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Featured
Short Course or Primer
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Feb 13, 2022
Regulatory Content and Submission Primer: Content from Authoring to Archive
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Feb 09, 2022
Short Course: Structured Data: IDMP is Not the Goal
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Feb 08, 2022
Short Course: The Future of Documents: Deep-Dive into Structured Content
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Program Committee
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Venkatraman Balasubramanian, PhD, MBA • SVP and Global Head, Industry Solutions - Healthcare and Life Sciences
Orion Innovation, United States -
Karen McCarthy Schau • Director, Risk-based Study Management
Vertex Pharmaceuticals, United States -
Peter Terbeek, MBA • Senior Director, Regulatory Operations
Astellas, United States -
Jake Doran • Head of Digital
MAPS Public Benefit Corporation (MAPS PBC), United States -
Jo English • Vice President, Regulatory Information Management
Calyx, United Kingdom -
Michiel Stam • Director Regulatory Information Management
Qdossier - A Celegence Company, Netherlands -
Danielle Beaulieu, PhD • Senior Director, Global Regulatory Business Capabilities
Bristol-Myers Squibb, United States -
Kristen Sauter, MBA • Director, Global Regulatory Informatics & Analytics
Takeda Pharmaceuticals, United States -
Vahe Ghahraman, PhD • Senior Director, Global Regulatory Operations Head
Apellis Pharmaceuticals, Inc. , United States -
Cindy Chiu • Senior Director, Regulatory Affairs Operations and Quality Management
Merck & Co., Inc., United States -
Joanne Malia, MS, MSc • Director, Development Records Management
Regeneron Pharmaceuticals, United States -
Jamie O'Keefe • Head, Clinical and Regulatory Consulting Services
Astrix Technology, Inc, United States -
Stacy Tegan • Program Director
Transcelerate Biopharma Inc., United States -
Divya Gangaramani, PhD, RAC • Senior Regulatory Specialist
VIR Biotech, United States -
Rob Labriola, MS • Exec. Director, Regulatory Operations
Garuda Therapeutics, United States -
Sandra Krogulski, MA • Director, GRSO Innovation and Business Operations Lead
Bristol-Myers Squibb Company, United States -
Demetra Macheras, MBA • Director, Regulatory Policy and Intelligence - Regulatory Affairs
AbbVie, United States -
Ethan Chen, MBA, MS, PMP • Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
FDA, United States -
Jonathan Resnick, PMP • Project Management Officer, OBI, OSP, CDER
FDA, United States
