Preparation for Pharmacovigilance Audits and Inspections

Date: 25th September 2024

Time: 09.30am – 1.30pm GMT

Venue: Online virtual interactive course via Zoom

Cost: £250 + VAT


Target audience:

New PV professionals; Individuals in departments that work closely with PV; PV professionals with a number of years of experience, PV professional who require refresher and/or evidence of training on GVP Module III; Quality Assurance Professionals.

Pharmacovigilance audits and inspections are planned to run at a very fast pace, in a short time with an exchange of lots of information. Good preparation is the key to a successful outcome. This advanced live Zoom training course will help participants to prepare for Pharmacovigilance audits and inspections. Accomplished and qualified trainers who conduct audits frequently and have participated in many audits and inspections from various health authorities across the globe will share the regulatory requirements, expectations of inspectors, their own experience, best practices, tips and tricks to host and take part in audits and inspections. The session will cover how to make the most of the time available for preparation once an audit or inspection has been announced, major points to be considered during the audit or inspection, and a practical approach that must be taken into account while drafting responses and proposing the CAPAs for the report. Participants will work on real-life examples from case studies and practice their communication skills that will help them prepare and host the inspections and also work on how to respond to the inspection report.

Participants will explore the entire life cycle of how to be inspection ready in order to achieve the best outcome right from the notification for both surprise / routine inspections, inspection hosting, response to the inspection report and its closure. This course will also provide a comprehensive overview of Module III (Pharmacovigilance Inspections) and Module IV (Pharmacovigilance Audits) to cover different types of audits of the Guideline on Good Pharmacovigilance Practices produced by the European Medicines Agency.

The course includes a test of understanding to obtain a formal certificate as evidence of training.

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