Date(s) And Time(s):
Oct 25 2010 7:45AM - Oct 29 2010 3:30PM
Hotel Renaissance Penta
Clinical Safety/Pharmacovigilance, Regulatory Affairs
This course is designed to provide a firm grounding in key aspects of Global Clinical Pre and Post Marketing Safety. This five-day training course, presented by the European Medicines Agency, is the only one of its kind.
DEFINITIONS AND METHODS IN PHARMACOVIGILANCE (TOPIC 1)
Topic 1 will provide a concise overview of the objectives and the scope of Pharmacovigilance and Risk Management and the relationship between the two concepts. The development of key definitions based on Community legislation and consensus fora such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and the CIOMS Working Groups will be summarised. Practical examples and exercises will be used to illustrate the key definitions and vocabulary applied in Pharmacovigilance.
REGULATORY ASPECTS IN PHARMACOVIGILANCE AND PRACTICAL EXAMPLES (TOPIC 2)
The roles and responsibilities of marketing authorisation holders and national Competent Authorities in the conduct of Pharmacovigilance are defined in Community legislation and further detailed in Volume 9A of the ‘Rules Governing Medicinal Products in the European Union and Guidelines on Pharmacovigilance for Medicinal Products for Human Use’. Topic 2 will provide a concise summary of the adverse reaction reporting requirements of marketing authorisation holders in the post-authorisation phase and illustrations based on practical case studies. Furthermore, the roles and responsibilities of sponsors of interventional clinical trials in line with the implementing texts published in relation to Directive 2001/20/EC are summarised. Taking into account the international dimension of Pharmacovigilance, the session will further address key differences in the regulatory environment of the US and Japan. Aspects that need to be taken into account in establishing a Pharmacovigilance database, the use of MedDRA as well as the key functionalities of the EU’s EudraVigilance system and the FDA’s Adverse Event Reporting System (AERS) will be discussed. The main elements will be provided for the establishment of quality system assurance in Pharmacovigilance including aspects of good Pharmacovigilance practices, the elaboration of Standard Operating Procedures (SOPs) and the preparation for audits and inspections.
DIAGNOSIS AND MANAGEMENT OF ADVERSE DRUG REACTIONS (TOPIC 3)
EUROPEAN BRANCH OFFICE
Tel.: +41 61 225 51 51
Fax: +41 61 225 51 52