Description
Overview of regulatory requirements of pharmaceutical companies, contracting research organizations, and communication with regulatory agencies. Negotiation and collaboration between sectors, incentives such as FDA priority review vouchers, project management, manufacturing and distribution, phase IV post-marketing and continued monitoring, pharmacovigilance and post-marketing changes.
Reference text in its original language
Overview of regulatory requirements of pharmaceutical companies, contracting research organizations, and communication with regulatory agencies. Negotiation and collaboration between sectors, incentives such as FDA priority review vouchers, project management, manufacturing and distribution, phase IV post-marketing and continued monitoring, pharmacovigilance and post-marketing changes.
Sources and references
Dates and sources are retained to help you verify the information. Translations are provided to facilitate reading; the official source governs conditions and requirements.
Source reference : https://calendar.carleton.ca/grad/courses/HLTH/