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:
Who Will Benefit:
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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