ComplianceOnline

How to Build Effective Metrics for Vendor Oversight

Instructor: Beat Widler
Product ID: 704766
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2016

Training CD

$329.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This training program will explain what the critical areas and elements of vendor oversight are and how you can set such a system up for yourself at your company.

Why Should You Attend:

The new ICH E6 addendum includes one new area that has been the concern of many competent authorities ever since: vendor oversight. There are several reasons why this topic has made it into the ICH E6 addendum. The first being the fact that more and more activities in clinical trials are outsourced to service providers and therefore a sponsor of a clinical trial relinquishes control. The second being the fact that most of the sponsors are not in an adequate position to ensure their obligation of oversight. This has been demonstrated quite significantly in the past years as the lack of or inappropriate vendor oversight was the most cited finding in health authority inspections.

In this webinar, attendees will learn why oversight is important and not just a requirement stipulated by regulations. They will also understand how to identify the important areas of oversight, how to make metrics work and how to avoid common mistakes in the sponsor oversight responsibilities of CROs.

Areas Covered in the Webinar:

  • Why is oversight important?
  • Understand how to identify the important areas of oversight
  • How to make metrics work for you
  • How to avoid common mistakes in the sponsor oversight responsibilities of CROs

Who Will Benefit:

  • Clinical operations personnel
  • Quality personnel
  • Regulators
  • Clinical Site staff

Instructor Profile:

Dr. Beat Widler is a Ph.D. graduate from the Swiss Federal Institute of Technology in Zurich, and holds the Swiss Diploma of Pharmaceutical Medicine. He operates as an independent CQA, quality risk management, GCP and pharmacovigilance auditing expert and is managing partner at Widler & Schiemann AG in Zug Switzerland.

Over his 30-year long career in the pharma industry he built his extensive knowledge in the field of clinical development. From 1986 till 2011, Dr. Widler worked for Hoffmann-La Roche first as an international drug regulatory affairs officer, then as a senior clinical research scientist. In 1993 he then joined the international clinical quality assurance department. From 1997 to 2011, he was the global head of the department for quality, ethics and systems’ in Roche Pharma.

Dr. Widler is an active member in a variety of international GCP working parties and he regularly lectures at DIA, EFGCP, WHO, ECPM (University Basel) seminars. In the areas of quality risk management and Quality by Design he was an active member of the CTTI (Clinical Trials Transformation Initiative) and OECD working groups. He is a founding member of ACRES – the Alliance for Clinical Research Excellence and Safety, founding member of the Midata Cooperative and a member of the SAFE-Biopharma Advisory Board. He was the project leader for the development of the Association of the British Pharmaceutical Industry (ABPI) Clinical Trial Disclosure Toolkit, released in August 2013.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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