Keynote abstract
At the first part of the workshop we will give a short history of pharmacovigilance, and an overview of the international collaboration (WHO, ICH, EU). The importance of adverse drug reaction monitoring was recognized in Croatia already in 1974 when the National Centre for Adverse Drug Reaction was instituted in the University Hospital Zagreb. In March 2005, after new legislation came into force, the obligation of pre- and post-marketing drug safety surveillance was delegated to the Agency for Medicinal Products and Medical Devices (Agency) and the Agency’s Pharmacovigilance Unit was than formed.
The principles of Pharmacovigilance will be given and the reporting method will be discussed: differences about adverse events found in clinical trial phase and post marketing. Also the definitions of seriousness, expectedness of ADRs will be given, and how we complete a causality assessment.
The workshop will deal also with the regulatory requirements in the EU and Croatia in the field of Pharmacovigilance. The importance of Periodic Safety Updates Reports (PSURs) will be stressed, and in the end there will be some examples of regulatory actions which were taken for safety reasons in the past.
