Labelling Symposium with Health Canada
Dec 03, 2021, 2:42 pm: Thank you for accepting the Microsoft team invitation to join the upcoming workshop. I have sent two invites, one for Session one, Dec 07, 2021, and the second for Session two, Dec 08, 2021. If you have not yet accepted the invitation, please accept the invite so that you can join without any issues. I have double-checked my invite list and everyone who is registered has been sent the invite. Please check your Junk folder/spam folder if you have not received my invite.
Thank you.
Hareet Aujla, CAPRA Administrator
Link to all presentations will be emailed by Queenia Lee (qlee@apotex.com).
The calendar invitations with the link to join the Symposium for each day will be sent to registrants via the email address in their registration.
If you have not received the invitation by noon on Dec 06th, please contact the CAPRA administrator (administrator@capra.ca).
MARK YOUR CALENDARS for December 7 & 8, 2021 and share this news with your colleagues!
Registration is open from November 3rd to December 2nd, 2021.
Click here for the brochure (revised December 2, 2021).
The CAPRA Symposium Committee will host two virtual interactive sessions to provide several labelling updates and best practices sessions from Health Canada.
Session one will focus on the XML Product Monograph (PM) project and provide a detailed overview of the new 2020 PM Master Template with best practices related to conversion of the PM to the 2020 format. Session two will cover the new draft guidance, Electronic Media in Prescription Drug Labelling, plus updates from the Natural and Non-prescription Health Products Directorate (NNHPD). Best practices will be shared for submissions filed through the Administrative pathway.
This Symposium will also feature Industry perspectives and provide attendees an opportunity to raise questions with Health Canada on these topics.
This event will be of interest to:
- Regulatory Affairs professionals from medical devices, pharmaceuticals/biologics, NHPs, as well as veterinary drugs
- Clinical Research and Contract Research Organizations
- Clinical Data Management/Pharmacovigilance
- Research and Development
Please share the news of this event within your organization.
CAPRA Symposium Committee
Speakers / Panelists
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Tracy E. Brown
Project Manager, Business Informatics Division, Resource Management and Operations Directorate
Tracy E. Brown
Project Manager, Business Informatics Division, Resource Management and Operations Directorate
Health Canada
Tracy Brown as worked at Health Canada in the regulatory environment for almost 20 years. Her career began at the Pest Management Regulatory Agency, though the majority of Tracy’s career was spent in the Office of Regulatory Affairs within the Biologics and Radiopharmaceutical Drug Directorate as a Senior Regulatory Project Officer. Tracy has been involved in many large projects during her career, is now a Project Manager within the Resource Management and Operations Directorate, where she is the lead on the XML PM project.
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Lynda O’Reilly
Educator, Regulatory Project Management Division, Therapeutic Products Directorate, Health Products & Food Branch
Lynda O’Reilly
Educator, Regulatory Project Management Division, Therapeutic Products Directorate, Health Products & Food Branch
Health Canada
Lynda is the Educator for the Regulatory Project Management Division (RPMD), within the Therapeutic Products Directorate (TPD) of Health Canada. Prior to taking on the role as educator, she had been the Regulatory Project Manager (RPM) for the AIDS & Viral Diseases Division (AVDD) since 2004.
In addition to the day-to-day responsibilities within RPMD, Lynda is an active member of several working groups including, but not limited to: Product Monograph Working Group, Best Practices (for RPMD), Structured Product Monograph, and Health Products & Food Branch (HPFB) Medication Incident Working Group.
Lynda is also a Registered Nurse, with more than 3 decades of clinical experience in a variety of primary healthcare and teaching settings. Lynda has also co-authored peer-reviewed articles with regard to compliance and hepatotoxicity related to pharmaceutical treatment of latent tuberculosis; a Canadian perspective of taking multiple drug therapies for persons with HIV infection; and causes of death of HIV-infected persons in Ottawa over a specific time period.
In early 2004, prior to joining TPD, Lynda collaborated in the Respiratory Illness Surveillance [Post-SARS (Severe Acute Respiratory Syndrome)], which was a joint Health Canada – Ottawa Hospital Infection Prevention & Control research project.
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Khaled Yahiaoui
Associate Director ‐ Regulatory Affairs, Operations
Khaled Yahiaoui
Associate Director ‐ Regulatory Affairs, Operations
Merck Canada Inc
Khaled has spent the last 10 years of his regulatory career in refining his experience in regulatory operations management. He holds the position of Associate Director, Regulatory Affairs – Operations, at Merck Canada. Khaled also holds a Regulatory Affairs Certification from RAPS and master’s degrees in Drug Development, Biochemistry and Computer Science. He is actively participating to the XML PM pilot from the early stages through testing and close collaboration with Health Canada XML PM team. As a result, in August 2020, he successfully led the filing of the first XML PM for a real submission in Canada.
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Jacqueline Bruner and Amanpreet Kainth
Senior Director, Encoding Technology and Senior Team Lead, Regulatory Affairs
Jacqueline Bruner and Amanpreet Kainth
Senior Director, Encoding Technology and Senior Team Lead, Regulatory Affairs
i4i
Jacqueline Bruner and Amanpreet Kainth together have years of experience with XML encoding technology, XML/SPL compliant submissions, and the development and use of i4i’s platform on a global basis. With extensive involvement in the FDA SPL initiative, they have formed the core i4i team working with Health Canada and sponsors, on the development of the XML PM project and its rollout.
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Sandra Alderdice
Supervisor, Labelling Division, Therapeutic Products Directorate, Health Products & Food Branch
Sandra Alderdice
Supervisor, Labelling Division, Therapeutic Products Directorate, Health Products & Food Branch
Health Canada
Sandra Alderdice is a supervisor in the Labelling Division within the Therapeutic Products Directorate (TPD) of Health Canada. She has worked at Health Canada for over 20 years in a variety of regulatory positions in the TPD, Biologic and Radiopharmaceutical Drugs Directorate, and the Medical Devices Directorate. Sandra has a Bachelor’s Degree in Biochemistry from McMaster University.
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Taranum Singh
Supervisor, Labelling Division, Therapeutic Products Directorate, Health Products & Food Branch
Taranum Singh
Supervisor, Labelling Division, Therapeutic Products Directorate, Health Products & Food Branch
Health Canada
Taranum Singh is a Supervisor in the Bureau of Gastroenterology, Infection and Viral Diseases, Labelling Division in the Therapeutics Products Directorate (TPD) of Health Canada. She has worked in the Health Products and Food Branch (HPFB) for over 15 years. She has a degree in biochemistry from the University of Ottawa.
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Jason Di Muzio
Acting Manager, Non‐prescription Drugs Evaluation Division (NDED), Bureau of Product Review and Assessment, Natural and Non‐prescription Health Products Directorate, Health Products and Food Branch
Jason Di Muzio
Acting Manager, Non‐prescription Drugs Evaluation Division (NDED), Bureau of Product Review and Assessment, Natural and Non‐prescription Health Products Directorate, Health Products and Food Branch
Health Canada
Jason DiMuzio is the Manager of Label Review in the Non-prescription Drugs Evaluation Division, Natural and Non-prescription Health Products Directorate (NNHPD), Health Canada. In his current role, Jason applies expertise in the implementation of plain language labeling during the pre-market assessment of non-prescription drugs. Prior to this role, he worked in submission coordination for both non-prescription drugs and natural health products, and in risk communication evaluation. Jason holds a Master of Science in Health: Science, Technology and Policy from Carleton University and an Honours Bachelor’s Degree with Specialization in Chemistry from the University of Ottawa.
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Rohini Gupta
Senior Regulatory Affairs Officer, NDED, Natural and Non‐prescription Health Products Directorate, HPFB
Rohini Gupta
Senior Regulatory Affairs Officer, NDED, Natural and Non‐prescription Health Products Directorate, HPFB
Health Canada
Rohini Gupta is a Senior Regulatory Affairs Officer in the Non-prescription Drugs Evaluation Division, Natural and Non-prescription Health Products Directorate (NNHPD), Health Canada. In her role, Rohini evaluates non-prescription drug labels in accordance with the Food and Drug Regulations and for plain language labelling compliance to ensure the safety of Canadian consumers. Rohini holds an Honours Bachelor’s Degree with Specialization in Life Sciences from Queen’s University
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Beatrice Lee
Bureau of Licensing Services and Systems, NNHPD
Beatrice Lee
Bureau of Licensing Services and Systems, NNHPD
Health Canada
Beatrice Lee has been with Health Canada since 2002. Beatrice is currently a Manager with the Bureau of Licensing Services and Systems at the Natural and Non-prescription Health Products Directorate (NNHPD), responsible for the evaluation of information submitted by site licence applicants to determine compliance with the requirements under the Natural Health Products Regulations.
Prior to joining NNHPD, Beatrice was a supervisor and Acting Manager in the Workplace Hazardous Materials Bureau in the Healthy Environments and Consumer Safety Branch, managing claims for exemption under the Hazardous Materials Information Review Act to protect confidential business information on safety data sheets for hazardous products. Beatrice has extensive experience with the administration of the Controlled Drugs and Substances Act and its Regulations, occupying various roles within the Office of Controlled Substances.
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Jaqueline Coté
Senior Policy Advisor, Bureau of Policy, Risk Management & Stakeholders, NNHPD
Jaqueline Coté
Senior Policy Advisor, Bureau of Policy, Risk Management & Stakeholders, NNHPD
Health Canada
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Marianne Giordano
Sr. Regulatory Officer, Administrative Services Unit, Labelling Division, Therapeutic Products Directorate, Health Products & Food Branch
Marianne Giordano
Sr. Regulatory Officer, Administrative Services Unit, Labelling Division, Therapeutic Products Directorate, Health Products & Food Branch
Health Canada
Marianne joined Health Canada in 2006. She holds a Bachelor’s of Science with Honors in Human Kinetic from the University of Ottawa. She has been a member of the Administrative Submissions Unit since 2018 as a Senior Regulatory Affairs Officer.
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Kiyomi Leslie
Sr. Regulatory Specialist, Labelling Division, Therapeutic Products Directorate, Health Products & Food Branch
Kiyomi Leslie
Sr. Regulatory Specialist, Labelling Division, Therapeutic Products Directorate, Health Products & Food Branch
Health Canada
Kiyomi Leslie joined Health Canada in 2018. She holds a Bachelor of Science in Chemical Engineering from Queen’s University and an Environmental Science Certificate from Mount Royal University. Kiyomi was a member of the Administrative Submissions Unit for over two years and is currently a Senior Regulatory Specialist with the Labelling Division in the Therapeutic Product Directorate.
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