EMA Excellence in Pharmacovigilance: Clinical Trials and Post-Marketing

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 now also including highlights and updates on the implementation of the new pharmacovigilance legislation and the latest news on the international harmonisation and standardisation activities in pharmacovigilance.

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)

Pharmacovigilance is first based on the medical assessment of the adverse events passively or actively collected in organised schemes. It is then essential to be able to identify consistently the nature of events, their seriousness, their expectedness and to assess causality with the suspect drug(s). This session will provide clues for the recognition of two serious events involving target organs of drug toxicity.

SIGNAL DETECTION (TOPIC 4)

New safety signals may emerge at any time following product launch and must be evaluated for relative risk, medical importance, and likelihood of occurrence. This session will provide an understanding of safety data classification and approaches to signal detection using traditional and quantitative methods.

RISK MANAGEMENT (TOPIC 5)

In accordance with the European Guideline on Risk Management System, risk management plans (RMPs) are now submitted by companies to propose activities aiming to identify, characterise or minimise risks associated with medicinal products. Given the potential public health implications and costs of such interventions, RMPs should be based on robust epidemiological methods. This session aims to provide the background for understanding drug-related risks, to review epidemiological methods for detecting signals and assessing risks, and to present recent developments regarding risk communication.