Topics to be covered over the 2 day course:

• Overview of ICH & EU pharmacovigilance
• SAHPRA pharmacovigilance document requirements
• Pharmacoviligance audits & inspections
• Periodic Benefit-Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs)
• Risk Management Plans (RMPs)
• Roles and responsibilities of a licence holder
• Post registration ADR Reporting
• Implications of: Recalls; labelling updates & variations
• Medicine Safety Alert
• Standard Operating Procedures (SOPs) related to pharmacovigilance
• Roles and responsibilities of the person qualified for pharmacovigilance

Why you should attend?

• Gain an understanding of post-marketing pharmacovigilance.
• Essential information will be covered to aid for those working in pharmacovigilance or entering the field of pharmacovigilance.
• Capitalise on the opportunity to participate in interactive discussions and exchange experiences with other delegates.
• Each attendee will receive a course pack containing comprehensive documentation which will be a valuable source of reference.

Steps to register:

1. Choose the quantity of seats you want (delegates can only book more than 1 seat if from the same company), & then click the “checkout” button.
2. Enter personal information & click the “confirm & proceed” button.
3. You will then be directed to a page reflecting the Twinz Foundation banking details (note that payments can only be processed via EFT & once you receive an invoice).
4. Click the “buy now” button to finalise registration (note payment is not required at this stage).
5. Once you have completed steps 1 to 4, you will receive, via email, a booking confirmation ticket and shortly thereafter an invoice.
6. Once you make payment, you will receive a valid ticket for attendance.
7. If you have registered for the training and payment is not received 48 hrs prior to the start of the training, you will be liable for full payment of the course even if you decide not to attend unless you have made prior arrangements with the provider.