ACDRS 2024 Session 5 - Global Clinical Trials Authorization and Marketing Authorization Processes

Date: 
Wednesday, September 4, 2024 - 8:00 am to Friday, September 6, 2024 - 4:00 pm
Location: 
University of California Washington Center (UCDC), 1st floor meeting room

Full map

1608 Rhode Island Ave NW, Washington DC

This is Session 5 of 6. Must register for the entire 2024 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)

 

Lecturers

Yumiko Asano, MSc Head of Chugai Partnering, Chugai (Japan)
Eric Brodsky, MD Associate Director, Labeling Policy Team, OND, CDER, US FDA
Danielle H. Corwin, PhD Chief of Staff for Regulatory Strategy and Business Excellence, Global Regulatory Affairs, Specialty Care, Sanofi
Daniela Drago, PhD RAC FRAPS FTOPRA Expert Consultant, NDA Partners
Michael Dyszel R&D Project Excellence Lead, CSL Bering
Sara Eggers, PhD

Director, Decision Support and Analysis Staff, Office of Program and Strategic Analysis/Office of Strategic Programs, CDER, US FDA
Lola Fashoyin-Aje, MD MPH Director, Office of Clinical Evaluation, Office of Therapeutic Products, Center for Biologics Evaluation and Research, US FDA
Kurt Karst, JD Director, Hyman, Phelps & McNamara, PC
Qi Liu, PhD MStat FCP Associate Director for Innovation and Partnership, Office of Clinical Pharmacology, CDER, US FDA
Anabela Marcal, PharmD (to be confirmed) 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
Donna Rivera, PharmD MSc Associate Director of Pharmacoepidemiology, Oncology Center of Excellence, US FDA
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
Prabha Viswanathan, MD, Deputy Director, Office of Pediatric Therapeutics, Office of Clinical Policy and Programs, Office of the Commissioner, US FDA
Kimberly Wolfram, MS Head of Global Regulatory Affairs CMC, Biologics/ATMP, Biogen
Wendy (Xiaojun) Yan, MBA Senior Vice President, Senior Advisor, BeiGene, Ltd. (China)
Michelle Zucatti, MHA Strategic Communications Lead, 3D Communications

Additional faculty - case study proctors

Lisa Boyette, MD PhD Executive Director, Clinical Development Gilead Sciences
Christine E. Garnett, PharmD Lead, Interdisciplinary Team for Cardiac Safety Studies and Clinical Analyst, Division of Cardiovascular and Renal Products, Office of New Drugs, CDER, US FDA
Caroline (Carrie) Grimes Head of Portfolio Program Management - R&D Performance Solutions, AbbVie
Charlie T. Gombar, PhD ACDRS Director
Nashaat Rasheed, PhD MEng MSc Science Policy Analyst, Biomarker QP, OND, US FDA

Topics

  • 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 cell and gene therapies
  • Enhancing diversity in clinical trial populations
  • Chemistry, Manufacturing, and Control (CMC) section of regulatory applications
  • US FDA advisory committee meetings and CHMP oral explanations
  • Starting a clinical trial and obtaining scientific advice in the European Union, China, and Japan
  • Procedures and approaches to obtain marketing authorizations from the European Medicines Agency (EMA), National Medical Products Administration (NMPA) of China, Pharmaceuticals and Medical Devices Agency of Japan, and the US FDA
  • Development of pediatric therapeutics
  • Real-world data and real-world evidence
  • Artificial intelligence and machine learning in drug development