All EventsRAPS 2020 Convergence (Regulatory Affairs Professionals Society)Start Date:13 Sep 2020End Date:16 Sep 2020Location: Virtual ConferenceRegion:North Americavisit the conference websitethought leadership1Advanced Therapy – What Is It?Date: Monday, September 14 at 12:00 PM – 1:30 PM ETModerated 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 Agency2Cannabis and Plant Derived Products as Pharmaceutical Products: Challenges and HarmonizationDate: Monday, September 14 at 2:05 PM – 3:00 PMModerated by: Ahmed Abouelnour, MSc., RAC, Senior Specialist, Regulatory Affairs, MedicagoSpeakers: – John Joines, RPh, RAC, Senior Manager, Regulatory Affairs (PPD)– Michael Craig, BSc Pharm, Principal Consultant, PARAXEL International3Technology and Innovation Case Studies in Regulatory AffairsDate: 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, Certara4Regulatory-Grade Evidence: Is There Global Consensus On Existing Real-World Evidence (RWE) Frameworks?Date: Tuesday, September 15 at 11:00 AM – 12:30 PMModerated by: Ilker Oztop, PhD, Director, Data Science Portfolio Management, Janssen PharmaceuticalsSpeakers: – 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 Agency5Gene Editing – Where are We Now?Date: Tuesday, September 15 at 1:00 PM – 2:30 PMModerated 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 PC6Introduction to Advanced Therapies: Focusing on Regulatory Considerations for the Development of CAR-T Cell Immunotherapy ProductsDate: Wednesday, September 16 at 12:05 PM – 1:00 PMModerated 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 Agency7Companion Diagnostics in an Evolving Global Regulatory Landscape: Alignment of Co-Development Strategies for Diagnostics and Targeted TherapiesDate: Wednesday, September 16 at 10:35 AM – 11:30 AMModerated by: Kenneth Butz, Associate Director, Regulatory Affairs (PPD)Speakers: Armin Ritzhaupt, PhD, MPH, European Medicines AgencyLearn More about our regulatory affairs expertise