The Workshop: “ICH Endorsed Pharmacovigilance”
The Agency for Medicinal Products and Medical Devices (HALMED) and the Drug Information Association (DIA) are organising a workshop on ICH standards for pharmacovigilance (E2) entitled "ICH Endorsed Pharmacovigilance”. The workshop will be held on 28 and 29 November 2013, at HALMED’s premises, Robert Frangeš Mihanović Street 9 (Sky Office Building).
The workshop will include topics related to pharmacovigilance standards impleneted in a pre- and post-authorisation phase and the implementation of ICH guidelines in an international environment. The workshop includes also case studies and examples from practice.
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project aimed at harmonising regulatory authorities in Europe, Japan and USA and pharmaceutical manufacturers of those regions in interpreting and implementing technical requirements and guidelines for granting marketing authorisations by reducing and avoiding the need for repeated testing during the research and development of medicines.