BLG 699 Chapter Notes - Chapter 10: European Medicines Agency, Postmarketing Surveillance, Benefit Shortfall

• School: Ryerson University
• Department: Biology
• Course: BLG 699
• Professor: Nagina Parmar

Document Summary

Health product vigilance framework intended to serve as evergreen document capturing current product vigilance system & conceptually describes future integrated p(cid:396)odu(cid:272)t (cid:448)igila(cid:374)(cid:272)e s(cid:455)ste(cid:373) that"ll (cid:271)e de(cid:448)eloped o(cid:448)e(cid:396) (cid:374)e(cid:454)t 3 to 5 (cid:455)ea(cid:396)s. Continually promote high standards of product of vigilance. Facilitate access to products vital to health and well-(cid:271)ei(cid:374)g th(cid:396)ough a (cid:862)life (cid:272)(cid:455)(cid:272)le app(cid:396)oa(cid:272)h(cid:863) to p(cid:396)odu(cid:272)t (cid:448)igila(cid:374)(cid:272)e. Health canada will be an international force in field of product vigilance, leading to incr. public confidence. Important for product vigilance system to remain open, transparent, accessible, and accountable. Continued safe and effective use of products depends on thorough and ongoing understanding of benefit-risk as they become known through real-world experience. 1. 4 the need for a canadian health product vigilance framework. Two federal initiatives (blueprint for renewal and food and consumer safety action. Plan) aimed to modernize regulatory system to better respond to changes in regulatory environment and better protect health and safety: shift achieved by implementing lifecycle approach to regulating health products.