Speakers

Marcia Bailey, BSN, MHS, RN

Safety Evaluation & 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 an Associate Director, Pharmacovigilance Scientist at Sierra Oncology Inc.

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

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.

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

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, MBA, MS

Director, Bureau of Biologics, Radiopharmaceuticals and Self-care products
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 the Director of Bureau of Biologics, Radiophamaceuticals and Self-care products 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

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, 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

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

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).

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

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

Professional Services Director
I4i Inc., Canada

Mary Speagle

Senior Director, Regulatory Affairs
TPIreg, Innomar Strategies Inc, Canada

Jacqueline Bruner

Product Specialist
i4i, Canada

Christina Stavrinidis, MS

Senior Manager Regulatory Operations
Gilead Sciences, Inc., Ireland

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.

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.

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 20+ yrs of experience in Clinical Development and Regulatory Policy. Her activities advancing the environment for pediatric and maternal health include: ICH E11A Expert Work Group, C-Path International Neonatal Consortium, EFGCP Children's Medicines WP, IQ Consortia Clin Pharm Leadership Group Pediatric WG & NIH/NICHD National Advisory Council on Child Health & Human Development. In her career, Christina has over 40 peer-review published articles and 100 invited lectures.

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 a 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 Master in Public Administration at the École Nationale d'Administration Publique.

Kim Godard, PhD

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

Dr. Kim Godard is the Director of the Health Product Inspection and Licensing Division at Health Canada. Kim leads the program that oversees the administration of the Good Manufacturing Practices (GMP) Framework, the issuance of Drug Establishment Licensing for pharmaceutical products sold in Canada, and for advancing Canada’s drug GMP compliance programs through mutual recognition agreements (MRA) between regulatory authorities. Before joining the GMP program, Kim held various roles within the Health Portfolio including that of Director of the Globally Harmonised System for workplace chemicals; Associate Director of the inspection program for pharmaceuticals, as well as Senior Advisor in the area of Tobacco Control.

Melissa Kampman, PhD, MS

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

Melissa Kampman is a 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, real world evidence, and regulatory policy and decision-making.

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.

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 was 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

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

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.

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.

Tanya Ramsamy, PhD

Executive Director, Medical Device Directorate
Health Canada, Canada

Tanya Ramsamy obtained her PhD from the University of Ottawa and joined Health Canada in 2005. Tanya has held numerous reviewer and management positions in the (former) Natural Health Products Directorate and the Therapeutic Products Directorate. More recently, Tanya was the Associate Director in the Office of Clinical Trials where she was actively involved in clinical trial modernization and in Health Canada’s response to COVID-19 and an Associate Director in the Medical Devices Directorate (MDD) responsible for managing the applications for COVID test devices. She is currently the Executive Director of the Bureau of Investigational Testing Authorization, Special Access Program and Post-Market Surveillance in the MDD.

Jeffrey Skene, MSc

Director, Bureau of Cardiology, Allergy and Neurological Science
Health Canada, Canada

Jeffrey Skene has been with Health Canada since 2003. He began his career at Health Canada in Regulatory Affairs and quickly joined the group responsible for the review of monoclonal antibodies as a CMC reviewer. He advanced to the position of Manager of the Monoclonal Antibodies Division, before becoming Associate Director in the Bureau of Gastroenterology, Infection and Viral Diseases. Mr. Skene moved to the role of Associate Director in the Bureau of Evaluation in the Medical Devices Directorate as part of the COVID-19 pandemic response before assuming his current role as Director of the Bureau of Cardiology, Allergy and Neurological Sciences in the Pharmaceutical Drugs Directorate.

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

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

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

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.

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.

Reena Gill, MPH

Senior Clinical Operations Manager
AbbVie Corporation, Canada

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.

Laura King, MBA

Vice Chair, Regulatory Operations Teams
Innovative Medicines Canada, Canada

Laura began her career in the pharmaceutical industry in Medical Information, but quickly developed an interest in regulatory affairs, and has spent more than 25 years in a variety of regulatory affairs roles including several large pharma companies, start-ups and consulting companies. She assumed her current role of Head of Regulatory Affairs for Novartis pharmaceuticals in 2013, and enjoys participating in both IMC an BioteCanada regulatory committees. Laura holds a B.Sc. in Cell and Molecular Biology and a MBA.

Chin Koerner, MS

Executive Director, Development and 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 spanning 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 a variety of regulatory capacities. Chin holds a Master's degree in Immunology from Syracuse University.

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.

Rim Lejmi Mrad, PhD

Supervisor, Marketed Health Products Decorate
Health Canada, Canada

Doctor Rim Lejmi Mrad is a supervisor at the Marketed Health Products Directorate. She leads COVID-related regulatory advertising and helms a team that uses Artificial Intelligence to protect Canadians against illegal, false, and misleading advertising in relation to health products. Dr. Lejmi Mrad joined Health Canada in 2011 and held various positions in policy, scientific evaluation of health products and regulatory area. She holds a Master’s degree in Microbiology and Immunology with specialization in Human & Molecular Genetics and a PhD in Cellular and Molecular Medicine both from the University of Ottawa.

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.

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.

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 previously worked as a biostatistician and senior biostatistician, assessing study design and conduct as well as statistical methodologies and analyses in pre-market prescription drug submissions at the Therapeutic Products Directorate (TPD). He has been manager of the Biostatistics, Epidemiology, and Pharmacometrics Unit of TPD since 2015.

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.

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

Principal Consultant – Data Protection
Innovatec, France

Richardae Araojo, PharmD, MS

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

RDML 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, MSc

Global Program Regulatory Director
Novartis Pharma AG, Switzerland

Currently working in the area of Regulatory Affairs for Novartis, Scott has over 20 years of industry experience from both the CRO world and within Pharma, in roles focusing on Data Management, Data Standards and Digital Innovation. Prior to his current role in Regulatory Affairs Policy, Scott led several of Novartis’s digital innovation projects. Since his transition into Regulatory, Scott continues to advise digital program teams internally in areas such as eConsent, eSource, Decentralized Clinical Trials, Blockchain & AI, and collaborates externally in several cross-industry initiatives.

Rose Mary Cianflone, MSc

Regulatory Affairs Specialist
Novartis Pharmaceuticals Canada Inc., Canada

Rose Mary Cianflone joined Novartis Pharmaceuticals Canada in 2007 and is currently a Regulatory Affairs Specialist. She gained various experience in the pharmaceutical industry working in basic research, quality assurance and clinical research. She began her career in Regulatory Affairs at Pfizer. She holds a BSc in Biochemistry (Co-op) from Concordia University and a MSc in Drug Development from University of Montreal.

Gerald J. Dal Pan, MD, MHS

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

Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. In this capacity, he is involved in both the premarket and postmarket regulation of drugs and therapeutic biologics, and in the implementation of the drug safety provisions of the Food and Drug Administration Amendments Act and other initiatives.

Marie Odile N. Gomis, MS

Manager, Regulatory Operations and Enforcement Branch
Health Canada, Canada

Holder of a Master of Science from McGill University, Marie Odile had more than 10 years experience in the pharmaceutical industry with extensive knowledge of GMP regulated environment, before joining Health Canada in 2012. She is currently the Manager of the Medical Device Establishment Licence Unit within the Regulatory Operation and Enforcement Branch at Health Canada. Passionate about Compliance and Enforcement, she has also worked for the Natural and Non-prescription Health Products Directorate as well as for the Controlled substances and Cannabis Branch. Marie Odile lives in Ottawa, Ontario and enjoys family time and painting on her spare time. To get in touch with Marie Odile, you can email her at Marie-odile.n.gomis@hc-sc.gc.ca

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.

Nicole Mahoney, PhD

Executive Director, Regulatory Affairs, GDD
Novartis Pharmaceuticals Corporation, 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

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

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.

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.

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.

Yonghua Jing, PhD, MS

Senior Director/Team Lead, Real-World Evidence Analytics
AbbVie, United States

Dr. Jing has held industry positions with major pharmaceutical companies over the past 15 years and has led team to generate real world evidence that support multiple blockbuster drugs (Abilify, Eliquis, Plavix and Humira). Since 2014 he is with AbbVie and holds the position of Senior Director of Real World Evidence & Analytics. He works with colleagues from different functions at AbbVie to develop an AbbVie-wide real world data platform and integrated real world evidence capability. He is also the HEOR point person that evaluates the recent developments on the application of Real World Evidence for regulatory decision making. He represented AbbVie at PhRMA (The Pharmaceutical Research and Manufacturers of America) RWE working group. He w

Leslie D Madden, LLM, MBA

Head of Regulatory Affairs, Canada
Moderna, United States

Leslie Madden is the Head of Regulatory Affairs (Canada) at Moderna, responsible for leadership & strategic oversight of the registration of Moderna’s mRNA-based therapies, including the COVID-19 vaccine program. She has more than 15 years of experience with roles extending across the disciplines of RA, marketing, sales, QA, PV and BD. Prior to joining Moderna she was the Director of Regulatory at Elvium, Global Regulatory Lead at Biogen (US), and held positions at Galderma and GSK. Leslie earned a BSc from York University, an MBA from Rotman School of Management and a Global Professional LLM from the Faculty of Law at University of Toronto. She also serves as an Advisor for the Life Sciences Career Development Society (LSCDS).

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.

Michael Schunk, DVM

Principal
Michael Schunk Biologics Consulting, Canada

Michael Schunk DVM, DVSc More than 25 years in the biologics/vaccine industry. Michael has worked for Sanofi Pasteur in Toronto and Lyon and Medicago in Quebec and North Carolina. He retired as Executive Vice-President of Operations from Medicago and began consulting. His career responsibilities have spanned Development, Tech transfer, QC, QC, and Manufacturing Operations. He developed and implemented industrial corporate strategies that matured organizations form Phase 1 to commercial readiness. He as been involved in CMC preparations and representing CMC in submissions to Canada, US and Europe. He has experience in preparing and executing GMP inspections by FDA, Health Canada, Europe and WHO

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, PhD

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. He received the 2021 CSPS award of leadership in pharmaceutical Sciences

Kim Fookes

Global Head, Diversity and Inclusion in Clinical Trials
Novartis Pharmaceuticals, United States

Kim has 28+ years of experience working in clinical research. Prior to being named the Global Head of DICT, Kim was responsible for all US clinical trial deliverables across Novartis’ portfolio, including early and late phase across oncology and non-oncology. She joined Novartis from AbbVie where she was the Head of Site Management & Monitoring, overseeing Global Site Management. While at AbbVie, Kim also managed operations for the Global Medical Therapeutic Areas and US Medical Affairs. Prior to AbbVie, she worked at Takeda, TAP, CROs, and Site Research Centers. She received her undergrad in Biology from Valdosta State University and enjoys yoga, poker, and painting.