Ranked in 1 Practice Areas
2

Band 2

Life Sciences: Regulatory/Compliance

Nationwide - Canada

5 Years Ranked

About

Provided by Ingrid E VanderElst

Canada

Practice Areas

Ingrid VanderElst is co-chair of the Ontario region’s Life Sciences group. Regularly assisting clients in the health products and related service industries, Ingrid advises on regulatory and intellectual property issues. Clients include pharmaceutical, natural health product, medical device, cosmetic and food manufacturers, as well as pharmacy and laboratory services providers and agri-business operators.

On the regulatory side, Ingrid has assisted clients with product licensing, establishment licensing, manufacturing requirements (including GMP compliance), packaging and labeling reviews, as well as advised on advertising, marketing and distribution, product recalls, drug pricing (including PMPRB compliance) and reimbursement issues, including formulary listing. As regards intellectual property matters, she advises on licensing and transfer of patents and trademarks, patent and trademark prosecution, patent listing under the Patented Medicines (Notice of Compliance) Regulations and data protection, and provides support on the acquisition or disposition of technology assets and intellectual property portfolios.

A significant component of Ingrid’s practice relates to advising clients on privacy related to regulated health products and allied services industries. This includes providing guidance on health privacy issues associated with clinical trials, sponsored research and patient support programs, as well as privacy considerations that arise in connection with commercial operations of pharmacies, laboratories and other health services providers. Ingrid has assisted clients with drafting patient informed consents in the context of clinical trials and patient support programs, drafting privacy policies and consents for patient-facing websites, providing guidance concerning information transfers in connection with corporate transactions and dealing with privacy complaints and privacy breaches, including assessment of reporting obligations. Ingrid also provides advice concerning compliance with Canada’s anti-spam law for companies operating within the regulated health products and related services industries.

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