Industrial Pharmacy 2

Module 1

Pilot Plant Scale up Techniques

General Considerations- including significance of personnel requirements, space requirements, raw materials, pilot plant scale up considerations for solid, liquid orals, semi solids and relevant documentations, SUPAC guidelines, introduction to  platform technology.

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Module 2

Technology Developement & Transfer

WHO Guidelines for Technology Transfer (TT)

Terminology, Technology Transfer Protocol, Quality risk management, Transfer from R & D to production (Process, packaging and cleaning), Granularitary of TT Process (API, excipients, finished products, packaging materials) Documentation, Premises and equipmentss, qualification and validation, quality control, analytical method transfer, Approved regulatory bodies and agencies. Commercialization

Practical aspects and problem (case studies), TT agencies in India - APCTD, NRDC, TIFAC, BCll, TBSE/SIDBI.

TT Related Documentation

Confidentiality agreement , licensing, MoUs, legal issues.

Module 3

Regulatory Affairs

Introduction, Historical overview of Regulatory Affairs, Regulatory authorities

Role of Regulatory affairs department, Responsibility of Regulatory Affairs Professionals

Regulatory Requirements for Drug Approvel

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 FDA Submissions, Management of Clinical Studies.

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