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Virtual Event

02 nov 2020 1:00 p.m. - 04 nov 2020 4:25 p.m.

(Central Europe Standard Time)

4051 Basel, Switzerland

Pharmacovigilance Strategies Workshop

Session 1: Recent and Future Development on Pharmacovigilance Practices

Session Chair(s)

Francoise  Sillan, MD

Francoise Sillan, MD

EU1 UK QPPV

Ipsen, France

This session will be dedicated to future trends of regulations and guidelines within and outside Europe. Following Brexit, the move of EMA from London to Amsterdam and the recent COVID 19 pandemic this activity has been deprioritized since end 2018. This session will present the challenges on pregnancy and lactation safety monitoring from EMA, MHRA and IMI perspectives. There will be an update on the future developments of post approval safety data management with the revision of ICHE2D guideline by Expert Working Group which will include the revision of the management of reports from patient support programmes and market research programmes.

Speaker(s)

Johan  Hellmér, MD, PhD

E2D: update of Post Approval Safety Data Management - Definition and Standards for Expedited Reporting

Johan Hellmér, MD, PhD

Takeda Pharmaceuticals, Sweden

EUQPPV

Corinne  de Vries, PhD, MA, MSc

EMA Pregnancy Guidelines

Corinne de Vries, PhD, MA, MSc

European Medicines Agency, Netherlands

Head of Translational Sciences Office

David John Lewis, PhD

IMI Conception Project

David John Lewis, PhD

Novartis Pharma Gmbh, Switzerland

Former Head QPPV PRRC Office, Patient Safety & Pharmacovigilance

Belen  Granell Villen

Panel discussion with Q&A, with the additional participation of:

Belen Granell Villen

The Association of the British Pharmaceutical Industry (ABPI), United Kingdom

Quality and Safety Policy Executive (MRPharmS)

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