News and events

2017-12-12 - 2017-12-15 : PDCO

Paediatric Committee (PDCO): 12-15 December 2017

The Paediatric Committee (PDCO) is the committee that is responsible for assessing the content of paediatric investigation plans, which describe how a medicine should be studied in children, as well as waivers and deferrals.

2017-12-11 - 2017-12-12 : EMA

A common data model in Europe? – Why? Which? How?

This meeting will aim to define the opportunities and challenges in applying a common data model in Europe to support regulatory decision-making and agree guiding principles for the development of such a model, including key criteria for validation in the context of regulatory decision-making. A common data model could help harmonise healthcare data across multiple data sets and provide a mechanism to conduct pan-European studies in a timely manner to address regulatory questions. At the same time, applying a common model to European data has multiple challenges. The meeting will bring together regulators with academia, data holders and the pharmaceutical industry.

2017-12-11 - 2017-12-14 : CHMP

Committee for Medicinal Products for Human Use (CHMP): 11-14 December 2017

The Committee for Medicinal Products for Human Use (CHMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning human medicines.