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Regulatory Submissions, Information, and Document Management Forum


  • Venkatraman  Balasubramanian, PhD, MBA

    Venkatraman Balasubramanian, PhD, MBA

    • President and CEO
    • Cabeus, Inc., United States

    V. “Bala” Balasubramanian is the President & CEO of Cabeus, a niche firm providing information management products, solutions & services for Life Sciences. With over three decades of IT experience, Bala is a thought leader & presenter on RIM, IDMP, regulatory analytics, enterprise architecture & process design. He provides the vision for a cloud platform called ReALM™ to transform the regulatory value chain for Life Sciences. Prior to Cabeus, Bala developed IT strategies & capabilities for companies such as Bristol-Myers Squibb, Roche, Aventis, Merrill Lynch, AT&T, Bell Atlantic & IBM. Bala has his Ph.D. & MBA from Rutgers University, M.S. in Computer Science from NJIT and B.S. in Electronics Engineering from India.

  • Christian A. Buckley, MBA, RAC

    Christian A. Buckley, MBA, RAC

    • Associate Director, Regulatory Affairs
    • Astellas, United States

    Chris has worked in the regulatory setting for over 19 years. By starting out building CANDAs for large Pharma, he has acquired extensive electronic submissions experience on cutting edge technology. With scores of global filings, his experience includes several NDA submissions across four organizations. Chris specializes in leading implementation projects related to submissions and RIM process improvements focused on global harmonization. With his MBA degree, RAC certification, change agent specialization and biotech management experience, he enjoys developing teams to improve electronic submission processes. Chris has a passion for travel focused on mountain adventures with his family and friends.

  • Brooke  Casselberry, MS, RAC

    Brooke Casselberry, MS, RAC

    • Owner
    • Cyan Life Sciences, United States

    Brooke is a partner at IDENTIFICA focusing on Client Engagement and Regulatory Strategy. She has more than 15 years of experience in Life Sciences supporting industry clients in standards and process implementation, strategy, and business development. Brooke volunteers her time supporting networking communities like DIA and mentoring others in Regulatory for Life Sciences.

  • Michelle L. Charles, MPH

    Michelle L. Charles, MPH

    • Director, Regulatory Affairs, Gene Therapy Program & Orphan Disease Center
    • University of Pennsylvania, Perelman School of Medicine, United States

    Michelle began her career at Merck in 2001 and has moved into various roles within regulatory. Most recently Michelle has moved into the RIM group as Business Lead for Merck’s RIM system. In this role she is responsible for the development of process and the regional support of the system. Michelle has also participated in multiple forums including PhRMA and eRI DIA. Michelle received her BS in Biology from Millersville and a Masters of Public Health from Johns Hopkins.

  • Cindy  Chiu

    Cindy Chiu

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

  • Steven  Clark, MSc

    Steven Clark, MSc

    • Director
    • Amgen, United Kingdom

  • Jake  Doran

    Jake Doran

    • Founder, Managing Director
    • List Innovations, LLC, United States

    Jake has 20+ years of life sciences leadership experience across various roles. Jake has recently left corporate executive role to form LiST Innovations, an organization dedicated to assisting life sciences companies in their quest to implement innovative technology solutions. Prior to this venture, Jake held key leadership positions with Johnson & Johnson, supporting Global Regulatory Affairs and the Clinical Development organizations. In addition, Jake has also worked closely with various industry trade groups, where he is a key partner with the FDA and an industry advocate for the PDUFA V and upcoming PDUFA VI technology implementation strategies.

  • Sholeh  Ehdaivand

    Sholeh Ehdaivand

    • President and CEO
    • LMK Clinical Research Consulting, United States

    Sholeh, a recognized innovative professional with over 15 years of experience in the Clinical Research Industry, has expertise & knowledge in all areas of the clinical trial & document management processes. Her experience includes TMF Reference Model subject matter expert, eTMF management, clinical trial management, site selection, vendor relations, EDM, regulatory submissions, QC processes & implementation, IRB communications & regulatory inspection participation and preparation. The Principal Consultant & President & CEO of LMK Clinical Research Consulting & the Facilitator for the Metrics Champion Consortium's (MCC) newly formed TMF initiative, she leads cross-functional experts to develop & implement TMF metrics and processes.

  • Betsy  Fallen, RN

    Betsy Fallen, RN

    • Consultant
    • BAFallen Consulting LLC, United States

    Following a career in Pharma, Betsy is an independent consultant in the clinical and regulatory process and regulated content management space. Betsy is a passionate advocate for moving life sciences business on-line to increase efficiency and compliance. Driven by her background in Nursing, one of her interests is the impact and benefit of technology to clinical sites, including improving the patient experience.

  • Ron D. Fitzmartin, PhD, MBA

    Ron D. Fitzmartin, PhD, MBA

    • Senior Advisor, Office of Strategic Programs, CDER
    • FDA, United States

    Ron Fitzmartin is Sr. Advisor in the Office of Strategic Programs, CDER, FDA where he is focused on electronic submissions and standardized study data to support regulatory review. Prior to FDA, Ron was VP, Informatics at Daiichi Sankyo, VP, Biostatistics and Data Management at Daiichi Medical Research, and Exec Dir, Biostatistics and Data Management at Purdue Pharma L.P. Ron was elected President of the DIA 07-09. Ron received a PhD in statistics from the University of Maryland.

  • Mark A. Gray

    Mark A. Gray

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

    Mark has over 30 years experience in Information Management including; software developer/project manager in CBER; Director of Applications Development & Services in CDER; and PDUFA IT Program Director. Mark currently work’s for CBER’s Bioinformatics Support Staff. His responsibilities include representing CBER in the development of international electronic submission standards, with a focus on the ICH electronic Common Technical Document (eCTD).

  • Virginia  Hussong

    Virginia Hussong

    • Data Standards Program Manager, OD, BSS, CBER
    • FDA, United States

    Virginia Hussong is Program Manager for Data Standards in the Center for Biologics Evaluation and Research, U.S. FDA, and has been with FDA for 13 years, overseeing implementation of data standards and electronic submissions. Her current focus is data standards strategy, development and related policy within CBER, including collaboration with other FDA Centers, government agencies and SDOs to achieve a better quality review process.

  • Ty  Molchany

    Ty Molchany

    • Principal Consultant
    • Paragon Solutions, United States

    Ty Molchany has been working on content management systems in the regulated pharmaceutical and healthcare industries for the past 11 years. He is a principal in the Information Management group at Paragon Solutions and has worked to advise clients on industry best practices and address client specific business needs to develop and implement industry leading solutions. As a volunteer, Ty is a member of the DIA EDM Reference Team SIAC and leads the contributions and updates to the labeling portion of the DIA EDM Reference model. He also participates in the EMA SPOR Task Force.

  • Theresa M. Mullin, PhD

    Theresa M. Mullin, PhD

    • Director, Office of Strategic Programs, CDER
    • FDA, United States

    Dr. Theresa Mullin plays a lead role in a number of CDER’s strategic initiatives including the human drugs international program, drug user fee negotiation and implementation, regulatory informatics, and major program evaluations and other initiatives. She is currently serving as FDA’s lead negotiator for the 2017 reauthorizations of the Prescription Drug User Fee Act and the Biosimilar User Fee Act. She leads the FDA Patient Focused Drug Development Initiative and heads the FDA delegation to the International Council on Harmonization, the primary venue for international harmonization of drug regulatory standards.

  • Thomas J. Noto

    Thomas J. Noto

    • Sr. Director, Regulatory Operations
    • United States

  • Daniel F. Orfe, MS

    Daniel F. Orfe, MS

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

    Dan has 25 years of experience in Regulatory Operations and Submission publishing. He’s a subject matter expert in "cloud-based" eCTD and EDMS solutions and consults via Regulatory eSubmissions. At Radius Pharmaceuticals he had responsibility for activities associated with production/delivery of regulatory filings and EDMS processes/tools. At Teva Dan oversaw an initiative to harmonize submission publishing and document management. At Datafarm he had responsibility for global Submission and Publishing Services. At Merck, Dan established and managed electronic submission production group. Speaker/session chair at 11 DIA Annual meetings, DIA EDM Conference Co-chair from 2009 through 2011 and DIA RSIDM Conference program committee member.

  • Sudip  Parikh, PhD

    Sudip Parikh, PhD

    • Senior Vice President and Managing Director, DIA Americas
    • DIA, United States

  • Vada A. Perkins, BSN, MS, MSc, RN

    Vada A. Perkins, BSN, MS, MSc, RN

    • Founder and Managing Principal
    • Identifica, United States

    Vada A. Perkins is the Founder and Managing Principal of IDENTIFICA LLC, an independent global regulatory consulting practice offering Global Product Lifecycle (GPLC) data governance solutions in conformance with regional regulatory requirements and international data standards to optimize business for clients from concept to execution.

  • Sarah  Powell, RAC

    Sarah Powell, RAC

    • President
    • Powell Regulatory Services, United States

    Sarah has over 29 years of experience in pharmaceutical and related regulated industries. Most recently, Sarah has worked on assisting clients with projects related to process improvements, standards development, defining filing strategies and writing and review of submission content. Prior to that, Sarah worked on projects related to implementation of regulatory solutions and has contributed to defining product strategies for industry leading software solutions.

  • Ellen  Reilly, MBA

    Ellen Reilly, MBA

    • Vice President
    • DocuSign, United States

    Ellen Reilly has 30 years of experience working in large global pharmaceuticals, biotechnology organizations as well as medical device clients. Currently, Ellen is the Vice President, Life Sciences and Healthcare for Docusign working on driving the adoption into the industry. Prior to joining DocuSign, Ellen held roles at Forest Pharmaceuticals were she was the VP of Global Supply Chain for Forest Pharmaceuticals & the VP of Corporate IT Systems supporting Human Resources, Finance, Informatics and Supply Chain. Ellen holds a Bachelors degree in Computer Science from LaSalle University, and an MBA in the International Management program from Drexel University.

  • Michiel  Stam

    Michiel Stam

    • Regulatory Information Scientist
    • eCTDconsultancy B.V., Netherlands

    Michiel Stam is a Regulatory Information Scientist at eCTDconsultancy B.V. and has a strong focus on electronic submissions for Drug Regulatory Affairs and Pharmacovigilance. In this role he has lead various submission and information management projects for Pharma and Biotech companies. eSubmission projects include preparation and submission of initial marketing authorization applications and post-authorization maintenance for Agencies in the EU (CAPs, NAPs and MRP/DCP), US (NDA and BLA) and other regions, including GCC and Swiss Medic submissions. Since 2011 Michiel has worked on XEVMPD and IDMP (Identification of Medicinal Products) related topics, Registration Tracking and Semantic interoperability.

  • Dimitri  Stamatiadis, PhD, MBA

    Dimitri Stamatiadis, PhD, MBA

    • Maia Consulting, Switzerland

    Dr. Stamatiadis graduated from the University of Patras with a BS in Biology and with a Masters degree and a PhD from the University of Paris VI. Subsequently, he obtained an MBA from the University “La Sorbonne”. Dr Stamatiadis has more than 25 years Pharmaceutical industry experience in Europe and the USA. In 2012 he founded MAIA Consulting based in Geneva, Switzerland. Dr Stamatiadis has a long experience in deploying enabling technologies in small and large companies. He is an active member of the DIA, a seasoned presenter and author of several articles on digital technologies in Pharmaceutical R&D.

  • Stacy J. Tegan

    Stacy J. Tegan

    • Manager, Regulatory Technology Consulting
    • Accenture Accelerated R&D Services, United States

    Stacy Tegan is a Manager of Regulatory Technology Consulting in Accenture Accelerated R&D Services, bringing 18+ years of experience in the Pharmaceutical industry. She works with pharmaceutical and biotech organizations to improve R&D processes.

  • Jamie Marie Toth, MS

    Jamie Marie Toth, MS

    • Director/Head of TMF Operations
    • Daiichi Sankyo, Inc., United States

    Ms. Toth has over 18 years of IT experience in the pharmaceutical industry. She joined Daiichi Sankyo after working at a CRO for 8 years, spending 5 years in the launch of an eTMF project, system selection and building of an operational group to support eTMF. She is a Steering Committee member for the DIA TMF Reference Model Working Group and a member of the Scientific Archivist Group (SAG). She received her Master’s Degree in Clinical Research & Organizational Management at Drexel University, a Bachelor of Arts in Business & Technology from Fairleigh Dickinson University and has an Associates of Applied Sciences in Computer Systems & Technology from Mercer County Community College.

  • Olga  Alfieri, MBA, MSc, RAC

    Olga Alfieri, MBA, MSc, RAC

    • Director
    • Eisai Inc, United States

    Olga Alfieri is the AD, Global Submissions at Eisai with over 22 years of GRO professional experience. She operates as a global strategic partner and subject matter expert in collaboration with the GRO Submissions team (Europe, Asia and Emerging Markets) in the design and implementation of technology facilitating the creation and maintenance of global submissions.

  • Robert  Connelly, MBA

    Robert Connelly, MBA

    • Product Management
    • Synchrogenix, United States

    Rob Connelly brings a wealth of experience in regulatory operations and electronic publishing to GlobalSubmit, having developed a variety of internal systems and overseen the submission of marketing applications to several countries during his nearly 20 years in the life science industry. Mr. Connelly successfully scaled and presided over a growing regulatory operations group at ViroPharma, and fulfilled a variety of roles in regulatory operations at GlaxoSmithKline. His expertise includes evaluating and working with dozens of publishing, tracking and document management systems, and customizing those solutions to function efficiently within the parameters set forth by individual organizations with unique environments.

  • Emily  Hall

    Emily Hall

    • Senior Manager, Regulatory Operations
    • ACADIA Pharmaceuticals Inc., United States

    Emily Hall, Senior Manager Regulatory Operations, Polaris Pharmaceuticals, Inc. (San Diego, CA). Seasoned Regulatory Affairs professional experienced in successfully managing projects both domestically and internationally. Extensive project management experience leading numerous development and improvement teams including multi-national, multi-cultural teams.

  • Adam F Kroetsch

    Adam F Kroetsch

    • Operations Research Analyst
    • Food and Drug Administration, United States

  • Sandra A. Krogulski

    Sandra A. Krogulski

    • Regulatory Operations Submission Manager
    • Accenture, United States

    Sandra Krogulski is currently a Submission Manager at Accenture. As a Submission Manager, Sandra oversees the management of numerous regulatory submission projects ensuring projects are in compliance with global regulatory requirements and meeting submission timelines. Her primary focus is on life-cycle submissions, helping support over 1,000 sequences this past year including annual reports, CMC supplements, labeling supplements, Advertising/Promotional Labeling submissions and other amendments. Sandra has also supported original applications and regions including the US, Canada, EMA and other rest of world dossiers.

  • Elizabeth  McLellan

    Elizabeth McLellan

    • Director of Compliance and Quality
    • Suvoda, United States

  • Meghan  Mendoza, MBA, RAC

    Meghan Mendoza, MBA, RAC

    • Senior Manager, Regulatory Operations
    • Amgen, Inc., United States

    Meghan Mendoza is a Senior Manager of Global Regulatory at Amgen. She serves as the North American Publishing Lead with specific responsibility for the United States and Canada. Meghan has 11 years’ experience working in the biotechnology industry. Prior to leading a Publishing Organization, she served as one of the US Regulatory Information Management Leads with specific responsibility for cross functional interactions and mergers and acquisitions. She’s held various positions throughout Regulatory and Safety. Meghan holds a Masters in Business Administration and has earned her RAC credential from Regulatory Affairs Professional Society (RAPS).

  • Sue  Metz

    Sue Metz

    • VP, Technical
    • PAREXEL International, United States

    Sue Metz works for PAREXEL International and is a subject matter expert with hands-on experience in Regulatory Information Management and IDMP. Sue has +30 years’ experience defining and designing software, processes, and services in the life sciences industry. Most recently, Sue has been responsible for developing and delivering Gap Assessment strategies as well as for driving the planning, development, and implementation strategy for IDMP clients. She is a standing member of the EU SPOR Task Force for IDMP and the Substance & Product sub-group, the US TAG ISO/TC 215/WG6 involved in defining the ISO IDMP Implementation Guides, and is on the IRISS IDMP Leadership Team.

  • Lisa D. Mulcahy

    Lisa D. Mulcahy

    • Owner, Principal Consultant
    • Mulcahy Consulting, LLC, United States

    Lisa has an extensive 23 year career in Bio-Pharmaceutical R&D having worked as a Study Coordinator, at a CRO, and a biotech company, and in large pharma in both Trial Mgmt and Quality & Compliance. She is now a content management consultant, working solely on Trial Master File process assessment, improvement and eTMF implementation projects. She is the DIA Document & Records Management Community Global Chair & Co-Leader of the TMF Reference Model team.

  • Matt  Neal, MA

    Matt Neal, MA

    • Senior Director, Product Management, Regulatory & Clinical Solutions
    • PAREXEL, United States

    Matt Neal joined PAREXEL in 2016 as the Senior Director of Product Management for Regulatory Solutions. Before joining PAREXEL, Matt was a Director of Regulatory & Safety Operations at Amgen, Inc. and prior to that he was one of the pioneering members of the Regulatory Submissions Department for GlaxoSmithKline and has been publishing and submitting electronic dossiers to the FDA since 1996, and submitted the very first fully electronic NDA for GSK in 1999. Matt holds a Masters in Communication from Temple University.

  • Dawn M Niccum, BSN, MS, RN, PMP

    Dawn M Niccum, BSN, MS, RN, PMP

    • Director, Quality Assurance
    • Inseption Group, United States

    Dawn Niccum is Director, Quality Assurance for the inSeption Group and responsible for all areas of QA including compliance, Policies and SOPs, and training. She was formerly with Endocyte, Inc. With over 20 years of pharmaceutical experience, Ms. Niccum holds a Master’s Degree in Regulatory Affairs and Quality Compliance, certifications as a Clinical Research Associate (CCRA), Registered Quality Assurance Professional – GCP (RQAP-GCP) and Project Manager (PMP), and is a registered nurse.

  • Patti  Palm-Principe, MS

    Patti Palm-Principe, MS

    • Director of Client Services
    • Cabeus, Inc., United States

    Patti Palm-Principe, Director of Client Services for Cabeus, Inc., a niche firm providing information management products, solutions & services for Life Sciences. Patti has been recognized as an energetic & inspired IT professional supporting teams from R&D to Manufacturing. She has led the delivery of systems for Dossier & Document Publishing, Regulatory Commitment Management & Information Management, CMC Authoring & Change Control, Quality Systems (GCP & GMP) & alignment of data & processes across business units. Prior to Cabeus, Patti was with Bristol Meyers Squibb where she was recognized as a cross functional team leader thinking strategically & delivering solutions that enhanced business processes & more importantly data quality.

  • Timm  Pauli

    Timm Pauli

    • Sr. Director, eSubmission Services, Head of Regulatory Operations
    • PharmaLex GmbH, Germany

    Timm Pauli joined PharmaLex in 2014 as Head of Regulatory Operations, where he is responsible for all electronic submission activities, regulatory information management and related topics. Previously he worked at Merck Serono heading the Dossier & Submission Management department and at Baxter, where he held several global positions in Biostatistics, Pharmacovigilance and IT. Timm studied Pharmacy and Medical Informatics at the Universities of Frankfurt and Heidelberg (Germany). Timm was Merck Serono representative in the EFPIA Regulatory Information and Technology Strategy Committee, in the EFPIA eCTD Focus Group as well as the EMA “Article 57 Implementation Working Group”.

  • Jim  Reilly

    Jim Reilly

    • Senior Director, Vault RIM
    • Veeva Systems, United States

    Jim Reilly is a Director of Product Strategy at Veeva Systems, where he is responsible for defining the market approach for the Vault Regulatory suite of products. For the last 15 years, he has held a variety of senior positions in Regulatory publishing, software delivery, consulting, and sales. Jim is interested in all things regulatory, data standards, and process engineering-oriented.

  • Kevin  Remphrey

    Kevin Remphrey

    • Merck, United States

  • Jonathan  Resnick

    Jonathan Resnick

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

  • Karin  Sailor

    Karin Sailor

    • Consultant
    • SRO Inc., United States

    Karin Sailor is a global regulatory professional with 23 years of experience in the medical device industry. She has experience in both regulatory affairs and regulatory operations. Her experience includes work in small, medium and large medical device companies, as well as industry leadership through trade associations and regulator groups.

  • Mary Ann  Slack

    Mary Ann Slack

    • Deputy Director, Office of Strategic Programs, CDER
    • FDA, United States

    Ms. Slack has over 30 years’ technology and informatics experience implementing informatics solutions to business problems. Since joining FDA in 2003, she has been engaged in data standards development efforts in CDISC, HL7 and ISO in support of Agency needs. Ms. Slack is an FDA representative to the International Conference on Harmonization (ICH) and currently serves as Deputy Director for CDER's Office of Strategic Programs and leads CDER's data standards program.

  • Peter  Terbeek

    Peter Terbeek

    • Director, Regulatory Affairs
    • Astellas, United States

  • Akira  Yamaguchi, MBA

    Akira Yamaguchi, MBA

    • CTO
    • LORENZ Life Sciences Group, United States

    After an international career in management consulting and information technology at Software AG and Comshare, Akira Yamaguchi joined LORENZ Life Sciences in 1995. His initial role was software development in the field of electronic submissions, achieved in 2001 with the release of docuBridge as a major company milestone. In 2003, Mr. Yamaguchi became responsible for LORENZ' overall software product development. In his Project SME role, Mr. Yamaguchi advises larger customer implementation projects. His current task is to develop the strategic directions of LORENZ' software portfolio.

  • Jack  Yeager

    Jack Yeager

    • CEO
    • Sylogent, United States

    Jack has leveraged his interest in design, technology and automation to build a career in software development. He is currently focused on information automation solutions for the life sciences, insurance and lending industries. “These heavily regulated industries have no choice but to automate their information workflows as they grapple with fewer resources, shorter timelines and more public date disclosure”, stated Yeager.

  • Hermineh  Aghanian

    Hermineh Aghanian

    • Regulatory Operations Senior Manager
    • Amgen, United States

    Hermineh Aghanian is a Sr. Manager of Global Regulatory Affairs and Safety Operations at Amgen. She serves as the Management of Regulatory Information Lead responsible for the US, CA and Asia Pacific regions. Hermineh has 15 years of experience working in the biotechnology industry. Prior to moving into a Regulatory Operations role, she held various positions throughout Regulatory and started her career in the department of Pharmacokinetics and Drug Metabolism. Hermineh holds a Masters in Regulatory Science from University of Southern California. In 2008, she earned her RAC credential from the Regulatory Affairs Professional Society (RAPS).

  • Cathy  Carfagno

    Cathy Carfagno

    • Associate Director Merck IT
    • Merck & Company Inc., United States

  • Jillian E. Carinci, MS

    Jillian E. Carinci, MS

    • Associate Director, Regulatory Operations
    • Accenture Regulatory, United States

    Jillian partners with sponsors to manage numerous regulatory submission projects. She ensures compliance with global regulatory requirements, delivering within scope, on time, and with the highest quality. She has managed original applications to regions including the US, EU, and CH, and lifecycle maintenance submissions. Jillian holds a Bachelor’s degree in Chemistry from Lafayette College and a MS in Regulatory Affairs and Quality Assurance from Temple University.

  • Thomas  Christensen, RAC

    Thomas Christensen, RAC

    • Senior Regulatory Affairs Manager
    • SynteractHCR, United States

    Thomas Christensen has 15 years industry experience in regulatory affairs focusing on document management, publishing and submission of applications / authorizations. He has managed electronic publishing projects for submission to competent authorities this includes submission life-cycle management and maintenance during approval and into post-marketing.

  • Sandra  Herder

    Sandra Herder

    • Director Regulatory Operations
    • The Medicines Company, United States

  • Lana Jokhan Holder, MS

    Lana Jokhan Holder, MS

    • Sr. Project Manager
    • Life Sciences Solutions Transperfect, United States

    Lana Holder is a Senior Project Manager at TransPerfect Life Sciences. Lana is responsible for maintaining the quality of client Trial Master File integrity, eTMF contents and management. She also works in conjunction with the Operations Team as well as the Global Document Management Team. Prior to her work at TransPerfect Life Sciences, she worked at Integra life Sciences as part of their Corporate Regulatory Affairs Team in partnership with operations, manufacturing, quality systems and engineering to facilitate overall Regulatory Compliance, with Johnson & Johnson, as well as at Merck & Co. Lana holds a MS degree in the Biological Sciences and Molecular Biology from CW Post, Long Island University, New York.

  • Thomas  Hornbaek Svendsen, MS

    Thomas Hornbaek Svendsen, MS

    • Principal Consultant
    • NNIT A/S, Denmark

    Thomas Hornbaek Svendsen works as principal consultant at NNIT and has more than 15 years of consulting experience within the life sciences domain with special focus on regulatory affairs and key expertise within document management, submission management and registration tracking. Thomas has recently been part of several IDMP projects across Europe as project manager and subject matter expert.

  • Jared  Lantzy, PMP

    Jared Lantzy, PMP

    • Manager, Global Regulatory Agencies and Processes
    • LORENZ Life Sciences Group, United States

    Jared Lantzy is the Manager of Global Regulatory Agencies and Processes at LORENZ International LLC. His primary expertise is in the development and maintenance of regulatory data standards for human pharmaceutical registration. Mr. Lantzy is a former member of the ICH M8 Expert Working Group tasked with developing the next major version of the eCTD, eCTD v4.0. Mr. Lantzy’s other experience includes Project Management, IT Business Analysis, and Hardware and Software Systems Analysis. He holds a B.S. in Information Technology from Juniata College in Huntington, Pennsylvania, USA.

  • Rick  London

    Rick London

    • Product Manager
    • GlobalSubmit, United States

    Mr. London could be considered a modern day polymath. He has pioneered a number of products for the digital age including applications, products and services focused on consumer based design that deliver high adoption, user experience and performance. He is Product Manager for GlobalSubmit’s COLLABORATE, a regulatory and submissions focused DMS for Life Science. Mr. London is adjunct professor of Gamification in Business Marketing and Enterprise Applications at Villanova University, pioneered the development of environmentally responsible printing, founded an online rental marketplace for Italian villas, teaches advanced 5-string banjo and an author of 5 contemporary art photography books.

  • Sheila  Mahoney-Jewels, MBA

    Sheila Mahoney-Jewels, MBA

    • Principal Consultant
    • smjstrategies, inc., United States

    Sheila has over 20 years’ experience in regulatory, clinical and IT, having operated on both the sponsor and vendor sides. Her current focus is augmenting and expediting critical innovation through the application of opportunity Win-Loss Review research to vendor corporate strategy. Sheila has, an eMBA from Columbia University and BA from Smith College.

  • Aaron  Niman, MPH

    Aaron Niman, MPH

    • Research Officer, Office of Surveillance and Epidemiology, CDER
    • FDA, United States

  • Mary Anne Potok

    Mary Anne Potok

    • Technical Manager, Regulatory Operations
    • MMS Holdings Inc., United States

    Mary Anne Potok is a Regulatory Operations Technical Manager, having joined MMS Holdings in Canton, MI, in 2013. She serves as Global Resource Manager for the Regulatory department and shares resourcing responsibilities within the MMS-Asia headquarters in Bangalore, India. She brings nearly 15 years of experimental and operational experience in the academic, clinical, and pharmaceutical arenas. Her campaigns for organizational efficiency, inter-departmental cooperation, and global integration have helped pharma partners of all sizes achieve success. She has a strong professional interest in clinical trial transparency and working with small to mid-sized pharma clients as they navigate the electronic submission process.

  • Beth  Robinson

    Beth Robinson

    • Executive Director, Clinical Compliance and Operations
    • Horizon Pharma, United States

  • Olaf  Schoepke, PhD

    Olaf Schoepke, PhD

    • Director of Strategic Development
    • Samarind Limited, 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.

  • Angela  Shain

    Angela Shain

    • Manager, Regulatory Operations
    • Amgen, United States

    Angela has been at Amgen for 10 years and her current role is Manager, Global Regulatory Affairs and Safety Operations. She currently leads Global Out-licensing and Integrations for Regulatory Operations. During her tenure in Regulatory Operations, she has led the US RIM group as well as the Global Site Initiation team through organizational changes and developed processes to support the changes. Previous to Amgen, she worked at numerous clinical research sites as a Certified Clinical Research Coordinator in multiple specialty disciplines.

  • Vikesh  Srivastava

    Vikesh Srivastava

    • Associate Director, Business Informatics Division, HPFB
    • Health Canada, Canada

    Vik is responsible for the strategic and operational leadership of the HPFB IT investment plan and governance aimed to modernize and drive efficiencies within the regulatory program areas. Vik holds an Undergraduate Degree in Biochemistry & Finance from the University of Ottawa, second Undergraduate Degree in Computational Biology/Computer Science Graduate Degrees in Genomics & Computer Science from McGill University.

  • Lise  Stevens

    Lise Stevens

    • Prinicpal Owner
    • Saturn Services LLC, United States

  • Kevin  Tompkins, MBA

    Kevin Tompkins, MBA

    • Director, Head of North America, Global Submissions Management
    • Teva Pharmaceuticals, Inc, United States

  • Hans  van Bruggen, MSc

    Hans van Bruggen, MSc

    • Regulatory Affairs Scientist
    • eCTDconsultancy B.V., Netherlands

    Hans worked for over 30 yr in Global or EU pharmaceutical industry. He held various scientific positions in Nonclinical Development and Regulatory Affairs. Since 1999 he has been involved in datamodeling for electronic maintenance, storage and exchange of regulatory information. Hans approaches business processes from an adequate benefit-risk evaluation of drugs for the patients. Therefore, he breaks down silos, applies innovative and intuitive solutions and works towards single data sources.

  • Jan  Voskuil

    Jan Voskuil

    • CEO
    • Taxonic, Netherlands

    After obtaining a PhD in theoretical linguistics, Jan worked for several start-ups in the field of artificial intelligence. Jan has worked as senior solution architect at Logica and was involved in several large-scale, high-profile innovation programs. Jan is a technology evangelist in the field of Linked Data and Semantic Web technology, and specializes in language processing, controlled vocabularies and business glossaries. Jan is currently employed as CEO of Taxonic, which he co-founded in 2012. Taxonic is a consultancy that focusses on applying Linked Data technologies to real world business problems.

  • Aloka  Chakravarty, PhD

    Aloka Chakravarty, PhD

    • Acting Deputy Director, Office of Biostatistics, OTS, CDER
    • FDA, United States

    Dr. Chakravarty joined CDER in 1992. She served as an Adjunct Faculty in Depart. of Statistics, Foundation for Advanced Education in the Sciences, NIH. She is an internationally recognized thought leader in the area of safety evaluation, surrogate markers and biomarkers in drug development and has presented and published widely on it. Dr. Chakravarty received the FDA Award of Merit in 2008 and Dr. Frances O. Kelsey Drug Safety Excellence Award in 2012. She received her PhD in Statistics from Temple University, and M.Stat from Indian Statistical Institute. Dr. Chakravarty is a Fellow of ASA and an Associate Editor of Statistics in Biomedical Research.

  • Jennifer  Costello

    Jennifer Costello

    • Manager, Global Regulatory Operations
    • Teva Pharmaceuticals, United States

    Jennifer Costello is a Manager in the Regulatory Submissions Management group at Teva Pharmaceuticals. Jennifer began her career in publishing and dossier management at Octagon Research Solutions before moving to Teva. Currently she manages a publishing team that focuses on Post-Approval activities for Teva’s Generics portfolio. Jennifer has over 5 years of submission publishing experience and has been involved with development of standards and procedures, training, and implementation of change management. She has a BS in Business from Chestnut Hill College.

  • Mark  Cottingham

    Mark Cottingham

    • Sr. Business Lead in Operational Business Excellence Group of Pharma Technical
    • F. Hoffmann-La Roche Ltd, Switzerland

    Mark Cottingham is currently working as a Senior Business Lead within the Pharma Technical Regulatory department at Roche. He has worked in the Pharma industry for over 15 years with the last 10 years in Regulatory. He is currently implementing a RIM solution which will provide a strong framework for implementing structured authoring solutions. He likes to focus on automation to enable the business to focus on value adding activities.

  • Thomas John Denaro

    Thomas John Denaro

    • Director, Regulatory Global Systems
    • BD Biosciences, United States

    Thomas Denaro has over 25 years of industry experience in Regulatory Affairs and Compliance. In his 12 years at BD, Tom has held positions in clinical operations, corporate regulatory affairs and compliance with accomplishments that include the successful global implementations of clinical data & trial management systems. Since 2011 in his current role as the Director of Corporate Regulatory Global Systems, Tom has implemented a global product registration system and a worldwide advertising & promotional material approval system. Tom holds a Bachelors of Science from Nyack College in New York.

  • Steve  Gens, MS

    Steve Gens, MS

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

    Steve has 30 years of experience with the majority in the biopharmaceutical industry. His early career was spent at J&J and then moved into consulting where he managed several healthcare consulting practices for Booz Allen Hamilton and First Consulting Group. Steve has deep experience in strategic planning, organization development, industry benchmarking, and leading or facilitating strategic change. Steve has a Masters in Organization Development and a Bachelors of Science in Computer Science.

  • Lindsey  Hart

    Lindsey Hart

    • Senior CMC Regulatory Science Specialist, CMC Regulatory and Process Sciences
    • Regeneron, United States

  • Ronald  Hernando, MBA

    Ronald Hernando, MBA

    • Director, Regulatory Operations
    • MacroGenics, Inc., United States

    As a Southern California resident, Ronald Hernando graduated from UC San Diego and was lucky enough to land in Regulatory Affairs right out of college. After 4 years of paper cuts in Regulatory Affairs/Quality Assurance, Ron left paper submissions behind, and has spent the last 12 years focusing on Regulatory Operations. Ron has been enjoying the past 5 freezing winters of Rockville, MD overseeing Regulatory Operations at MacroGenics, Inc. As the Director of Regulatory Operations, he is responsible for 13 INDs, and managing all electronic submissions-related software, training, and personnel.

  • Paul  Houston

    Paul Houston

    • CDISC Europe - Head of European Operations
    • CDISC, France

  • Kanchana  Iyer, MS

    Kanchana Iyer, MS

    • Senior Regulatory Affairs Specialist
    • PENTAX Medical, United States

    Kanchana Iyer, MS is a senior regulatory affairs specialist at PENTAX Medical, a healthcare industry leader in endoscopic imaging. She has worked as a biomedical engineer at the FDA, serving as lead reviewer of premarket submissions in the Office of Device Evaluation and as regulatory communications project manager in the Office of Communication and Education. Kanchana has a Master's of Science in Biomedical Engineering. Her experience in academic research includes investigations of novel biomaterials in the medical device industry, computational modeling of cardiovascular disease and tissue engineering processes. Outside of the office Kanchana enjoys playing the violin, creative writing, and volunteering within the community.

  • Bhanu  Kannan, MSc

    Bhanu Kannan, MSc

    • Consumer Safety Officer, Office of Compliance and Biologics Quality, CBER
    • FDA, United States

    Bhanu is a reviewer in CBER Bioresearch monitoring Branch for 15 years assigning inspections and assessing regulatory compliance of the insepcted parties with regard to FDA regulations. Prior to joining this Branch she participated in the basic research on signal trasduction mechanisms in CBER labs

  • Jenny  Lester, MPH

    Jenny Lester, MPH

    • Research Manager
    • Samuel Oschin Comprehensive Cancer Institute, United States

    Jenny Lester, MPH, CCRP, is a Research Manager in the Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center. She graduated from the University of Georgia with a Bachelor of Science and earned her Master of Public Health degree from Morehouse School of Medicine. She focused the first half of her career in HIV education, prevention, and testing. She began working in cancer at CSMC in 2006 and has worked over the last several years to improve clinical trial processes.

  • William  P Liston

    William P Liston

    • Regulatory Associate - Submissions Specialist
    • Pfizer Inc., United States

  • Jim  Nichols

    Jim Nichols

    • Vice President
    • Cunesoft Inc., United States

    Jim has nearly 30 years of experience with compliant software solutions for regulated processes in the Life Sciences and Healthcare arena. Currently, Jim serves as the Vice President Life Sciences, North America for Cunesoft. He also is the President & CEO of the IRISS Forum – a not-for-profit organization. Jim has held executive management positions at Liquent, Thomson Reuters, ePharmaSolutions and DitaExchange. He has a Bachelor of Science degree in Mathematics from The Pennsylvania State University.

  • Daniel  Offringa

    Daniel Offringa

    • Senior Principal Consultant
    • Pharmaceutical eConsulting, United States

    Dan has a 25+ year regulatory career. Over the past 15 years he has worked in the electronic submissions field for both FDA and industry, including guidance promulgation, standards and process development, and system implementation. He is currently a Senior Principal Consultant for Pharmaceutical eConsulting with a focus on publishing. He has been responsible for numerous marketing applications and submissions to multiple regulatory authorities. Dan holds a bachelor’s degree in Psychology and Zoology from Duke University.

  • Mia  Prather

    Mia Prather

    • Supervisory Program Analyst, CDER
    • FDA, United States

    Mia Prather is Lead of the Data Management Services Team within the Office of Business Informatics, CDER. Mia oversees CDER’s document control center operations, records management and master data management functions. Her team has direct responsibility for document intake, processing and delivery to CDER’s reviewer community. Mia has been with CDER for 13 years and was previously with Booz Allen Hamilton.

  • Patricia  Santos-Serrao, RAC

    Patricia Santos-Serrao, RAC

    • Director, Clinical & Regulatory Solutions
    • Mastercontrol, United States

    Patricia entered the Life Sciences Industry in 1994 starting her career at Schering-Plough in Kenilworth, NJ and later joining Boehringer Ingelheim Pharmaceutical in Ridgefield, CT. Within both organizations she took a leading role in transitioning business processes, document management and submission compilation from a paper to electronic system. She is a member of Regulatory Affairs Professional Society (RAPS) and has also earned her Regulatory Affairs Certification (RAC) from RAPS and the Regulatory Affairs Certification Board (RACB). She is also a member of the Drug Information Association (DIA) and a member of the TMF Reference Model Working Group (sponsored by DIA).

  • Karin  Schneider, MLIS, MS

    Karin Schneider, MLIS, MS

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

  • Nancy Pire Smerkanich, DrSc, MS

    Nancy Pire Smerkanich, DrSc, MS

    • Assistant Professor, Clinical Pharmacy; Educational Liaison & Instructor, ICRS
    • University of Southern California, United States

    Dr. Smerkanich recently completed her doctorate in Regulatory Science on the Implementation of Benefit-Risk Frameworks in Industry. She leads the clinical regulatory courses while continuing to provide regulatory guidance to her academic and industry peers. In her new role at USC, she brings many years of practical regulatory knowledge and experience to academia. With over 30 years of experience, Dr. Smerkanich has participated in all regulatory aspects of drug development, having served as Regulatory Liaison, US Agent, and Global Regulatory Lead across all therapeutic areas.

  • Gareth  Sully, PhD

    Gareth Sully, PhD

    • Vice President, Site Startup and Regulatory
    • INC Research, United Kingdom

    Dr Sully is charge of the global TMF management and was formerly the regional head for clinical trials that were in Start-Up in the EMEA region. A career spanning 18 years working within the clinical operations departments of CROs, he has gained strategic and operational experience with regulatory procedures, challenges of clinical trial (CT) delivery and the evaluation of technologies for CT optimization in the start-up space. He has led INC Research through a reevaluation of the eTMF platform and advised & driven clinical system integrations of in house systems. He earned his BSc in Biochemistry & Pharmacology from Southampton University and his PhD from Imperial College London.

  • Todd  Tullis

    Todd Tullis

    • Product Manager
    • Veeva, United States

    Todd Tullis has 16 years of experience in clinical technology across pharma, CRO, medical device, and research site organizations. From CTMS to EDC to eTMF, and everything in between, this diverse perspective fuels Todd’s career mission: to improve human health through more efficient and more effective clinical trials. He has been volunteer contributor to the TMF Reference Model for 6 years and currently serves on the Steering Committee. Todd holds a degree in genetics from the University of California, Davis and lives in San Francisco where he coaches youth baseball in his spare time.

  • Donna  Yosua

    Donna Yosua

    • 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 is the global IDMP business lead for Merck.

  • Bernie  Coney, MA

    Bernie Coney, MA

    • Head of Regulatory Advisory Services
    • Kinapse, United States

    Bernie Coney is the Head of Regulatory Information Management (RIM) Advisory Services at Kinapse who works with clients and industry on technology and processes related to areas that include Information Management, Registration Management, Submissions Management/Publishing, Labeling, IDMP and other areas that impact the Regulatory Affairs discipline. Prior to Kinapse, Bernie was the Head of Regulatory and Quality Assurance IT at Shire Pharmaceuticals, responsible for the Technology strategy, implementation, and innovation within R&D IT, as well as the Head of Regulatory Technology and Information Management. He has also work in the software vendor space delivering SCM and RIM solutions, as well as Pfizer Regulatory.

  • Paul  Fenton, MBA, MS

    Paul Fenton, MBA, MS

    • CEO
    • Montrium, Canada

    Paul Fenton holds a degree in management from London Metropolitan University as well as an MBA in Technology Management from the Université du Québec à Montréal. Paul has significant industry experience at a senior management level in the development, deployment and management of computerized systems for use in regulated clinical trials. He co-founded Montrium in 2005. He has worked on major clinical technology projects both in Europe and North America and has a strong background in CDISC and ICH standards as well as in the integration of systems and processes for clinical trials. He is a regular speaker at industry events and is actively involved in several projects for the development of clinical research standards and platforms.

  • Jean M. Mulinde, MD

    Jean M. Mulinde, MD

    • Senior Policy Advisor, Office of Scientific Investigations, OC, CDER
    • FDA, United States

    Jean Mulinde currently serves as Senior Policy Advisor in the Division of Clinical Compliance Evaluation, Office of Scientific Investigations (OSI) in the Office of Compliance at CDER. Before joining OSI, she was a Lead Medical Officer in the Division of Anti-Infective and Ophthalmology Products (Office of New Drugs, CDER).

  • Gina  Ross

    Gina Ross

    • Managing Director, Regulatory Submissions & Admin Ops, Regulatory Sciences
    • Cardinal Health, United States

    Gina A. Ross has been involved in the pharmaceutical industry for the past 18 years and has been Treasurer for IRISS Forum for the past 5 ½ years. Gina has been the Managing Director of Regulatory Submissions Operations for Cardinal Health Regulatory Sciences (CHRS), formerly Beckloff Associates, a pharmaceutical scientific and regulatory consulting firm, for the past 2 years. Prior to her current position, Gina was the Director of Publishing at CHRS for 16 years. Gina has given several presentations to industry and CHRS clients on CTD and eCTD implementation.