Back to Agenda
Session 5: Challenges of the Implementation
Session Chair(s)
Nick Sykes, MS
Policy Advisor, Regulatory Strategy, EFPIA, Belgium
This session will take the form of a panel discussion involving commercial and non-commercial sponsors, member state representatives, and service providers. Panellists will respond to specific questions set by the chair along with questions being posed from the audience. Key considerations to be discussed include the challenges that exist with implementing the Regulation and actions that can be taken to maintain momentum in the face of delays in the final implementation date.
Panel Discussion with Q&A
Speaker(s)
Elisna Maree
Associate Director - Regulatory Affairs , Vectura Limited, United Kingdom
Stéphanie Kromar
Senior Regulatory Affairs Manager, European Organisation for Research and Treatment of Cancer (EORTC) , Belgium
Leona Fitzgerald
Senior Director, Regulatory Affairs, PPD, United Kingdom
Judith Creba, PHD
Sr. Global Program Regulatory Director, Reg Affairs GDD Region EU, Novartis Pharma AG, Switzerland
Lucie Kravackova, DrMed
Senior Clinical Assessor, State Institute for Drug Control (SUKL), Czech Republic
Karen Kiilerich
Special Legal Consultant, The National Committee on Health Research Ethics , Denmark
Have an account?