Event and meeting calendar

2017-07-03 - 2017-07-06 : PRAC

Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 July 2017

The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee that is responsible for assessing all aspects of the risk management of medicines for human use.

2017-07-03 - 2017-07-03 : EMA

Fourth industry stakeholder platform on the operation of the centralised procedure for human medicines

The objective of these platform meetings is to foster a constructive dialogue with industry stakeholders on operational matters of the centralised procedure and to identify opportunities for improvement. The focus of this fourth meeting is the outcome of the tripartite survey between rapporteurs, Industry and the European Medicines Agency on initial marketing authorisation applications. Other topics include an exchange of experience with the new accelerated assessment process and the new linguistic review process, share experience with the use of the effects table to support benefit-risk discussions and to get Industry feedback on some important updates in our post-authorisation procedures.