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News about GMP/cGMP

2009-08-10

EMEA: Announcement of European Medicines Agency priorities for adverse drug reaction research

 At its plenary meeting on 19 March 2009, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted its 2010 priorities for drug safety research based on recommendations from the CHMP’s Pharmacovigilance Working Party.

 

The priorities were developed with a view to them being considered as future topics for the 4th Call of the European Commission's Framework Program (FP7).

On 30 July 2009, the Commission published several calls for proposals of FP7 including three calls under the ‘Health’ Theme. The priorities for adverse drug reaction research are reflected in the call ‘FP7-HEALTH-2010-single-stage’, call topic HEALTH.210.4.2-3, Adverse drug reaction research and the European Medicines Agency now wishes to release complementary information with the aim to support researchers in developing proposals that meet the needs of the respective selected research area (please see links below).

Proposals to the call topic HEALTH.2010.4.2-3: Adverse drug reaction research should address one of the below areas and more than one project might be funded.

  1. Long-term effects in children and in young adults of methylphenidate in the treatment of attention deficit hyperactivity disorder (ADHD)

  2. Long-term adverse effects of immunomodulators (monoclonal antibodies)

  3. Long-term adverse skeletal effects of bisphosphonates

  4. Medicine use in pregnancy (design of effective pregnancy prevention programmes, recommendations for safe use in pregnancy)

  5. Suicidal behaviour in relation to certain drug use (antidepressants, antipsychotics, varenicline, montelukast)

  6. Safety aspects of antipsychotics in demented patients

Further information on the FP7 calls and specifically on the call ‘FP7-HEALTH-2010-single-stage’ can be found at http://cordis.europa.eu/fetch?CALLER=FP7_NEWS&ACTION=D&RCN=31090 and http://cordis.europa.eu/fp7/dc/index.cfm?fuseaction=UserSite.CooperationDetailsCallPage&call_id=278

Source: EMEA News Release, AUG 2009

 

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