DIA s 9 th Annual Canadian Meeting New Models New Frameworks New Partnerships

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1 DIA s 9 th Annual Canadian Meeting New Models New Frameworks New Partnerships Meeting: November 1-2, 2011 Tutorial: October 31, 2011 The Marriott Ottawa Hotel Ottawa, Ontario, Canada PROGRAM CO-CHAIRPERSONS Neerja Goyal Director, Regulatory Strategy and Policy GlaxoSmithKline, Canada Alice Hui Manager, Regulatory Project Management Division Therapeutic Products Directorate Office of Business Transformation PROGRAM COMMITTEE Kimby Barton Director, Bureau of Cardiology, Allergy & Neurological Sciences Therapeutic Products Directorate Louise Blythe Head, Regulatory Affairs, Strategic Product Development Lifecycle Management AstraZeneca Canada, Inc. Cathy Parker Director, Office of Policy and International Collaborations, Biologics and Genetic Therapies Directorate Sandra Usik Associate Vice President Regulatory Affairs, Quality and Safety Eli Lilly Canada Inc The biopharmaceutical community continues to experience paradigm shifts in drug development. Further global changes will likely occur with respect to drug development and regulatory oversight and traditional and non-traditional partnerships in healthcare. Several factors influencing these changes include: new scientific approaches; biomarkers and individualized medicines; health care reform; technological advances; and the interplay between safety pharmacovigilance and effectiveness research. In order to remain competitive, Canada will need to foster innovation in these areas to facilitate market access to medicines. The rapid pace of change will create new opportunities and challenges to our current ways of thinking and operating. This program will highlight information on changes occurring to drug development models, regulatory oversight frameworks and new emerging opportunities and challenges with traditional and non-traditional partnerships in healthcare. TUTORIAL Monday, October 31, 2011 Preregistration required. See inside. WHO SHOULD ATTEND This program will benefit individuals involved in Regulatory affairs Policy/pharmacoeconomics Clinical development Drug safety/pharmacovigilance Patient safety Worldwide Headquarters Drug Information Association, Inc. 800 Enterprise Road, Suite 200 Horsham, PA 19044, USA Regional Offices Basel, Switzerland Tokyo, Japan_ Mumbai, India Beijing, China In collaboration with

2 2 CONTINUING EDUCATION Drug Information Association has been approved as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 8405 Greensboro Drive, Suite 800, McLean, VA 22102; (703) Drug Information Association is authorized by IACET to offer 1.3 CEUs for this program. The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is designated for 3.25 contact hours or.325 continuing education units (CEU s) L04-P. Type of Activity: Knowledge CONTINUING EDUCATION CREDIT ALLOCATION Program: 1.0 IACET CEUs Tutorial #1: Project Management in the BioPharmaceutical Sector:.3 IACET CEUs Tutorial #2: Benefit Risk Assessment: Pre vs Post Market: Pharmacy UAN # L04-P; 3.25 contact hours or.325 CEUs;.3 IACET CEUs If you would like to receive a statement of credit, you must scan your name badge at each session you attend and complete the on-line credit request process through My Transcript at Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests November 17, Disclosure Policy: It is Drug Information Association policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosures will be included in the course materials. Benefit from DIA Membership Stay informed Build professional relationships Develop your career Learning Objectives: At the conclusion of this meeting, participants should be able to: Recognize the recent advances and challenges in drug development (e.g. biomarkers, comparative effectiveness, risk management) and the implications of these changes to academia, industry, regulators, payers and healthcare practitioners Explain the changes occurring to the regulatory framework and how this aligns with other jurisdictions Discuss innovative and non-traditional partnerships and the opportunities and challenges they present Distinguish barriers to innovation and exploring the removal of these barriers through partnerships or other means

3 DAY 1 TUTORIAL DAY MONDAY, OCTOBER 31, :00 am 1:30 pm TUTORIAL REGISTRATION 1:30 5:00 pm TUTORIAL Benefit Risk Assessment: Pre vs Post Market Co-Tutorial Instructors Lawrence Liberti, MS, RPh, RAC Executive Director Centre for Innovation in Regulatory Science (CIRSCI) Robyn Lim, PhD Scientific Advisor, Office of Legislative and Regulatory Modernization Heath Products and Food Branch We balance benefits and risks for every activity in daily life. Regulators, drug developers, clinicians, patients, payers and other stakeholders apply benefit-risk (BR) assessments to medicines. Despite the wide use of intuitive approaches, the use of formal frameworks for the evaluation of a medicine s BR is a relatively new, continually emerging science. A common framework for assessing and communicating BR can be used during development to inform go/no-go decisions and to build a product s label. BR assessment is an imperative component of post-approval surveillance. This tutorial is designed to introduce participants to the concepts that underlie some of the more common techniques to assess the BR of medicines and to provide a forum to discuss these approaches to more effectively communicate BR assessments with heterogeneous stakeholders. Participants will join in an in-class BR assessment exercise. Tutorial Target Audience This tutorial is designed for pharmaceutical scientists and healthcare professionals with responsibility for assessing and/or communicating the benefits and risks of medicines to internal company audiences, regulators, healthcare professionals, HTAs and patients. No background in statistics is required. Tutorial Learning Objectives At the conclusion of this tutorial, participants should be able to: Discuss some of the most common BR assessment initiatives being investigated world-wide Explain how to construct a BR decision tree and understand its practical use Recognize BR frameworks that can be used during development phases to inform strategic decisions Explain how BR frameworks can use post-approval to assess the evolution of a medicine s BR profile. 4:00 6:00 pm CONFERENCE REGISTRATION EXHIBIT OPPORTUNITY Space is available for exhibits which attendees are free to visit during the meeting and receptions. For further information contact: Jeff Korn, Exhibits Associate Phone Fax Jeff.Korn@diahome.org EVENT INFORMATION Joanne Wallace, Program Manager Phone Fax Joanne.Wallace@diahome.org

4 DAY 2 TUESDAY, NOVEMBER 1, :30-8:30 am REGISTRATION AND CONTINENTAL BREAKFAST 8:30-8:45 am OPENING PLENARY SESSION Susan Cantrell Director, North America DIA Neerja Goyal Director, Regulatory Strategy and Policy GlaxoSmithKline, Canada Alice Hui Manager, Regulatory Project Management Division Therapeutic Products Directorate Office of Business Transformation 8:45-9:00 am WELCOME 9:00-9:30 am KEYNOTE ADDRESS #1 Philip Blake President and CEO Bayer, Inc. Canada Chair, Rx&D 9:30-10:00 am KEYNOTE ADDRESS #2 David Griller, PhD, FCIC, FRSC Partner SECOR Consulting David Griller is a partner in SECOR Consulting and has a passion for life sciences. His clients range from major pharmaceutical companies such as Pfizer, Merck, Sanofi, Novartis and AstraZeneca, to medium and small biotechnology firms involved in drug discovery and diagnostics. David works frequently on public policy issues in life sciences with, for example, Rx&D, Industry Canada,, and the Ontario Institute for Cancer Research. He also co-founded and managed Oncozyme Pharma Inc. a start-up in oncology which is now testing its technology in human clinical trials. David spent a third of his career as a research chemist at the National Research Council of Canada. He always had a strong leaning towards business and has worked in management, strategic planning and consulting with Plastic Constructions Inc. Deloitte Haskins and Sells and KPMG. He is a fellow of both the Royal Society of Canada and the Canadian Institute of Chemistry. 10:00 10:45 am REFRESHMENT BREAK IN THE EXHIBIT HALL Philip Blake is President & CEO, Bayer Inc. and Head of Bayer HealthCare in Canada. Under his leadership, the organization has become one of the country s top five healthcare companies, a Canada s Top 100 Employer, Top Green Employer and Top 50 Employers in the GTA. Bayer Inc. is headquartered in Toronto and employs approximately 800 professionals from coast to coast. Mr. Blake was appointed President & CEO of Bayer Inc. in In his 28 year career with Bayer, Mr. Blake has held leadership positions around the world focusing on global strategic product marketing, business development, clinical planning, product developments and sales management. He was also responsible for the successful integration of a major Canadian pharmaceuticals company into Bayer s pharmaceutical business in Canada. In 2007, Mr. Blake had the honour of acting as the Chairman of the Board of Canada s Research-Based Pharmaceutical Companies Rx&D, the national association representing more than 22,000 employees working for over 50 pharmaceutical companies across Canada. During his one year term, Mr. Blake focused on improving patient access to innovative new treatments and partnering with governments to make affordable healthcare for Canadians a priority. Mr. Blake is the in-coming Chairman of this association which will take effect November Mr. Blake attended Bristol University and Oxford University Business School in the United Kingdom, with extended business training at INSEAD Fontainbleu in Paris, France and the Wharton Business School in Philadelphia, USA. He is also a member of the Ivey Biotech Advisory Council, University of Western Ontario, Richard Ivey School of Business, as well as a Chartered Corporate Director earning this prestigious designation in 2006 from the Directors College at the DeGroote School of Business, McMaster University. In 2006, Mr. Blake was inducted into the Canadian Pharmaceutical Marketing Hall of Fame and in 2008 was named Communicator of the Year by the International Association of Business Communicators (IABC). Mr. Blake became a Canadian citizen in July :45-11:15 am KEYNOTE ADDRESS #3 Paul Glover Assistant Deputy Minister Paul Glover was appointed Assistant Deputy Minister (ADM) of the at in February HPFB takes an integrated approach to managing the health-related risks and benefits of health products and food through the regulatory system. The Branch also promotes conditions that enable Canadians to make health choices and provides information so that they can make informed decisions about their health. Paul was the ADM of the Healthy Environments and Consumer Safety Branch at from September 2008 to January Previous to that, he was in the Privy Council Office s Operations Branch, where he worked on a wide range of social policy issues. He began his career at in 1986, in the informatics area. Paul then moved on to health systems management and assumed progressively more responsible jobs, eventually leading, as Director General, a number of business units, including First Nations and Inuit Health Programs, the Non-Insured Health Benefits Program, and the Safe Environments Program. Over the years Paul has served on numerous governing bodies, including the Board of Directors of the Queensway Carleton Hospital, the Advisory Board for the Canadian Institutes of Health Research, and the Queen s University Board of Directors for the Centre for Water and the Environment. He has been a member of the National Academies of Science in the U.S.A. and the International Joint Commission. Paul earned his Master in Business Administration from Queen s University.

5 DAY 2 TUESDAY, NOVEMBER 1, :15 am 12:00 pm PANEL DISCUSSION WITH 3 PLENARY SPEAKERS 12:00 1:30 pm LUNCHEON IN THE EXHIBIT HALL 1:30 3:00 pm PARALLEL TRACKS SESSION 1 Track 1 NEW MODELS Subsequent Entry Biologics (Biosimilars) Cathy Parker Director, Office of Policy and International Collaborations, Biologics and Genetic Therapies Directorate, Health Products and Food Branch Track 2 NEW FRAMEWORKS Off-label use: Guerilla Marketing or Life-saving Intervention? Kimby Barton Director, Bureau of Cardiology, Allergy & Neurological Sciences Therapeutic Products Directorate Track 3 NEW PARTNERSHIPS Electronic Media: Opportunities and Challenges of the Electronic Dialogue Alice Hui Manager, Regulatory Project Management Division, Therapeutic Products Directorate Office of Business Transformation The expiration of patents and/or data protection for biologic drugs such as recombinant human growth hormones, erythropoeitins, interferons, and other protein products, is ushering in an era for subsequent entry biologics (SEBs), also known as Biosimilars. SEBs are biologic products that would be authorized for use (or enter the market) in Canada subsequent to an already approved biologic product whose patent has expired, and relying in part on prior information regarding safety and efficacy that is deemed relevant due to the demonstration of similarity to the reference biologic drug. In March 2010, released the document Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs) which outlines processes and data requirements for the approval of SEBs under the existing regulations for new drugs under Part C, Division 8 of the Food and Drug Regulations. The document was developed following extensive consultation with industry. To date only one SEB has been approved in Canada. This session will provide the perspective of both the regulator and industry on the issues of importance concerning the introduction of SEBs onto the Canadian market. Biosimilars Barriers to Market Entry Dr. Michel Mikhail Senior Vice President Fresenius Kabi Deutschland GmbH Industry Perspective Dr. Karen Burke Director of Regulatory Affairs Amgen, Canada, Inc. Regulator s Perspective Dr. Kwasi Nyarko Office of Policy and International Collaboration, BGTD Off-label use of therapeutic products is a widely occurring and well-recognized phenomenon, and for some patient groups may represent their only access to certain medications. Depending on your perspective, off-label use may be a questionable practice that enhances the sale of drugs by pharmaceutical companies, or may be an effective means to treating otherwise untreatable diseases. This session will discuss whether the current regulatory framework for off-label use needs to be updated, providing perspectives from industry, the regulator and health care professionals on this challenging area of patient management. Off-label use of Marketed Drugs; the Facts and Regulatory Implications Julie Blouin, BPharm, MSc, PhD Manager, Health Economics and Reimbursement Strategy Novartis Pharmaceucials Canada Inc. Challenges Associated with Off-Label Advertising Alain G. Musende, PhD Head, Regulatory Advertising Unit Therapeutic Effectiveness and Policy Bureau Marketed Health Products Directorate Physician s Perspective Ajit Ninan, HonsBSc, MD, FRCPC Diplomate of the American Board of Psychiatry and Neurology Chief of Treatment, CPRI Assistant Professor Schulich School of Medicine and Dentistry Department of Psychiatry, Division of Child and Adolescent Psychiatry How can electronic media complement traditional healthcare information services? With the use of the internet now widespread, the popularity of social media growing, and an increasing number of informed healthcare consumers turning to electronic media as sources of health information, this session will explore the opportunities and challenges presented by an increasingly electronic environment, the dialogue it generates, and its interface with regulatory standards for the advertising of health products in Canada. Medical Information Websites Bonnie Jean Macfarlane Manager, Medical Information Janssen, Inc. Social Media Marketing Deirdre Cozier Manager, Regulatory Operations, Policy & Intelligence Sanofi-Aventis Canada, Inc. A Regulatory Perspective Patrick Massad Chief Review Officer Pharmaceutical Advertising Advisory Board 3:00 3:30 pm REFRESHMENT BREAK IN THE EXHIBIT HALL

6 DAY 2 TUESDAY, NOVEMBER 1, :30 5:00 pm PARALLEL TRACKS SESSION 2 Track 1 NEW MODELS Personalized Medicines: A Revolution in Healthcare Neerja Goyal Director, Regulatory Strategy and Policy GlaxoSmithKline, Canada Track 2 NEW FRAMEWORKS Risk Management Planning: Where are we now? Kimby Barton Director, Bureau of Cardiology, Allergy & Neurological Sciences Therapeutic Products Directorate Track 3 NEW PARTNERSHIPS Use of Electronic Media in Clinical Trials Karen Feltmate President, Redstone Health Group Inc. Personalized medicines are playing an increasingly integral role in health care. Catalyzed by rapidlyemerging information from life sciences research and the availability of sophisticated information technologies, personalized medicines holds the promise of more targeted therapeutics that can improve efficacy and reduce adverse side effects. This session will explore progress to date and highlight opportunities and challenges in this rapidly evolving area. Personalized Medicines: An Industry Perspective Joel (Clay) Stephens, PhD Senior Director, Pharma Therapeutics, Molecular Medicine Pfizer Translating Development into Clinical Delivery Jean-Claude Tardif, MD, FRCPC, FACC, FCAHS Director, Research Center / Cardiologist Montreal Heart Institute Research Center Current and Future Value in Canada Katherine Bonter Director of Advocacy and Promotion Center of Excellence in Personalized Medicine It has been several years since most major jurisdictions implemented some form of postmarket Risk Management Planning (RMP). Health Canada notified of its intent to implement RMP on an interim basis in early In that time there has been a great deal written and discussed on the strengths and limitations of this type of intensive post-market activity, and on the difficulties associated with evaluation of effectiveness of risk mitigation activities. This session will provide guidance on practical tips for putting in place RMPs in Canada, as well as information on evaluation of risk management plans. In addition, the regulator will provide an update on what has been doing during the early phases of RMP implementation. Risk Management Planning: Practical Tips for Putting Global RiskMAPs into Action in Canada Diana Basmadjian Head/Associate Director Pharmacovigilance Sanofi-Aventis Canada, Inc. RMPs at Marc Berthiaume, MD Director, Marketed Pharmacologicals and Medical Devices Bureau, MHPD Risk Management Plan Evaluation Aileen Li Manager, Risk Management Plan Drug Safety & Surveillance Janssen, Inc. Electronic media is being used increasingly in the conduct of clinical trials. In fact, clinical trials are leaving paper behind as electronic media is making lives easier for patients, Investigators, CROs and Sponsors. This session will look at new partnerships in this research space, how electronic media is being used in clinical trials, the associated operational and regulatory advantages, and challenges within the Canadian regulatory environment. Use of Electronic Media David Leventhal Director, Clinical Innovation Worldwide Research & Development Pfizer, Inc. Decisional, Planning and Workflow Issues in Implementing Electronic Informed Consent Susan Brink CEO Consent Solutions, Inc. CRO/EPRO Best Practices Gregg Jewett Sr. Director, Strategic Alliances and Partnerships, CRF Health 5:00 6:30 pm NETWORKING RECEPTION

7 DAY 3 7 WEDNESDAY, NOVEMBER 2, :30-8:30 am REGISTRATION AND CONTINENTAL BREAKFAST 8:30 10:00 am PARALLEL TRACKS SESSION 3 Track 1 NEW MODELS Track 2 NEW FRAMEWORKS Track 3 NEW PARTNERSHIPS Evolutions in Pharmacovigilance Legislative and Regulatory Modernization Fostering Patient Safety Louise Blythe Sandra Usik Head, Regulatory Affairs, Strategic Product Development Lifecycle Management AstraZeneca Canada, Inc. Cathy Parker Associate Vice President Regulatory Affairs, Quality and Safety Eli Lilly Canada, inc. Today, pharmacovigilance is an ever-changing landscape. Signal detection is required by regulatory Health Authorities such as the FDA, EMA and ; however, traditional qualitative signal detection methods are deemed no longer sufficient and quantitative methods are being implemented in most jurisdictions. This session will explore different signal detection methods and their application within the Canadian context. Canada s regulatory systems for health products have served Canadians well over the years. However, recent trends such as advances in science and technology, globalization and changing consumer demands are driving the need for regulatory modernization in Canada and around the world. In light of these trends, is working with stakeholders to update its regulatory systems. This session will examine the range of evidence that is informing the modernization of regulatory instruments and mechanisms. Fostering patient safety is a continuous responsibility and role that all partners in health care share, including patients with the goal of maximizing clinical benefit and reducing risk of drugs. In this session, hear from some of those partners as they discuss how they work to fulfill that role through various mechanisms, including monitoring, communication and education and an also gain an understanding of a patient s perspective and needs for information to allow them to achieve the best decision of care. Views Joanne Garrah Associate Director Office of Legislative and Regulatory Modernization Policy Planning and International Affairs Directorate Industry and Pharmacists: Partners for Patient Safety Catherine Wiebe Project Leader, Pharmacovigilance Sanofi-Aventis Canada, Inc A Signal Detection Method for small-tomidsize drug Safety Databases Dr. Yola Moride Former President, ISPE: Associate Professor University of Montreal Faculty of Pharmacy Industry Perspective on Signal Detection Methods Dr. Lin Zhang Patient Safety AstraZeneca, LP Regulator s Perspective Ariel E. Arias, MD PhD Marketed Health Products Directorate Director, Office of Policy and International Collaborations Biologics and Genetic Therapeutics Directorate Industry Views Sandra Wainwright, PhD Director, Regulatory Affairs Merck, Canada President, ISPE: Associate Professor Pharmacist s Perspective Speaker has been invited Fostering Patient Safety Laurel Taylor Chief Operations Officer Canadian Patient Safety Institute University of Montreal 10:00 10:30 am REFRESHMENT BREAK IN THE EXHIBIT HALL New DIA Member Benefit! Become a DIA member and gain access to DIA ConneX. Network with Professional Colleagues Anywhere Anytime! Thousands of your colleagues will be part of DIA ConneX, so don t get left behind. How Can DIA ConneX Help You? Get answers to on-the-job questions DIA ConneX You DIA s new members-only social networking-style website is a vital resource for professionals like you looking to connect with others in your field and improve your job performance. A ccess shared resources such as white papers and articles Network with thousands of your colleagues worldwide Get connected at

8 DAY 3 WEDNESDAY, NOVEMBER 2, :30 am 12:00 pm PARALLEL TRACKS SESSION 4 Track 1 NEW MODELS Use of Scientific Data for Decisions about Patient Care Neerja Goyal Director, Regulatory Strategy and Policy GlaxoSmithKline, Canada Optimizing patient care is grounded in having robust scientific evidence about the benefits and risks of therapeutic products. Although scientific data is generated over the entire life cycle of the product, the levels of evidence associated with different types of data vary. Physicians must synthesize all of this information into making the best decisions on treatment options and disease management for their patients. This session will explore the complementary nature of the different levels of evidence and how this can be used to deliver improved quality of care for patients. Use of Scientific Data for Decisions about Health Products a Perspective David Clapin, PhD, MBA, DABT Branch Science Advisor, Health Products & Food Branch The Emperor s New Clothes How to use (and not use) Clinical Trial Data to Guide Quality Patient Care Jan M. Kornder, MD General Cardiology Lead Physician Fraser Health Authority Use of Scientific Data for Decisions about Health Products an Industry Perspective Laurent Carty Director of Medical Strategy and Regional Operations Sanofi-Aventis Track 2 NEW FRAMEWORKS Extraordinary Use and Emergency Preparedness Cathy Parker Director, Office of Policy and International Collaborations, Biologics and Genetic Therapies Directorate, Health Products and Food Branch Many drugs used to treat emerging diseases or health conditions caused by chemical, biological, radiological or nuclear (CBRN) agents cannot be tested in traditional clinical trials under the recommended conditions of use because of the sporadic or infrequent nature of the event leading to exposure. In April 2011, the Extraordinary Use New Drug (EUND) regulations were enacted under the Food and Drug Regulations. This new regulatory framework will allow the authorization of emergency-use drugs, based on limited human safety studies and supporting animal studies. The session will discuss the impact of this new regulatory framework, from both the perspective of the regulator,, and a principle user and purchaser of EUNDs, the Department of National Defense. Industry sponsors will have th+e opportunity to acquire a clearer understanding of the criteria and data requirements for EUNDs. Regulatory Perspective Barbara Wong Senior Policy Analyst Office of Policy and International Collaboration Biologics and Genetic Therapies Directorate Emergency Preparedness at Department of National Defense Milan Patel B.SC., CerRAP Regulatory Affairs Project Officer Director Health Services Operations Canadian Forces Health Services Group Headquarters-Department of National Defense Track 3 NEW PARTNERSHIPS Collaborative Approaches Alice Hui Manager, Regulatory Project Management Division, Therapeutic Products Directorate Office of Business Transformation There is increasing stakeholder interest in working together through collaborative, rather than singular, approaches in order to identify and take action on common visions and objectives. This session will explore innovative and non-traditional means of collaboration between stakeholders to deliver outcomes as efficiently, effectively, and sustainably as possible. Examples of innovative stakeholder models will be explored, as well as the opportunities and challenges of these collaborative efforts. Innovative Opportunities for Collaboration and Modernization Initiatives Vikesh Srivastava MSc Associate Director Business Informatics Industry Perspective Craig Anderson Manager, Regulatory Affairs Operations AstraZeneca Canada, Inc The Government of Canada and Bill and Melinda Gates Foundation Lilja Jónsdóttir Senior Policy Advisor, Strategic Issues Section Strategic Issues & Integrated Management Division Centre for Communicable Diseases Public Health Agency of Canada 12:00 1:30 pm LUNCHEON IN THE EXHIBIT HALL (EXHIBIT HALL CLOSES AT 1:30 PM) 1:30 3:00 pm CLOSING PLENARY SESSION International Collaboration: Strategic Approaches to Regulatory Cooperation and Implementation in the Canadian Context There is an increasing focus and effort by health product regulators to collaborate on an international level. Please join us for a panel discussion to explore continuing developments in inter-agency collaboration, and how this is shaping approaches within the Canadian context. Session Co-Chairs Alice Hui Manager, Regulatory Project Management Division Therapeutic Products Directorate, Office of Business Transformation Rocelyn DelCarmen Head, Regulatory Affairs, Strategic Operations & Quality Assurance AstraZeneca Canada Inc. Panelists Louise Dery A/Director, Policy, Planning and International Affairs Directorate, Agnes V. Klein, DrPH, MD Director Centre for the Evaluation of Radiopharmaceuticals and Biotherapeutic Products Vicky Hogan, M. SC, PhD Director, Office of Risk Management and Science Marketed Health Products Directorate, 3:00 pm MEETING ADJOURNED

9 REGISTRATION FORM Register online or fax this page to DIA Canadian Annual Meeting: New Models, New Frameworks, New Partnerships Event #11019 Tutorial: October 31, 2011 Meeting: November 1-2, 2011 The Marriott Ottawa Hotel, Ottawa, Ontario, Canada Registration Fees If DIA cannot verify your membership, you will be charged the nonmember fee. Registration fee includes refreshment breaks, luncheons, and reception (if applicable), and will be accepted by mail, fax, or online. Member Early-bird Opportunity On or before After Available on nondiscount member fee only OCT. 10, 2011 OCT. 10, 2011 Member Fee US $1340 q US $1490 q Join DIA now to qualify for the early-bird member fee! MEMBERSHIP US $140 q To qualify for the early-bird discount, registration form and accompanying payment must be received by the date above. Does not apply to government/academia/nonprofit members. Nonmember Fee US $1630 q A one-year membership to DIA is available to those paying a nonmember registration fee. If paying a nonmember fee, please indicate if you do, or do not, want membership. I want to be a DIA member q I do NOT want to be a DIA member q Discount Fees MEMBER NONMEMBER Government (Full-time) US $595 q US $735 q Charitable Nonprofit/Academia (Full-time) US $745 q US $885 q *If paying a nonmember fee, please check one box above, indicating whether you want membership. TUTORIAL: Monday, October 31, 1:30-5:00 PM Benefit Risk Assessment: Pre vs Post Market US $405 q TRAVEL AND HOTEL The most convenient airport is Ottawa International Airport and attendees should make airline reservations as early as possible to ensure availability. The Marriott Ottawa Hotel is holding a block of rooms at the reduced rate below until October 7, 2011, for the DIA event attendees. Room availability at this rate is guaranteed only until this date or until the block is filled. Single $149 CN Double $149 CN Please contact The Marriott Ottawa Hotel by telephone at or and mention the DIA event. The hotel is located at 100 Kent Street, Ottawa, ON K1P 5R7 CANCELLATION POLICY: On or before OCTOBER 24, 2011 Administrative fee that will be withheld from refund amount: Member or Nonmember = $200 Government or Academia or Nonprofit (Member or Nonmember) = $100 Tutorial (if applicable) = $50 Cancellations must be in writing and be received by the cancellation date above. Registrants who do not cancel by that date and do not attend will be respons ible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations. You may transfer your registration to a colleague at any time but membership is not transferable. Please notify DIA of any such substitutions as soon as possible. Substitute registrants will be responsible for nonmember fee, if applic able. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants. Participants with Disabilities: DIA event facilities and overnight accommodations are accessible to persons with disabilities. Services will be made available to sensory-impaired persons attending the event if requested at least 15 days prior to event. Contact the DIA office to indicate your needs. TO RECEIVE A TABLE TOP EXHIBIT APPLICATION, PLEASE CHECK GROUP DISCOUNTS* Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred. Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia. To take advantage of this offer, please make a copy of this registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA. q Please indicate that this form is part of a group registration by checking this box and list below the names of the other three registrants from your company. 1. q EXHIBIT INFORMATION Attendees may visit the exhibits during the event and receptions. Contact Jeff Korn, Exhibits Associate, Phone Fax , Jeff.Korn@diahome.org EVENT INFORMATION Contact Joanne Wallace, Program Manager, Phone Fax , Joanne.Wallace@diahome.org Please check the applicable category: q Academia q Government q Industry q CSO q Student (Call for registration information) Last Name First Name M.I. Payment options: Register online at or check payment method. q CREDIT CARD number may be faxed to: You may prefer to pay by check or bank transfer since non-u.s. credit card payment will be subject to the currency conversion rate at the time of the charge. Visa MC AMEX Exp Date Card # Degrees q Dr. q Mr. q Ms. Job Title Company Name (printed) Signature Address (As required for postal delivery to your location) Mail Stop q CHECK drawn on a US bank payable to and mailed along with this form to: Drug Information Association Inc, P.O. Box , Philadelphia, PA , USA. Please include a copy of this registration form to facilitate identification of attendee. q BANK TRANSFER When DIA completes your registration, an will be sent to the address on the registration form with instructions on how to complete the Bank Transfer. Payment should be made in US dollars. Your name and com pany, as well as the Event I.D. # must be included on the transfer document to ensure payment to your account. 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10 Member Early-bird Rate Register by October 10, 2011 SAVE $150! DIA s 9 th Annual Canadian Meeting New Models New Frameworks New Partnerships October 31 - November 2, 2011 The Marriott Ottawa Hotel Ottawa, Ontario, Canada