For clinical trials, it’s a new ball game. The ICH E6 (R2) guidelines now require trial sponsors to institute risk assessment at both the system and clinical trial levels; and require drug and biologics makers to qualify vendors.
FDAnews has teamed up with Technical Resources International Inc. to present a two-day hands-on workshop aimed at helping you understand and comply with new ICH E6 (R2) rules.
Trial sponsors now must institute risk assessment at both the system and clinical-trial levels. Have you established your program yet? Is your maintenance program complete? If not, this hands-on, interactive workshop is just the ticket. Prepare to discover:
- What the new guidelines require
- How to establish your program step-by-step
- Critical elements of starting your program: A walk-through
- How to conduct risk assessment at both system and clinical-trial levels
- Evaluating the risks: Your options
- Risk mitigation and reporting strategies
- Common pitfalls and how to sidestep them
- And much more!
Your leader, Dr. Susan Leister, Director-QA of Technical Resources International, is a seasoned veteran of the clinical-trial wars. She will be joined by special guest speaker, Linda Sullivan, Executive Director, Metrics Champion Consortium.
You’ll receive a binder of course and reference materials you’ll turn to long after the workshops have ended, including:
- The revised Guidance along with all applicable regulations
- Illuminating articles and white papers on risk management
- Sample tools and templates
- PowerPoints and slides
- And more besides!
Getting new drugs to market is too important to leave to chance. Make sure you dot all the i’s and cross all the t’s. These workshops get you where you need to be ... in a hurry.