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Session 5 – EU Regulatory Updates
Session Chair(s)
Stephen Knowles, MD, MRCP
Chief Medical Officer
Halozyme Therapeutics, United States
Mick Foy
Director of Delivery
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
You will hear from a member of the MHRA on initiatives to move beyond the implementation of the new pharmacovigilance legislation to enable the operation of the requirements to the highest possible standards against agreed standards and best practice - The SCOPE project, a three year EU-wide pharmacovigilance project, is being coordinated by the MHRA to help member states meet the requirements of the new pharmacovigilance legislation. The second presentation, given by an Industry representative, will look at the implications of the new CT regulations for PASS studies, both interventional and non-interventional. The final presentation will be a view from the EMA on regulatory pathways for Adaptive licensing, an increasingly important way to make medicines available quickly for life-threatening diseases where there is no currently available effective treatment.
Speaker(s)
SCOPE Project
Mick Foy
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Director of Delivery
The New EU CT Regulations: Implications for Interventional and Non-Interventional PASS
Michelle Bulliard, BSN
IQVIA, Switzerland
Vice President, Global Head Real-World Evidence Strategy Unit
Adaptive Pathways
Hans-Georg Eichler, MD, MSc
Austrian Association of Social Security Bodies, Austria
Consulting Physician