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Regulatory Affairs (RA)

  • Introduction to different types of Pharmaceutical products:
  • Basic concepts on Rx, OTC, API, Starting material, DP/FP, Generics vs. Innovator drugs, Biologics vs. Biosimilars, Laws vs. Regulations vs. guidelines.
  • Drug discovery and development
  • Worldwide regulatory agencies and their role
  • Approval process for each of the below products in US/EU/India: [covers development path, submissions, regulatory expectation for development, approval and market]
  • Post-market regulatory obligations
  • GLP’s:¬† 21 CFR 58 -The History of GLP, The Idea behind GLP, The Areas of Application, The Pillars of Good Laboratory Practice, Where Can GLP be Profitably Applied?, Indian GLP and International GLP.
  • CMC topics: GMP (US/EU/Indian/ PIC), Preformulation studies (Drugs and Generics), ICH Q 7 guideline, 21 CFR 210 and 211, Medical device CE marking and ISO certifications.
  • Audits, pre and post approval Inspections, handling post inspection/ audit queries.
  • Collecting, organizing and compiling various regulatory submissions in compliance with the applicable regulations:
  • ASEAN and BRIC regulations and registration process of Drugs and Biologics.
  • Different stages of interactions, briefing packages, responses and corrective measures during drug approval process with FDA.
  • PDUFA meetings and advisory committee meetings with US FDA, EU scientific advisory committee.
  • ¬†Regulations of Drugs and cosmetics Act, 1945 and its importance to Indian pharma industry.
  • Recent regulatory changes in Indian DCGI and compiling dossiers for various DCGI submission:
Hands on workshops in next 15 days:
  • Word template of CTD structure.
  • Hands on work of filling different regulatory forms in US/EU/India.
  • Preparing for Regulatory interviews (Example interview questions will be provided).
  • Communication skills.
  • 2-3 seminars each of individual students to enhance their confidence and presentation skills.
  • Explaining the real difficulties faced in a pharma industry and providing Corrective and Preventive Actions (CAPA).

Programs in Regulatory Affairs

S.No

Course Details

Duration

Training Fee

Additional Support

Class

Online

1

Certificate Program

3-Months

20K

25K

  • Study Material
  • Training Certificate
  • Training with software facility
  • Resume Preparation
  • Soft Skills Development
  • Communication Skills Training

2

Internship Program

5-Months

40K

40K

  • Study Material
  • Training Certificate
  • Project work for 2 Months
  • Training with software facility
  • Resume Preparation
  • Soft Skills Development
  • Communication Skills Training

3

Job Oriented Program

6-Months

70K

No

  • Study Material
  • Experience Certificate
  • Training with software facility
  • Salary : 6K from 4 to 6th Month

4

Job Oriented Program

1-Year

200K

No

  • Study Material
  • Experience Certificate
  • Training with software facility
  • Salary : 7K from 4th to 12th Month