Managing Legal & Business Risks in
Clinical Trials in Canada
Exploring Administrative Costs that RESULT from Failing to Manage Legal & Business Risks
of Clinical Trials
Michelle Moldofsky, LL.B., LL.M.
Policy & Legal Advisor, Office of Research Administration, St. Michael’s Hospital
Navigating Other Essential Legal & Policy Considerations
Livia Maduri
AssociateGowlings
Michelle Moldofsky, LL.B., LL.M.
Policy & Legal Advisor, Office of Research Administration, St. Michael’s Hospital
Contracts Law: Nuts & Bolts. THEN…Applying the Law of Contracts to Clinical Trial Agreements
Chantal Quiniou – Pharma Perspective
Legal Counsel, Pfizer Canada Inc.
Aaron Leahy, B.A., LL.B. – Hospital Perspective
Legal Counsel, The Hospital for Sick Children
Diana Raymond-Watts – Institutional Perspective
Research Manager, Women’s College Research Institute
“Audit Readiness”...Are You Sure You’re Ready?
Jason Ridderikhoff, B.Sc.N. – Pharma Perspective
Regional Operations Manager, Clinical Research, Eli Lilly Canada Inc.
Case Law: Decision Impacts and How to Deal With Them
Mathieu Gagné
Partner, Fasken Martineau DuMoulin LLP
Budgeting for Clinical Trials: The Experts’ Approach!
Lisa Johnston, RN, BScN, CCRP – Institutional Perspective
Manager, CRP Professional Practice, Department of Clinical Research Practice University Health Network
John Akitt – Site Perspective
President and Co-Founder Trial Management Group (TMG)
Peter Thompson – Pharma Perspective
Regional Research Manager – Atlantic Research & Development Department, Eli Lilly Canada Inc.
Confronting the Ethical Issues of Clinical Trials
Moderator:
Dr. Catriona McMahon, BSc., MBChB, FRCA (UK), MRPM (UK)
Vice-President, Medical Affairs AstraZeneca Canada Inc.
Panellists:
Pierre Gervais, B. Pharm., MSc
President and Research Director, Q&T Research
Jack Corman
President, IRB Services, Executive Member, National Council on Ethics in Human Research (NCEHR), Voting Member,
Canadian General Standards Board (CGSB)
Martin Letendre LLB, LLM – External / Independent Ethics Board Perspective
Director of Ethics and Legal Affairsethica Clinical Research Inc.
Richard Sugarman, MSW – Internal / Institutional Ethics Board Perspective
Chair, Research Ethics BoardThe Hospital for Sick Children
Maximizing the Efficiency of Clinical Trial Management: Insight From the Various Perspectives
Dr. Pierre Geoffroy, MD, CM, MSc, FCFP
Medical Director, Biovail Contract Research
Karen Arts, BSN (honours), RN, CCRC – Investigator Perspective
Director, Business Development, Ontario Institute for Cancer Research
Dr. Catriona McMahon, BSc., MBChB, FRCA (UK), MRPM (UK) – Pharma Perspective
Vice-President, Medical Affairs, AstraZeneca Canada Inc.
Managing the Legal & Business Challenges Surrounding Participant Recruitment and Protection
Dr. J. Carter Thorne, MD, FRCP, FACP
Principal Investigator, The Arthritis Program Research Secretary-Treasurer, Canadian Rheumatology Research Consortium
Maria Rossin, B.A., LL.B., J.D.
Research Counsel, The Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Carl Wibbenmeyer
Chief Operating Officer, The Patient Recruiting Agency
Proper Use of Placebos in Clinical Trials: A Sleeping Giant
Anne Tomalin, BA, BSc, RAC
President, CanReg Inc.
Dr. Ronald Heslegrave
Chair, Research Ethics Board, University Health Network, Ontario Cancer Research Ethics Board
Competition Among Clinical Trials: The Canadian Market
Bradley Miller
Investment Advisor, Life Sciences, Foreign Affairs & International Trade Canada
Dr. Ronnie Aronson, MD, FRCPC, FACE – Site Perspective
Executive Director, LMC Endocrinology Centres