6th Edition Clinical Trials in Canada

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Description

Report Code: PHP09363. April, 2009. Montreal, QC

ARTICLE I

Clinical Research in Canada: A Canadian and Global Perspective

Nestor Nituch
Unit Director, Regional Clinical Operations
Bristol-Myers Squibb Canada

ARTICLE II

Clinical Research in Canada: A Research Ethics Perspective

Dr. Ron J. Heslegrave, Ph.D.
Chair, Research Ethics Board
University Health Network
Ontario Institute for Cancer Research

ARTICLE III

Clinical Research in Canada: A Canadian and Global Perspective

Dr. J. Carter Thorne, MD, FRCP, FACP
Principal Investigator
The Arthritis Program Research Secretary-Treasurer
Canadian Rheumatology Research Consortium

ARTICLE IV

Master Clinical Trial Agreements: A Long-term Approach for Managing Clinical Trial Contracts

Keith Francis
Head, Clinical Operations (Canada)
Bayer Inc.

ARTICLE V

How Can We fast-tract the Clinical Trial Contract Process?

Dr. Margaret H. Kerr, B.A., LL.B., M.A., PhD.
Barrister & Solicitor

ARTICLE VI

When Things go Wrong: How Your Contract Impacts the Management of Clinical Trial Incidents

Sébastien Lanctôt, LL.B., LL.M., DESScl, DCL
Professor, Faculty of Law
University of Sherbrooke

Martin Letendre, LL.B., LL.M.
Director of Ethics and Legal Affairs
ethica Clinical Research Inc.

Pierre Visockis, LL.B.
Attorney
Fraticelli Provost

ARTICLE VII

How CROs Can be Deployed Effectively and Efficiently in Clinical Trials

Marie-Luce Fortier, LL.L, LL.B.
Lawyer, Legal Affairs
Senior Manager, Development of Contractual Research
Research Centre of the Centre Hospitalier de l’Université de Montréal (CHUM)

Murray L. Jensen, M.Sc.
Director of Clinical and Scientific Affairs
ethica Clinical Research Inc.

ARTICLE VIII

Confidential Disclosure Agreements: When the Study Starts

Alaine C. Grand, BSW, LL.B.
Legal Counsel
AstraZeneca Canada Inc.

Michelle Moldofsky, LL.B., LL.M.
Policy & Legal Advisor
Office of Research Administration
St. Michael’s Hospital

ARTICLE IX

Investigator-Initiated Trials: Funding Agreements

Dr. Ann-Merie O’Halloran, Ph.D.
Manager
Clinical & Regulatory Capabalities and Compliance
Novartis Pharma Canada Inc.

Michelle Moldofsky, LL.B., LL.M.
Policy & Legal Advisor
Office of Research Administration
St. Michael’s Hospital

ARTICLE X

Clinical Trials: Quality, Speed, Access

Karen Arts, BSN (honours), RN, CCRC
Director, Business Development
Ontario Institute for Cancer Research

Paul J. Becker
Contracts Manager
Wyeth Research

ARTICLE XI

What Industry and Principal Investigators Need to Know

Patrice Vézina, FCIP, CRM
Damage Insurance Broker
President and CEO, Operations
Vézina Assurances Inc.

ARTICLE XII

Indemnification: A User’s Guide

Dr. Margaret H. Kerr, B.A., LL.B., M.A., Ph.D.
Barrister & Solicitor

Dr. Pierre Geoffroy, MD, CM, MSc, FCFP
Medical Director
Biovail Contract Research

ARTICLE XIII

Intellectual Property and Publication Rights: Bridging the Gap

Lenni Carreiro, M.Sc., LL.B.
Patent Counsel
Intellectual Property Dept.
sanofi pasteur

ARTICLE XIV

Registration of Clinical Trials and Publication of Results: Towards a more Transparent Era?

Yann Joly, LL.B., LL.M., Ph.D. Candidate
Project Manager, HumGen International
Centre for Research in Public Law
Faculty of Law, University of Montreal

ARTICLE XV

Negotiation Skills and Strategies: What You Need to Know for Any Successful Negotiation

Maria Rossin, B.A., LL.B., J.D.
Research Counsel
The Samuel Lunenfeld Research Institute
Mount Sinai Hospital