(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。

NH Berlin Alexanderplatz

2017 年 04 月 25 日 8:00 上午 - 2017 年 04 月 26 日 4:30 下午

Landsberger Allee 26-32, 10249 Berlin, Germany

Essentials and Overview of the Regulatory Framework in Europe

ONLY 1 OFFERING IN 2017! The course will give an overview of the European regulatory system for human medicines.

返回 Agenda

SESSION 8: PHARMACOVIGILANCE

Session Chair(s)

Katarina Jelic Maiboe, PHD

Katarina Jelic Maiboe, PHD

Denmark

  • Pharmacovigilance legislation
  • Post-authorisation Safety Study (PASS) & Post-Authorisation Efficacy Study (PAES)
  • Dossier requirements: Risk Management Plan (RMP), Periodic Safety Update Report (PSUR)
  • Safety procedures / referrals
  • Pharmacovigilance Risk Assessment Committee (PRAC)

Speaker(s)

Katarina Jelic Maiboe, PHD

PHARMACOVIGILANCE

Katarina Jelic Maiboe, PHD

Denmark

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。