years of experience. He was an early planner and adopter for the electronic Common Technical Document (eCTD), previously serving on Bio and PhRMA working groups for eCTD and electronic submissions. Rob has served as a leader of dynamic Regulatory Operations teams of all sizes, including past roles at Janssen, Millennium, Sunovion, and Alexion. His submission expertise includes global investigational and marketing applications. Rob has a demonstrated ability to drive and deliver operational strategies and an in-depth understanding of all facets of Regulatory Operations, including publishing, submission management, document management, and regulatory systems and tools.

Sandra  Krogulski, MA

Sandra Krogulski, MA

Director, GRSO Innovation and Business Operations Lead, Bristol-Myers Squibb Company, United States

Sandy Krogulski is an experienced and solution oriented individual with over 10 years of submission experience. Sandy joined BMS in 2018, working on global submissions and process evolution. In her current role, Sandy is focusing on digitalization and automation of processes to improve submission strategy and business operations.

Demetra  Macheras, MBA

Demetra Macheras, MBA

Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie, 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., Canada, ICH, and WHO 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 27 years of industry experience and has held positions in Regulatory Affairs, QA, Compliance, and Operations. Demetra is also active in a number of external industry associations.

Ethan  Chen, MBA, MS, PMP

Ethan Chen, MBA, MS, PMP

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, Analytics and Business Intelligence, Electronic Submission and Portal Collaboration programs. 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 13 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, DSB, 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; Director, Division of Data Management Services & Solutions managing CDER’s electronic submission program, and ICH M8 (eCTD) Rapporteur. Mark has been with CBER's data standards group since 2014, and his current responsibilities include representing CBER in the development and implementation of international electronic submission standards.

Hans  van Bruggen, MSc

Hans van Bruggen, MSc

CSO, Qdossier, a Celegence Company, 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

Managing Director, Fonto, RWS, Netherlands

Jan Benedictus is founder and managing director 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 increasingly in Pharma and Life Sciences. 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

Business Informatics Specialist, 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

Senior Manager Regulatory Initiatives, Viatris, 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

Director 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

Manager, Global Regulatory Affairs , Gan & Lee Pharmaceuticals Corp. US, United States

For over 15 years’ I have been in Regulatory Affairs for large and small Pharmaceutical and Medical Device companies. I am currently Senior Regulatory Affairs Manager of Global Regulatory Affairs for Gan & Lee Pharmaceutical US Corporation. During my years in the industry, I have contributed to the production, manufacturing, registration, and marketing of medicinal products, that include biopharmaceuticals, Oligonucleotides, and orphan-drugs designated for specified rare diseases or conditions.

Jillian E. Carinci, MS

Jillian E. Carinci, MS

Senior Director, Head of Submission Sciences, Biogen, United States

Jillian Carinci is Sr. Director, Head of 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 Information and Compliance, Daiichi Sankyo, 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

Industry Expert, Retired, 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  Fredericks, MBA

Richard Fredericks, MBA

Senior Director, Regulatory Operations and Technology, Mersana Therapeutics, United States

I have been in the life sciences industry for over fifteen years functioning entirely in the Regulatory Operations space. My career began in regulatory publishing and over the past decade has gravitated towards the technology and process side of the business. I currently lead the RIM group at Mersana Therapeutics where I am responsible for the creation and evolution of the Regulatory Information Management business unit; RIM ecosystem, publishing and associated operating procedures. Prior to Mersana I have worked at several other pharmaceutical/biotech companies including Black Diamond Therapeutics, 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, benchmarking 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

Management Consultant, Main5 GmbH & Co. KGaA, Germany

Dominik Gigli is a senior expert in Regulatory Information Management and IDMP with 10+ years in the pharmaceutical industry driving the digital transformation in Regulatory Affairs. With his strengths drawing the big picture and vision towards data driven regulatory submissions and particular understanding of the steps and obstacles how to get there, Dominik is helping Life Science transform their organization to a digital future. Before joining MAIN5 in 2022, Dominik was working in several leading positions in Regulatory Operations focusing on RIM, IDMP, Data Management, Data Governance Data Quality, Reporting and Analytics in Merck Healthcare and Fresenius Kabi.

Ginny  Hussong

Ginny Hussong

Branch Chief, Data Standards, CBER, FDA, United States

Ginny serves as Chief of CBER's Data Standards Branch, where she leads a multidisciplinary team that advances standards such as eCTD, CDISC, IDMP, ICSR, SPL and related terminologies. In addition, conducts technical validation of clinical study data, leads related reviewer training, and industry outreach. She is co-Chair of the FDA Data Standards Advisory Board and 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

Senior Vice President 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 and Dendreon. Dominique joined Accumulus as SVP of Regulatory Innovation in early 2022 coming from Amgen where he was heading Global Regulatory Operations. As part of his role at Accumulus, Dominique is supporting global Accumulus platform adoption from Health Authorities and Biopharmaceutical organizations. 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 Regulatory Technology expert groups. 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, Samarind, 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

Vice President, 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

Managing Partner, Leapahead Solutions, Inc., United States

Cary Smithson is the Senior Director, Business Transformation and Systems Management at PharmaLex and has over 30 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 co-leads the DIA RIM Working Group, 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, Safety, Regulatory and Quality Customer Engagement, IQVIA Technologies, 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

Frank Dickert started with an apprenticeship in the pharmaceutical industry and afterwards studied biochemistry with a focus on bioinformatics and structural biochemistry. In 2011 he took an opportunity as a Regulatory Affairs Specialist at a pharmaceutical company and was responsible for centralized, DCP/MRP and national procedures. In 2017 Frank joined EXTEDO’s Regulatory Competence Center and since then, he is consulting pharmaceutical companies in regulatory business and eCTD submissions and IDMP worldwide. Furthermore, he is analyzing and optimizing regulatory business processes and document lifecycles with or without software, resolving customer support issues with different eSubmission tools, and offers regulatory consulting with

Ron  Fitzmartin, PhD, MBA

Ron Fitzmartin, PhD, MBA

Senior Advisor, Office of Regulatory Operations, CBER, FDA, United States

Ron Fitzmartin is Senior Informatics Advisor, Office of Regulatory Operations, 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

Founder and CEO, Life Sciences Practice Leader, Cloudhub BV, Netherlands

Susant Mallick comes up with 23+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 and partners in pharma and healthcare to drive digital transformation in clinical and regulatory landscape. He was instrumental in implementing/building many Regulatory solutions using advanced technology. Innovation and Digital Transformation in Healthcare and Life Sciences are two key focus areas.

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

Consultant, United States

As the Senior Regulatory Affairs Director for Business & Technology Transformation, Donald works with the Regulatory Affairs and Drug Development Solutions (RADDS) team at IQVIA to add and update technology solutions to RADDS's 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.

Vada A. Perkins, DrSc, MSc

Vada A. Perkins, DrSc, MSc

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States

Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal products worldwide. He received his degrees from Johns Hopkins University, University of Southern California, and the University of Maryland.

Nichelle Ann Sage

Nichelle Ann Sage

Associate Director, Regulatory Information and Submission Management, 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 Tech, 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 a visionary leader with a focus on innovation and positive change. At the heart of his mission is the widespread adoption of cutting-edge Informatics solutions, aimed at ensuring the availability of safe, effective, and new medicines for patients. As a U.S Excellence in Government Leadership Fellow, Mr. Senay is recognized for his excellence in delivering impactful results. Holding a master's degree from The Johns Hopkins University and being a Certified Program Manager, he brings extensive knowledge and expertise to advance the FDA CDER mission.

Samuel  Thompson

Samuel Thompson

Managing Consultant, NNIT, United States

Sam has 20 years of cross functional, multi-disciplinary experience across Life Science, Healthcare, and Information Technology, focused on the applied use of data technology for clinical, regulatory and safety applications. His specific experience includes the design and implementation of lakes/warehouses, ETL scripting, and implementing regulatory compliant data management solutions. Special experiences/knowledge within: • Identification of Medicinal Products (IDMP) Readiness Assessment and Implementation • Clinical, Safety and RIM Vault implementations • Data Architecture with specific focus on Master data Management, Data Stewardship and Data Governance • SDTM, ADaM, PQ/CMC FHIR, IDMP (ISO) standards.

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

Advisory Managing Director, Life Sciences, 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, data cleansing/harmonization and adoption of emerging digital technologies.

Donna  Yosua

Donna Yosua

Director, InforMaster Data Management & Data Governance, Merck & Co., Inc, United States

Donna Yosua leads the Merck Data Harmonization & Interoperability project which includes the implementation of a regulatory data hub and canonical data model with reusable data publications, and the corresponding regulatory data governance framework. Donna is a seasoned Life Sciences Strategist/Business Architect and an expert in Regulatory Information Management with 25 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.

Mitzi  Allred, PhD

Mitzi Allred, PhD

Director, Clinical Operations, Merck & Co., Inc, 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 Strategic Programs, CDER, FDA, United States

Sridhar (Sri) Mantha is currently Director of the Office of Strategic Programs (OSP) at the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. As the Director of OSP, Sri leads center-wide strategic and operational planning, performance analysis, and implementation and business informatics. Prior to joining CDER in Dec 2020, Sri spent 25 years in the Lifesciences industry spanning Drugs, Biologics and Medical Device products. Sri held operational and leadership roles across Clinical Regulatory Informatics, Drug Safety, Quality and Information technology functions. Sri has master's degrees in engineering, Business Administration and Data Science.

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

Director of Sales & Account Management, Lorenz Life Sciences Group, 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. Phlexglobal is now part of Cencora PharmaLex. Jim holds a Bachelor of Science in Mathematics from The Pennsylvania State University.

Katherine  Novak, MS

Katherine Novak, MS

Principal Product Manager, Accumulus Synergy, 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

Associate Director, Johnson & Johnson Innovative Medicines, 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

Senior 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

Associate Director, Regulatory Technology Sales, IQVIA Technologies , United States

Christopher  Joneckis, PhD

Christopher Joneckis, PhD

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

*Chris Joneckis currently serves as the and the Office Director For the Office of Regulatory Operations and Associate Director for Review Management in the Center For Biologics Evaluation and Research (CBER) at FDA. In this capacity, he Is the Center’s authoritative expert on review management, directing the review management staff and providing leadership for review program activities for biologics, devices and combination products executed throughout the offices of CBER. He is responsible for the development, implementation and oversight of several CBER programs including policies, procedures and standards for review, data standards, information technology, regulatory affairs, document control, regulatory database and regulatory business

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

Associate Director, 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

Executive Director, CMC Regulatory Affairs, Gilead Sciences, United States

Sarah Pope Miksinski has been with Gilead since July 2023 and is currently an Executive Director in CMC Regulatory Affairs. She represents Gilead in various external capacities In 2021, she was appointed as the PhRMA Topic Lead for ICH M4Q(R2) and was appointed to the ISPE Board of Directors in 2022. She concurrently serves as the Rapporteur of the ICH Quality Discussion Group (QDG). Previously, Sarah served at AstraZeneca for over 5 years, holding roles in the CMC Regulatory Affairs space. Prior to that, she held a lengthy tenure at FDA, lasting from 2002-2018.

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  Schmuff, PhD

Norman 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

Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER, 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. He currently leads the development of the RIM Whitepaper 3.0 as part of the RIM Working Group, and leads the Culture of Quality initiative as part of the FDA/MDIC Case for Quality.

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

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