News and events

27/06/2013 - 28/06/2013 : EMA

Annual workshop on the European Network of Paediatric Research at the European Medicines Agency

Day one of the workshop is being organised with the assistance of The Organisation for Professionals in Regulatory Affairs (TOPRA) and is an open meeting with members of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) for all stakeholders: patient / parent organisations; network representatives; pharmaceutical-industry staff responsible for paediatric studies; and regulators. Day two is being attended by members of the Enpr-EMA. Places limited. Registration by invitation only.

24/06/2013 - 27/06/2013 : CHMP

Committee for Medicinal Products for Human Use (CHMP): 24-27 June 2013

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. It does not currently publish the minutes or agendas of its meetings. It does publish highlights after each meeting.

19/06/2013 - 19/06/2013 : EMA

First information day on periodic safety update reports (PSURs) – International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E2C(R2) periodic benefit-risk evaluation reports

This information day provides a forum to hear the latest news from regulators running the assessment process and pharmaceutical-industry experts from the ICH E2C Expert Working Group. The discussion will focus on how to ensure the high quality of PSURs and assessment for public health, and on the greater emphasis on meaningful evaluation of important new risk information in the context of a medicine’s benefits. Places limited.

19/06/2013 - 21/06/2013 : CAT

Committee for Advanced Therapies (CAT): 19-21 June 2013

The Committee for Advanced Therapies (CAT) is the committee that is responsible for assessing the quality, safety and efficacy of advanced-therapy medicines. It does not currently publish the minutes or agendas of its meetings. It does publish a meeting report after each meeting.

13/06/2013 - 13/06/2013 : MB

Management Board meeting: 13 June 2013

The Management Board is an integral governance body of the Agency. It has a supervisory role with general responsibility for budgetary and planning matters, the appointment of the Executive Director and the monitoring of the Agency’s performance.

12/06/2013 - 14/06/2013 : PDCO

Paediatric Committee (PDCO): 12-14 June 2013

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.

11/06/2013 - 12/06/2013 : COMP

Committee for Orphan Medicinal Products (COMP): 11-12 June 2013

The Committee for Orphan Medicinal Products (COMP) is the committee that is responsible for reviewing applications for 'orphan medicinal product designation' for medicines intended for the diagnosis, prevention or treatment of rare diseases.

11/06/2013 - 13/06/2013 : CVMP

Committee for Medicinal Products for Veterinary Use (CVMP):11-13 June 2013

The Committee for Medicinal Products for Veterinary Use (CVMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines. It does not currently publish the minutes or agendas of its meetings. It does publish a meeting report after each meeting.

10/06/2013 - 13/06/2013 : PRAC

Pharmacovigilance Risk Assessment Committee (PRAC): 10-13 June 2013

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.

06/06/2013 - 06/06/2013 : EMA

Patients' and Consumers' Working Party

The participants are discussing issues in relation to their general involvement in the European Medicines Agency's activities, giving particular focus to preparation for the election of a new co-chair, Agency training, feedback from the European Patients' Academy on Therapeutic Innovation, public summaries for herbal medicines, the European Union Clinical Trials Register, a workshop on patient-support programmes and patient representation on the Agency's Management Board. Registration by invitation only.

05/06/2013 - 05/06/2013 :

European Medicines Agency Human Scientific Committee’s Working Party with Healthcare Professionals’ Organisations (HCPWP)

The participants of this meeting will be discussing issues in relation to their general involvement in the Agency’s activities. They will focus on the establishment of the Healthcare Professionals’ Organisations Working Party (HCPWP), including the mandate and rules of procedures, roles and responsibilities of the HCPWP members, procedure for election of chairs and other practical information.

05/06/2013 - 05/06/2013 :

Patients' and Consumers' Working Party and Healthcare Professionals' Working Group joint meeting

This is a joint meeting with representatives from patients', consumers' and healthcare professionals' organisations. The participants will be discussing issues in relation to their general involvement in the European Medicines Agency’s activities, giving particular focus to supply shortages, feedback from the Agency workshop on medication errors, benefit-risk-assessment visualisation tools and the communication strategy on additional monitoring.