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Update on Health Canada Risk Evaluation of N-nitrosamine Impurities in Canadian Human Pharmaceutical, Biological and Radiopharmaceutical Products

Update on Health Canada Risk Evaluation of N-nitrosamine Impurities in Canadian Human Pharmaceutical, Biological and Radiopharmaceutical Products

by Jenn Porter | Apr 29, 2021 | Canadian Regulatory, OTC Drugs

The deadline for the first step of Health Canada’s risk evaluation for the presence of N-nitrosamine impurities in Canadian human pharmaceutical, biological and radiopharmaceutical products was March 31, 2021. This deadline applied to Market Authorization Holders...
Tighter Restrictions to be implemented for Talc

Tighter Restrictions to be implemented for Talc

by Jenn Porter | Apr 29, 2021 | Canadian Regulatory, Cosmetics, Natural Health Products, OTC Drugs

The Government of Canada conducts risk assessments of substances under the Canadian Environmental Protection Act, 1999 (CEPA) to determine whether they present or may present a risk to human health or to the environment. A final risk assessment was recently completed...

Recent Posts

  • Maine PFAS Reporting Deadline Approaching
  • Notice to Stakeholders concerning the Cosmetic Ingredient Hotlist
  • Amendments to the NHP Regulation
  • California Bill AB-2787 proposes to ban microplastics in leave-on products
  • Mandatory Section 71 (S. 71) Survey due by September 14th, 2022

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    Delsie Braganza

    Delsie joined the Focal Point Research team in 2011 and has been an invaluable asset for our clients. With her strong regulatory and quality assurance background, she is able to audit facilities, set up and maintain GMP compliant facilities, develop strong quality management systems, and co-ordinate successful Health Canada inspections. In addition to this, Delsie oversees all submissions made to Health Canada and the US FDA.

    Delsie obtained an Honours Bachelor of Science (Hons. B. Sc.) in Pharmaceutical Chemistry from the University of Toronto, Post-Graduate Certificate in Pharmaceutical Regulatory Affairs and Quality Operations (RAQ) from Seneca College and Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS). When she’s not learning something new, Delsie loves spending time with family, going on road trips or long walks, and swimming.

     

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    Robert Fichtner

    Since co-founding Focal Point over 20 years ago, Rob has led our Regulatory and Scientific practice. A chemist by training, his experience includes Cosmetics, Drugs, Medical Devices, Consumer Products and Natural Health Products (Dietary Supplements). Rob has participated in the launch of thousands of products including their formulation, manufacturing and regulatory submissions for approval. His wealth of experience spans almost 40 years in innovation.
    Rob has been involved in all aspects of innovation and new product development. He shares some of his insights in his new video series “Lectures in Innovation”. You can view the first video here.
    When not supporting innovators, Rob spends his time becoming a better sailor and guitar player.