Help with ADR Research
European Union focuses on adverse drug reaction research.
While the EU pushes ahead with its discussions of tighter rules on pharmacovigilance, some help has been announced for research into adverse drug reactions.
At the end of July, the EU invited proposals for research into half a dozen specific areas. Three of these concern long-term effects: of methylphenidate on children and young adults being treated for attention deficit hyperactivity disorder; of monoclonal antibodies as immunomodulators; and of adverse skeletal effects of bisphosphonates.
The other fields cover medicine use in pregnancy (investigating the design of effective pregnancy prevention programs and recommendations for safe use in pregnancy); suicidal behavior in relation to antidepressants, antipsychotics, varenicline, and montelukast; and the safety aspects of antipsychotics in demented patients.
Further information 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.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
