FDAnews Announces: ICH E6 GCP Interactive Workshop: How to Build a Sponsor Risk Management Program, Dec. 11-12, 2018

Tuesday, October 9, 2018 Clinical Trials News
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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.

FALLS CHURCH, Va., Oct. 9, 2018 /PRNewswire-PRWeb/ -- 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

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:

  •     What the new guidelines require
  •     How to establish a program step-by-step
  •     Critical elements of starting a program: A walk-through
  •     How to conduct risk assessment at both system and clinical-trial levels
  •     Evaluating the risks: options
  •     Risk mitigation and reporting strategies
  •     Common pitfalls and how to sidestep them
  •     And much more!

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:

  •     QA/QC managers and staff
  •     RA managers and staff
  •     Compliance auditors
  •     Manufacturing managers
  •     Project managers
  •     Senior managers
  •     Supply chain and logistics managers

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

About FDAnews: FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

 

SOURCE FDANEWS



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