fr

Regulatory Affairs Pharmaceutical

Description

This course describes the role of the Regulatory Affairs department in a pharmaceutical firm and focuses on the "submission process" - the regulatory requirements at the various stages in a drug product's development from inception through IND (Investigational New Drug) and NDS (Notice Of Compliance). The functions of relevant divisions of the Health Protection Branch are discussed. Also covered are: DINs (Drug Identification Numbers), Provincial Formulatory Submissions, drug labelling and drug advertising, SOPs (Standard Operating Procedures), compliant handling (including Adverse Drug Reactions), recalls, Plant Master Files (PMF), Drug Master Files (DMF) and regulatory inspections. (Lecture only).
 
Note: Check with the institution regarding start/end dates, prices, and delivery method. These may vary according to program, section, and/or semester. 
 

Overview

Seneca Polytechnic logo
  • Institution: Seneca Polytechnic
  • Level: College
  • Language: English
  • Course Code: PFT810
  • Delivery Method: Fully Online/Distance

Enrol Now

Disclaimer:
Check with the institution regarding start/end dates, prices, and delivery method. These may vary according to program, section, and/or semester.