Dear Students the Lecture Notes has been uploaded for the following topics:WHO guidelines for Technology Transfer(TT): Terminology, Technology transfer protocol, Quality risk management, Transfer from R & D to production (Process, packaging and cleaning), Granularity of TT Process (API, excipients, finished products, packaging materials) Documentation, Premises and equipments, qualification and validation, quality control, analytical method transfer, Approved regulatory bodies and agencies, Commercialization- practical aspects and problems (case studies), TT agencies in India- APCTD, NRDC, TIFAC, BCIL, TBSE / SIDBI; TT related documentation- confidentiality agreement, licensing, MoUs, legal issues, ntroduction, Historical overview of Regulatory Affairs, Regulatory authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs Professionals Drug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDASubmissions, Management of Clinical Studies, Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP, Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs.
Dear Students the Lecture Notes has been uploaded for the following topics:WHO guidelines for Technology Transfer(TT): Terminology, Technology transfer protocol, Quality risk management, Transfer from R & D to production (Process, packaging and cleaning), Granularity of TT Process (API, excipients, finished products, packaging materials) Documentation, Premises and equipments, qualification and validation, quality control, analytical method transfer, Approved regulatory bodies and agencies, Commercialization- practical aspects and problems (case studies), TT agencies in India- APCTD, NRDC, TIFAC, BCIL, TBSE / SIDBI; TT related documentation- confidentiality agreement, licensing, MoUs, legal issues, ntroduction, Historical overview of Regulatory Affairs, Regulatory authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs Professionals Drug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDASubmissions, Management of Clinical Studies, Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP, Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs.
Assignment topic is Technology Transfer , Six SIgma and COPP and due date is 17-08-2025.
Dear Students the Youtube Video has been uploaded for the following topics:Technology TransferPharma Regulatory AffairsQuality Management System - QMS
Dear Students the Question Bank has been uploaded for the following topics:Pilot plant scale up techniques:, Technology development and transfer, Regulatory affairs, Quality management systems:, Indian Regulatory Requirements:
Dear Students the Puzzles has been uploaded for the following topics:regulatory approvals, Pilot plant scale up techniques:, Technology development and transfer:, Regulatory requirements for drug approval:, Quality management systems, Indian Regulatory Requirements:
