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Session 5: Challenges of the Implementation
Session Chair(s)
Nick Sykes, MS
Policy Advisor
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
Vectura Limited, United Kingdom
Associate Director - Regulatory Affairs
Stéphanie Kromar
European Organisation for Research and Treatment of Cancer (EORTC) , Belgium
Senior Regulatory Affairs Manager
Leona Fitzgerald
PPD, United Kingdom
Senior Director, Regulatory Affairs
Judith Creba, PhD
Novartis Pharma AG, Switzerland
Sr. Global Program Regulatory Director, Reg Affairs GDD Region EU
Lucie Kravackova, DrMed
State Institute for Drug Control (SUKL), Czech Republic
Senior Clinical Assessor
Karen Kiilerich
The National Committee on Health Research Ethics , Denmark
Special Legal Consultant