Adverse Drug Events – Reporting & Regulatory Requirements™

Course Description

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.

Learning Objectives

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
• Pharmacovigilance
• Safety issues
• Coding
• The new Final Rule requirements for reporting SARs/SUSARs
• The differences in reporting requirements between the US and EU

Past Participants' Comments

"The course director did a great job covering a lot of necessary information while making it applicable and interesting. He has a broad knowledge base, but was still very willing to have others share experiences to enhance the course. This was a great investment of my time!" Diane C., Clinical Specialist, MED Institute

"Lots of good materials and discussions. The course was very interactive and complete." David U., Dir. Clinical Development, Medicines for Malaria Venture - Geneva

"Very informative – gained valuable understanding of ADE reporting history." Susan W., Sr. Product Support Specialist, Pfizer

"I like the Course Director's process of having exercises after each module to review the basic topics covered in that module. He also easily refers back to the regulations when questions are asked. I highly recommend this course...the best Adverse Events training available!" Marissa F., Manager, Vasogen

"I highly recommend this class to anyone who is involved in clinical research and operation in the investigator sites and sponsor sites, as well as health professionals. Thank you so much and I am looking forward to taking other classes you offer in the future!" Ge Z., MD, PhD, Manager of Clinical Development, Siemens Medical Solutions USA

"This was a wonderful course – I thoroughly enjoyed the instructor!" Felisa P., Clinical Data Manager, BioMimetics