CAPRA: Hybrid Annual Education Day 2024
2638 Steeles Ave E, Brampton,
ONTARIO, L6T 4L7
CAPRA remains committed to educating and connecting our members.
Education Day will be held on Wednesday, June 5, 2024, at the Pearson Convention Centre; Brampton ON.
Please see the brochure for the Final agenda, registration information, and sponsorship opportunities.
This is an opportunity to hear from Health Canada/Industry on current hot topics of interest in regulatory affairs.
Topics will include:
- XML PM Update
- RMPs and Risk Management Measures
- Third party data
- Challenges and Opportunities of RWE in Regulatory Decision Making
- Rare Disease Update
- Natural Health Products Update
See you soon.
Registration Deadline: Friday, May 24, 2024, 4 p.m.
*Registrants may be substituted, but no refunds will be issued after the deadline.
*Disclaimer: CAPRA reserves the right to amend the conference (including but not limited to speakers' identities, topics, locations, and the timing of speakers) without notice to you. If the conference is canceled for any reason whatsoever, such reason not within the control of CAPRA, CAPRA shall not be liable for any cost or loss otherwise incurred.
**Update: This Education day will be hosted using Go To Webinar.**
Event Registration Form: Please provide your first name, last name, and the email address you intend to use for logging in on the day of the Education Day.
Registered attendees will receive an official Go To Webinar link to join the Education Day after the Registration deadline.
Please ensure that you check the system requirements to avoid any connection issues on the day of the event.
In case of unexpected interruptions, such as a power outage, please log back, and Education Day will restart from where it was disconnected.
Speakers / Panelists
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Ms. Tracy E Brown
Senior Project Manager, Business Informatics Division, Health Products and Food Branch
Ms. Tracy E Brown
Senior Project Manager, Business Informatics Division, Health Products and Food Branch
Health Canada/ Government of Canada
Tracy Brown as worked at Health Canada in the regulatory environment since 2000. She started her career at the Pest Management Regulatory Agency before joining the Health Products and Food Branch, where she has worked for most of her career. Tracy has worked in regulatory roles in both the Biologic and Radiopharmaceutical Drugs Directorate and the Pharmaceutical Drug Directorate. She participated in many regulatory projects and led the guidance document revisions for related to the CTD and eCTD formats. Tracy is currently a Senior Project Manager within the Resource Management and Operations Directorate’s Business Informatics Division, where she has successfully led several major projects. Tracy assumed the lead of the XML PM project in 2020.
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Ms. Marilyne Chamoun
Senior Scientific Evaluator , Marketed Pharmaceuticals Bureau
Ms. Marilyne Chamoun
Senior Scientific Evaluator , Marketed Pharmaceuticals Bureau
Health Canada/ Government of Canada
Marilyne is a Senior Scientific Evaluator in the Marketed Health Products Directorate at Health Canada. She has over 17 years of experience in the pharmacovigilance and risk management of pharmaceutical products. Marilyne holds a Bachelor’s degree in Biology/Biotechnology from the University of Ottawa and a Masters Degree in Pharmaceutical Sciences with specialization in Drug Development from L’Université de Montréal.
Marilyne is currently involved in modernization activities for RMP reviews within the department.
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Dr. Marie-Therese Bawolak, PhD (elle/she)
Manager, BIO-3 Bureau of Biologics, Radiopharmaceuticals and Self-care products (BBRS) Marketed Health Products Directorate
Dr. Marie-Therese Bawolak, PhD (elle/she)
Manager, BIO-3 Bureau of Biologics, Radiopharmaceuticals and Self-care products (BBRS) Marketed Health Products Directorate
Health Canada/ Government of Canada
Marie-Thérèse Bawolak is a Manager in the Marketed Health Products Directorate at Health Canada. She holds a B.Sc. in Pharmacology from Université de Sherbrooke, and a M.Sc. and a Ph.D. in Experimental Medicine, from Université Laval. Marie-Thérèse joined Health Canada as a Scientific Evaluator in 2011. She has experience in the pharmacovigilance and risk management of both biologic and pharmaceutical products. Marie-Thérèse is currently leading modernization activities related to Risk Management Plan reviews at Health Canada
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Dr. Torrey Parker
Bureau of Medical Sciences
Dr. Torrey Parker
Bureau of Medical Sciences
Health Canada/ Government of Canada
Dr. Torrey M. Parker graduated from the University of Ottawa School of Medicine in 2009. She completed her residency at the Children’s Hospital of Eastern Ontario (CHEO) in the speciality of Pediatrics in 2015. She completed part of a fellowship in Pediatric Hematology-Oncology at CHEO. She then worked as a full-time community Pediatrician from 2015 to 2017 and then returned to CHEO as a staff consulting Pediatrician in 2017. In February 2020, she joined Health Canada in the Pharmaceutical Drugs Directorate (PDD) in the Bureau of Medical Sciences (BMS) as a Medical Evaluator. In December 2020, she became one of the managers in BMS whose team works on primarily pre-market drug authorizations in oncology, hematology, infectious diseases, gastroenterology, dermatology, and ophthalmology. She continues to work part-time at CHEO as a consulting Pediatrician. She is also cross appointed as an Assistant Professor at the University of Ottawa, Faculty of Medicine.
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Dr. Jennifer Kasbary
Bureau of Medical Sciences
Dr. Jennifer Kasbary
Bureau of Medical Sciences
Health Canada/ Government of Canada
Dr. Jennifer Kasbary graduated from the University of Ottawa School of Medicine in 2015. She completed her residency in Family Medicine at McGill University in 2017. She then worked as a full-time community family physician from 2017-2019. She then joined Health Canada with the Bureau of Medical Sciences (BMS) in the Pharmaceutical Drugs Directorate (PDD) as a Medical Evaluator. She is currently one of the manager in BMS who’s team primarily works on pre-market drug authorization review in cardiology, nephrology, neurology, psychiatry, gynecology, urology, metabolic and rare diseases, allergy and respirology. She also continues to practice medicine in the community part-time.
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Mary Speagle
Senior Director, Regulatory Affairs
Mary Speagle
Senior Director, Regulatory Affairs
Innomar Strategies Inc.
Mary Speagle is Senior Director Regulatory Affairs at Innomar Strategies where she heads up a consulting team specializing in US and Canadian Regulatory Affairs. Mary’s broad experience covering 20 years in regulatory consulting includes both prescription and OTC drugs (Pharmaceuticals, Biologics, Natural Health Products), Medical Devices and Cosmetics. Mary has been working in the consulting area since 1998. Prior to joining Innomar Strategies, she headed up consulting teams at TPIreg , Mapi Life Sciences (previously OptumInsight and CanReg Inc.). She is a prior contributing author to the RAPS Essentials of Healthcare Product Labeling and Fundamentals of Canadian Regulatory Affairs. Mary served for many years on the CAPRA Board of Directors and the RAPS Editorial Board. Mary is an active member of numerous industry associations.
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Andrew Raven
Manager for Biostatistics, Epidemiology, and Pharmacometrics Unit, HPFB
Andrew Raven
Manager for Biostatistics, Epidemiology, and Pharmacometrics Unit, HPFB
Health Canada / Government of Canada
Andrew Raven has been the manager of the Biostatistics, Epidemiology, and Pharmacometrics Unit in the Pharmaceutical Drugs Directorate (PDD) of Health Canada since 2015. Before this, he worked as a biostatistician and senior biostatistician in TPD since 2004. He holds a BSc in Molecular Biology & Genetics and a MSc in Mathematics & Statistics both from the University of Guelph.
The Biostatistics, Epidemiology, and Pharmacometrics Unit provides expertise to evaluate the statistical designs, methodologies, conduct, analyses, and interpretation of clinical studies and other evidence (including RWE) provided by sponsors in their pre-market prescription pharmaceutical drug submissions.
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Jay Patel
Regulatory Affairs Specialist | Non-prescription Drugs Evaluation Division (NDED) | Natural and Non-prescription Health Products Directorate
Jay Patel
Regulatory Affairs Specialist | Non-prescription Drugs Evaluation Division (NDED) | Natural and Non-prescription Health Products Directorate
Health Canada/ Government of Canada
Jay is a Regulatory Affairs Specialist (Product Information Officer) who primarily uses his wealth of experience in the evaluation of Non-prescription Drug Labelling. He has supported many policy related initiatives, including those for Plain Language Labelling and the upcoming Non-prescription Drug Action Plan. Jay enjoys most of all opportunities to provide drug submission related guidance to clients, and responding to their inquiries. From previously working with ROEB, he has other experience in assessments of foreign drug manufacturing establishments flagged as potential risk sites.
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Fiona Frappier
Manager, Biologic and Radiopharmaceutical Drugs Directorate, Health Product and Food Branch
Fiona Frappier
Manager, Biologic and Radiopharmaceutical Drugs Directorate, Health Product and Food Branch
Health Canada
As policy manager Fiona Frappier is responsible for developing regulations and industry guidance while improving stakeholder outreach. She is working on new regulations for Clinical trial Modernization and is the Health Canada chair for the Rare Disease Cluster. She also manages stakeholder communication on complex product approvals and ensures timely decisions and coordinated communications. Fiona has 14 years' experience at both Health Canada and the Public Health Agency of Canada working on interdepartmental science policy issues. Prior to this she completed her PhD in Microbiology and Immunology at the University of Ottawa.
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