Audit and Inspection in Pharmacovigilance

Course Structure

14:00 – 18:00 COURSE SESSION DAY 1
14:00 – 18:00 COURSE SESSION DAY 2

Program

DAY 1

14.00 Introduction to the course

14.10 What are the main regulatory requirements and the organization of the PV System?

• Main requirements and key points
• Key PV processes
• Interactions with other company departments
• Q&A time

15.50 Coffe Break

16.10 GVP Audit

• Regulatory requirements
• Risk based approach
• Audit announcement, preparation and conduction
• CAPA plan monitoring
• KPIs on audit activities

17.40 Q&A Time
18.00 Closure of day one

DAY 2

14.00 Focus on GVP Inspection requirements

• Regulatory requirements
• Risk based approach
• Inspection announcement
• Q&A Time

15.30 Coffee Break

15:50 GVP inspection readiness

• Key points in the preparation of inspection
• Interaction with other company departments
• GVP inspection days

16.30 What are the main inspector’s expectations?

• Sharing of most common finding and experience
• Discussion

17:15 Key takeaways
18:00 Closure of the course

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.