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Delta Hotels Ottawa City Centre

Oct 18, 2022 1:00 PM - Oct 19, 2022 9:10 PM

101 Lyon Street North, Ottawa, ON K1R 5T9, Canada

Canada Annual Meeting


Maria  Anillo

Maria Anillo

Regulatory Affairs Project Manager, AstraZeneca Canada Inc., Canada

Maria Anillo is a Regulatory Affairs Project Manager at AstraZeneca Canada Inc. and holds a Master of Science degree in Molecular and Cellular Biology from the University of Guelph. She has over 4 years of experience in the brand name pharmaceutical industry working on both established and marketed products in various therapeutic areas. Prior to joining AstraZeneca, she was a Senior Associate, Established Products & Regulatory Operations at Boehringer Ingelheim (Canada) Ltd. and she completed the Pharmaceutical Regulatory Affairs and Quality Operations at Seneca College. Her current role allows her to expand her regulatory knowledge and maintain regulatory compliance of approved products.

Marcia  Bailey, BSN, MHS, RN

Marcia Bailey, BSN, MHS, RN

Safety Evaluation and Risk Management Scientific Director, GSK, Canada

Marcia is a registered nurse with many years of clinical and industry experience. In addition to her past role as a clinical research data management subject matter expert, more than a decade of pharmacovigilance duties has helped Marcia acquire much of the knowledge, skills, and abilities needed to help companies manage today’s evolving drug safety responsibilities and regulations. Marcia has been a DIA conference speaker and is currently a Safety Evaluation & Risk Management Scientific Director at GSK.

Marilyne  Chamoun, MSc

Marilyne Chamoun, MSc

Senior Scientific Evaluator, Marketed Pharmaceuticals Bureau, Health Canada, Canada

Marilyne Chamoun joined Health Canada in 2006. She holds a Master's degree in Pharmaceutical Sciences from Université de Montréal and has over 15 years of experience in pharmacovigilance and risk management working within the Marketed Health Product Directorate.

Mandy  Collier

Mandy Collier

Director, Health Products and Food Branch, Health Canada, Canada

Mandy Collier is the Director of the Office of Planning, Performance and Review Services in the Pharmaceutical Drugs Directorate (PDD) of Health Canada. She has worked in the Health Products and Food Branch (HPFB) for over 15 years in a variety of policy, advisory and management positions in the PDD, Biologic and Radiopharmaceutical Drugs Directorate, and the HPFB Assistant Deputy Minister’s Office. She has a degree in pharmacology from McMaster University.

Lucye  Galand, DVM, MBA, MSc

Lucye Galand, DVM, MBA, MSc

Acting Director, BGIVD, Therapeutic Products Directorate, HPFB, Health Canada, Canada

Although most of her regulatory career in Health Canada has been spent in the pharmacovigilance world, she has recently migrated to the pre-market assessment of pharmaceuticals program in the Therapeutic Products Directorate. Lucye has significant work and management experience in the Health Products and Food Branch (HPFB), where she has held a number of management positions in different Directorates. She is currently Acting Director of the Bureau of Gastroenterology, Infection and Viral Diseases. Her academic specialization is pharmacology.

Lorella  Garofalo, PhD

Lorella Garofalo, PhD

Head of Regulatory Sciences, Pfizer Canada, Canada

Lorella has been with Pfizer Canada since 2001 assuming roles of increasing responsibility in clinical research as well as medical affairs and is currently head of regulatory sciences for Pfizer Canada. She obtained a BSc (Honours) in Biochemistry and a PhD in Pharmacology & Therapeutics from McGill University. Prior to joining Pfizer, Lorella was a drug assessment officer at TPD, Health Canada and since 1999 has maintained an academic appointment with the department of Pharmacology & Therapeutics at McGill. She has served as a member of the board of directors/advisory councils for various research organizations and is a member of the regulatory affairs committees of Innovative Medicines Canada and BIOTECanada.

Agnes  Jankowicz, MS

Agnes Jankowicz, MS

Vice President, Pharmacovigilance, Veristat, Canada

Agnes is an industry leader with over twenty years of experience in pharmacovigilance (PV) and medical information (MI) both in the pharmaceutical industry as well as in the consulting environment. She is a Vice President of Pharmacovigilance at Veristat, a CRO whose team includes experienced and dedicated PV professionals. Agnes in an expert PV auditor and a recognized pharmacovigilance educator engaged in teaching pharmacovigilance courses and presenting on various PV topics. Agnes holds a graduate degree in Pharmacology & Toxicology and, prior to joining the pharmaceutical industry, was involved in academic research.

Yatika  Kohli, PhD, MBA

Yatika Kohli, PhD, MBA

Chief Regulatory and Strategy Officer, NoNO Inc, Canada

Dr. Yatika Kohli is an accomplished Senior Regulatory Professional with strong leadership skills, strategic foresight and business acumen. At NoNO Inc, Dr. Kohli is leading all strategic and global regulatory initiatives for NoNO’s products. With more than 20 years of experience in Biotech/Pharmaceutical industry, Dr. Kohli has expertise in developing global regulatory and clinical strategy with project and product management across multiple modalities and jurisdictions. She led the regulatory activities for the registration and launch of two blockbuster vaccines for Sanofi Pasteur in the USA and Apotex’s first biosimilar product in Europe.

Judith  Mergl, MSc

Judith Mergl, MSc

Director, Regulatory Affairs and Operational Services, AbbVie Corporation, Canada

Judith started her career with AbbVie/Abbott in 1992 and has since assumed various roles of increasing responsibility in Regulatory Affairs, Pharmacovigilance, and Quality Assurance. She currently leads a team of Regulatory Affairs professionals primarily focused on biopharmaceutical clinical development and commercial product drug submissions in the areas of Immunology, Oncology, Virology, Neuroscience, Hormone Replacement Therapy, and Specialty Care. Judith also oversees Aesthetics and Medical Devices and is an active member of Innovative Medicines Canada’s Regulatory Affairs Operational Team and BIOTECanada’s Biologics Regulatory Affairs Group (BRAG).

Myriam  Salem, MSc

Myriam Salem, MSc

Pharmacovigilance Manager, Health Canada, Canada

Myriam Salem is currently a pharmacovigilance manager in the Health Products and Food Branch (HPFB) at Health Canada. She previously led the Good Pharmacovigilance Practices inspection Program within the Regulatory Operations and Enforcement Branch (ROEB) and worked within HPFB as a senior scientific evaluator for several years. Prior to joining Health Canada, she held various positions in the pharmaceutical industry and academia at Merck Frosst Canada and McGill's Lady Davis Institute. She holds a master’s degree in pharmacology from Université de Montréal and a master’s degree in Pharmacovigilance and Pharmacoepidemiology from a consortium of European Universities under the EU2P program.

Marcia  Sam

Marcia Sam

Regulatory Affairs Strategy and Policy Manager, Hoffmann-La Roche Canada Limited, Canada

Marcia Sam is enjoying her role as a Regulatory Affairs Strategy and Policy Manager at Roche Canada. With over 16 years of experience in the Biotech/Pharmaceutical industry, she has a diverse range of experiences with exposure to different areas of drug development, regulatory submissions in therapeutic areas as Hematology, Neuroscience, Oncology, Virology, Rare Diseases, etc., volunteered on the regulatory affairs committees of IMC, was a past guest speaker and instructor for regulatory courses at Seneca College of Applied Arts and Technology. She holds a BSc (Honours) degree in Neuroscience/Biology from the University of Toronto and a Post-graduate diploma in Pharmaceutical Regulatory Affairs and Quality Operations from Seneca College.

Vanessa  Zapata

Vanessa Zapata

Associate Director, Regional Pharmacovigilance Officer, Merck Canada Inc., Canada

Vanessa Zapata started her career in the pharmaceutical industry in 1998. For 12 years, she fulfilled different roles in the Clinical research field. In 2011, she moved to Pharmacovigilance where she has held various roles of increasing responsibility. She currently fulfills a position of Associate Director, Regional Pharmacovigilance at Merck Canada Inc. She also is the business owner of the company’s Global Pharmacovigilance training that gets assigned annually to more that 115 000 employees and external partners around the world.

Oxana  Iliach, PhD

Oxana Iliach, PhD

Senior Director Regulatory Strategy, Certara, Canada

Oxana Iliach, PhD is a Sr. Director, Regulatory Strategy and Policy at Certara/Synchrogenix. She has more than 15 years of experience in the healthcare industry including the last 10+ years in regulatory affairs. Her specialty is developing and executing regulatory strategies for drugs for rare diseases, pediatrics, advanced therapy products and biosimilars, with a focus on Chemistry, Manufacturing and Control (CMC). Oxana has experience with the FDA, EMA, Health Canada, and other smaller agencies. She is also a part-time lecturer at Northeastern University, Toronto campus and professor at Seneca College of Applied Arts and Technology. Oxana is a member of CAPRA, RAPS, CORD and IRDiRC.

Aurela  Balla, DrMed

Aurela Balla, DrMed

Senior Director, Pharmacovigilance, Merck Canada Inc., Canada

Aurela first joined Merck Canada in 2013 and is currently the PV Lead (Sr. Director). She is a physician by training, specialized on Anesthesiology- Emergency Medicine. After immigrating to Canada, she obtained a D.E.S.S, Research & Drug Development from University of Montréal, and has worked prior to joining Merck in different Clinical/Hospital and Industry roles. She is a member of Canadian PV & MI Network, TransCelerate, and actively participating on ICH/HC/TransCelerate initiatives/surveys/questionnaires/guidance’s review to promote Global PV harmonization, influence adoption the new PV legislation in Canada and facilitate incorporating PV aspects on complex business activities, aiming to improve patient safety and healthcare.

John K. Wong, MPharm, RPh

John K. Wong, MPharm, RPh

Consultant, Regulatory Drug Advertising, Canada

John Wong is a pharmacist graduate from Université Laval, Quebec, Canada. He started his career at the Toronto General as an Oncology Pharmacist. In 1998, he joined the Pharmaceutical Advertising Advisory Board (PAAB), a national regulatory body for the review of drug advertising, and later became the Deputy Commissioner. After 10 years at PAAB, John decided to cross over to the ‘other side' and landed at Ogilvy CommonHealth as an Account Director where he helped launch specialty products in Oncology, Hematology and HIV. John was recently the Director, Regulatory Drug Advertising & Promotion at TPIreg/ Innomar Strategies, providing consultation and review services for drug and medical device advertising.

Daniel L Keene, MD, MA, FRCPC

Daniel L Keene, MD, MA, FRCPC

Associate Director, Office of Clinical Trials , Health Canada, Canada

Dr. Daniel Keene is the associate director of the Office of Clinical Trials at the Pharmaceutical Drug Directorate at Health Canada. After obtaining his medical degree from the University of Saskatchewan, he completed his post-graduate medical training in pediatrics at the Hospital for Sick Children in Toronto, and neurology at the Montreal Neurological Institute. He is a fellow of the Royal College of Physicians and Surgeons of Canada with speciality certification in both pediatrics and neurology. In addition, he has obtained a Master of Arts in Public Policy from Carleton University and a Graduate Certificate in Academic Excellence in Epidemiology form the School of Public Health, University of Michigan.

Carla  Che

Carla Che

Director, Regulatory Affairs, Gilead Sciences Canada, Inc., Canada

Carla is a Director of Regulatory Affairs at Gilead Sciences Canada, Inc. Carla’s experience includes leading and developing regulatory strategies for NDSs (pharmaceutical drugs), labeling, and drug advertising & promotion. She is passionate about project management and process improvements.

Yola  Moride, PhD, FISPE

Yola Moride, PhD, FISPE

President, YolaRX Consultants, Canada

Prof. Yola Moride has a strong track record of methodological expertise in pharmacoepidemiology and therapeutic risk management. She is Research Professor at Rutgers University and President of YolaRX Consultants. She received a PhD in Epidemiology from McGill University and a Post-doctoral Fellowship in Pharmacovigilance from the University of Bordeaux (France). She was President of the International Society for Pharmacoepidemiology (ISPE) and Vice-President of the International Society of Pharmacovigilance (ISoP). She also served on the Steering Group of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) at the European Medicines Agency, and was a member of CIOMS Working Group IX on risk min.

David  Boudreau

David Boudreau

Director General, Medical Devices Directorate, Health Products and Food Branch, Health Canada, Canada

David Boudreau has a biochemistry and a chemical engineering degree with honours, both from the University of Ottawa. While at university, he did lab work at the National Research Council (NRC). He worked for three years at i-STAT, as a Process Engineer in the manufacturing of medical devices for blood tests. In March 2010, he joined the Office of the Commissioner of Official Languages (OCOL), as Special Advisor. In January 2014, he was promoted to the Assistant Director position, and was in charge of external audits and evaluations. In November 2014, he returned to the Patent Office as Director, where he was responsible for 145 employees. In January 2018, he joined Health Canada, as Executive Director of the Medical Devices Bureau.

Marie-Claude  Brutus Lopez, RPh

Marie-Claude Brutus Lopez, RPh

Coordinator, Canada Vigilance Program, Marketed Health Products Directorate, Health Canada, Canada

Marie-Claude Brutus is a Regional Coordinator with Health Canada’s Canada Vigilance Program who works in the surveillance of the safety of health products in the Canadian Market. She believes it is in everyone’s interest to provide access to patients to safe and effective medicines. As part of her job she interacts with Canadians and health care professionals to take their reports of adverse reactions suspected of medications they have used, prescribed, administered or dispensed. Marie-Claude has worked for CVP for the last fourteen years. She is a Registered Pharmacist with the Ontario College of Pharmacist and has worked in both hospital and community pharmacy settings. Marie-Claude holds a Bch. in Pharmaceutical Sciences from U ofHavana

Saskia  De Moree, JD, MA

Saskia De Moree, JD, MA

Manager, Office of Legislative and Regulatory Modernization, Health Canada, Canada

Saskia de Morée is a manager of a regulatory policy team at the Office of Legislative and Regulatory Modernization at the Policy, Planning and International Affairs Directorate in Health Canada. She holds a B.A. and M.A. from Carleton University and an LL.B from Schulich School of Law and, after several years in the private and municipal sectors, joined the Government of Canada over 18 years ago with a focus on legislative and regulatory development.

Todd  Georgieff, MBA, RPh

Todd Georgieff, MBA, RPh

Consultant, Consultant , Canada

Todd has been working in Drug Development for more than 30 years. He has extensive experience in clinical operations and also participated in and led many large-scale change and process improvement initiatives. Todd is currently Product Owner for implementation of a new Protocol authoring. Prior to his current role, he was Roche’s Program Lead for TransCelerate.

Satya Rashi Khare, PhD, MBA, MSN

Satya Rashi Khare, PhD, MBA, MSN

Canada Lead, Patient Engagement, Novartis Pharmaceuticals Canada Inc., Canada

Dr. Khare has extensive experience engaging patients in clinical contexts, health services research, national cancer care initiatives, and most recently, drug development. She has held numerous leadership positions in health and research settings where she has focused on how to improve the delivery of care to patients and how to respond to evolving system level changes. This has included leading a national surgical quality improvement program and creating standardized quality indicators in the top 4 cancers. In all of her work, Dr. Khare strives to include the voices of historically underrepresented groups and promotes a health equity-focused lens.

Larissa M Lefebvre

Larissa M Lefebvre

Manager, Submission Management Division, OCT, Health Canada, Canada

Mrs. Larissa Lefebvre is currently the Manager of the Submission Management Division within the Office of Clinical Trials, in the Therapeutic Products Directorate of Health Canada. She started her career in the federal government in 2007 with the Patented Medicines Price Review Board, then working in the Healthy Environment and Consumer Safety Branch before moving to the Health Products and Food Branch where she held various regulatory positions related to pharmaceutical products. She holds a Bachelor degree with a Specialization in Biochemistry and a Major in French from the University of Western Ontario.

David P. Leventhal, MBA

David P. Leventhal, MBA

Enterprise Clinical Trial Data Sharing Lead, Global Data Dissemination, Pfizer Inc, United States

David Leventhal is the Enterprise Clinical Trial Data Sharing Lead at Pfizer. He oversees the expansion and implementation of Pfizer’s Clinical Trial Data Sharing Policy and serves as a single point of leadership for enterprise-wide sharing of sponsored clinical trial data. He is also a representative to stakeholders within and outside of Pfizer as it relates to data sharing. As such, he partners with leaders in the clinical research community. Importantly, David manages centralized data sharing governance at Pfizer as they continue to demonstrate their commitment to transparency and data sharing. He has been with Pfizer for 27 years, and in that time has served in a variety of R&D and innovation functions including prog

Benny  Ling, MSc

Benny Ling, MSc

Senior Scientific Evaluator, Marketed Pharmaceuticals Bureau, Health Canada, Canada

Benny Ling is a senior scientific reviewer in the Marketed Pharmaceuticals Bureau in Health Canada. He holds a Master's degree in Pharmacology and Toxicology from the University of Western Ontario and has been working in Health Canada for over 15 years.

Celia  Lourenco, PhD

Celia Lourenco, PhD

Director General, Biologic and Radiopharmaceutical Drugs Directorate, HPFB, Health Canada, Canada

Celia Lourenco, PhD has been the Director General of the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) of the Health Products and Food Branch of Health Canada since November 2018. She was previously the Senior Executive Director of the Therapeutic Products Directorate (TPD) and held other management positions within TPD over a period of about 10 years. In her various management roles, Celia has been responsible for the review and authorization of a variety of new drugs for human use, either for clinical trials or for market authorization in Canada. Celia has contributed to international initiatives such as ICH and IPRP, she co-chairs the ICMRA COVID-19 working group and participates on DIA's Council of Regulators.

Camille  Proulx

Camille Proulx

Senior Corporate Regulatory Compliance and Enforcement Advisor , Health Canada, Canada

Camille Proulx (she/her) is a Senior Corporate Regulatory Compliance and Enforcement Advisor within Health Canada’s Health Product and Compliance Directorate. Her current role is to coordinate yearly proactive risk management projects (PRMPs) relating to drugs and natural health products (NHPs). Since 2010, she has held several positions within Health Canada in the field of compliance and enforcement for drugs, NHPs, clinical trials, and biologic products. She holds a Bachelor of Science degree (Honours) in Biochemistry from the University of Ottawa.

Krithika  Shetty, PhD

Krithika Shetty, PhD

Associate Director, Certara, Canada

Krithika is an Associate Director of Clinical Pharmacology at Certara. Prior to joining Certara in Nov 2021, she was a clinical pharmacology reviewer at the Division of Cancer Pharmacology I at the US FDA for 3 years. While at the FDA she contributed to scientific review of numerous regulatory submissions across all phases from INDs to BLA/NDA submissions. Prior to that, Krithika was at Novartis for 3.5 years where she focused on the DMPK and early clinical development of biologics. Krithika has a degree in Pharmacy from the Birla Institute of Technology and Science (BITS) in Pilani India, and a PhD in Pharmaceutical Sciences from the State University of New York in Buffalo, US.

Kimberly  Smith, MD, MS

Kimberly Smith, MD, MS

Real-World Evidence Analytics Team, Office of Medical Policy, CDER, FDA, United States

Kimberly Smith is a nephrologist with the Real-World Evidence Analytics team in the Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration. In her current role, she develops and implements programs and policies related to the use of real-world evidence in drug development. Prior to her current role, Dr. Smith served at FDA as team leader for the Division of Clinical Trial Quality in OMP and as the nephrology team leader in the Division of Cardiology and Nephrology in CDER’s Office of New Drugs. Before joining the FDA, she was with the Coverage and Analysis Group at the Centers for Medicare and Medicaid Services.

Erik  Vollebregt, JD, LLM

Erik Vollebregt, JD, LLM

Partner, AXON Lawyers, Netherlands

Erik's practice focuses on (medical) technology, pharmaceuticals, healthcare and life sciences in regulatory matters and he is active in litigation, commercial and transactional work in all of these fields.

Alysha  Croker, PhD

Alysha Croker, PhD

Director, Centre for Policy, Pediatrics and International Collaboration, BRDD, Health Canada, Canada

Dr. Alysha Croker is the Director of the Centre for Policy, Pediatrics and International Collaboration, Health Products and Food Branch, Heath Canada. In this position, Dr. Croker is responsible for developing ways to increase access to safe and effective health products for pediatric populations in Canada, among other files. Previously, Dr. Croker managed the Canada Excellence Research Chair and the Canada First Research Excellence Fund programs for Canada’s federal research funders. She also led the development of the CIHR's training and equity strategies where she received the Innovation Award. Dr. Croker has a PhD from Western University where she studied the molecular mechanisms of breast cancer metastasis and therapy resistance.

Sarah  Frise, PhD, MS

Sarah Frise, PhD, MS

Global Head Safety Epidemiology and Risk Management, AstraZeneca, Canada

Sarah holds a Masters Degree in Physiology and Phd in Epidemiology. Sarah holds the position of the Global Head Safety Epidemiology and Risk Management at AstraZeneca. She is an active member of many Pharmacovigilance and Safety epidemiology working groups including Beyond Covid Monitoring (BeCOME), ISPE BRACE, IMI Gravitate. In addition to pharmacoepidemiologic methods related to the conduct of Safety Epidemiology studies, she has a special interest in designing and implementing Risk Minimisation/Mitigation Interventions and assessing the effectiveness of these interventions.

Iva  Galic, DMD, MSc

Iva Galic, DMD, MSc

, European Medicines Agency, Netherlands

Iva Galic started her career in pharmacovigilance at a CRO covering different regulatory and scientific elements related to pharmacovigilance system over 10 years ago. She currently holds a role of Pharmacovigilance Inspector Expert at the Croatian Agency for Medicinal Products and Medical Devices. Iva is a medical professional with additional master degree in pharmacovgiilance and pharmacoepidemiology jointly awarded by the European Universities coordinated by the Université de Bordeaux.

Chantal  MacDonald

Chantal MacDonald

Regulatory Affairs Project Manager, Astrazeneca, Canada

Chantal MacDonald has worked in regulatory affairs for over 10 years, with a specialization in clinical trials for the last 5 years. Chantal has been a part of all aspects of the pharmaceutical industry, including roles with Health Canada, Clinical Research Organizations, consultant agencies, and industry. Chantal is currently the Regulatory Affair Project Manager for all AstraZeneca Canada clinical trials. She holds an Honours Bachelor of Science degree from the University of Toronto, CRA certification from Michener Institute, and a diploma in RAQC from Seneca College.

Michael  Moreyne, MBA

Michael Moreyne, MBA

Associate Director Digital, Data & Analytics, Medical Affairs, Merck, Canada

Over the past 15+ years Michael has worked on innovative transformational projects specializing on helping companies digitize their workforce and leverage data into strategic new capabilities. Michael has helped diverse organizations develop innovation hubs and Agile digital strategic solutions all through change management initiatives and upskilling cross-functional teams. He has extensive digital transformational experience including his role as a CEO of two Digital Marketing agencies specializing in AI, big-data and data-driven solutions. Leveraging new technologies, he has transformed data into actionable customer insights, journeys, human-centered designs, product development strategies and rapid prototyping solutions.

Karma M. Rabon-Stith, PhD, MBA, PMP

Karma M. Rabon-Stith, PhD, MBA, PMP

Global Oncology Real World Evidence CoE Lead // Senior Director Team Lead, Pfizer Inc., United States

Currently the Global Oncology Real World Evidence Lead at Pfizer, Dr Karma Rabon-Stith is a Pharmaceutical Executive with over 15+years of Biopharmaceutical Industry experience. She is a PhD trained scientist and Epidemiologist with solid experience leading cross-functional drug development teams. Dr Rabon-Stith’s background in drug development spans a broad spectrum of therapeutic areas, including oncology, respiratory, autoimmune, cardiovascular, metabolic and atopic dermatitis. She has also worked across various stages of development with experience in pre-clinical, early and late development, and post-marketing development.

Mia  Spiegelman

Mia Spiegelman

Vice President, Regulatory Affairs, Medtech Canada, Canada

Mia Spiegelman is the Vice President Regulatory Affairs at Medtech Canada and holds a B.Sc. in Chemistry from York University as well as Certification in Pharmaceutical Regulatory Affairs and Quality Operations from Seneca College. She has worked in various Medical Device, Pharmaceutical, Cosmetic and Consulting companies while holding various roles within the Quality and Regulatory fields. Her current role responsibilities include developing, leading, implementing and managing the Regulatory Affairs strategic initiatives for Medtech Canada and its members in order to ensure that Canada has a globally competitive regulatory environment.

Nancy  Tam, MS

Nancy Tam, MS

Head of Medical Writing, Pfizer Inc, United States

Nancy Tam is the Head of Medical Writing at Pfizer and has more than 20 years of experience as a medical writing professional in the biopharmaceutical industry. Nancy is involved with various strategic initiatives ranging from protocol design to structured content authoring/content reuse. Nancy is a member of the TransCelerate Clinical Content & Reuse workstream.

Kristen  Zorn

Kristen Zorn

Associate Director / Manager, Policy Development, Health Canada, Canada

Kristen Zorn joined Health Canada over 20 years ago after completing her degree in Biology at the University of Waterloo. She has worked extensively in Regulatory Project Management in PDD with the Bureau of Gastroenterology, Infection and Viral Diseases and the Bureau of Metabolism, Oncology and Reproductive Sciences. Kristen was the Associate Director in the Bureau of Cardiology, Allergy and Neurological Sciences for three years and in 2021 she joined the Bureau of Policy, Science and International Programs, dividing her time as a manager of policy development and Associate Director.

Nicole  Abou Nakad, MSc

Nicole Abou Nakad, MSc

Regulatory Affairs Project Manager , Roche Diagnostics, Canada

Nicole Abou Nakad is the Regulatory Affairs Project Manager at Roche Diagnostic Canada. She joined Roche in 2013. She holds Master in Chemistry and Master in Sciences Pharmaceuticals- Regulatory Affairs program at the University of Montreal. Prior to working at Roche, Nicole worked for two years within the pharmaceutical industry. Her expertise for over 10 years in Medical device, allows her to contribute to the fight against the pandemic and deliver a critical diagnostics products to Canadian patients and customers.

Vatche  Bartekian, MSc

Vatche Bartekian, MSc

President, Vantage BioTrials, Canada

Mr. Bartekian is President of Vantage BioTrials, an award-winning Canadian CRO specializing in clinical trial management services. He's contributed his drug development knowledge to the pharma & device industry for over 24 years and has gained vast experience handling complicated trials across an array of therapeutic areas. He has also contributed his knowledge as an Advisor to Global Affairs Canada’s Life Science division, and Colorectal Cancer Canada’s Scientific Advisory Board for the establishment of a Patient Group Pathway Model to Accessing Cancer Clinical Trials. Vatche was also honored in 2021 by his alma mater, Concordia University, as a “Top 50 under 50 Who are Shaping Tomorrow” for his work in combatting Covid-19.

Louise  Binder, JD

Louise Binder, JD

Health Policy Consultant, Save Your Skin Foundation, Canada

Louise is a lawyer and health policy advocate involved in informing the development of health policy & systemic treatment access practices from a patient perspective for more than 25 years. She started her work in HIV in the 1990s after her own diagnosis, before effective treatments were available. She co-founded the Canadian Treatment Action Council (CTAC) in 1996, which successfully ensured access to treatments and quality care for people living with HIV. She had a special interest in women's issues, chairing the Ontario women's HIV organization Voice of Positive Women for over a decade and working internationally as well. Six years ago Louise began similar work in oncology and is the Health Policy Consultant at Save Your Skin Foundation.

Oanh  Dang, PharmD

Oanh Dang, PharmD

Pharmacotherapy Specialist, Regulatory Science Staff, OSE, CDER, FDA, United States

Oanh Dang is the Regulatory Science and Applied Research Lead for Pharmacovigilance she leads multiple Research and Development projects at the FDA's Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research. Her research focuses on the application of artificial intelligence that aim to improve the efficiency and effectiveness of pharmacovigilance processes. She also worked as a post market surveillance safety reviewer in the FDA CDER Division of Pharmacovigilance.

Vinay  Dilawri

Vinay Dilawri

Business Analyst, Health Canada, Canada

Vinay Dilawri is a Senior Business Analyst with the Health Products and Food Branch. Mr. Dilawri is a versatile and experienced IM / IT professional with over 25 years of managerial and technical experience across various IT initiatives in both public and private organizations. Mr. Dilawri has supported several HPFB information technology initiatives over the past 10 years, and is supporting the development of the Clinical Trials Transparency Portal. Mr. Dilawri holds a Bachelor of Science in Physiology from McGill University and Masters in Information Technology.

Melissa  Hunt, MSc

Melissa Hunt, MSc

Director, Health Canada, Canada

Melissa Hunt joined Health Canada in 2005. She holds a Bachelor of Science in Life Sciences from Queen’s University and a Master of Science in Pharmacology from the University of Toronto. Prior, Melissa worked for several years within the pharmaceutical industry. At Health Canada she has been a Scientific Evaluator and a Manager in the Marketed Pharmaceuticals and Medical Devices Bureau within the Marketed Health Product Directorate (MHPD), as well as a member of the core team for the Health Products and Food Branch "Regulatory Review of Drugs and Devices" initiative. Since 2018 she has held the position of Director of the Bureau of Metabolism, Oncology and Reproductive Sciences within the Pharmaceutical Drugs Directorate.

Catherine  Njue, PhD

Catherine Njue, PhD

Manager, Office of Biostatistics, Health Canada , Canada

Dr. Catherine Njue is the manager for the Office of Biostatistics in the Biologic and Radiopharmaceutical Drugs Directorate (BRDD), Health Canada. In this position, she leads the biostatistics team that is primarily involved in evaluating the statistical methodology of clinical trials and other sources of evidence for biologics (e.g., vaccines, blood products) and related biotechnology products and radiopharmaceuticals. She also provides statistical expertise in the drafting, review and implementation of standards and guidelines developed by Health Canada, ICH, and WHO working groups.

Bruce  Wozny, MA

Bruce Wozny, MA

Sr. Policy Officer, Health Products and Food Branch, Marketed Health Products, Health Canada, Canada

Bruce Wozny has been a senior policy officer with the Marketed Health Products Directorate of Health Canada since 2002. Before that he worked in compliance and enforcement of the Food and Drugs Act and Regulations. He is currently working on vigilance policy, including the development of regulations and guidelines for Risk Management Plans and other vigilance tools and activities.

Denis  Arsenault, MBA

Denis Arsenault, MBA

Manager, Policy Development, Health Products and Food Branch, Biologic and, Health Canada, Canada

Denis Arsenault is a manager in the Office of Policy and International Collaboration within Health Canada's Biologic and Radiopharmaceutical Drugs Directorate (BRDD). In this capacity, Mr. Arsenault leads policy development initiatives for BRDD on a number files including regulatory modernization and biosimilar biologic drugs.

Lauren Tesh Hotaki, PharmD

Lauren Tesh Hotaki, PharmD

Senior Regulatory Health Project Manager, Oncology Center of Excellence, CDER, FDA, United States

Lauren Tesh Hotaki is a Senior Regulatory Health Project Manager in the OCE. She holds a Doctor of Pharmacy degree from The Philadelphia College of Pharmacy, Philadelphia, PA, and board certification in Pharmacotherapy and Infectious Diseases. She joined The Oncology Center of Excellence and the Project Orbis team in 2020. Currently, Lauren manages applications with foreign regulatory counterparts under Project Orbis, facilitates international communication and assists with OCE internal planning for advisory committee meetings.

Donna  Janzen

Donna Janzen

Director, Regulatory Strategy & Policy, Hoffmann-La Roche, Ltd., Canada

Donna Janzen is currently the Director of Regulatory Strategy & Policy at Roche Canada. She has worked at Roche for over 20 years in a variety of roles spanning across Clinical Research, Medical Affairs, Evidence Generation and most recently Regulatory Affairs. Throughout her career the majority of her roles have focused on health data: collection, curation, data analysis, and optimal data usage for the variety of stakeholders that require it to optimize patient outcomes in our Canadian healthcare ecosystem.

Stuart  Nicholls, PhD

Stuart Nicholls, PhD

Senior Clinical Research Associate & Strategy for Patient Oriented Research Faci, Ottawa Hospital Research Institute, Canada

Dr. Stuart Nicholls is the Strategy for Patient-Oriented Research (SPOR) Program Facilitator in the Office for Patient Engagement in Research Activities (OPERA) at the Ottawa Methods Centre. In his capacity as SPOR Program facilitator Stuart consults with researchers to provide methodological guidance regarding all aspects of Patient-Oriented Research. In addition, Dr. Nicholls provides training and education on patient engagement in research and actively contributes to research in this field.

Sarah  Topham, MSc

Sarah Topham, MSc

Policy Analyst, Health Products and Food Branch, Health Canada, Canada

Sarah Topham is a Policy Analyst with Health Canada’s Health Products and Food Branch and holds a Bachelor of Science degree from the University of Waterloo as well as a Master of Science degree from McGill University. With over 13 years combined experience in clinical and research roles outside of government along with regulatory policy in the Pharmaceutical Drugs Directorate, she has a breadth of understanding across disciplinary boundaries and has been involved in a variety of drug policy initiatives. Sarah is currently supporting the Transparency project under Clinical Trials Modernization.

Nadia  Giancaspro

Nadia Giancaspro

Senior Policy Analyst, Health Canada, Canada

Nadia Giancaspro has been with Health Canada since 2001. She is a Senior Policy Analyst within the Therapeutics Directorate of the Health Products and Food Branch. Her latest work has been focused on the development of regulations, policies and guidance on issues related to special access to drugs in Canada, the opioid crisis, H1N1, and other emergency-related issues.

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