CAPRA Virtual Education Day 2022

Details Download to Calendar Speakers / Panelists Downloads Sponsors

June 14, 2022 8:45am to June 15, 2022 12:00pm EDT

Virtual

REGISTRATION is NOW OPEN

Our topics for Education Day 2022 will include the following:

Clinical Trial Modernization
Common Quality Deficiencies Observed in Drug Submissions for Pharmaceutical Drugs
Strategies for Filing Efficient Submissions
Post-NOC Quality Guidance Document
XML Product Monograph Updates
Real World Evidence (RWE) Across the Product Life Cycle: An Update
An Update by the Natural and Non-Prescription Health Products Directorate (NNHPD)

We know you have been waiting patiently. Thank you! NEW this year - CAPRA is excited to introduce our event platform.

If you have registered but not yet received your confirmation, please ensure you have followed both steps.

REGISTRATION will be a 2-step process:

STEP 1: Event Registration form: Complete the Registration form on our brand-new event page. Make sure to add your First name, Last name and the Email address that you will use to log in the day of the event.

STEP 2: Payment: Click on the Registration button or scroll down to make a payment. NOTE: you must log into your CAPRA account to complete this activity.

Both steps must be completed to receive the link to the event. We will be sending you a link and password to access the virtual event in a separate email prior to the event.
Please Note: Registration will be open until June 10, 2022. Participants may be substituted, but no refunds will be issued.

Click here for the agenda.

Speakers / Panelists

Larissa Lefebvre

Manager of the Submission Management Division within the Office of Clinical Trials, in the Therapeutic Products Directorate of Health Canada
Larissa Lefebvre

Manager of the Submission Management Division within the Office of Clinical Trials, in the Therapeutic Products Directorate of Health Canada

Mrs. Larissa Lefebvre is currently the Manager of the Submission Management Division within the Office of Clinical Trials, in the Therapeutic Products Directorate of Health Canada. She started her career in the federal government in 2007 with the Patented Medicines Price Review Board, then working in the Healthy Environment and Consumer Safety Branch before moving to the Healthy Products and Food Branch where she held various regulatory positions related to pharmaceutical products. She holds a Bachelor degree with a Specialization in Biochemistry and a Major in French from the University of Western Ontario.
Tracy Brown

Project Manager, Business Informatics Division, Health Products and Food Branch, Health Canada
Tracy Brown

Project Manager, Business Informatics Division, Health Products and Food Branch, Health Canada

Tracy Brown is the Project Manager for the XML PM Project. Tracy began her regulatory career at the Pest Management Regulatory Agency, where she worked as a scientific screening officer. In 2005, Tracy moved to the Office of Regulatory Affairs within the Biologics and Radiopharmaceutical Drug Directorate. Her role as a Senior Regulatory Project Officer included participation in many projects, including leading roles in the revisions to guidance documents for preparing submissions in the CTD and eCTD formats. In 2018, Tracy moved to the Resource Management and Operations Directorate as a Project Manager where she has led several major projects, including the Medical Devices Post-Market System Renewal and the XML PM Project.
Mohammed Faisaluddin

Regulatory Project Manager, Regulatory Project Management Division, Therapeutic Products Directorate (TPD), Health Canada
Mohammed Faisaluddin

Regulatory Project Manager, Regulatory Project Management Division, Therapeutic Products Directorate (TPD), Health Canada

Mohammed completed his Bachelor of Engineering, specializing in chemical engineering, at Laurentian University in April 2018. He then enrolled in the Pharmaceutical Regulatory Affairs and Quality Operations (RAQC) program at Seneca College, and later joined the Regulatory Project Management Division (RPMD) in TPD as a co-op student. Mohammed stayed on as a student in RPMD through the Federal Student Work Experience Program (FSWEP) until he returned to Seneca College to finish the RAQC program. After completing the program, Mohammed was bridged in as a Regulatory Project Manager (RPM) for the Bureau of Pharmaceutical Sciences (BPS) in July 2020, where he managed generic products/submissions. Mohammed has since then moved to the Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD) as a RPM, where he now manages innovative Aids and Viral Diseases drugs.
Hugo Hamel

Manager, Radiopharmaceuticals and Monoclonal Antibodies (inflammation) Division
Hugo Hamel

Manager, Radiopharmaceuticals and Monoclonal Antibodies (inflammation) Division

Hugo Hamel graduated from the University of Montreal with a B.Sc. in Biochemistry, a M.Sc. in Molecular Biology and a M.Sc. in Pharmaceutical Sciences. He also graduated with a MBA in 2015.

Mr. Hamel spent his last 21 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 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 overview of the Health Canada’s Post-NOC changes Quality Guidance document.
Dr. Susan Lum

Manager, Bureau of Pharmaceutical Sciences, Therapeutic Products Directorate, Health Products and Food Branch, Health Canada
Dr. Susan Lum

Manager, Bureau of Pharmaceutical Sciences, Therapeutic Products Directorate, Health Products and Food Branch, Health Canada

Dr. Susan Lum is a Manager within the Bureau of Pharmaceutical Sciences, Therapeutic Products Directorate (now Pharmaceutical Products Directorate), Health Products and Food Branch, Health Canada. She serves as a Health Canada Expert Working Group (EWG) member on the ICH Q13 regulatory guidance document for Continuous Manufacturing of Drug Substances and Drug Products. Dr. Lum, a Canadian-qualified pharmacist, earned her B.Sc.Phm., M.Sc. in polymers and controlled drug delivery and her Ph.D. in pharmaceutics at the University of Toronto. Prior to joining Health Canada, she was employed within the pharmaceutical industry at a number of companies, including Patheon Inc. (now Thermo Fisher), providing technical and strategic oversight on new drug projects with challenging molecules and on new technologies and platforms. Dr. Lum is the author or co-author of a number of peer-reviewed research papers, abstracts, a patent and a book chapter (Drugs and the Pharmaceutical Sciences series). She served on the American Association of Pharmaceutical Scientist’s Pediatric Formulation Task Force. Her international expertise was previously recognized with the Ebert Prize, co-sponsored by the Journal of Pharmaceutical Sciences and the American Pharmaceutical Association.
Jackie Côté

Senior Policy Analyst at the Natural and Non-Prescription Health Product Directorate of Health Canada.
Jackie Côté

Senior Policy Analyst at the Natural and Non-Prescription Health Product Directorate of Health Canada.

Jackie Côté is a senior policy analyst at the Natural and Non-Prescription Health Product Directorate of Health Canada. She has been on the team for two years, leading a number of projects to implement the Self-Care Framework, including improving the labelling of natural health products.