ICH Addendum and its Implication on Clinical Development

Why Should You Attend:

The ICH addendum will most likely come into effect early 2017. The amendment to the efficacy guideline E6 is quite comprehensive in its coverage. There are many areas that were amended, i.e. investigator oversight and responsibilities, records management, quality and risk management, service provider oversight, risk based monitoring and root cause analysis when deficiencies are discovered. The parts on quality and risk management as well risk based monitoring are the largest in content, however the vendor oversight might be the most interesting given the fact that the majority of findings during health authority inspections were in that particular area.

Learning Objectives:

• Learn about the addendum: the background and why it was proposed.
• What does this mean for your organization?
• What processes will be affected and how can you prepare.

Areas Covered in the Webinar:

• Investigator oversight and responsibilities
• Records management including source data, trial data handling and procedures
• Quality and risk management
• Vendor oversight and subcontracting
• Risk-based monitoring
• Root cause analyses in case of non-compliance

Who Will Benefit:

• Clinical operations personnel
• Quality personnel
• Clinical site staff
• Investigators

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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