- 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 20 participants! 💥 Use Coupon Code: SGDRA15 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