SG Pharma Trainings

Course available for 1 year after purchase

 This Course is best suitable for Quality control, quality assurance and production department employees, who wants to enhance their knowledge & migrate to Regulatory affairs department.

- It is best suitable for M.Pharmacy, B.Pharmacy & M.Sc. freshers who wants to pursue their career into Regulatory affairs department.

Course duration: 1 Months

Timings: Evening 8 pm to 9 pm

Mode of teaching: Online 

Medium of teaching: Through SG Pharma trainings APP

🎁 Special Offer: ₹500 OFF for first 30 participants!
💥 Use Coupon Code: SGDRA16

Trainer: Varsha Kakkar
-worked in both API and Formulation organizations 
-17+ years' experience in Regulatory affairs
- worked in Industries like Dr. Reddy's, Cipla, Pfizer...etc. 

Course Syllabus:

✦✧ Regulatory requirements for US, EU, and ROW markets (in detail) ✧✦

✦ US Submission ✦
✧ What is USFDA & How it Works
✧ Types of DMF (Drug Master File) in Detail
✧ What is CTD Format in Detail
✧ How to Write DMF
✧ How to Represent
✧ Annual Updates
✧ Deficiency Responses
✧ Queries from USFDA
✧ US Inspections
✧ EIR (Establishment Inspection Report)
✧ FDA 483
✧ Recall Product
✧ Change Controls

✦ EU Submissions ✦
✧ EMA (European Medicines Agency)
✧ Types of Submissions
✧ Centralised
✧ Decentralised
✧ MRP (Mutual Recognition Procedure)
✧ How to Write ASMF (Active Substance Master File)
✧ How to Represent
✧ Variations
✧ What are COS (Certificate of Suitability)
✧ When Can a Product Go for COS Filing
✧ How to Submit COS to EDQM (European Directorate for Quality of Medicines)
✧ Its Validity
✧ Renewal of COS
✧ Deficiency Responses
✧ Inspection

✦ ROW Markets ✦
✧ Registration Procedures for ROW
✧ Semiregulated Market
✧ Registrations in Different Countries
✧ Drug Registration in ASEAN Countries
✧ ACTD Format

✦ CTD Format ✦
✧ DMF Submission in this Format
✧ How to Prepare Dossier/DMF in eCTD Format
✧ Dummy DMF
✧ Technical Package
✧ Types of Modules
✧ Module 1 (M1) Administrative Information
✧ Module 2 (M2) Quality Overall Summary
✧ Module 3 (M3) Manufacturers Section (Drug Product and Drug Substance)
✧ Module 4 (M4) Non-Clinical Data
✧ Module 5 (M5) Clinical Data
✧ eCTD

✦ Indian Submissions ✦
✧ The Drug Controller General of India (DCGI)
✧ Functions of DCGI
✧ CDSCO (Central Drug Standard Control Organisation)
✧ Functions of CDSCO
✧ Regulatory Authorities in India: Roles & Responsibilities
✧ Indian Submission Procedure
✧ Approval Procedure
✧ Guidelines
✧ Overview of Guidelines
✧ ICH Guidelines
✧ Good Manufacturing Practices

✦ Other Activities ✦
✧ Preparation for Job Interview
✧ Overall Group Discussion
✧ Interview-Based Queries
✧ Technicalities
✧ Communicating Skills

✦ Post Course Assistance ✦
✧ Get in touch with us after completion of training for further guidance or help
✧ Course Material will be provided at the end of the training program for future reference

Student Concession Offer

Student concessions are available for this course. If a group of 10 or more students enrolls together, an additional group discount is offered.

Standard Course Fee: ₹3,500

Group Discounted Fee (10+ students): ₹2,500 per student

Valid student ID cards are required to avail this offer.

Certificate Course in " Drug Regulatory Affairs"(DRA-16)

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Demo Class

Maharashtra

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