FALLS CHURCH, Va., Oct. 9, 2018 /PRNewswire-PRWeb/ -- ICH E6 GCP Interactive Workshop: How to Build a Sponsor Risk Management
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 companies understand and comply with new ICH E6 (R2) rules.
Trial sponsors now must institute risk assessment at both the system and clinical-trial levels. Has a program been established? Is the maintenance program complete? If not, this hands-on, interactive workshop is just the ticket. Prepare to discover:
The conference 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.
Attendees will receive a binder of course and reference materials they'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 *Activities *PowerPoints and slides *And more besides!
Meet the Presenters: Dr. Susan Leister, Director-QA of Technical Resources International, boasts 20-plus years of industry experience and holds CQA and CSSBB certifications from American Society for Quality. She serves on the ASQ Section 509 Executive Committee and served as a 2012 and 2013 Maryland Performance Excellence Award Examiner and a 2013 ASQ International Team Excellence Award Judge. She has served as a part-time faculty member of the University of Phoenix Undergraduate and Graduate School of Business for the past five years.
Linda Sullivan, Executive Director, Metrics Champion Consortium Ms. Sullivan is Co-Founder & Executive Director of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has been a featured speaker at Performance Metrics, Risk-Based Monitoring, Quality Management & Clinical Trial Oversight industry meetings. Ms. Sullivan received a B.S. in Biology from Trinity College and a M.B.A. from Dartmouth College where she was named a Tuck Scholar.
Who Will Benefit The workshop is aimed at every sector of the clinical trials world — drug and biologics makers; trial sponsors, trial sites and CROs; academic medical centers and IRBs — and the individuals who make trials happen:
Conference Details: ICH E6 GCP Interactive Workshop: How to Build a Sponsor Risk Management Program **Presented by FDAnews and Technical Resources International, Inc.** Dec. 11-12, 2018, Raleigh, NC http://www.fdanews.com/iche6gcp
Tuition: Early Bird Registration (until Nov. 13, 2018): $1,947 Regular Registration (after Nov. 13, 2018):: $2,197
Easy Ways to Register: Online: http://www.fdanews.com/iche6gcp By phone: 888-838-5578 or 703-538-7600
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