San Antonio, Texas

RAPS 2020 Convergence (Regulatory Affairs Professionals Society)

  • Start Date:

    13 Sep, 2020

  • End Date:

    16 Sep, 2020

  • Location:

    Virtual Conference

  • Region:

    North America


thought leadership

1

Advanced Therapy – What Is It?
Date: Monday, September 14 at 12:00 PM – 1:30 PM ET


Moderated by: Kirsten Messmer, PhD, RAC, Principal Regulatory Affairs Specialist (PPD)

Speakers:
– Tobias Fleischmann, Dr. rer. nat., Dipl. Biol., Principal Regulatory Affairs Specialist (PPD)
– Kamali Chance, PhD, MPH, RAC, Chief Regulatory Office, BioSciences Corporation
– Ana Hidalgo-Simon, MD, PhD, European Medicines Agency

Moderated by: Ahmed Abouelnour, MSc., RAC, Senior Specialist, Regulatory Affairs, Medicago

Speakers:
– John Joines, RPh, RAC, Senior Manager, Regulatory Affairs (PPD)
– Michael Craig, BSc Pharm, Principal Consultant, PARAXEL International

3

Technology and Innovation Case Studies in Regulatory Affairs
Date: Monday, September 14 at 2:05 PM – 3:00 PM




Speakers:
– Brian Wellins, MBA, Senior Director, Pharmacovigilance and Regulatory Affairs (PPD)
– Rob Connelly, MBA, Product Management, Certara

Moderated by: Ilker Oztop, PhD, Director, Data Science Portfolio Management, Janssen Pharmaceuticals

Speakers:
– Eric Faulker, MPH, Vice President, Real-World Value and Strategy (Evidera)
– Dharmi Shah, PharmD, Post-Doctoral Fellow, Global Regulatory Affairs – Labeling, Sanofi
– Xavier Kurz, MD, MSc, PhD, Head of Surveillance & Epidemiology, European Medicines Agency

5

Gene Editing – Where are We Now?
Date: Tuesday, September 15 at 1:00 PM – 2:30 PM


Moderated by: Kirsten Messmer, PhD, RAC, Principal, Regulatory Affairs (PPD)

Speakers:
– Daniel O’Connell, PhD, Associate Director, Intellia Therapeutics, Inc
– Aron Stein, PhD, Vice President, Global Regulatory Affairs, Sangamo Therapeutics, Inc.
– James Valentine, JD, Associate, Hyman, Phelps & McNamara PC


Moderated by: Kirsten Messmer, PhD, RAC, Principal, Regulatory Affairs (PPD)

Speakers:
– Richard Dennett, PhD, Senior Director, Regulatory Affairs (PPD)
– Ana Hidalgo-Simon, MD, PhD, European Medicines Agency

Moderated by: Kenneth Butz, Associate Director, Regulatory Affairs (PPD)

Speakers: Armin Ritzhaupt, PhD, MPH, European Medicines Agency