FDAnews Announces: Early Bird Pricing Ends on July 11 for ICH E6 GCP Interactive Workshops, Aug. 8-10, 2018

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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.

ICH E6 GCP Workshop

ICH E6 GCP Workshop

ICH E6 GCP Interactive Workshops
**Presented by FDAnews and Technical Resources International, Inc.**
Aug. 8-10, 2018, Waltham, MA
http://www.fdanews.com/iche6gcp

Early bird pricing for ICH E6 GCP Interactive Workshops ends on Wednesday, July 11.

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 three days of hands-on workshops aimed at helping companies understand and comply with new ICH E6 (R2) rules. Regardless of where a company fits on the clinical-trials spectrum, one or both of these workshops is sure to be right.

Course 1 (Two Days)
How to Build a Sponsor Risk Management Program
Aug. 8-9, 2018

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!

Course 2 (One Day):
Supplier/Vendor/Contractor Qualification
Aug. 10, 2018

Drug and biologics makers now must qualify vendors under updated ICH E6 (R2) guidelines. This day-long workshop teaches a systematic approach to ensuring that vendors and suppliers perform to standard. Attendees will 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 learn 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

Attendees will learn the key elements of quality and supply agreements, and highlight challenges in the vendor qualification process and how to resolve them. Among the specifics covered are:

  •     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

Early bird pricing ends on Wednesday, July 11.

Meet the Presenter:
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.

Who Will Benefit:
These workshops are 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 Workshops
**Presented by FDAnews and Technical Resources International, Inc.**
Aug. 8-10, 2018, Waltham, MA
http://www.fdanews.com/iche6gcp

Tuition:
Early Bird Registration (until July 11, 2018):

  •     Complete Conference: $1,947
  •     Course 1: $1,597
  •     Course 2: $797

Regular Registration

  •     Complete Conference: $2,197
  •     Course 1: $1,797
  •     Course 2: $897

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.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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