- Posted on: 24/03/2024
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3 months online certification course in drug regulatory affairs
Happy to announce 3 month Certificate course in Drug regulatory Affairs
Fill this Google for any query
https://docs.google.com/forms/d/e/1FAIpQLScspRbBJMEx9pmlFvd-b4pUOsWhYF7uNnrJ4X-CzGXjZh83Pg/viewform?usp=sf_link
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
Timing for class
1 pm to 3pm (2 hours weekly on Saturday and Sunday)
All classes are virtual through Zoho
Course will starts from 14 April 2024 onwards
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
If any query email us at mypharmacareer2@gmail.com
Frequently asked questions
1) Which certification we get after this course
Answer- You will get certification of course completion from Global Pharma Academy which is ISO and MSME certified
2) Details about Global Pharma Academy
Answer- Visit at www.globalpharmaacademy.com
3) can we pay fees in installment
Answer- one time payment only since fees already affordable
4) For which job we can apply after this course
Answer- You can apply in all clinical research and data management jobs such as clinical research coordinator ,clinical research associate ,data management trainee
5) Is this course is for freshers or experience people
Answer- This course is ideally created for freshers and early level experience student
6) Can i get help for placement after this course
Answer- We will help to prepare for interview and also work on soft skills so that you can give your best during actual interview
7) How many seats are there
Answer- 40
8) Can i get recording of class
Answer- Yes, you can get live class and recording as well
9) can I access this class from mobile also?
Answer-Yes you can