Canadian Pharmacovigilance and Risk Management Strategies Conference
Marcia Bailey, BSN, MHS, RN
- Senior Specialist, Pharmacovigilance and Medical Information
- Otsuka Canada Pharmaceutical Inc., Canada
Marcia is a registered nurse and former critical care nurse whose clinical experience includes 16 years as a staff/charge nurse in various hospitals and departments. She has also worked as a clinical study coordinator and research assistant, and is celebrating her 20th year in the pharmaceutical industry. Marcia has been a subject matter expert and valued international team member for a number of data management initiatives. 8 years in pharmacovigilance and recent health studies have endow Marcia with the knowledge, skills and fortitude necessary to adapt to today’s increasing drug safety responsibilities and regulations. Marcia is currently a Senior Pharmacovigilance and Medical Information Specialist at Otsuka Canada Pharmaceutical Inc.
Rita Cassola, RPh
- Executive Director PV
- Certus PV Services Inc, Canada
Rita Cassola is an Executive Director of Pharmacovigilance at Certus PV Services Inc. Rita is a registered pharmacist with over 15 years of experience in global and Canadian pharmacovigilance. Rita’s experience includes 6 years of senior PV consultancy and 10 years in increasingly senior PV roles within the pharmaceutical industry. Prior to joining the pharmaceutical industry, Rita spent 4 years in academia and 10 years in hospital pharmacy. Rita is engaged in teaching pharmacovigilance courses and has presented at several conferences/webinars organized by professional associations.
Colin D'Cunha, MD, MHS, FRCPC
- Director, Global Medical Affairs
- Apotex Inc., Canada
Dr. D’Cunha is the Director, Global Medical Affairs at Apotex Inc. responsible for Medical Affairs activities within the group. Prior responsibilities included Pharmacovigilance. He has over 16 years experience in public health at both the local and provincial levels of government. He has held senior positions including Chief Medical Officer of Health, Commissioner of Public Health and Assistant Deputy Minister, Ontario, Chief Occupational Medical Officer, Manitoba and Medical Officer of Health, Scarborough. He has actively participated in national population health matters. Dr. D'Cunha graduated in medicine from the University of Bombay, and obtained his Masters of Health Science from the University of Toronto.
Marc F. Poitras, PhD, MBA
- Scientific Manager, Marketed Pharmaceuticals and Medical Devices Bureau
- Health Canada, Canada
Dr. Poitras has worked at Health Canada in different capacities in Pharmacovigilance and drug safety for the last 9 years. His undergraduate and graduate training includes a BSc in Biotechnology and MSc/PhD degrees in Pharmacology from the University of Sherbrooke. He also completed post-doctoral training programs in cellular biology and neuroscience at Johns Hopkins University and New York University. He then completed a MBA at the University of Ottawa. Dr. Poitras is currently working as a Scientific Manager at the Marketed Health Products Directorate.
Session Chair Invited
- United States
Raleigh E. Malik, PhD
- Senior Scientific Liaison
- DIA, United States
Dr. Raleigh Malik is a Sr. Scientist at DIA in Washington, DC, where she supports the advancement of DIA’s global content strategy by providing scientific expertise related to therapeutic drug development and regulatory disciplines. Prior to joining DIA, Dr. Malik supported medical and commercialization functions within pharma as both a medical writer and medical reviewer. Dr. Malik has a PhD in Molecular Biology and Biochemistry from Indiana University School of Medicine and a BS in Cell Biology and Biochemistry from Bucknell University.
Maha Hadj-Omar, MD, MSc
- Director, Global Medical Safety
- Pharmascience Inc., Canada
Dr. Hadj-Omar is Director, Global Medical Safety at Pharmascience Inc. responsible for managing the local and international PV operations, Risk Management Plans, signal detection, benefit-risk assessment and other PV activities. Maha's experience spans over 15 years in drug safety within both Global and Canadian-based pharmaceutical corporations. She is trained as a medical doctor, specialised in medical microbiology from Algiers. Maha completed a master’s degree in Drug Development - Clinical Research from Université de Montréal.
Melissa Hunt, MSc
- Scientific Manager
- 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 to working at Health Canada, Melissa worked for several years within the pharmaceutical industry in pharmacovigilance. Melissa has worked as both a Scientific Evaluator and, in her current position, a Manager in the Marketed Pharmaceuticals and Medical Devices Bureau (MPMDB) of the Marketed Health Products Directorate (MHPD) at Health Canada; where she has been responsible for the evaluation and management of a number of drug safety issues.
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.
- Corporate Regulatory Compliance & Enforcement Advisor
- Health Canada, Canada
Sophie Lafrance has worked in federal regulations since 2005 when she joined Health Canada’s Health Products and Food Branch Inspectorate (now known as the Health Product Compliance Directorate, RORB). She is the national coordinator of the Good Pharmacovigilance Practices (GVP) inspection program since 2008. Her role is to support the delivery of Canada’s national GVP inspection program by providing support to inspectors for their inspections, assisting in resolving emerging issues arising from these inspections, liaising with the Marketed Health Products Directorate (MHPD), and contributing to the development of program regulations, policies, and guidelines.
Anne Tomalin, RAC
- Therapeutic Products Inc, Canada
Anne has practiced exclusively in the area of Regulatory Affairs in Canada since 1971. She has worked for three pharmaceutical companies: Wyeth, Roche and Searle. She started the regulatory consulting company, CanReg Inc, that was later sold to a US company. After working with the purchaser for 4 years, Anne set up her current regulatory consulting company, Therapeutic Products Inc. (TPIreg), which provides regulatory consulting in Canada and the US, including eCTD publishing. TPIreg also provides QA services in Canada and the US and holds and Establishment Licence with Health Canada as an importer. Anne operates out of Hamilton, Ontario.
Adriana Ziff, RPh
- Director, Drug Safety/Pharmacovigilance & Product Information, Medical Sciences
- Purdue Pharma Canada, Canada
She holds a Master’s Degree in Pharmacy, an adult teaching certification and is currently the Head of Drug Safety and Medical Information at Purdue Canada. Adriana is adult teaching certified and taught a college level pharmacology course and lectured at schools of pharmacy. At Baxter, Wyeth and Forest, Adriana developed a broad range of knowledge and expertise in Canadian and international safety and GMP regulations and led a number of innovative changes. In her current role at Purdue, Adriana is tasked with the ongoing assessment and monitoring of safety compliance and signals, the development of safety data exchange agreements, and the management of medical information.
Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
- Vice President, Global Head of Early Access and Risk Management
- IQVIA, United Kingdom
Dr Stella Blackburn. MB BS, MA, MSc, FRCP(Ed), FISPE, FFPM, DLSHTP, Dip Pharm Med.VP, Global Head of Early Access & Risk Management, Real World Insights at IQVIA. Stella studied medicine at Cambridge and Guys and worked in hospital medicine before joining the pharmaceutical industry. She has worked in pharmacovigilance and pharmacoepidemiology for 30 years: in industry (11+ years) as a regulator (nearly 17 years) and CRO (3+ years).She has an MSc in Epidemiology from the London School of Hygiene and Tropical Medicine. In 1997 she joined the European Medicines Agency (EMA). Stella developed EU policy on risk management, writing the EU guidelines on this topic and was part of the core team implementing the 2010 PhV legislation.
- Regulator Project Manager, Health Products & Food Branch
- Health Canada, Canada
Sarah Clayman joined Health Canada in 2005. She holds a Bachelor of Science and a Bachelor of Education from the University of Ottawa. She has previously worked in the international division of the Health Products and Food Branch. In 2013, she joined the Marketed Health Products Directorate and is currently the managing editor of the Health Product InfoWatch, a monthly Health Canada publication highlighting health product safety information. She is also working on the development of regulatory guidelines.
- Health Canada, Canada
Sophie Sommerer is the Director of the Marketed Health Products Safety and Effectiveness Information Bureau at Health Canada where she is responsible for overseeing the Canada Vigilance Program, which collects, assesses and disseminates adverse drug reaction and medical device problem reports for marketed health products. Prior to this, Sophie held positions as the acting director and the associate director of Health Canada’s Bureau of Cardiology, Allergy and Neurological Sciences, following over 10 years working primarily in health promotion policy at the Public Health Agency of Canada. Sophie has a Bachelor of Science (Honours) in Biology from Queen’s University and a Master of Science in Biology from Carleton University.
Eileen Tan, JD
- Legal Council
- Aptoex Inc., Canada
Eileen Tan provides legal support to many of Apotex’s business functions, including its Global Pharmacovigilance and Global Medical Affairs teams. She also handles all privacy matters for the Apotex group of companies. Eileen was admitted to the Ontario bar in 2011, and holds a J.D. from York University’s Osgoode Hall Law School, as well as a BBA from Wilfrid Laurier University.
Gerald J. Dal Pan
- Director, Office of Surveillance and Epidemiology, CDER
- FDA, United States
Dr. Dal Pan is the Director of the Office of Surveillance and Epidemiology in FDA’s CDER, where he is responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. He is involved in both the premarket and postmarket regulation of drugs and therapeutic biologics. He is a member of the WHO Advisory Committee on the Safety of Medicinal Products, and has served on working groups of the CIOMS and ICH.
Bruce Wozny, MA
- Sr. Policy Officer
- Health Canada, Canada
Bruce Wozny has been a senior policy officer with the Marketed Health Products Directorate of Health Canada since 2002. He is currently working on vigilance policy, including the development of regulatory guidelines.