Overview

This introductory course offers a comprehensive overview of the fundamental principles of pharmacovigilance (PV) audits and inspections. Delivered as a two-day webinar with two-hour sessions each day, it helps participants understand global audit standards and regulatory expectations while developing practical skills to plan, conduct, and follow up on audits effectively. The program focuses on identifying risks, addressing gaps, and strengthening compliance within PV systems. Participants will also learn strategies to maintain continuous inspection readiness and meet EU and UK regulatory requirements.

Recordings will be available for those unable to attend live.

View Agenda.

Featured topics

Time (SGT)	Time (KST)	Topic
Day 1 (16 Dec)
3:00 – 5:00	4:00 – 6:00	1. EU Regulatory requirements 2.Audit readiness, planning and operation, self-audit
Day 2 (17 Dec)
3:00 – 5:00	4:00 – 6:00	3. PV inspection readiness 4. Management and FU of PV inspection 5. Specifities of EU and UK PV inspections

Who should attend?

Professionals most likely to benefit from this advanced course will have experience in:

- Pharmacovigilance

- Drug Safety

- Regulatory Affairs

- Quality Assurance

- Risk Management

- Medical Affairs

A sound knowledge of Pharmacovigilance is a must. A practical experience in audits and inspections is desirable.

Learning objectives

- Understand the standard for PV audit and inspection

- Plan and conduct pharmacovigilance audits based on risk assessment

- Identify and follow-up on corrective and preventive actions (CAPAs)

- Host and manage a pharmacovigilance inspection

- Execute the inspection readiness based on local requirements as well as global guidelines

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Pharmacovigilance Audits and Inspections - Introductory Course

Overview

Featured topics

Who should attend?

Learning objectives

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