A Risk-Based Approach to Monitoring – Implications for Sponsors, CROs, Investigators and IRBs — AN UPDATE

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Pharmaceutical,
  • Thursday, September 06, 2012

FDA has issued draft guidance on monitoring of clinical investigations that may well result in a truly seismic shift in traditional approaches to monitoring, including significant implications to employment opportunities. The previous webinar on this topic featured highly experienced former Clinical Research senior directors and managers from both large pharma and small biotech share their thoughts and perceptions on the monitoring issue.

Since then, The FDA has made a number of public presentations supporting a risk-based approach, advocating a move away from intensive on-site monitoring and towards more remote data monitoring.

Although the Guidance remains in draft form, it is clear that the key elements of the Final Guidance will likely be retained. Some sponsors and CROs have already begun to adopt a risk-based approach, but the key questions around operationalizing the Guidance and its implications to all drug development stakeholders remain.

Mr. Yingling will present his perceptions from the legal and regulatory perspective based on his extensive experience both at the Agency and subsequently in private legal practice.

Dr. Alp will discuss recent initiatives at the highest levels to integrate a risk-based approach to clinical trial monitoring, from his perspectives as both ICON Vice President and physician professionally bound by the principles of the Declaration of Helsinki.

Ms. Duchesne will present practical implementation aspects of risk based monitoring from her perspective as a former senior manage in pharma, now responsible for North America-wide monitoring with one of the premier global CROs.



Mr. Gary Yingling, BS, MS, JD, Partner, K&L Gates, Washington DC

Mr. Yingling’s practice focuses on regulatory and legal issues concerning food, drugs, medical devices and cosmetics. His primary efforts have been working with issues involving the Food and Drug Administration. An area of particular interest has been clinical research/contract research organization/sponsor matters.

Prior to entering private practice, Mr. Yingling was the president of the Food and Drug Law Institute for nine years. Before joining the institute, he was in government for ten years serving in FDA’s office of the general counsel. Before attending law school, he practiced community pharmacy and is a registered pharmacist in Maryland and the District of Columbia. He is also General Counsel for the Consortium of Independent Review Boards, and is deeply involved in consultations on FDA and OHRP legislative and regulatory reform.

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Nicholas Alp, PhD, BM BCh, FRCP, DM, Vice President, Scientific Council, ICON plc, and Hon. Consultant Cardiologist, Oxford University Hospitals NHS Trust

Dr. Alp is a board certified interventional cardiologist and clinician scientist, and joined ICON in 2011 as Global Lead of Cardiovascular Science. Dr Alp trained at London (BSc), Cambridge (PhD) and Oxford (BM BCh, DM) Universities, and has practiced clinical medicine for more than 17 years. He has held senior academic appointments at Oxford University, leading basic science and clinical research teams in cardiovascular medicine, and has authored more than 60 original papers.

Dr. Alp has extensive experience in the design and execution of Phase I, II and III protocols for submission to Regulatory Authorities, and maintains an Honorary clinical appointment at Oxford University Hospitals NHS Trust.

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Anick Duchesne, BSc, DSA, Senior Director, CRA Management - North America, ICON plc

Anick Duchesne is a Senior Director for ICON’s CRA function for North America. Prior to holding this position, she was responsible for leading the business activities within ICON’s Canadian affiliate.

Before joining the CRO industry, Ms. Duchesne held the positions of Director, Medical Affairs at Debiovision and previous to this in the clinical research department at Pfizer Canada. She was responsible for the site management and monitoring, research operations, biometrics and data-management, and pharmacy services teams. She also held management positions at Glaxo Wellcome, and professional and supervisory positions for Bristol Myers Squibb.

Ms. Duchesne has a Bachelor’s degree in molecular biology from the Université du Québec à Montréal, and an Administration degree from Université de Montréal, HEC (school of business). She is a lecturer at McGill University on the Biotechnology program and has also lectured at the International Education Associate Conference. Ms. Duchesne has written articles for the European Pharmaceutical Contractor magazine.

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Who Should Attend?

Senior Researchers, Investigators, IRB Administrators, and individuals responsible for research performance and oversight at research sponsors, organizers, CROs and SMOs.

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Institutional Review Board Services™ (IRB Services)

Institutional Review Board Services™ (IRB Services), established in 1993, is a wholly independent company with ethics boards and knowledgeable staff in both Canada and the USA. We are the only independent IRB designated by the Minister of Health to review research in the province of Saskatchewan.

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