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Christelle  Gedeon

Christelle Gedeon, PhD

Associate Fasken
It remains to be seen whether other Canadian provinces will follow Ontario’s lead in enacting a similar regime for the regulation of recreational cannabis.
Jurisdiction Ontario, 2012 | Quebec, 2011
Language(s) English, French
Office(s) Toronto
Contact

Christelle Gedeon’s practice is focused on the life sciences industry specifically on products regulated under the Food and Drugs Act, including drugs, devices, food, cosmetics and cannabis. Frequently sought after to support clients navigate product approvals and licensing, design and implement international clinical trials and facilitate national product launches. Christelle also assists with North American advertising campaigns and in reviewing regulatory submissions for foreign and U.S. companies entering the Canadian marketplace.

The firm’s resident regulatory affairs specialist, Christelle prepares regulatory submissions for medical devices, pharmaceutical products, cosmetics, foods and cannabis products. She also assists clients with designing and managing their clinical trials, and coordinating the marketization of products (including the Special Access Program). She regularly advises on pharmacovigilance reporting and assist with product development and intellectual property portfolio management for drug products, medical devices, natural health products and other life science innovations.

Complementing the regulatory affairs aspects of her practice, Christelle is also active member of the firm's intellectual property group and is often engaged to provide transactional support to the firm's corporate commercial and life science clients.

 

 

 

Education

  • Registered Trade-mark Agent
  • LLB, BCL, (Dean's List) McGill University
  • Ph.D., Clinical Pharmacology and Toxicology University of Toronto
  • BSc (Hons) with distinction, Neurosciences University of Toronto

Memberships & Affiliations

  • Member, Canadian Society of Pharmacology and Therapeutics (2004-2010)
  • Member, American Association of Clinical Pharmacology (2005-present)
  • Member, Canadian Bar Association (2011-present)
  • Member, Ontario Bar Association
  • Member, Young Bar Association of Montreal
  • Member, Young Women in Law 
  • Chair, Canadian Association of Professionals in Regulatory Affairs (2015-Present)
  • Editor in Chief, NOC magazine (2013-2015)
Article Canada Moves One Step Closer to Legalizing and Regulating Cannabis Pith & Substance, and Life Sciences and Health Law Bulletin
Article Regulating Industry Through Compliance with Advertising Regulations BioTechnology Focus
Article Say What? Health Canada is Cracking the Whip on Advertising Violations Regulatory Affairs Professionals Society
Medicinal Marijuana: Insights & Challenges location location Toronto
Do’s and Don’ts of Buying and Selling your IP Assets location location Toronto
Counterfeit Drugs: Is this a first world problem? location location Toronto Toronto, ON