ICH E6 GCP Interactive Workshops

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The clinical trials world is going back to school. New ICH E6 (R2) guidelines require trial sponsors to institute risk assessment at both the system and clinical-trial levels; and require drug and biologics makers to qualify vendors.

You can get all the training you need to meet these challenges with three days of hands-on workshops aimed at helping you understand and comply with new ICH E6 (R2) requirements. Teaming up with Technical Resources International Inc., we’ve created a pair of workshops that meet the needs of everyone along the clinical-trials spectrum, from trial sponsors to trial operators and overseers.

Course 1 (Two Days)

How to Build a Sponsor Risk Management Program
Wednesday-Thursday, Aug. 8-9, 2018

Trial sponsors now must institute risk assessment at both the system and clinical-trial levels. This helps drug and biologics makers master the intricacies of the new guidelines with hands-on, interactive training. You’ll 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!

Leader Dr. Susan Leister, Director-QA of Technical Resources International, is a seasoned veteran of the clinical-trial wars. Her binder of course and reference materials is one 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
  • Activities
  • PowerPoints and slides
  • And more besides!

See the full two-day schedule

 

Course 2 (One Day)

Supplier/Vendor/Contractor Qualification
Friday, Aug. 10, 2018

Updated ICH E6 (R2) guidelines require drug and biologics makers to qualify vendors. In this day-long workshop you’ll learn a systematic approach to ensuring vendors and suppliers meet your standards ... discover how to vet vendors well in advance and avoid wasting time and money on vendors not qualified to perform key processes and services ... and master procedures to:

  • Formalize and document the vendor qualification process
  • Get backup vendors in place to safeguard the flow of critical supplies
  • Qualify new vendors faster

Your leader, Dr. Susan Leister, Director-QA of Technical Resources International, is a seasoned veteran of the clinical-trial wars. She walks you through key elements of quality and supply agreements, and highlight challenges in the vendor qualification process and how to resolve them. Specifics covered will include:

  • Requirements for a compliant vendor/supplier/contractor qualification program
  • Applying a risk-based approach to the supplier/vendor selection process
  • Understanding supplier assessments, pre-approval and re-assessment
  • Quality agreements and supplier agreements
  • How to handle vendor problems up to vendor disqualification
  • And more besides!

The course-materials binder supports your day of hands-on learning, and will prove useful again and again in months to come. Contents include:

  • The revised Guidance along with all applicable regulations
  • Illuminating articles and white papers on vendor programs
  • Sample vendor survey tools
  • Sample Quality Agreement templates
  • Case study materials
  • PowerPoints and slides
  • And more besides!

 

See the full one-day schedule

 

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.


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