February 19-20, 2009 InterContinental Hotel, Montreal CLINICAL TRIALS. A Legal, Business and Ethical Guide to Maximize Integrity and Minimize Exposure

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1 February 19-20, 2009 InterContinental Hotel, Montreal Managing Legal Risks in Structuring and Conducting CLINICAL TRIALS A Legal, Business and Ethical Guide to Maximize Integrity and Minimize Exposure Co-Chairs Caroline McNicoll General Counsel and Corporate Secretary Pharmascience Inc. Catriona McMahon Vice-President, Medical Affairs AstraZeneca Canada Inc. Leading industry experts: Anapharm Canadian Centre for Clinical Research and Development CHUM - Research Center Health Canada Ministry of Health and Social Services of Quebec Ontario Cancer Research Ethics Board ProMetic Life Sciences Inc. Pfizer Canada Inc. Q & T Research sanofi-aventis Canada Inc. St. Michael s Hospital The Hospital for Sick Children The premier legal and regulatory clinical trial event that will help you... AVOID common pitfalls when negotiating clinical trial provisions intellectual property, publication, indemnification, and more PREPARE for increased pharmacoviligance and product lifecycle regulation of drugs COMPLY with the new obligations of central ethics review REVIEW significant developments in clinical trial case law to better manage risks ADOPT best practices when selecting sites RESOLVE contentious clinical trial issues when recruiting candidates and obtaining consent Gain additional value by attending the pre-conference workshop In-Depth Overview of a Clinical Trial Agreement Boilerplate and Beyond Official Publication: Register Now CanadianInstitute.com

2 A One-of-a-Kind Forum on Overcoming the Challenges in Conducting and Structuring Clinical Trials During the last few years, heightened public attention has been brought to the clinical research process, with an increased demand being made for transparency to avoid abuses. This recent public awareness has created numerous challenges for the industry. Compliance rules have proliferated as efforts and strategies have been developed by the key players to avoid the costly consequences of scandals. At this moment, traditional ways of doing things are being challenged by new control mechanisms, such as central ethics review, harmonization of the clinical trial agreement and increased pharmacovigilance. In addition, there are a number of critical issues in ensuring proper management of protocols, contracts, consents, and other documents, including negotiation of the applicable agreement documents in light of the different perspectives and priorities of the parties involved. Plus, the daily management of clinical trials from the challenges of ensuring properly structured recruiting incentives to those associated with avoiding data privacy and security pitfalls. The Canadian Institute s 1 st Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials is the one place that industry professionals can come to resolve these and other pressing concerns. This event will allow you to meet the increased demand for transparency in the clinical research process from every angle: legislative, regulatory, compliance, and litigation. Its front-line faculty includes experts from sponsors, CROs, hospitals, government representatives, and academic research institutions, as well as expert attorneys. Plus, add value to your experience by attending our pre-conference workshop: In-Depth Overview of a Clinical Trial Agreement Boilerplate and Beyond. Register today by calling The Canadian Institute toll free at , by faxing your registration form to or by registering online at We look forward to seeing you at the conference! Advisory Board Members: Jacques Turgeon Director of the Research Center, Centre Hospitalier de l Université de Montréal Michel Gagné Partner, Fasken, Martineau, DuMoulin Pierre Gervais President, Q & T Research WHO SHOULD ATTEND Pharma, Medical Device and Biotech companies: Legal Counsel Regulatory Affairs Director of Clinical Research/ Clinical Trials/Medical Affairs Scientific Affairs Compliance Officers Clinical Researchers Members of IRBs CROs: Legal Counsel Regulatory Affairs Scientific Affairs Hospitals and Research Institutions: Contract Officer Legal Counsel Director of Clinical Research/ Clinical Trials/Medical Affairs Government Officers/Regulators Pharmaceutical Law Attorneys Heathcare Attorneys SPECIAL OFFER! Delegates who register for this event will receive the Pharma & Bio Pharma Industry Guide courtesy of Contact Canada, a $ value! (while supplies last) Pharma & BioPharma Canada - Canada's leading national comprehensive desk top reference on the industry. Profiles on several hundred companies, key contacts and key activities. Visit for more details on this and other exceptional vehicles. Contact Canada publishes a family of industry reference guides on life sciences, clean energy and food. Visit for more details. Register at or in Toronto or

3 Wednesday, February 18, 2009 Pre-Conference Workshop 9:00am - 12:00pm (Registration begins at 8:0am) In-Depth Overview of a Clinical Trial Agreement Boilerplate and Beyond Kathleen Sauvé Director, Legal Affairs Anapharm Timothy A. Dunn Senior Legal Counsel sanofi-aventis Canada Inc. When conducting a clinical trial, the protocol and its ancillary documents are not the only key-documents setting out the terms and obligations of the sponsor and the CRO/site. The clinical trial agreement is an essential component of such documentation, but is sometime overlooked and many times not fully understood. Representatives of a sponsor and CRO/site will present an in-depth overview of a clinical trial agreement, while providing tips and advice on how to successfully negotiate such agreements. The key provisions of clinical trial agreements Going beyond the boilerplate provisions The challenges in negotiating clinical trial agreements Where does the clinical trial agreement fit in amongst the required clinical trial documentation? Kathleen Sauvé is a lawyer practicing in business law for more than 10 years. In 2006, she established the legal department at Anapharm, a contractual research organization that has been offering bioanalytical laboratory services for over 14 years, as well as services related to the clinical development in Phase 1, bioequivalence, and regulatory affairs to the pharmaceutical, biotech and generic industry. She has been leading the legal group since then. Ms. Sauvé is specialized in writing and negotiating different contract agreements that govern the services provided by Anapharm. Timothy Dunn is a lawyer specialized in Canadian healthcare law. His practice focuses on four business processes in the healthcare industry: development, manufacturing, marketing and distribution. He advises manufacturers of pharmaceutical products for primary care and specialty segments, medical devices, hospital products, nutritional products, over-the-counter healthcare products, and natural health products. He is a member of both the Ontario & Quebec Bars as well as being a registered Trade-Marks Agent. Thursday, February 19, :00 Registration Opens and Coffee Served Q 8:45 Opening Remarks from the Co-Chair Caroline McNicoll General Counsel and Corporate Secretary Pharmascience Inc. Avoiding Pitfalls When Negotiating Key Points of Contention in Clinical Study Agreements 9:00 Resolving Contentious Clinical Information Issues Concerning Publication Rights, Data Ownership and Confidentiality Terms Aaron Leahy, B.A., LL.B. Hospital perspective Legal Counsel - Legal Services, Corporate Ventures The Hospital for Sick Children Patrick Sartore Sponsor perspective Senior Legal Counsel and Corporate Secretary ProMetic Life Sciences Inc. Determining data ownership rights between the parties Negotiating a reasonable publication strategy Addressing the scope of the sponsor s rights to pre-publication review Considering first publication rights when clinical trials are part of a multi-center study Managing information disclosure issues (confidentiality) Establishing the extent of liability for disclosure of confidential information 9:45 Maximizing Intellectual Property Rights Aaron Leahy, B.A., LL.B. Hospital perspective Legal Counsel - Legal Services, Corporate Ventures The Hospital for Sick Children Patrick Sartore Sponsor perspective Senior Legal Counsel and Corporate Secretary ProMetic Life Sciences Inc. Minimizing disputes over IP rights in discoveries arising out of clinical trials - defining the disclosure/notification requirement for inventions and discoveries - drafting clear language regarding invention ownership Determining the ownership and proper use of biological samples - deciding whether biological sample data analysis will be provided - negotiating parameters of proper use in the clinical trial agreement as against the uses set forth in the protocol Conflicts between Institutional IP Policy vs sponsor s goals Invention disclosure, appropriation (students, technicians, doctors, etc.) Sponsors objectives in appropriating IP 10:15 Morning Coffee Break Q 10:0 Negotiating Risk Allocation with Limitation of Liability, Indemnification, and Insurance Provisions Kathleen Sauvé Director, Legal Affairs Anapharm Register at or in Toronto or

4 Timothy A. Dunn Senior Legal Counsel, sanofi-aventis Canada Inc. Michel Gagné Partner, McCarthy Tétrault Understanding why indemnification is so critical to sponsors, CROs and sites in clinical study agreements Determining who should be indemnifying and who should be indemnified Negotiating the scope of indemnification Identifying exclusions/limitations of liability Exclusions/limitations to providing medical treatment for any injury caused by clinical trials Procuring clinical trial insurance and subrogation: - what can be covered by insurance? what is excluded? - special concerns for small companies Physician malpractice and its impact on indemnification 12:00 Networking luncheon for speakers and delegates 1:15 Adapting to the Harmonization of Clinical Trial Agreements in Canada Michelle Moldofsky Ontario Policy and Legal Advisor, St. Michael s Hospital Olga Farman Quebec Lawyer, Lavery, de Billy, L.L.P. Ontario s experience with the harmonization of clinical trial agreements Interaction between various Ontario initiatives to standardize clinical trial agreements Quebec s experience with the harmonization of the principles guiding the negotiation of clinical trial agreements Impact of these principles on the provisions contained in a clinical trial agreement 2:0 Afternoon Refreshment Break 2:45 Understanding and Complying with the New Obligations of Central Ethics Review Claude Dussault Associate General Director - Evaluation, Research and Innovation Quebec Ministry of Health and Social Services Ronald Heslegrave Chair, Research Ethics Board University Health Network Ontario Cancer Research Ethics Board The obligations under the new system What are some of the implications for the players involved? Quebec s experience with a centralized mechanism of ethical review The experience of the Ontario Cancer Research Ethics Board (OCREB) with Central Ethics Review in Ontario 4:00 Preparing for Increased Pharmacovigilance and Product Lifecycle Regulation of Drugs Bill C-51 Maurica Maher Senior Scientific Advisor Office of Legislative and Regulatory Modernization Policy, Planning and International Affairs Directorate Health Canada Examining post-market safety activities Assessing the objectives and role of Health Canada after a drug hits the market under Bill C-51 Benchmarking progress How can the industry be proactive to avoid unnecessary financial burden? 4:45 Conference adjourns Friday, February 20, :00 Continental breakfast 9:00 Opening Remarks from the Co-Chair Catriona McMahon Vice-President, Medical Affairs AstraZeneca Canada Inc. 9:15 Clinical Research Investment Trends as a Strategic Tool for Sites and Sponsors Deciders Pierre Gervais President Q & T Research Where are R&D projects being placed worldwide? - trends for Canada - trends for emerging economies (BRIC) A look at Canadian data, with emphasis on - Quebec public and private sectors - Ontario public and private sectors Canadian examples of provincial successes and hurdles to overcome Is Canadian clinical research a growing or a decreasing sector? What can be done to gain study allocation in Canada? 10:00 Best Practices when Recruiting Candidates and Obtaining Free Consent Jack Corman President IRB Services What constitutes acceptable recruitment methods? Are recruiting incentives permissible? If so, how should they be structured? Register at or in Toronto or

5 What are some of the initiatives that have been established in order to obtain free consent? What are the challenges when obtaining consent: - compensation vs payment of the candidates - obtaining consent for every phase of studies - obtaining fully informed free consent Emerging trends regarding consent and recruitment Focus on some the best and worst case scenarios regarding consent Litigation risks regarding consent Is the consent form a legal contract? When is the ERC/REB involved? 10:45 Morning Coffee Break Q 11:00 Complying with the Rules Related to Investigator-Initiated Clinical Trials Marie-Luce Fortier Medical institution perspective Lawyer, Legal Affairs Research Centre CHUM Chantal Quiniou Pharma perspective Legal Counsel Pfizer Canada Inc. What is an investigator-initiated clinical trial? What are the obligations of the parties when the institution/investigator is assuming the regulatory responsibilities of a clinical trial sponsor? What if a new drug is used? Pharma perspective vs Institution perspective 12:15 Networking luncheon for speakers and delegates 1:0 Best Practices in Selecting Sites for Clinical Trials Sylvie Haviernick Senior Regional Study Manager Canadian Centre for Clinical Research and Development Wyeth Research The experience of the Canadian Centre for Clinical Research and Development in selecting sites for Wyeth Assessment of site suitability, includes: Defining site selection criteria per protocol or clinical program through country and sites feasibility process Assigning specifically trained site managers to selection process Identifying Potential Investigators and /or Sites based on several criteria - confirmation of subject population and enrollment capability within defined timelines - availability of qualified personnel - implemented standard operating procedures - exposure to continuous GCP training - proven adherence to regulatory compliance based on past internal or external audits Maintenance of long-term suitability for participating Investigators and/or Sites 2:10 Afternoon Refreshment Break 2:25 Reviewing Significant Developments in Clinical Trial Case Law to Manage Risks Mathieu Gagné Partner, Fasken Martineau DuMoulin LLP A review of case law regarding clinical trials and its impacts on the structuring and conduction of the trials Particulars of clinical trial case law Liability of the intervening parties involved in research (investigator, institutions, Research Ethic Boards, contract research organization and sponsors) Applicable standards with respect to the risks that must be divulged to the research subject Pitfalls that must be avoided in light of the case law :05 Ensuring the Protection of Personal Information Frédérique Desruisseaux Senior Legal Counsel, sanofi- aventis Canada Inc. Understanding the Canadian privacy legislation framework Ensuring compliance with privacy legislation in clinical research practices and documentation Resolving personal information issues relating to Informed Consent Forms Responsibility for third party transfer Recognizing, assessing and minimizing the risks when transferring clinical research data to other jurisdictions Privacy considerations: electronic health records, secondary use of data, practices in pharmacovigilance, professional databases :50 How to Prepare for a Clinical Trial Inspection A representative of the HPFB Inspectorate Health Products and Food Branch, Health Canada The Health Products and Food Branch Inspectorate conducts inspections of clinical trials in Canada in order to verify and assess compliance to Division 5 of the Food and Drug Regulations. This presentation will provide an overview of the inspection process and will include a summary of findings from inspections completed in the past few years. 4:0 Conference adjourns Sponsorship & Exhibition Opportunities Maximize your organization s visibility in front of key decisionmakers in your target market. For more information, contact Director Business Development Daniel Gellman at ext. 89, toll-free ext. 89 or by at Register at or in Toronto or The Canadian Institute, 2008

6 February 19-20, 2009 InterContinental Hotel, Montreal Managing Legal Risks in Structuring and Conducting CLINICAL TRIALS A Legal, Business and Ethical Guide to Maximize Integrity and Minimize Exposure To expedite your registration, please mention your Priority Service Code 269X09.INH REgistration form Attention Mailroom: If undeliverable to addressee, please forward to: Legal Counsel, Director of Clinical Research, Clinical Trials, Medical Affairs Top Reasons to Attend ' Ê : The premier legal and regulatory event in Canada Get the best practices from the industry leaders Learn to better draft clinical study agreements Network with government regulators and industry leaders 5 EASY WAYS TO REGISTER * 8 Phone: or Fax: or Mail: The Canadian Institute 129 Bay Street Toronto, Ontario M5R 2C4 Online: step step 2 step 1 conference code: 269X09-MTL YES! Please register the following delegate for the Clinical Trials event Fee Per Delegate Register & Pay by January 22, 2009 Register & Pay after January, 2009 o Conference Only $ TPS 5% + TVQ 7.5% = $ $ TPS 5% + TVQ 7.5% = $2251,86 o Conference + Workshop $ TPS 5% + TVQ 7.5% = $ $ TPS 5% + TVQ 7.5% = $ o I am attending, please add the conference materials CD-ROM to my order $195 + $15.95 (S & H) (+ applicable taxes) contact details NAME ORGANIZATION ADDRESS POSITION CITY PROVINCE POSTAL CODE TELEPHONE TYPE OF BUSIness APPROVING MANAGER Payment Please charge my o VISA o MasterCard o AMEX Number Signature FAX Expiry no. OF EMPLOYEES POSITION o I have enclosed my cheque for $ including GST made payable to The Canadian Institute (GST No. R ) For group discounts please call o Wire Transfer ($CAD) Please quote the name of the attendee(s) and the event code 269X09 as a reference. Beneficiary: The Canadian Institute Bank Name: HSBC / Account #: Address: 150 Bloor St, Suite M100, Toronto, ON Swift Code: HKBCCATT / Branch #: 1062 Administrative Details Venue: HOtel InterContinental Montreal Address: 60 SAINT ANTOINE STREET WEST, MontrEal TEL.: Hotel Reservations For information on hotel room availability and reservations, please contact Hotel InterContinental Montreal at When making your reservation, please ask for The Canadian Institute s Corporate Rate. Program Materials Conference participants will receive a comprehensive set of conference materials prepared by the speakers, as an excellent reference source after the conference. If you have paid and are unable to attend, the conference materials will be shipped to you upon request only. Request must be received within 0 days upon conclusion of the conference. Payment Policy Payment must be received in full by the conference date. All discounts will be applied to the Conference Only fee (excluding add-ons), cannot be combined with any other offer, and must be paid in full at time of order. Group discounts available to individuals employed by the same organization. Cancellation and Refund Policy You must notify us by at least 48 hrs in advance if you wish to send a substitute participant. Delegates may not share a pass between multiple attendees without prior authorization. If you are unable to find a substitute, please notify The Canadian Institute in writing no later than 10 days prior to the conference date and a credit voucher will be issued to you for the full amount paid. Credit Vouchers are valid for 1 year and are redeemable against any other Canadian Institute conference. If you prefer, you may request a refund of fees paid less a 25% service charge. No credits or refunds will be given for cancellations received after 10 days prior to the conference date. The Canadian Institute reserves the right to cancel any conference it deems necessary and will, in such event, make a full refund of any registration fee, but will not be responsible for airfare, hotel or other costs incurred by registrants. No liability is assumed by The Canadian Institute for changes in program date, content, speakers or venue. Incorrect Mailing Information To advise us of changes to your contact information, please send amendments by Fax to or us at CanadianInstitute.com or visit our website and click on update your customer information.

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