Upcoming events / Executive Training

September

19

2017

Marketing Authorisation Outside the ICH Region
September

20

2017

PharmaFORUM Webcast International
September

25

2017

Masterclass EU QPPV
September

28

2017

Regulatory Leaders FORUM
September

28

2017

HTA Assessment in Germany, Spain, the UK and the EU
October

09

2017

Pharmacovigilance Inspection Readiness
October

17

2017

Advanced Pharmacovigilance Writing and Management
October

17

2017

CMC Documents: Scientific Writing for Regulatory Submission
October

24

2017

Marketing Authorisation in ASIA
October

25

2017

Getting Biosimilars on the US Market
October

26

2017

PV Requirements in Emerging Markets
November

21

2017

Marketing Authorisation for Human Medicines in Latin America
November

22

2017

Off-Label Use in Europe
November

27

2017

EU Regulatory Affairs Introductory Training Course
November

29

2017

Scientific Writing: Abstracts and Posters
December

06

2017

The EU Regulatory Affairs Expert
December

07

2017

Set up of a Global PV Quality & Compliance System
January

23

2018

Toxicology Winter School

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Pharmacovigilance Inspection Readiness

09-10-2017

In order to ensure that marketing authorisation holders comply with pharmacovigilance obligations, competent authorities conduct pharmacovigilance inspections at specific intervals. Our workshop will provide insights into the current pharmacovigilance inspection strategy in Europe.

After attending the seminar you will:

know the differences in the inspections of the two major authorities in Europe;
be able to plan and prepare for pharmacovigilance inspections according to the different requirements; and
improve how you process findings during and after the inspection.

9 October 2017 in Frankfurt