Current Challenges in Pharmacovigilance Pragmatic Approaches : Report of CIOMS Working Group V

In spite of progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines, consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for the pharmaceutical industry and drug regulators.;The CIOMS Working Group V generated proposals for pragmatic approaches to dealing with issues such as: classification and handling of individual safety case reports from a variety of sources; new approaches to case management and regulatory practices; improvements and efficiences in the format, content and reporting of periodic safety update reports; and determination and use of populations exposure date. The Group also looked at the state of expedited and periodic clinical safety reporting requirements around the world and made recommendations for enhancing the harmonization steps already made. The volume also deals with unfinished and unresolved issues from previous working groups. Overall the document is a comprehensive treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professions.