ACDRS 2023 Session 5 - Global Clinical Trials Authorization and Marketing Authorization Processes

Wednesday, September 27, 2023 - 8:00 am to Friday, September 29, 2023 - 4:00 pm
University of California Washington Center (UCDC), 1st floor meeting room

1608 Rhode Island Ave NW, Washington DC

This is Session 5 of 6. Must register for the entire 2023 Course and not per session.

Session Co-chairpersons:
Daniela Drago, PhD RAC FRAPS FTOPRA, Expert Consultant, NDA Partners
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


Asha Das, MD Director, Division of Clinical Evaluation Oncology, Office of Therapeutic Products, Center for Biologics Evaluation and Research, US FDA
Matias Diez Head of International Regulatory, Sanofi
Daniela Drago, PhD RAC FRAPS FTOPRA Expert Consultant, NDA Partners
Michael Dyszel Vice President, Product Development Leader, Pyxis Oncology
Sara Eggers, PhD

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

Carlos O. Garner, PhD Vice President, Global Regulatory Affairs, Eli Lilly and Company
Qi Liu, PhD MStat FCP (to be confirmed) Associate Director for Innovation and Partnership, Office of Clinical Pharmacology, CDER, US FDA
Anabela Marcal, PharmD EMA Liaison Official to US FDA, European Medicines Agency
CAPT David Moeny, RPh MPH Director, Division of Epidemiology II, Office of Surveillance and Epidemiology, CDER, US FDA
Adora Ndu, PharmD JD Chief Regulatory Affairs Officer, BridgeBio
Lihua Pan

Head of China Policy, Drug Regulatory Affairs, Novartis

Andrew Robertson, PhD JD MS Vice President, Head of Global Regulatory Policy and Innovation, Takeda
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
Michelle Zucatti, MHA Strategic Communications Lead, 3D Communications

others to be confirmed


Additional faculty - case study proctors

Janelle Burnham, MD Clinical Director, Pediatric Center of Excellence, Pfizer

Caroline C. Grimes

Head of R&D Performance Solutions, AbbVie


(subject to change)

  • US 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 rare diseases and gene therapies
  • Challenges with and approaches to multi-country clinical trials
  • US FDA advisory committee meetings and CHMP oral explanations
  • FDORA, PDUFA VII, and their impact on US FDA-regulated industry and US FDA
  • Starting a clinical trial and obtaining scientific advice in the EU, the UK, Japan, China, low-income countries, and the US
  • Procedures and approaches to obtain marketing authorizations from the European Medicines Agency (EMA), National Medical Products Administration (NMPA) of China, and the US FDA
  • Corporate social responsibility
  • Real-world data and real-world evidence
  • Artificial intelligence and machine learning