This course is designed to provide a firm grounding in key aspects of Global and mainly European Clinical Pre- and Post-Marketing Safety regulatory requirements. This five-day training course now also includes highlights and updates on the 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 (ICH) 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 EU legislation and further detailed in the Good Pharmacovigilance Practices (GVP). Topic 2 will provide a concise summary of the individual and periodic 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 all stakeholders of interventional clinical trials, in line with the implementing texts published in relation to Directive 2001/20/EC, are summarised.
Aspects that need to be taken into account in establishing a Pharmacovigilance database as well as the key functionalities of the EU’s EudraVigilance system will be discussed.
The main elements will be provided for the establishment of a quality system in Pharmacovigilance including aspects of the applicable GVP modules, the elaboration of Standard Operating Procedures (SOPs) and the preparation for audits and inspections.
This session will provide an understanding of safety data classification, using MedDRA terminology and Standardised MedDRA Queries (SMQs) and approaches to signal detection using traditional and quantitative methods.
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 likelihood of occurrence 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.
RISK MANAGEMENT (TOPIC 5)
In accordance with the GVP Module V on Risk Management System, risk management plans (RMPs) should be 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.