ACDRS 2022 Session 5 - Global Clinical Trials Authorization and Marketing Authorization Processes

Monday, September 26, 2022 - 10:00 am to Friday, September 30, 2022 - 3:00 pm

This is Session 5 of 6. Must register for the entire 2022 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, Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research (CDER)
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


  • 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


Wilson Bryan, MD Director, Office of Tissues and Advanced Therapies, CBER, US FDA
Daniela Drago, PhD RAC Chief Regulatory Officer, Aurion Biotech
Mike Dyszel Senior Director, Global Program Head, Pulmonology/Ophthalmology/Established Products & CSR, Bayer US LLC
Sara Eggers, PhD

Director, Decision Support and Analysis Staff, Office of Program and Strategic Analysis/Office of Strategic Programs, CDER, US FDA

Janice Evans

Senior Advisor, Regulatory, Eli Lilly

Florence Houn, MD MPH FACP Consultant
Andy Lee Senior Vice President, Global Clinical Trial Operations, Merck
Zili Li, MD MPH Vice President, Head of Asia Pacific R&D, Janssen Research & Development (China)
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 (EMA) Liaison Official at US FDA
Adora Ndu, PharmD JD Chief Regulatory Affairs Officer, BridgeBio
Fortunato (Fred) Senatore, MD PhD FACC

Medical Officer, Division of Cardiovascular and Renal Products, CDER, US FDA 

Peter Stein, MD

Director, Office of New Drugs, CDER, US FDA 
Toshiyoshi Tominaga, PhD

Project Professor, Clinical and Translational Research Center, School of Medicine, Keio University (Japan)

Lynne Yao, MD

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

Judith Zander, MD

Director, Office of Pharmacovigilance and Epidemiology (OPE), Office of Surveillance and Epidemiology (OSE), CDER, US FDA

Additional faculty - case study proctors

Lauren Brunke, PharmD RPh Director, Global Labeling, Regulatory Affairs, Eli Lilly and Company
Janelle Burnham, MD Clinical Director, Pediatric Center of Excellence, Pfizer
Nicholas Langevin, MS RAC Director, Regulatory Affairs, Sunovion Pharmaceuticals
Todd Page, PhD DABT Senior Director, Global Regulatory Affairs - North America, Eli Lilly and Company
Lt. Commander Melissa A Reyes, MD MPH FAAD DTMH Medical Officer, Division of Pharmacovigilance I, OPE, OSE, CDER, US FDA