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 Clinical Trials and their phases, Pharmacovigilance, PSUR

Class 11

Frequently asked interview questions with answers

Course  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

Who can ENROLL

Anyone who wish to learn Drug Regulatory Affairs from science background

Common questions and answers

1)Can I get job in Drug regulatory affairs after this course?

Ans-Yes we will make job readiness in this class where you will get all knowledge and skills required to get job in regulatory

2)which companies hire freshers for regulatory domain

Ans-Mostly all CRO’s (contract Reserch organisations),BPO (e.g TCS ,cognizant etc),sponsored companies and consultancy (e.g.genpact,freyr etc)

3)who can apply for regulatory job

Ans-pharma,life sciences,medical science students

4)Can I get certificate after this course

Ans-Yes you will get certificate of course completion after this course ends

5)Can I know more about’Global pharma academy’ which provides this course

Ans-Yes,Global pharma academy is ISO and MSME certified national level institute which established to provide professional courses in pharmaceutical industry at most affordable price so that everyone can learn from top industry experts and get their dream job.

To know more kindly visit our website www.globalpharmaacademy.com