| Greetings!
Level 3 of our Natural Health Products workshop series moves beyond initial approval and into the ongoing regulatory responsibilities that govern products once they are on the market. Building on earlier sessions covering classification, licensing, manufacturing, and labelling, this workshop focuses on maintaining compliance across the full product lifecycle in Canada and beyond.
The session provides a practical overview of Canadian post-market requirements, including importation, exportation, and distribution. Participants will gain clarity on the responsibilities of licence holders, importers, and distributors, along with key exemptions for personal use and clinical trials. The workshop also introduces Master Files and their role in protecting proprietary ingredient information while supporting product licence and clinical trial applications.
A key focus is clinical trial oversight for NHPs. Attendees will learn when authorization is required, how trial phases differ, and what Health Canada expects in terms of applications, ethics approval, and adverse reaction reporting. The session also covers pharmacovigilance requirements, helping participants identify, assess, and report adverse reactions in line with regulatory expectations.
In addition, the workshop provides a comparative overview of international frameworks, including U.S. dietary supplement regulation under DSHEA and FDA oversight, offering insight into global compliance considerations.
This workshop is designed for professionals and students working with Natural Health Products and dietary supplements who need a practical understanding of post-market and global regulatory requirements. It is particularly relevant for those in regulatory affairs, quality assurance, product development, manufacturing, import/export, compliance, and clinical research roles.
The session is led by Andreea Simo, a regulatory affairs and quality professional with experience across global organizations such as PepsiCo and Jamieson Vitamins, as well as consulting firms and start-ups. Her background ensures a practical, industry-aligned understanding of how Natural Health Products are managed beyond approval and throughout their lifecycle. | 
