3-Hour Virtual Seminar - Good Pharmacovigilance Practice

Pharmacovigilance or drug safety -is a broad term that describes the Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. Before a medicine is authorised for use, evidence of its safety and efficacy is limited to the results from clinical trials, where patients are selected carefully and followed up very closely under controlled conditions.

This means that at the time of a medicine's authorisation, it has been tested in a relatively small number of selected patients for a limited length of time. After authorisation the medicine may be used in a large number of patients, for a long period of time and with other medicines. Certain side effects may emerge in such circumstances. It is therefore essential that the safety of all medicines is monitored throughout their use in healthcare practice.

Why should you Attend: This course has been planned to provide you with the essential skills and tools to prepare and host a regulatory inspection and to facilitate the response and follow-up to the inspection outcome, findings (483s) and the necessary Corrective Actions and Preventive Actions (CAPA).

The course incorporates inspections at sponsor and contract research organisation (CROs) sites, as well as at the investigator site. The course will also cover common inspectional findings, current inspection finding trends, and inspection critical topics/focus trends. A review of the differences between methodologies of FDA inspections and EMA is also included.

This course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments in pharmacovigilance in Europe, the USA, and Japan.

Areas Covered in the Session:

• Pharmacovigilance overview: Brief history
• The need to have pharmacovigilance process
• Aims of Pharmacovigilance
• Pharmacovigilance for generics versus new medicinal products
• What are drug risks?
• Measures to identify drug risks
• Pharmacovigilance system: Minimum required elements
• The Risk Management System
• Pharmacovigilance concepts' definitions
• Responsibility of Sponsor/Marketing Authorization Holders' employees
• Undertesting the legal frameworks and reading between the lines which is paramount to enable better understanding and consequently better