11th Annual Forum for Qualified Persons in Pharmacovigilance

This is the only forum designed for QPPVs by QPPVs, now in its 11th year and ever growing. This year’s objectives build on past successes and have been shaped by valuable feedback provided by participants.

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Session 3: Hot Topics – A Regulators’ Perspective

Session Chair(s)

Doris Irene Stenver, MD, MPA

Independent Pharmacovigilance Adviser

Unique Advice, Denmark

The activities in the Pharmacovigilance Risk Assessment Committee (PRAC) covers a wide range of procedures, and the level of experience has reached a high level of matureness more than 5 years after the 2012 EU pharmacovigilance legislation came into force. For the QPPV it is important to keep abreast with the PRAC activities, and the current session will provide valuable insight into the functioning of the PRAC. Which are the current hot topics the committee is dealing with? Who are the most important stakeholders and how does the PRAC cooperate with them? Answers to these and many more questions will be provided in this session.

Speaker(s)

PRAC updates

Doris Irene Stenver, MD, MPA

Unique Advice, Denmark

Independent Pharmacovigilance Adviser

Feedback on PRAC´s First Public Hearing and Highlights on Signal Management

Sabine Straus, MD, PhD, MSc

Medicines Evaluation Board (MEB), Netherlands

Former PRAC Chair

The RMP in the life cycle of the product – originator/generic/biosimilar

Emil Andrei Cochino, MD, MHS

European Medicines Agency, Netherlands

Scientific Senior Specialist (Risk Management)

The RMP in the life cycle of the product – originator/generic/biosimilar

Nuria Semis-Costa, MSc

European Medicines Agency, Netherlands

Scientific Specialist (Risk Management)

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11th Annual Forum for Qualified Persons in Pharmacovigilance

Session 3: Hot Topics – A Regulators’ Perspective

Session Chair(s)

Doris Irene Stenver, MD, MPA

Speaker(s)

PRAC updates

Feedback on PRAC´s First Public Hearing and Highlights on Signal Management

The RMP in the life cycle of the product – originator/generic/biosimilar

The RMP in the life cycle of the product – originator/generic/biosimilar

Be informed and stay engaged.