Good Pharmacovigilance Practices (GVP) Challenges for Canadian-based Pharmaceutical and Natural Health Product (NHP) Manufacturers: A Small Business Perspective.

There are several drugs on the market whose overall safety may not be fully known. Drug safety monitoring is important in identifying previously unknown side effects. This activity is not exclusive to drugs, but also applies to natural health products. Patient awareness of product safety is a major concern in Canada. Only about 5% of side effects experienced by Canadians are reported every year. This could be a danger to public health. Agencies, such as Health Canada, have specific rules in ensuring product safety. On the other hand, their requirements are sometimes repetitive and make it difficult for small companies to comply without incurring significant expenses. Therefore, companies need to have properly organized drug safety systems as well as experienced professionals, to comply with these rules the right way, and avoid repeating unnecessary, pricey tasks. This will avoid the risk of important products becoming unavailable. The purpose of this project is to evaluate challenges that small Canadian-based Pharmaceutical and NHP Manufacturers face in front of this reality.
In order to achieve this goal, the intern will use a hands-on approach that will expose him to the day to day reality of the work involved in monitoring drug safety, while analyzing the

Faculty Supervisor:

Grégoire Leclair

Student:

Louis Forti

Partner:

Euro-Pharm International Canada Inc.

Discipline:

Pharmacy / Pharmacology

Sector:

Other

University:

Université de Montréal