10th Annual Forum for Qualified Persons in Pharmacovigilance

This is the only forum designed for QPPVs by QPPVs, now in its 10th year and ever growing. This year’s objectives build on past successes and have been shaped by valuable feedback provided by participants of the past nine meetings. There is an enhanced opportunity for networking as the lectures are followed by a dinner.

Back to Agenda

Session 3 Hot Topics – A Regulators’ Perspective

Session Chair(s)

Doris Irene Stenver, MD, MPA

Independent Pharmacovigilance Adviser

Unique Advice, Denmark

Following completion of the implementation of the 2012 pharmacovigilance legislation, PRAC has engaged in further development of a wide range of areas. For the QPPV it is important to keep abreast with these developments. Among the ongoing activities is the development of the conduct of pharmacovigilance in relation to biologicals. The PRAC is also involved to an increasing extent in the scientific advice process, risk management planning for high risk products and in the development of the PAES concept. Finally, this session will highlight how PRAC utilizes real world evidence as a basis for their decisions.

Speaker(s)

Pharmacovigilance – Specific Aspects for Biologicals

Brigitte Keller-Stanislawski

Paul-Ehrlich-Institut, Germany

Head, Pharmacovigilance

Risk Management Planning for New Products

Margarida Guimaraes

European Medicines Agency, Netherlands

Scientific Administrator

Use of Real World Evidence in Decision-Making – Challenges and Opportunities

Xavier Kurz, MD, PhD, MSc