UCSF

ACDRS 2021 Session 5: The Global Registration and Approval Process

Date: 
Monday, October 25, 2021 - 10:00 am to Friday, October 29, 2021 - 3:00 pm
Location: 
virtual/online

This is Session 5 of 6. Must register for the entire course and not per Session.

Session Co-chairpersons:
Daniela Drago, PhD RAC, Chief Regulatory Officer, Aurion Biotech
Christine E. Garnett, PharmD, Lead, Interdisciplinary Team for Cardiac Safety Studies and Clinical Analyst, United States Food and Drug Administration (US FDA)
Murray "Mac" Lumpkin, MD MSc, Deputy Director - Integrated Development (Regulatory Affairs) and Lead for Global Regulatory Systems Initiatives, Bill and Melinda Gates Foundation 

Teaching Faculty

Wilson Bryan, MD

Director, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research (CBER), US FDA

Daniela Drago, PhD RAC Chief Regulatory Officer, Aurion Biotech

Michael Dyszel

Senior Director, Global Program Head, TA POE & CSR, Bayer US LLC

Sara Eggers, PhD

Office of Program and Strategic Analysis/Office of Strategic Programs, Center for Drug Evaluation and Research (CDER), US FDA
Dionna Green, MD FCP Acting Director, Office of Pediatric Therapeutics, Office of Clinical Policy and Programs, Office of the Commissioner, US Food and Drug Administration

Florence Houn, MD MPH FACP

Consultant

David King, PhD

Senior Director of Regulatory Affairs, Healx

Andrew G. Lee

SVP, Head Global Clinical Trial Operations, Merck Research Labs
Zili Li, MD MPH Vice President, Head of Asia Pacific R&D, Janssen Research & Development
Murray “Mac” Lumpkin, MD MSc Deputy Director – Integrated Development (Regulatory Affairs) and Lead for Global Regulatory Systems Initiatives, Bill and Melinda Gates Foundation
Anabela Marcal European Medicines Agency Liaison at US FDA
Diane Maloney, JD

Associate Director for Policy, Office of the Director, Center for Biologics Evaluation and Research, US FDA

Fortunato (Fred) Senatore, MD PhD FACC Medical Officer, Division of Cardiology and Nephrology, CDER, US FDA

Peter Stein, MD

Director, Office of New Drugs, CDER, US FDA
Toshiyoshi Tominaga, PhD Senior Advisor, Japan Self-Medication Industry

Lynne Yao, MD

Director, Division of Pediatrics and Maternal Health, CDER, US FDA

Judith Zander, MD

Director, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, CDER, US FDA

Additional faculty - case study proctors

Charlie T. Gombar, PhD ACDRS Director
to be confirmed  

Topics

  • US Food and Drug Administration (FDA) applicable laws, regulations, and guidance documents
  • FDA’s Center for Drug Evaluation and Research (CDER) new drug clinical trial and marketing authorization review processes
  • US benefit-risk methodology and considerations
  • US labeling requirements
  • US regulatory outcomes and appeals
  • US regulatory approaches to post-marketing
  • US regulatory requirements for pediatrics, rare diseases, and gene therapies
  • Challenges with and approaches to multi-country clinical trials
  • Starting a clinical trial and obtaining scientific advice in the European Union, the United Kingdom (UK), Japan, China, low-income countries, and the US
  • Procedures and approaches to obtain marketing authorizations from the European Medicines Agency (EMA), the UK’s Medicines and Healthcare products Regulatory Authority (MHRA), Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, National Medical Products Administration (NMPA) of China, WHO’s Prequalification Program and its collaborative process with low-income country National Regulatory Authorities, and the US FDA