KUK - LMS

Syllabus

MODULE NO / UNIT	COURSE SYLLABUS CONTENTS OF MODULE	NOTES
Course Code: CHEM 403 Course Name: Pharmaceutical Chemistry Special-V
1	Intellectual Property Rights - I Introduction - IPR, GATT, WTO. TRIPs – Its scope and options, the changing R & D processes and IPR, The IPR tool kit. Patents – Definition, types, the patenting process, patent cooperation treaty, conditions to be satisfied by an invention to be patentable, features. Intellectual Property Protections of Living Species – Compatibility between conventions, protecting inventions in biotechnology, protections of traditional knowledge, biopiracy and documenting traditional knowledge, some case studies.
2	Intellectual Property Rights - II Exercising and Enforcing of Intellectual Property Rights - Rights of an IPR owner, licensing agreements, criteria for patent infringement, case studies of patent infringement, IPR – a contract, unfair competitions and control, provisions in TRIPs, some case studies. Patent Laws - Introduction, Salient features of “The Patents Act 1970” , “The Patent Rules 2003” and “The Patent Rules 2005” Role of Patents in the Pharmaceutical Industry - Recent changes in IPR laws impacting pharmaceutical industry, intellectual cooperation in the pharmaceutical industry, some case studies
3	Drug & Cosmetic Act with special reference to schedule Y and M. Clinical trials & Good clinical practices (GCP), guidelines and related management- GCP guidelines, principles of ICH GCP, ethical principles related to GCP, clinical trials, SOPs, regulation: obtaining clinical trial permission, application for permission, report: clinical trial report, trial management: data monitoring committee (DMC).
4	Quality control and Quality Assurance: Requirements of GMP, cGMP, GLP, ISO-9000, regulatory requirements of drugs and pharmaceutical (USFD-NDA/ANDA), total quality management (TQM) Concept. Stability testing of new drug substances and products: Drug substance – criteria, storage conditions, long term testing, accelerated testing, frequency, evaluation, labelling; Drug product – Selection of batches criteria, specification, conditions of storage and testing, Calculation of shelf life and expiry date of products.