About Course
Scope: This course is designed to impart fundamental knowledge on the regulatory
requirements for approval of new drugs, and drug products in regulated markets of
India & other countries like the US, EU, Japan, Australia, UK, etc. It prepares the students
to learn in detail about the regulatory requirements, documentation requirements, and
registration procedures for marketing the drug products.
Objectives: Upon completion of the subject student shall be able to;
1. Know about the process of drug discovery and development
2. Know the regulatory authorities and agencies governing the manufacture and sale
of pharmaceuticals
3. Know the regulatory approval process and their registration in Indian and
international markets
Course Content
UNIT-1 NEW DRUG DISCOVERY AND DEVELOPMENT
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dd/mm/yy-New Drug Discovery and development: Stages of drug discovery.
00:00 -
New Drug Discovery and development: Drug development process.
00:00 -
New Drug Discovery and development: Introduction.
00:00 -
New Drug Discovery and development: Pre-clinical studies.
00:00 -
New Drug Discovery and development: Non-clinical activities.
00:00 -
New Drug Discovery and development: Clinical studies.
00:00 -
New Drug Discovery and development: Innovator and generics.
00:00 -
New Drug Discovery and development: Concept of generics.
00:00 -
New Drug Discovery and development: Generic drug product development.
00:00 -
REVISION
00:00
UNIT-2 Regulatory Approval Process
UNIT-3 Registration of Indian drug product in overseas market.
UNIT-4 Clinical trials.
UNIT-5 Regulatory Concepts.
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