Risk-Based Monitoring Beyond the RACT

Why Should You Attend:

In 2013 TransCelerate issued the RACT (Risk Assessment and Categorization Tool) and made it publicly available to everyone including instruction on how to use it. The RACT has been referred to as a standard, being the result of the combined brainpower of about 20 large pharmaceutical companies.

After the RACT was published it also got quite a lot of attention from the regulators, and not much later, presentations by regulators at conferences emphasized that they think the design of this tool is suboptimal. Nevertheless, the RACT is still in everyone’s mind and companies try to build IT systems around it using the catalogue of RACT items as a basis. However, will those systems and approaches stand scrutiny? This webinar will analyze this question with insight into the strengths and weaknesses of the RACT and how you can still use it in an improved way.

Areas Covered in the Webinar:

• Strengths and weaknesses of the RACT
• Where should it be used with caution?
• Establishing a comprehensive risk management approach to support risk-based quality management in clinical trials

Who Will Benefit:

• Clinical operations personnel
• Quality personnel
• 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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