(0)

DIA会员及用户请点击登录

登录

忘记用户 ID？ or 忘记密码？

Not a Member?

创建账户并加入。

The Crystal

2017 年 10 月 04 日 8:00 上午 - 2017 年 10 月 05 日 8:00 下午

1 Siemens Brothers Way, Royal Victoria Dock, London, E16 1GB, United Kingdom

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.

返回 Agenda

Session 3: Hot Topics – A Regulators’ Perspective

Session Chair(s)

Doris Irene Stenver, MD, MPA

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)

Doris Irene Stenver, MD, MPA

PRAC updates

Doris Irene Stenver, MD, MPA

Unique Advice, Denmark

Independent Pharmacovigilance Adviser

Sabine Straus, MD, PhD, MSc

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

Emil Andrei Cochino, MD, MHS

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)

Nuria Semis-Costa, MSc

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

Nuria Semis-Costa, MSc

European Medicines Agency, Netherlands

Scientific Specialist (Risk Management)

获得信息并保持参与

不要错失任何机会——请加入我们的邮件列表，了解DIA的观点和事件。