This course will provide participants with an understanding of drug safety at the investigational stage and during the marketing phase. Adverse event identification and reporting requirements will be addressed, as well as FDA, EMA, Health Canada and ICH roles in the drug safety process. The course will also discuss international law/regulations, ICH guidelines, Pharmacovigilance, definitions and current regulatory issues.
Adverse Event reporting requirements specific to the US, Canada, Japan, and Europe will be discussed and compared in detail. Participants will be provided with templates for reporting requirements in each region covered.
Multiple exercises are included to reinforce the lecture material. Through the use of various scenarios, participants will learn how to assess and report AEs including SAEs
Who Should Attend
This two-day adverse drug events training course is designed for those working in the clinical research, safety surveillance, regulatory affairs, medical affairs, QA/QC, and any others who would benefit from a complete understanding of international regulations regarding monitoring and reporting adverse events.
During this two day course you will learn about:
- Adverse Event (AE) Terminology
- Role & responsibilities of Pharma and the Regulatory Agency in AE reporting
- Pre & Post-marketing AE reporting requirements worldwide
- Product Safety Update Reports
- Safety issues
- The new Final Rule requirements for reporting SARs/SUSARs
- The differences in reporting requirements between the US and EU