- 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: 30 days Timings: Evening 8 pm to 9 pm Mode of teaching: Online Medium of teaching: Through SG PHARMA TRAININGS application (It was like Zoom) 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. Syllabus: Drug regulatory affairs program. • Overview of all the dept in industry and their role in RA • Regulatory requirements for US, EU and ROW markets (in detail) • Types of submissions DMF / CEP etc.…. (In detail) • Annual Updates • health authorities • Indian submissions • ICH guidelines/ cGmp • Preparation of query responses • Preparation for interview • Study Material • Communication Skills Training Training in detail • Overview of all the dept in industry and their role in RA • Q.A • Q.C • R.A • Analytical • R&D • Production • Warehouse • Microbiology • 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 USFDA • US inspections • EIR (Establishment of inspection report) • FDA 483 • Recall product • EU submissions • EMA (European medicine agency) • Types of submissions • Centralized • Decentralized • MRP (mutual recognition procedure) • How to write ASMF (Active substance master file) • How to represent • What is 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 • Health authorities • Discussion • Types of Health authorities • Their role in drug registration • How they differ • CTD format • 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) Nonclinical data • Module 5(M5) clinical data • eCTD • How to prepare Dossier /DMF in eCTD format • Indian submissions • The Drug Controller General of India • (DCGI) • Functions of DCGI • CDSCO (central drug standard control organization) • Functions of CDSCO • Regulatory Authorities in India; Roles & Responsibilities • Indian submission procedure • Approval procedure • Guidelines • ICH guidelines/ cGmp • Overview of guidelines • Overview of validations (Process, Analytical) • What is validation • Types of validation • Analytical validation • Overview of Instrumentation • Microbiology • Overview • Role of Microbiology in the regulated market • Addressing Regulatory queries • How to prepare query responses • What types of queries are expected • How to resolve them • Preparation for job interview