• Home
  • News and Events

News and events

  • Email
  • Help

This section of the website contains the European Medicines Agency's news and press releases, information on meetings and events, public consultations and related information.

For a scrolling feed of all of the new and updated information published on the website, see the what's new page.

Latest news

This month's events

February 2016

M T W T F S S
1 2 3 4 5 6 7
8 9 10 11 12 13 14
15 16 17 18 19 20 21
22 23 24 25 26 27 28
29
  • 24/02/2016 - 26/02/2016 : PDCO

    Paediatric Committee (PDCO): 24-26 February 2016

    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.

  • 22/02/2016 - 25/02/2016 : CHMP

    Committee for Medicinal Products for Human Use (CHMP): 22-25 February 2016

    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.

  • 18/02/2016 - 19/02/2016 : CAT

    Committee for Advanced Therapies (CAT): 18-19 February 2016

    The Committee for Advanced Therapies (CAT) is the committee that is responsible for assessing the quality, safety and efficacy of advanced-therapy medicines.

  • 16/02/2016 - 18/02/2016 : COMP

    Committee for Orphan Medicinal Products (COMP): 16-18 February 2016

    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.

  • 16/02/2016 - 18/02/2016 : CVMP

    Committee for Medicinal Products for Veterinary Use (CVMP): 16-18 February 2016

    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.

  • 08/02/2016 - 11/02/2016 : PRAC

    Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 February 2016

    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.

  • 05/02/2016 - 05/02/2016 : EMA

    Workshop for micro-, small- and medium-sized enterprises: statistical perspectives in regulatory clinical development programmes

    This workshop aims to provide an introduction to general statistical considerations in clinical trials, and address statistical aspects of exploratory and confirmatory clinical trials.

  • 04/02/2016 - 05/02/2016 : EMA

    Challenges for the approval of anti-cancer immunotherapeutic drugs

    Immunotherapy is becoming a fast growing area of new medicinal products in oncology. These new agents have brought important advances in patient care and have considerably changed the landscape of treatment options in melanoma and lung cancer patients. However, there are still many challenges on how to bring these agents through regulatory approval and into clinical practice. Appropriate patient population selection, new clinical trials designs, rational for the mechanism of action in different tumour types, innovative immunological-based products used in combination and assessing relative efficacy of these novel immunomodulating therapies are some of the key issues that we propose to address in a workshop organised with the Cancer Drug Development Forum (CDDF). The aim is to address these highly relevant issues and their impact on the regulatory environment.

  • 03/02/2016 - 05/02/2016 : EMA

    Training on electronic reporting of individual case safety reports (ICSRs) to EudraVigilance in the European Economic Area

    This training course covers all aspects on the functionalities of the EudraVigilance system, specifically EVWEB, the web interface tool for the electronic reporting of ICSRs, with practical examples and exercises in the EudraVigilance training environment. The training will include the fundamentals of electronic transmission of ICSRs and the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M2 safety and acknowledgment message specifications as well as the ICH E2B(R2) specifications on clinical safety data management in the frame of good pharmacovigilance practices and the current EudraVigilance business rules.

  • 01/02/2016 - 02/02/2016 : HMPC

    Committee for Herbal Medicinal Products (HMPC): 1-2 February 2016

    The Committee on Herbal Medicinal Products (HMPC) is the committee that is responsible for preparing the Agency’s opinions on questions relating to herbal medicines.