Dr Petracek to lecture at EMA Excellence in Pharmacovigilance
Oct 13, 2014
PharmInvent CEO Dr Jan Petracek is one of the leading experts who will be lecturing at the EMA Excellence in Pharmacovigilance: Clinical trials and post-marketing being held in London October 13th to October 17th 2014.
During this five-day long training course presented by the EMA, Dr Petracek will give a total of four lectures on topics such as Signal Management in the European Union, Challenges and Possibilities for Risk communication in EU, Industry perspective on Risk Management Plans, and Effectiveness of Risk Minimisation Measures.
The course is designed to provide a firm grounding in key aspects of Global and European Clinical Pre- and Post- Marketing Safety regulatory requirements. The course will also highlight and provide updates on the implementation of the new pharmacovigilance legislation as well as the latest news on international harmonisation and standardisation activities in pharmacovigilance. The key learning objectives include Risk Management, Signal Detection, Diagnosis and Management of Adverse Drug Reactions, Regulatory Aspects in Pharmacovigilance and Practical Examples, and Definitions and Methods in Pharmacovigilance.