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Bethesda North Marriott Hotel and Conference Center

Feb 06, 2017 7:00 AM - Feb 08, 2017 5:00 PM

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

Regulatory Submissions, Information, and Document Management Forum

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Want to learn more about Regulatory Submissions, Information, and Document Management Forum? You've come to the right site!

Continuing-Education

Short Course or Primer

To keep you at the forefront.

Feb 06, 2017

Course 1:

Global Identification of Medicinal Products (IDMP)

Feb 06, 2017

Course 3:

Achieving Regulatory Operations Excellence Through Outsourcing

Feb 05, 2017

Regulatory Content and Submissions Primer:

Program Committee

  • Michelle L. Charles, MPH
    Michelle L. Charles, MPH Director, Regulatory Affairs, Gene Therapy Program
    University of Pennsylvania, Perelman School of Medicine, United States
  • Ginny  Hussong
    Ginny Hussong Branch Chief, Data Standards, CBER
    FDA, United States
  • Sarah  Powell, RAC
    Sarah Powell, RAC President
    Powell Regulatory Services, United States
  • Jamie  Toth, MS
    Jamie Toth, MS Global Head, TMF Management & Records
    Beigene, United States
  • Venkatraman  Balasubramanian, PhD, MBA
    Venkatraman Balasubramanian, PhD, MBA SVP and Global Head, Industry Solutions - Healthcare and Life Sciences
    Orion Innovation, United States
  • Christian A. Buckley, MBA, RAC
    Christian A. Buckley, MBA, RAC Associate Director, Regulatory Affairs
    Astellas, United States
  • Brooke  Casselberry, MS, RAC
    Brooke Casselberry, MS, RAC Vice President, Advisory and Delivery
    Epista Life Sciences, United States
  • Cindy  Chiu
    Cindy Chiu Senior Director, Regulatory Affairs Operations and Quality Management
    Merck & Co., Inc., United States
  • Jake  Doran
    Jake Doran Head of Digital
    Lykos Therapeutics, United States
  • Betsy  Fallen, RN
    Betsy Fallen, RN Consultant
    BAFallen Consulting LLC, United States
  • Ron  Fitzmartin, PhD, MBA
    Ron Fitzmartin, PhD, MBA Senior Advisor, Office of Regulatory Operations, CBER
    FDA, United States
  • Mark A. Gray
    Mark A. Gray Senior Project Manager, DSB, CBER
    FDA, United States
  • Dominique  Lagrave, PharmD
    Dominique Lagrave, PharmD Senior Vice President of Regulatory Innovation
    Accumulus Synergy, United States
  • Thomas  Noto
    Thomas Noto Senior Director, Regulatory Operations
    Lexicon Pharmaceuticals, United States
  • Daniel  Orfe, MS
    Daniel Orfe, MS President and CEO
    Regulatory eSubmissions, LLC, United States
  • Vada A. Perkins, DrSc, MSc
    Vada A. Perkins, DrSc, MSc Vice President, Global Head of Regulatory Intelligence & Policy
    Boehringer Ingelheim, United States
  • Michiel  Stam
    Michiel Stam Director Regulatory Information Management
    Qdossier - A Celegence Company, United Kingdom
  • Stacy  Tegan
    Stacy Tegan Program Director
    Transcelerate Biopharma, Inc., United States

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