Pharmacovigilance Inspection Readiness

• Fundamentals: regulations, occurrence, types and aims
• Strategic planning and preparation for a (remote) GvP inspection
• Report, findings and follow-up measures
• Dos and don'ts, and factors of success
• Differences in inspection strategies between Europe and other areas in the world

Who should attend

In order to ensure that marketing authorisation holders comply with pharmacovigilance obligations, competent authorities conduct pharmacovigilance inspections at specific intervals. This Online-Course will provide insights into the current (remote) pharmacovigilance inspection strategies. In addition, the pros and cons of remote inspections from the different perspectives (authorities vs. industry) will be discussed.

After attending the online-seminar you will:

• be able to plan and prepare for pharmacovigilance inspections according to the different requirements and
• improve how you process findings during and after the inspection.

This seminar enables you to professionally prepare your pharmacovigilance inspections in accordance with the applicable requirements.Discuss your questions with experts from authorities and industry and find answers to your questions. After the seminar you will understand the current pharmacovigilance inspection strategies and will be able to improve your processes accordingly.