Drug Safety and Adverse Drug Reaction Reporting Workshop
Register for 3 Days online
April 22, 29 & May 6, 2020
10:00 a.m. – 12:00 p.m.
CAD $585.00 + HST
Live interactive and instructor led
This workshop will explain the importance of adverse drug reactions, the Canadian MEdEffect Scheme, the source of adverse drug reaction reports and the differences between serious and non-serious events. Ina addition, a MedEffet form will be completed in class.
- What is Pharmacovigilance and why it's important
- The WHO and drug safety
- ICH and drug safety
- Learning the terminology
- The regulatory landscape (US and EU) with a focus on Canada
Register for Day 1 online
- Pre and Post-market Adverse Event collection, assessment and reporting
- The expedited regulatory reporting process
- Sources for Drug Safety Information
- Criteria for reporting ADRs, and required assessments
- Drug product life cycle
Register for Day 2 online
- Coding of ADRs
- CIOMS and MedWATCH
- Reporting process in clinical trials
- Reporting timeframe
- Introduction to PSUR/PBRERs
- Regulatory Guidelines
- Introduction to signal detection and processing
- Introduction to risk management
Register for Day 3 online
Certificate of Attendance and Course Material
- All participants will receive a certificate of attendance upon completion of the course.
- The participants will be receiving specially prepared course manual.
Note: Registration closes one week prior to the start of workshop.