3 month online certification course in Drug Regulatory Affairs

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Categories Career oriented
by Admin

Topics covered
Class 1
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

Skill development classes

1) Resume preparation
2) How to search jobs
3) Expert advice
4)HR interview question discussion
5)Mock interview

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


7,999.00 8,999.00

Course Curriculum

Class 1
This class covers following Topic Definition Why DRA is required? Why drugs should be regulated? Regulatory authorities Roles of DRA professional How DRA department work ? Drug development process Guidelines used in regulatory affairs Example of schedule C drug

  • Introduction to regulatory Affairs

Class 2
This topic covers following points Quality guidelines Safety guidelines Efficacy guidelines Multidisciplinary guidelines

Class 3
This class covers following topic Scope of the guidelines Example of unacceptable change Approach to photo stability testing Drug substance Stability testing for new dosage forms Q1C Bracketing study design

class 4
This Class covers following topic Objective Stability data evaluation of drug substance Data evaluation for retest periods Stability data package for climatic zone 3 and 4 Validation of analytical procedures

Class 5
This topics covers following point Definition Class of residual solvents Permitted daily exposure calculation Analytical procedure Guidelines for elemental impurities

Class 6
this class covers following topic Objective Specifications:- for drug substances Specifications:- for tablet Specifications:- for capsule Skip testing Release vs shelf life acceptance criteria Design and development Parametric release alternative procedure justification of specifications

Class 7
this class covers Following topic Objective Content of Pharmaceutical development Overages Physicochemical and biological properties Manufacturing process development Container closure system

Class 8
This class covers following topic Objective Regional administrative information Artwork of carton Artwork of foil

Class 9
This class covers following topic Certificate of suitability Drug master file Drug substance content Content of 3.2.P drug product

Class 10
This class covers following point Module 4 ( nonclinical ,safety) Content of module 4 Module 5 ( Clinical /efficacy) Module 2 ( Common technical documents summaries) Asean common technical dossier Different between CTD and ACTD Overview of regulatory terminology PSUR

Class 11
This class covers following point Content What is dossier Regulated countries and it's authorities Types of DMF New drug application abbreviated new drug application

Class 12
This class covers following point European union Abbreviations of European countries Terminology Legal basis of the application in the European union Abridged application Data protection period Centralised procedure Decentralised procedure Product life cycle management

Class 13
This class covers following topic Overview of medical device in Regulatory affairs What are medical devices Classification of medical devices Regulatory pathways as per FDA Essential Documentation FDA Review Preclinical and clinical testing Quality system regulation

Class 14
This class covers following topic What is resume Importance of resume Importance of each tab of resume How to write an impressive resume How to address career gaps in your resume Tips for creating ATS friendly resume Do's and don'ts of resume

Class 15
This class Cover Following Point 1) Resume monitoring

Class 16
This class covers following point 1) HR Questions for Freshers

Class 17
This class covers following point Key skill for searching jobs Resume ,cover letter,email writing Online platform to find job opportunity at entry level Tips for freshers while searching for jobs Common mistakes freshers makes while job hunting LinkedIn profile

Class 18
This Class covers HR questions for Experienced students

Class 19
This class covers Walking vs scheduled Interview Walk in interview Scheduled interview Difference between walking vs scheduled interview Virtual interview Telephonic interview Walk in interview tips

Class 20
This Class covers PPT presentation of students on various topics

Class 21
This class covers PPT Presentation of students

Class 22
This class covers PPT Presentation of students

Class 23
This class covers LinkedIn Review

Class 24
This class covers Individual student mock interview

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