This 1-day workshop provides an overview of the Canadian regulatory and quality requirements for natural health products (NHPs). The course is designed to provide necessary basic practical knowledge to enable you to successfully market natural health products in Canada. It will provide an overview of required marketing authorization applications and ongoing regulatory and quality assurance obligations. Practical examples, links to online information and in-class help will be provided to give you the right tools to fulfill regulatory requirements.
This course will include a discussion of the following topics:
- Overview of the Natural Health Product Regulations
- -Focus will be on the regulations guiding import, distribution, licensing, testing, manufacturing and adverse event reporting
- Classification of products on the NHP-drug, food and cosmetic interface; includes practical examples and guidelines
- NHP licensing requirements for product licenses (NPN license) and site licenses for importers and Canadian manufacturers, packagers and labellers.
- Key topics will include how to file a license application; Health Canada review times; and considerations before filing an application
- Ongoing quality assurance and quality control requirements for natural health products (e.g. quality documentation systems, SOPs, quality agreements, GMP, labelling, batch testing, stability, complaint handling, adverse event reporting)
Who should attend
Graduates, employees with new responsibilities or interest in quality assurance and regulatory affairs for natural health products. Sales and marketing professionals. Individuals who would like to market a natural health product in Canada.
Mrs. Elfi Daniel-Ivad serves as Head of Submissions at Eurofins Experchem Laboratories Inc. In this role, she leads a team of regulatory professionals in the development of regulatory submission strategies for Natural Health Products (NHPs), OTC drugs, cosmetics, medical devices, food products, site licenses and medical establishment licences. Her responsibilities include the regulatory review of NHP, OTC drugs, cosmetics, food, household chemical and medical device labels ensuring compliance with Canadian regulations and managing post-approval changes to ensure regulatory compliance. Over the last decade, Mrs. Daniel-Ivad has developed a proven style of dealing with Health Canada authorities resulting in an excellent track record of getting regulatory submissions and applications approved. In addition, Mrs. Daniel-Ivad spearheads pharmacovigilance activities in close collaboration with clients and medical professionals, including the preparation of periodic safety update reports (PSURs). Mrs. Daniel-Ivad also has experience in preparing protocols and reports for method validations, equipment qualification, transportation, and temperature cycling studies. Furthermore, in the last three years Mrs. Elfi Daniel-Ivad worked with countless medical marihuana producer licence applicants to receive their growing and sales licence from Health Canada. Mrs. Daniel-Ivad received a B.Sc. in Technical Chemistry and a M.Sc. in Biotechnology and Nutrition from the Technical University of Graz, Austria. Further, she received a Postgraduate Regulatory Affairs Diploma (PRA) from the Academy of Applied Pharmaceutical Sciences Inc. (AAPS).
Registration Deadline: 13 Jun 2017
|Basic Member Promo:||$375.00||— Sold Out|
|Basic Member Group Tickets Promo:||$355.00||— Sold Out|
|Student Ticket:||$250.00||— Sold Out|
|Pro Ticket Promo:||$345.00||— Sold Out|
|Pro Group Tickets Promo:||$325.00||— Sold Out|
|Basic Member Regular:||$525.00||— Sold Out|
|Basic Member Group Tickets Regular:||$505.00||— Sold Out|
|Pro Ticket Regular:||$495.00||— Sold Out|
|Pro Group Tickets Regular:||$475.00||— Sold Out|