Under Canadian Regulations, Natural Health Products (NHPs) are defined as:

• Vitamins and minerals
• Herbal remedies
• Homeopathic mediciness
• Traditional medicines such as traditional Chinese medicines
• Probiotics, and Other products like amino acids and essential fatty acids

NHPs must be safe for consideration as over-the-counter products, be available for self-care and self-selection and not require a prescription to be sold.

This course is designed to help you navigate these new regulations, interact with the NHP directorate and successfully bring an NHP to the market.

• Requirements, current challenges and tools to help industry to comply with the regulatory requirements for Natural Health Products in Canada
• Site Licences, Good Manufacturing Practices and International Trade Certificate Requirements for Natural Health Products in Canada
• Natural Health Products - an overview
1. Scope of the NHP regulations
2. Product classifications
• Main Components of the NHP regulations
1. Product licensing
2. Site licensing
3. Good manufacturing practices
4. Labelling and Packaging
• Other Activities covered under the NHP regulations
1. Importing for sale in Canada
2. Distribution
3. Clinical Trials
4. Adverse Event Reporting
• Comparison with regulations in other jurisdictions
1. US
2. EU
3. Australia/New Zealand

• Each day concludes with a workshop

Dr. Sonya Agbessi Head of the Site Licence Assessment Unit NHPD, Health Canada

Mrs Sonya Agbessi obtained her PhD in biology (microbiology) from the "Université de Sherbrooke" and then, worked as a research scientist in a biotechnology company in Montreal. She joined the NHPD in 2005 where she is a GMP evaluator of site licence applications submitted by Canadian manufacturers, packagers, labellers and importers. She also acted as Head of the Site Licence Assessment Unit with the Bureau of Product Review and Assessment at the NHPD.

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Dr. Mary Mazur-Melnyk Chief Scientific Officer BioReg International

Dr. M. Mazur-Melnyk, has over 20 years experience in the areas of bio/pharmaceutics and medical devices and has held senior management positions both in Quality Assurance and Regulatory Affairs. She holds a M.Sc. in Medical Sciences and a Ph.D. in Molecular Biology. Currently she is the COO of BioReg International (BRI) - a leading global regulatory systems solutions provider to the healthcare industries. BRI is focused on providing reliable service and lasting solutions from basic regulatory, quality and product support to the most complex registration and compliance issues.

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Raymond W. Tsang, M.Sc. Manager, Site Licence Assessment and Coordination Division NHPD, Health Canada

Raymond W. Tsang is the Manager for the Site Licence Assessment and Coordination Division of the Natural Health Products Directorate (NHPD) of Health Canada since 2001. As part of his job, he is responsible for the Site Licensing, Good Manufacturing Practices and the International Trade Certificate Programs as they relate to the natural health products in Canada.

In addition, he is a member of the NHPD International Working Group involving in a number of international files, such as, the collaboration works with the World Health Organization (WHO) in Herbal Medicines, the Mexico-USA-Canada Health Fraud Working Group (MUCH) of the Trilateral Cooperation, and the State Food and Drug Administration (SFDA) of the People’s Republic of China, etc.

Prior to his appointment with the NHPD in Ottawa, he worked as the Acting Associate Chief for the Therapeutic Products Programme, and also as the Food and Drug Inspector for about fourteen years in the Ontario Region of Health Canada.

As an Action Manager, Mr. Tsang has received two distinct awards recently. They are the Assistant Deputy Minister’s Excellence Award for “Creativity and Innovation” and the Health Canada’s Outstanding Mentor Award for his work in 2008.

Mr. Tsang has a Master of Food Science Degree from the University of Manitoba and a Bachelor of Food Science Degree from McGill University.

Mr. Tsang is an Advisor, Founding Member and Former Director of the Friends of Alternative and Complementary Therapies Society (FACT) in Canada, a non-profit health practitioner and consumer educational group in Toronto since 1998.

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This one & a half day course is valuable for Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas:

• Regulatory Affairs
• Quality Assurance
• Product Submission
• Training
• Consultants
• Clinical Research
• Documentation and Technical Writing
• Project Management
• Product Development
• Others who interact together to launch a product

 

Registration Fee Includes: Presentation Materials, Luncheon, and Refreshments

Cancellation/Substitutions Policy: CANCELLATION POLICY: Cancellation is accepted in writing (by mail, or fax) up to 4 weeks before the program start date, after which cancellations are not accepted and do not qualify for refund or credit. All Cancellations are subject to a $210.00 CAD (incl. GST)/person processing fee. Substitution of delegate/s with the member/s of the same organization is permitted at any time. IPA reserves the right to postpone an event, prior to which time all the registered attendees will be notified a minimum of 2 weeks in advance. IPA shall not be responsible for any air fare, hotel or transportation costs incurred by registrant/s.

Hilton Garden Inn
Montreal Airport
7880 Côte de Liesse St. Laurent,
Montreal, Quebec, Canada H4T 1E7

For reservation please contact:
Mary Korakianitis
Tel: 514-788-5034 or 1-866-788-2518
Email: Mary.korakianitis@hilton.com

http://hiltongardendorval.com/

A special room rate has been prearranged for conference participants. Call the hotel directly at the above number and mention International Pharmaceutical Academy to receive the reduced room rate.