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DIA Canadian Annual Meeting

The Canadian Annual Meeting now includes a track for Pharmacovigilence and Risk Management Strategies!


Speakers

  • Marcia  Bailey, BSN, MHS, RN

    Marcia Bailey, BSN, MHS, RN

    • Associate Director, Pharmacovigilance Scientist
    • Sierra Oncology , 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 Senior Manager in Pharmacovigilance at Sierra Oncology Inc.

  • Marilyne  Chamoun, MSc

    Marilyne Chamoun, MSc

    • A/Manager
    • 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 10 years of experience in pharmacovigilance and risk management working as a scientific reviewer and acting manager in 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 Therapeutics Products Directorate (TPD) 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 TPD, Biologic and Radiopharmaceutical Drugs Directorate, and the HPFB Assistant Deputy Minister’s Office. She has a degree in pharmacology from McMaster University.

  • Deborah  Danoff, MD, FRCPC

    Deborah Danoff, MD, FRCPC

    • Medical Evaluator
    • Health Canada, Canada

    Dr. Danoff is a medical officer in the Marketed Health Products Directorate at Health Canada. Her current focus is post marketing surveillance for biologics including vaccines. She received her medical degree from McGill University Faculty of Medicine and completed specialty training in Internal Medicine and Clinical Immunology and Allergy at McGill. Her clinical practice focused on patients with complex allergy problems or autoimmune diseases. Her research focus included autoimmune diseases and issues related to medical education.

  • Samar  Darwish, MBA, MSc

    Samar Darwish, MBA, MSc

    • Director, Drug Regulatory Affairs
    • Boehringer Ingelheim, Canada

    Samar began her career in basic research in private and hospital settings, and is currently the Director of Regulatory Affairs at Boehringer-Ingelheim (Canada) Ltd., a global family owned Pharmaceutical Company. Samar’s proficiency includes over 25 years of experience in progressive roles in basic research and the Pharmaceutical Industry, with more than 18 years of proven strategic leadership and people management skills, motivating various teams in different functions to deliver high quality results in line with business priorities. She graduated from the University of Western Ontario with a M.SC. in Molecular Biology, and most recently completed her Executive MBA from the Ivey Business School in London Ontario.

  • Patrick  Fandja

    Patrick Fandja

    • Manager, Medical Devices Section
    • Health Canada, Canada

    Patrick Fandja has been with Health Canada since 2003 where he held various positions in regulatory area and scientific evaluation of health products. Currently, he is managing the team responsible for the post-market surveillance of medical devices within the Marketed Health Product Directorate at Health Canada. Patrick has a Master in Pharmaceutical Sciences from Université de Montréal, and MBA from Université de Québec à Montréal and Paris Dauphine

  • Fiona M Frappier, PhD

    Fiona M Frappier, PhD

    • Senior Policy Analyst
    • Health Canada, Canada

    Fiona Frappier is a Manager in the Office of Policy and International Collaboration at the Biologics and Radiopharmaceutical Drugs Directorate of the Health Products Food Branch at Health Canada. She has a PhD in HIV Immunology and 10 years of experience on multi-jurisdictional policy issues including COVID-19, rare diseases, genomics and antimicrobial resistance.

  • Agnes  Jankowicz, MSc

    Agnes Jankowicz, MSc

    • Executive Director, PV
    • Certus PV Services Inc., Canada

    Agnes is an industry leader with over fifteen years of experience in pharmacovigilance (PV) and medical information (MI) both in the pharmaceutical industry as well as in the consulting environment. In 2014, she co-founded Certus PV, an organization whose team of experienced and dedicated PV professionals provides expert PV & MI services to a wide range of pharmaceutical companies. Having conducted numerous GVP audits, Agnes in an expert PV auditor. She is also a recognized PV trainer with extensive experience as an instructor on various PV topics. Agnes holds a graduate degree in Pharmacology & Toxicology.

  • Yatika  Kohli, PhD, MBA

    Yatika Kohli, PhD, MBA

    • Executive Director - Global Regulatory Affairs
    • 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, Canada

    Over her 29-year career with Abbott/AbbVie, Judith has held various roles of increasing responsibility. She currently leads a team of Regulatory Affairs professionals focused on biopharmaceutical drug submissions for clinical development and commercial products in the areas of Immunology, Oncology, Virology, Neuroscience, Hormone Replacement Therapy, and Specialty Care. Judith also has general oversight of the Quality Assurance and Logistics teams and is an active member of BIOTECanada’s Biologics Regulatory Affairs Group (BRAG). Judith holds a Master’s Degree in Toxicology from Université de Montréal and a Bachelor’s Degree in Biochemistry (Specialty in Medicinal Chemistry) from Concordia University.

  • Kristin  Willemsen, MS

    Kristin Willemsen, MS

    • Vice President, Scientific & Regulatory Affairs
    • Food, Health & Consumer Products of Canada, Canada

    Kristin Willemsen is the Vice President of Scientific and Regulatory Affairs at Food, Health & Consumer Products Canada. Since 2008, she has been working with members to influence the regulation, policy and administration of over-the-counter drugs and natural health products. Kristin earned a Masters of Science from the University of Ottawa and is a Certified Association Executive.

  • Caroline  Croteau, PhD, RPh

    Caroline Croteau, PhD, RPh

    • Country Safety Lead
    • Pfizer Canada Inc, Canada

    Caroline Croteau has been with Pfizer Canada since 1996 assuming roles of increasing responsibility in medical information as well as medical quality operations and is currently head of the Drug Safety Unit for Pfizer Canada, where she oversees local pharmacovigilance activities. She is a licensed pharmacist with previous experience in both hospital and community settings. Caroline is a graduate from Laval University, School of Pharmacy and also holds a PhD in Medication and Population Health from University of Montreal, Faculty of Pharmacy.

  • Gilles  Durot

    Gilles Durot

    • Professional Services Director
    • I4i Inc., Canada

  • Jacqueline  Bruner

    Jacqueline Bruner

    • Product Specialist
    • i4i, Canada

  • Christine  Leckie

    Christine Leckie

    • A/Executive Director, Medical Device Directorate
    • Health Canada, Canada

    Christine joined the Medical Devices Directorate in April 2021 as the Acting Executive Director of the Bureau of Evaluation responsible for COVID Tests. She holds a Bachelor of Science in microbiology from the University of Guelph. Christine recently celebrated her 23rd year anniversary in the Federal Public Service. During her career she has worked in a number of regional compliance and enforcement positions in various programs and directorates within Health Canada, including as a medical devices and biologics inspector. Over the last 12 years, Christine has held a number of leadership positions within the Controlled Substances Program and the Cannabis Directorate.

  • Marie Odile  Gomis

    Marie Odile Gomis

    • Manager, Regulatory Operations and Enforcement Branch
    • Health Canada, Canada

  • Christopher P Boone, PhD, MHA

    Christopher P Boone, PhD, MHA

    • Vice President, Global Head, Health Economics and Outcomes Research
    • AbbVie, United States

    Christopher Boone, PhD has a career-long history as a dynamic, innovative thought leader and a public voice on the power of real-world evidence, health informatics, and big data analytics and its ability to radically transform the global health care system into a learning health system. Chris currently serves as the Vice President, Global Head of Health Economics and Outcomes Research at Abbvie. He is also an adjunct assistant professor of health administration at the New York University's Robert F. Wagner Graduate School of Public Service, an active board member of several influential organizations, and a co-founder of a few start-up companies.

  • Christina  Stavrinidis, MS

    Christina Stavrinidis, MS

    • Regulatory Publishing Manager
    • EXTEDO GmbH, Germany

  • Kenneth  Joly, MS

    Kenneth Joly, MS

    • Policy Analyst, Office of Policy and International Collaboration, BRDD
    • Health Canada, Canada

    Kenneth Joly is a Policy Analyst in the Office of Policy and International Collaboration at the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) of Health Canada, and he has worked at BRDD since 2008. Ken is one of the policy leads working to bring the Advanced Therapeutic Products pathway to life. He has extensive experience in policy development and stakeholder engagement and enjoys finding creative solutions to complex policy and regulatory issues. Ken has a Bachelor of Social Sciences from the University of Ottawa and a Master of Science in Political Science from the University of Nebraska at Omaha.

  • Bhavin  Patel, PharmD, RPh

    Bhavin Patel, PharmD, RPh

    • Senior Director, Drug Safety
    • Pfizer Inc., United States

    Bhavin Patel is a registered pharmacist and has over 20 years of experience within Pharmacovigilance with increasing responsibility in all areas of Individual Case Safety Reporting. He is located in the United States and in his current position at Pfizer Worldwide Safety, he works closely with the Digital and Information Management organization to drive technological innovation within safety to deliver efficiencies in case processing.

  • Christina  Bucci-Rechtweg, MD

    Christina Bucci-Rechtweg, MD

    • Global Head, Maternal Health and Pediatric Regulatory Policy
    • Novartis Pharmaceuticals Corporation, United States

    Christina is Global Head of Pediatric & Maternal Health Policy at Novartis. She graduated from the U Rochester Sch of Medicine & Dentistry and trained in Peds/Pediatric Critical Care Medicine at SUNY Buffalo. She has 16 yrs of experience in Clinical Development and Regulatory Policy. Her activities advancing the environment for pediatric and maternal health include: ICH, C-Path International Neonatal Consortium, EFGCP Childrens Medicines WP, IQ Consortia Pediatric WG & ICAN Scientific Advisor.

  • Carmen  DiMarino, JD

    Carmen DiMarino, JD

    • Executive Director, Assistant General Counsel, Europe
    • Zogenix International Limited, United Kingdom

    From September 2020, Carmen Di Marino is the Executive Director, Assistant General Counsel, Europe of Zogenix. She is responsible for the legal affairs function in the European Region, with headquarter in the UK. Before joining Zogenix, Carmen was the legal and compliance counsel for Europe of Bellicum Pharmaceuticals. Previously, She has served in the role of Chief Legal Officer of Dompé farmaceutici for more than 5 years. Carmen has extensive experience in legal, regulatory, compliance, and privacy matters in the pharma and biotech industries. Her focus is on rare diseases, including cell and gene therapy, and has supported early access and commercial launch readiness projects both in Europe and the USA.

  • Marc-André  Giguère

    Marc-André Giguère

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

    Marc-André Giguère has worked at Health Canada since 2016 where he joined as an inspector for the Health Product Compliance and Risk Management Division of the Regulatory Operations and Enforcement Branch. He started his career as an inspector conducting compliance verifications and Good Pharmacovigilance Practices (GVP) inspections Marc-André is currently the national coordinator of the GVP Inspection Program of Health Canada, where he is responsible for overseeing inspection activities and leading the Program’s initiatives. Marc-André has a Bachelor of Science in Pharmacology from the Université de Sherbrooke and is completing a Microprogram at the École Nationale d'Administration Publique.

  • Kim  Godard, PhD

    Kim Godard, PhD

    • Director, Health Product (Drug) Inspection and Licensing
    • Health Canada, Canada

  • Melissa  Kampman, PhD, MS

    Melissa Kampman, PhD, MS

    • Acting Manager and Senior Epidemiologist, Marketed Health Products Directorate
    • Health Canada, Canada

    Melissa Kampman is an acting manager and senior epidemiologist at Health Canada. She holds an MSc in Chemical and Environmental Toxicology and a PhD in Population Health. Her training is in pharmacoepidemiology and pharmacovigilance. Her main areas of interest are population health, study design methodology for pharmacoepidemiologic research, drug safety and effectiveness, and regulatory policy and decision-making.

  • Carole  Legare, MD

    Carole Legare, MD

    • Director, Office of Clinical Trials, TPD
    • Health Canada, Canada

    After gaining experience in clinical practice and public health, Dr Carole Légaré joined Health Canada in 2002 where she initially worked in pharmacovigilance. She also worked as a senior medical advisor for the Centre for Biologics Evaluation during the H1N1 influenza pandemic. In 2013, she joined the Therapeutic Products Directorate as the Director of the Office of Clinical Trials, where she oversees all activities related to the approval and pharmacovigilance of clinical trials involving pharmaceuticals as well as Health Canada’s Special Access Program. She is currently a member of the ICH E8 working group on General Considerations for Clinical Studies and the ICH E6 working group on Good Clinical Practice.

  • Amber  McLeod, PhD

    Amber McLeod, PhD

    • Lead, Regulatory Affairs
    • Abbvie Corporation, Canada

    Amber McLeod has held the role of Lead, Regulatory Affairs at AbbVie Canada since May 1, 2020. She leads a team of Regulatory Affairs professionals focused primarily on the filing and approval with Health Canada of biopharmaceutical drug submissions for clinical development and commercial products in the areas of Immunology, Oncology, Virology, Neuroscience, Hormone Replacement Therapy, and Specialty Care. Amber joined Abbott in January 1999. Over her 22-year career with Abbott/AbbVie, she held various roles of increasing responsibility where she led and managed countless regulatory filings, approvals and product launches in different therapeutic areas. Amber holds a Doctorate in Pharmacology and Therapeutics from McGill University.

  • Alain G. Musende, PhD

    Alain G. Musende, PhD

    • Manager, Section for Transparency and Advertising Regulatory Surveillance
    • Marketed Health Products Directorate, Health Canada, Canada

    Doctor Musende is a Manager at the Marketed Health Products Directorate (MHPD), which oversees regulatory advertising activities of regulated marketed health products. Additionally, as a commitment to transparency, Health Canada is publishing summaries of its Safety Reviews and Alain’s section leads this publication. Doctor Musende possesses a Bachelor of Science degree in chemistry (Université du Québec à Montréal), a Master’s degree in pharmaceutical sciences (University of British Columbia), and a Ph.D. in pathology and laboratory medicine (University of British Columbia). Dr. Musende is as well a part-time professor at the University of Ottawa, where he teaches biopharmaceutical sciences courses.

  • Jeffrey  Skene, MSc

    Jeffrey Skene, MSc

    • Division Chief, Monoclonal Antibodies
    • Health Canada, Canada

    Jeffrey Skene has been with Health Canada since 2003. He began his career at Health Canada in Regulatory Affairs and later joined the group responsible for the review of monoclonal antibodies as a CMC reviewer. Today, Mr. Skene is the Chief of the Monoclonal Antibodies Division that is responsible for CMC review of monoclonal antibody submissions, laboratory testing and On-Site Evaluations (OSE). He holds a M.Sc. in Biochemistry with a specialization in Molecular Biology.

  • Elizabeth  Toller, MA

    Elizabeth Toller, MA

    • Associate Director General, Policy, Planning and International Affairs Directora
    • Health Canada, Canada

    Elizabeth Toller is an experienced policy specialist and public sector leader with over eleven years’ experience working in the Government of Canada. Her passion for health issues and social policy has seen Elizabeth split her time in government between Health Canada, Immigration, Refugees and Citizenship Canada and the Privy Council Office. Elizabeth currently serves as the Associate Director General of the Policy, Planning and International Affairs Directorate, and the Executive Director for Regulatory Innovation in Health Canada’s Health Products and Food Branch. She helps lead her Branch towards greater agility in Canada’s food and drug regulations to support enhanced safety and innovation.

  • Melanie  Bhangoo, MS

    Melanie Bhangoo, MS

    • Manager, GMP Inspection Central
    • Health Canada, Canada

    Melanie has been in her current role as a Regulatory Compliance and Enforcement Manager for 2 years within the Health Product Inspection and Licensing Division of Health Canada. This is the area responsible for Good Manufacturing Practices (GMP) inspections of pharmaceutical firms in Ontario. She has worked at Health Canada for over 10 years. Initially as a chemist but eventually moving to the C&E side - first as a GMP inspector, then Manager. Prior to working at Health Canada, she was student in Montreal and Kingston specializing in Biochemistry. She has always been interested in a career in the public service and joined immediately following her studies.

  • Kate A Browne, MSc, RPh

    Kate A Browne, MSc, RPh

    • Signal Management Lead
    • European Medicines Agency, Netherlands

    Kate Browne is qualified as a pharmacist and holds Masters in both Pharmaceutical Medical and Health Services Management from Trinity College Dublin. In September 2020 she assumed the role of Signal Management Lead within the EMA. Prior to commencing her role within the European Medicines Agency (EMA), she was a pharmacovigilance assessor within the Health Products Regulatory Authority in Ireland.

  • Alysha  Croker, PhD

    Alysha Croker, PhD

    • Manager, Office of Pediatrics and Patient Involvement
    • Health Canada, Canada

    Following her PhD in cell biology studying the molecular mechanisms of breast cancer metastasis and therapy resistance, Alysha Croker joined the Canadian Institutes of Health Research in 2013 as an analyst. Since then, she has taken on a number of leadership roles managing high profile science policy and research files, including managing the Canada Excellence Research Chair and the Canada First Research Excellence Fund programs. Alysha joined Health Canada in 2019 as the manager of the Office of Pediatrics and Patient Involvement, a role which involves developing ways to increase access to safe and effective drugs and devices for children and youth in Canada and integrating the patient voice throughout the drug and device lifecycles.

  • Reena  Gill, MPH

    Reena Gill, MPH

    • Senior Clinical Operations Manager
    • AbbVie Corporation, Canada

  • Chin  Koerner, MS

    Chin Koerner, MS

    • Executive Director, Regulatory Policy
    • Novartis Pharmaceuticals Corporation, United States

    Chin Koerner is Executive Director of Regulatory Policy for Novartis Pharmaceuticals. Chin's has over 20 years of experience in Drug Development spaning from basic research to post approval. Prior to joining Novartis, Chin spent a number of years at the FDA and other small and large pharmaceutical companies in different regulatory capacities. Chin holds a Master's degree in Immunology from Syracuse University.

  • Rim  Lejmi-Mirad

    Rim Lejmi-Mirad

    • Scientifc Evaluator
    • Health Canada/Marketed Health Products Decorate, Canada

  • Celia  Lourenco, PhD

    Celia Lourenco, PhD

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

    Celia Lourenco, PhD is the Director General of the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) of the Health Products and Food Branch of Health Canada. 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 represents Health Canada at the Assembly and Management Committee of the International Council for Harmonization and at the Management Committee of the International Pharmaceutical Regulators Programme.

  • Bradley  Norton

    Bradley Norton

    • Managing Director and Senior Consultant
    • MWB Consulting Limited/Pharma Data Protection Services, United Kingdom

    A seasoned clinical development professional with an extremely broad knowledge of clinical development activities including program management, protocol design, clinical operations, vendor selection and oversight, regulatory, pre-clinical development oversight and pharmacovigilance, across a wide variety of clinical indications. A visionary leader with an entrepreneurial working style and a passion to maximise development opportunities, solve problems and drive projects forward. GASQ-accredited Data Protection certification, with experience in bridging GDPR and its influence in the Clinical Trials arena.

  • Andrew  Raven, MSc

    Andrew Raven, MSc

    • Manager for Biostatistics, Epidemiology, and Pharmacometrics Unit, HPFB
    • Health Canada, Canada

    Andrew Raven joined Health Canada in 2004. He holds a Bachelor of Science in Molecular Biology and Genetics and a Master of Science in Mathematics and Statistics both from the University of Guelph. He has worked as a biostatistician, senior biostatistician, and manager in the Biostatistics and Epidemiology Unit within the Therapeutic Products Directorate. He has been manager of the Biostatistics and Epidemiology Unit for 3 years.

  • Dawn P. Richards, PhD

    Dawn P. Richards, PhD

    • Director, Patient and Public Engagement
    • Clinical Trials Ontario, Canada

    Dawn Richards, PhD, is the founder of Five02 Labs Inc., and Director of Patient and Public Engagement at Clinical Trials Ontario. With a PhD (Analytical Chemistry) from the University of Alberta, and experience in a variety of roles during the past 20 years, it is her diagnosis with rheumatoid arthritis in 2006 that led her on a journey to combine her passion for science with making the most of her diagnosis. In her role at CTO, Dawn is charged with executing on CTO’s strategic pillar of patient and public engagement.

  • Claudia  Schaffer, RN

    Claudia Schaffer, RN

    • Head Case and Vendor Management
    • Merck Healthcare Kgaa, Germany

    Claudia Schaffer is the Head Case and Vendor Management at Merck Healthcare – Global Patient Safety and is located in Germany. She has served on TransCelerate's Common SAE Fields and Intelligent Automation Opportunities in Pharmacovigilance initiatives to contribute to the value and technology sub-teams. Claudia is a registered nurse and holds a BA in international management from FOM University of Applied Sciences for Economics and Management.

  • Trevor  Aldridge

    Trevor Aldridge

    • Senior Director, Quality and Compliance
    • Brevitas Consulting, Inc., Canada

    Trevor Aldridge is the Senior Director of Quality & Compliance at Brevitas Consulting Inc. and has more than 30 years of Industry and Regulatory Authority experience. Trevor has worked with a range of companies (some in late phase development). This included evaluation of CMO/CDMO cGMP operations, commercial formulation design, Quality Management Systems design and implementation and readiness for Pre-Approval inspections. Previous to Brevitas, Trevor was Director of Operational Quality and Compliance at Sanofi Pasteur Ltd, responsible for quality on the shop floor and for regulatory inspections. Prior to Sanofi, he was a Drug and Biologics Specialist with Health Canada, including inspections of pharmaceutical and biologics companies.

  • Samuel  Allan

    Samuel Allan

    • GDPR Consultant
    • MWB Consulting Limited/Pharma Data Protection Services, United Kingdom

  • Richardae  Araojo, PharmD, MS

    Richardae Araojo, PharmD, MS

    • Associate Commissioner for Minority Health, Director, Office of Minority Health
    • FDA, United States

    RADM Richardae Araojo serves as the Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity at the U.S. Food and Drug Administration. In this role, she provides leadership, oversight, and direction on minority health, health disparity, and health equity matters for the Agency.

  • Scott  Askin

    Scott Askin

    • Global Program Regulatory Director, Innovation
    • Novartis Pharma AG, Switzerland

    Currently working in the area of Regulatory Innovation for Novartis, Scott has nearly 20 years of pharma industry experience from both the CRO world and within Pharma, in roles focusing on Data Management, Data Standards and Digital Innovation. Prior to joining Regulatory Affairs, Scott led several of Novartis’s innovation projects. Since his transition into Regulatory Affairs, Scott continues to advise digital program teams internally and collaborates in several cross industry initiatives externally. Scott has a BSc in Computing and Management Sciences and is based in Basel, Switzerland.

  • Gerald J. Dal Pan, MD, MHS

    Gerald J. Dal Pan, MD, MHS

    • Director, Office of Surveillance and Epidemiology, CDER
    • FDA, United States

    Gerald J. Dal Pan, MD, MHS is the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. He is a member of the WHO Advisory Committee on the Safety of Medicinal Products. He received his MD from Columbia University College of Physicians and Surgeons and his Master of Health Science in Clinical Epidemiology from the Johns Hopkins University School of Hygiene and Public Health. He completed residency training in Internal Medicine at the Hospital of the University of Pennsylvania and in Neurology at the Johns Hopkins Hospital.

  • Andrea  Gilpin, PhD, MBA, MS

    Andrea Gilpin, PhD, MBA, MS

    • General Manager
    • The Rosalind and Morris Goodman Family Pediatric Formulations Centre , Canada

    Andrea Gilpin is the General Manager of the Goodman Pediatric Formulations Centre. Dr. Gilpin began her career as a scientist and completed her Doctorate in Molecular Biology and Biochemistry from the University of Toronto. After obtaining her MBA, her career brought her through several different roles including working 12 years in small biotechnology companies in investor relations and communications. In 2011, she took a position working at Pfizer and later spent 5 as years working at Novartis, first as Head of Corporate Communications for Novartis Canada and second, in a marketing oncology position in the Lung and Melanoma franchise. She is the Vice Chair of the Board for BioTalent and has her ICD designation.

  • Manfred  Hauben, MD, MPH

    Manfred Hauben, MD, MPH

    • Senior Director Product Safety Surveillance and Reporting
    • Pfizer Inc., United States

    Manfred Hauben MD, MPH Pfizer Inc New York Medical College; New York University School of Medicine; Brunel University; medical advisor EMEA Eudravigilance expert working group; leader of methodology subgroup CIOMS VIII working group on signal detection;member FDA-PhRMA SET expert working oup.

  • Oeystein  Kjoersvik, MSc

    Oeystein Kjoersvik, MSc

    • Product Owner/Business Analyst
    • Merck & Co., Inc., Czech Republic

    Oeystein Kjoersvik is currently a Product Owner/Business Analyst at MSD, functioning as a squad lead for an analytics group supporting QA through utilizing data science and other analytics tools. Oeystein also serves as a Machine Learning SME for TransCelerate's Intelligent Automation - Validation workstream. Prior to joining MSD, he was a Clinical System Specialist at Seattle Genetics. He holds a BS in Informatics from University of Washington and a MS in Bioinformatics from University of Bergen.

  • Nicole  Mahoney, PhD

    Nicole Mahoney, PhD

    • Executive Director, Regulatory Policy and Intelligence
    • Novartis, United States

    Nicole Mahoney is an Executive Director for Regulatory Policy at Novartis, and global regulatory policy lead for data and digital technologies, including real-world evidence and artificial intelligence. Prior to Novartis, she led Regulatory Policy at Flatiron Health, helping support the acceptance of real-world evidence for regulatory decision making in oncology. Nicole developed and advanced anti-infectives policies as a Director of Global Regulatory Policy at Merck, senior officer for the Pew Charitable Trusts' antibiotics and innovation project, and FDA Commissioner’s Fellow. She earned a doctorate in biochemistry from the Albert Einstein College of Medicine and was a postdoctoral fellow at the University of California, San Francisco.

  • Nicole  Mittmann, MSc

    Nicole Mittmann, MSc

    • Chief Scientist and Vice President of Evidence Standards
    • Canadian Agency for Drugs and Technologies in Health (CADTH), Canada

    Dr. Nicole Mittmann is CADTH’s Chief Scientist and Vice-President of Evidence Standards. At CADTH, Dr. Mittmann leads a diverse portfolio that encompasses Health Economics, Research Information Services, Scientific Affairs, including Scientific Advice and Patient Engagement, and Implementation Support and Knowledge Mobilization. She is responsible for building upon the agency’s strong methods frameworks and global networks with academia and representing CADTH both nationally and internationally. Current initiatives include harmonization of the deliberation processes and frameworks and determining the role of real-world evidence at CADTH. In her academic capacity, Dr. Mittmann holds a faculty position at the University of Toronto

  • Christophe  Roy, MBA

    Christophe Roy, MBA

    • Supervisor, Section for Transparency and Advertising Regulatory Surveillance
    • Marketed Health Products Directorate, Health Canada, Canada

  • Aline  Silahian

    Aline Silahian

    • Associate Director Regulatory Affairs
    • Pfizer Canada, Inc., Canada

    Aline Silahian joined Pfizer Canada in 2003 and currently leads the Regulatory Strategy team responsible for Inflammation & Immunology, Rare Disease and Vaccines. In her years at Pfizer she has led teams responsible for a diverse portfolio including Anti-infectives/HIV, Men & Women’s Health, Endocrinology, Ophthalmology, Respiratory, and several established brands. She began her career in the Pharmaceutical Industry at Abbott Laboratories Canada where she established internal Safety processes & systems and took on roles with increasing responsibility in Pharmacovigilance/Safety and Regulatory. Aline graduated from University of Montreal’s School of Pharmacy and worked for several years as a Community Pharmacist prior to joining Industry.

  • Paul  Litowitz, MBA, RAC

    Paul Litowitz, MBA, RAC

    • Manager, Public and Regulatory Affairs Outreach Section
    • Health Canada, Canada

    Paul Litowitz began working for Health Canada in 2008. He manages a public and regulatory affairs outreach team within the Canada Vigilance Program at the Marketed Health Products Directorate. Among other responsibilities, Paul oversees guidance for industry and hospitals concerning adverse reaction reporting regulations for marketed health products. Paul holds a Bachelor of Science from the University of Guelph, a post-diploma in Pharmaceutical Regulatory Affairs and Quality Operations from Seneca College, and a Master of Business Administration from the University of Windsor.

  • Leslie D Madden, MBA

    Leslie D Madden, MBA

    • Head of Regulatory Affairs, Canada
    • Moderna, United States

  • John Reinhard Pietzsch, DrSc

    John Reinhard Pietzsch, DrSc

    • Head of PV Data Science & Insight Generation
    • Bayer AG, Germany

    John is leading the Pharmacovigilance Data Science and Insight Generation team with Bayer. In this role he is actively shaping the future of Pharmacovigilance. Previously he served as a PV Process and System Implementation Leader, as well as Senior Strategy Consultant for Research and Development. John is a Biochemist by education and conducted his doctorate degree focussing on HIV and neutralizing antibodies at the Rockefeller University in New York and the Free University of Berlin.

  • Kelly  Robinson, MSc

    Kelly Robinson, MSc

    • Director General, Marketed Health Products Directorate
    • Health Canada, Canada

    Kelly joined Health Canada in 2001 and has experience in both the pre-market and post-market review and regulation of biologics and pharmaceuticals. Kelly has been involved in initiatives such as international work sharing, HTA alignment and policy related to submissions relying on third party data. Kelly has recently rejoined the Marketed Health Products Directorate as the Director General.

  • Representative Invited

    Representative Invited

    • Michael Schunk Biologics Consulting, Canada
  • Kaveeta  Vasisht, DrMed, MD, PharmD

    Kaveeta Vasisht, DrMed, MD, PharmD

    • Associate Commissioner for Women's Health, Director of the Office of Women’s Hea
    • FDA, United States

    Dr. Vasisht leads the FDA Office of Women’s Health in their work to protect and advance the health of women through scientific programs, policy, research, education, stakeholder collaboration, and outreach that incorporate an understanding of sex and gender differences to facilitate FDA decision making. She also serves as advisor to the Commissioner and key Agency officials on scientific, ethical, and policy issues and represents FDA on cross Agency expert committees focused on the health of women. She is board-certified in internal medicine and adult endocrinology. She completed her internal medicine and fellowship at the University of Chicago Hospitals and obtained her medical degree from the University of Medicine and Dentistry of NJ.

  • Ron  Boch

    Ron Boch

    • Vice President, Biotechnology and Industry Affairs
    • BIOTECanada, Canada

    Dr. Ron Boch is the Vice President, Biotechnology and Industry Affairs with lead responsibility for BIOTECanada’s policy development reflecting the diverse nature of Canada’s health, industrial and agricultural biotechnology sectors. He brings a wide range of scientific, research and commercialization expertise in his work with emerging companies, vaccine manufacturers and global pharmaceutical companies, having worked for over 25 years with industry particularly regarding biotechnology products, vaccines and formulation. Dr. Boch serves advisory Boards including the Industry Advisory Committee of the Drug Development and Innovation Centre at the University of Alberta.