Attention: SAHPRA Pharmacovigilance Unit Director; Ms. Florah Matlala will also be presenting the training event.

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.

Price includes lunch and refreshments.

Registration closes on the 13 September 2019, 9:00 am. Book your space today! Limited Seats Available