CAPRA Virtual Education Day 2021
The link to join the Education Day will be emailed to all registrants to the email address that was submitted in the Event Registration form.
If you have not received the link to join by the end of the day on June 04th, please contact the CAPRA administrator (email@example.com ).
Presentations for the event will be emailed to all registrants by the end of the day on Monday, June 07, 2021.
CAPRA continues to stay committed to providing education to our members and staying connected.
The Education Day will take place virtually on June 8th and June 9th, 2021. This is an opportunity to hear about hot topics of interest in regulatory affairs from Health Canada.
Topics will include the following:
- Pause the Clock
- Health Canada Implementation of ICH Q12: CMC Changes
- International Collaborative Review Activities: Updates on Access Consortium and Project Orbis
- Case Study: Industry Experience with Project ORBIS
- OTC Labelling: Canadian Drug Facts Table (CDFT)
- Covid-19-Future Regulatory Landscape
- Changes to the Filing of Post-NOC Submissions Following Cost Recovery 2020
- Regulatory Enrolment Process (REP)
- Strategies for Filing an Efficient Submissions
Click here for the Agenda.
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CAPRA Education Day Committee
Speakers / Panelists
Director in the Office of Business Integration within the Biologic and Radiopharmaceutical Drugs Directorate
Michèle Chadwick is currently the Director in the Office of Business Integration within the Biologic and Radiopharmaceutical Drugs Directorate. She has been co-lead on the Pause the Clock Project since she was the lead on the Regulatory Review of Drugs and Devices Team prior to taking on her current role.
Michèle has worked within the Federal Health Portfolio for over 20 years both Health Canada and Public Health Agency and Health Canada in various policy and regulatory capacities, predominantly in the realm of therapeutic products. Prior to coming to the federal government, she worked in the pharmaceutical Industry for 10 years.
Denis Arsenault has worked as a federal public servant for over 17 years. He is currently a Manager of Policy Development with the Office of Policy and International Collaboration within Health Canada's Biologic and Radiopharmaceutical Drugs Directorate (BRDD). In this capacity, Mr. Arsenault leads policy development initiatives on a number of files including regulatory modernization and biosimilar biologic drugs.
Acting Manager, Management of Drug Submissions Policy (Including Pause the Clock Option)
Heather Cherry is currently acting Manager of the Regulatory Project Management Division of the Therapeutic Products Directorate at Health Canada. Heather has a Bachelor of Sciences in Medicinal Chemistry from the University of Ottawa. She has been with Health Canada since 2008, first as a Regulatory Project Manager supporting the Bureau of Cardiology, Allergy and Neurological Sciences, then as Senior Regulatory Project Manager supporting the Bureau of Pharmaceutical Sciences and as Regulatory Affairs Manager since September 2018. Heather participated in the development of the Cost Recovery regulatory changes, which included Pause the Clock and Post-NOC Changes.
A/Manager, Radiopharmaceuticals and Monoclonal Antibodies (inflammation) Division, CERB, BRDD, HPFB
Hugo Hamel graduated from the University of Montreal with a B.Sc. in Biochemistry, an M.Sc. in Molecular Biology and an M.Sc. in Pharmaceutical Sciences. He also graduated with an MBA in 2015.
Mr. Hamel spent his last 20 years working with the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) at Health Canada as Senior Evaluator with the Monoclonal Antibodies Division and acting Division Manager of the Radiopharmaceuticals and Gene Therapies Unit. He is currently acting Division Manager of the Radiopharmaceuticals and Monoclonal Antibodies (Inflammation) Division.
During his career with BRDD, Mr. Hamel was involved with reviewing the Chemistry, Manufacturing and Controls information pertaining to Clinical Trial Applications (CTAs), New Drug Submissions (NDSs) and Post-Marketing changes associated with Biotherapeutics. He also acted from 2005-2021 as the BRDD lead of the working group in charge of developing and updating the Canadian Post-NOC changes quality guidance and represented Health Canada on the WHO drafting group in charge of developing the WHO Guidelines on procedures and data requirements for changes to approved biotherapeutic products.
Mr. Hamel is also a member of the ICH Q12 IWG and leads its implementation in Canada. He is pleased to provide an update on the implementation status of these important guidelines in Canada.
Policy and International Coordination Advisor, Office of Regulatory Intelligence and Risk Management, Biologic and Radiopharmaceutical Drugs Directorate
Shajan is a Policy and International Coordination Advisor with the Biologic and Radiopharmaceutical Drugs Directorate (BRDD), helping coordinate international work-sharing files for the branch. He joined Health Canada in 2016 and has experience in regulatory project management and drug product label review from previous roles in the Regulatory Project Management Division of the Therapeutic Products Directorate (TPD) and the Office of Regulatory Affairs of BRDD.
Mandy holds the position of Manager, Regulatory Affairs at AbbVie Canada since May 4, 2020. She leads a team of regulatory professionals and is focused on the filing and approval of biopharmaceutical drug and medical device submissions for clinical development and commercial products with Health Canada.
Mandy joined Abbott/AbbVie in February 2009 as a Safety Officer, and then transitioned to the Regulatory Affairs team, where over the past 12 years she has held various regulatory roles of increasing responsibility and has managed numerous regulatory filings, approvals and launches.
Mandy holds a Doctorate in Pathobiology and Bachelor’s degree in Forensic Science and Biology, both from the University of Toronto.
Regulatory Affairs Specialist, Non-prescription Drugs Evaluation Division (NDED), Bureau of Product Review and Assessment, Natural and Non-prescription Health Products Directorate, Health Products and Food Branch
Dr. Taiwo Womiloju received her PhD in Chemistry with specialization in organic chemistry from the University of Ibadan, Nigeria. After her graduation, she conducted scientific research at the University of New Brunswick, Fredericton, New Brunswick; Carleton University, Ottawa; and the Children’s Hospital of Eastern Ontario (CHEO), Ottawa. She has published 7 scientific papers in international journals. Dr. Womiloju joined Health Canada in 2005 as a Regulatory Information Officer with the Office of Submissions and Intellectual Property (OSIP). She joined the Non-prescription Drugs Evaluation Division (NDED), Natural and Non-prescription Health Products Directorate in 2009 as a Regulatory Affairs Officer. In 2018, Taiwo went on one-year assignment as a Scientific Evaluator with the Manufacturing and Chemical Evaluation Division of the Veterinary Drugs Directorate (VDD). While at VDD, Taiwo was involved in the review of chemistry and manufacturing data for prescription veterinary drugs and participated in revisions of guidance documents. She is currently a Regulatory Affairs Specialist with NDED. She is involved in the review of labelling documents for non-prescription drugs; updating and developing guidance documents and policies related to drug approval process; and mentoring new label reviewers. At Health Canada, Taiwo has received a number of awards including, the Assistant Deputy Minister's Excellence Awards for the Regulatory Cooperation Initiative (RCI) project with Therapeutic Goods Administration (TGA, Australia), the Regulatory Cooperation Council (RCC) Over the Counter Products project with the US-FDA, the Non-prescription Drug Monograph Attestation Pilot project and, the Plain Language Labelling Implementation.
a/Manager, Office of Policy and International Collaboration of the Biologic and Genetic Drugs Directorate, BRDD, HPFB.
Dr. Fiona Frappier is the lead manager in the development of the new Food and Drug Regulations for COVID-19. These new regulations translate the previous Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (ISAD IO) into regulatory amendments. Fiona has worked with departmental and interdepartmental colleagues in responding to the COVID-19 pandemic. Her work has focused on the Health Products and Food Branch.
Acting Manager, Health Products Food Branch; and Irena Pastorekova, Regulatory Affairs Specialist, Office of Submissions and Intellectual Property, Health Products and Food Branch
Sindy Fernando graduated with Honours Bachelor of Science Degree from the University of Guelph. She started her career at Health Canada in 2007 and has worked in numerous directorates within the Health Products and Food Branch, including the Natural and Non-Prescription Health Products Directorate, the Food Directorate, the Biologics and Radiopharmaceutical Drugs Directorate, the Therapeutic Products Directorate and the Resource Management and Operations Directorate.
She is currently a Senior Regulatory Affairs Specialist and Acting Manager at Resource Management and Operations Directorate, and is the lead Business Analyst on the Regulatory Enrolment Process Project.
Office of Submissions and Intellectual Property Resource Management and Operations Directorate
Irena Pastorekova has worked at Health Canada since 2006. Currently, she supervises the eReview group at the Office of Submissions and Intellectual Property whose responsibility is dossier ID issuance, support to industry, validation and automation of eCTD and non-eCTD submissions received via the electronic gateway. She is involved in policy development, roll-out of new projects and a member of M8 ICH group.
Regulatory Project Manager, Therapeutic Products Directorate, Regulatory Project Management Unit-BCANS
Joshua completed his Honours Bachelor of Science specializing in biological chemistry at the University of Toronto in April 2016. He then enrolled in the Regulatory Affairs and Quality Operations program at Seneca College in May 2016, and later joined the Regulatory Project Management Division (RPMD) in TPD as a co-op student in September 2016. Joshua stayed on as a student in RPMD through the Federal Student Work Experience Program (FSWEP) until he returned to Seneca College in September 2017 to finish the classes required for the program. After completing the program, Joshua was bridged into his current role as a Regulatory Project Manager (RPM) for the Cardio-Renal Division in BCANS starting in January 2018. Joshua has since been assigned to files undergoing many different initiatives, including Early Parallel Scientific Advice, HTA Alignment, and ACCESS International Worksharing. None of the above would have been possible without the constant support of his wife Jane and son Jaden.
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