3 month online Certificate course in Drug regulatory Affairs

Product Description

Syllabus
Topics covered
Class 1
i)Introduction
ii)Definition, Rationale, iii)Roles and responsibilities
Class 2
i)How Regulatory Affairs works in Pharmaceutical Company
ii)Different Regulatory Authorities
iii)Innovator and Generic Drugs
iv) Drug development process
Class 3
i)Different guidelines used in Regulatory work.
Class 4
i) ICH Guidelines
In depth Quality guidelines and Overview of Safety, Efficacy and Multidisciplinary guidelines
Class 5
CTD Structure
In depth Module wise content detailing
Class 6
i)ACTD Structure
In depth Part wise content detailing
ii) Difference between CTD and ACTD
Class 7
Dossier filing process for Europe, USA and Rest of world market
Class 8
Different types of documents required for Dossier preparation and their explanation
Class 9
Post approval process: Variations and Renewals
class 10
Overview of medical device regulatory
Class 11
Overview of Clinical Trials and their phases, Pharmacovigilance, PSUR
Class 12
Frequently asked interview questions with answers

Benefits
1)You will get certificate from ISO certified organization
2)You will get lifetime free counselling from our side
3)Recorded lectures
4)swot analysis,mock interview,skill improvement