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Regulatory affairs, requirements for drug approval (Unit:- 3):- Hand Written Notes


Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, Regulatory authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs Professionals Regulatory requirements for drug approval: 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.
Regulatory Affairs & Regulatory Requirements for Drug Approval Introduction Historical Aspect Regulatory Authorities Role of Regulatory Affairs Department Responsibility of Regulatory Affairs Professionals Regulatory Requirements for Drug Approval Drug Development Teams Non-clinical Drug Development Various Pharmacological Approaches to Drug Discovery Safety Pharmacology Toxicological Approaches to Drug Discovery Investigational New Drug (IND) Application Types of IND Applications Investigator’s Brochure (IB) Purpose of Investigator’s Brochure (IB) Contents of Investigator’s Brochure New Drug Application (NDA) Aim of NDA NDA Review Process Bio Equivalence Studies Clinical Research Protocols Data Presentation for FDA Submissions Management of Clinical Studies
• Questions

Introduction to regulatory affairs which include historical overview and current
scenario. Regulatory authorities and their role and responsibilities in the RA department. Various regulatory requirements for drug approval which include Investigational New Drug (IND) Application and New Drug Application (NDA). Data Presentation for FDA Submissions, Management of Clinical Studies.
The present scenario of the pharmaceutical industry is very well co-ordinated, efficient and docile as per international standards for the manufacturing of various types of Biological and Chemical drugs (which also include medical devices, traditional herbal products and cosmetics) used for the human consumption and veterinary purpose. Various challenges faced by the regulatory system result into current well-defined controlled regulatory
framework. The impact of this framework consequences into systematic manufacturing and marketing of safe, effective and qualitative drugs. With the vast growth of pharmaceutical industry, the legislations from each region have become more and more complicated and
created an urgent need for regulatory professionals.
Regulatory affairs is a dynamic and challenging profession which is developed from the desire of governments and act as an interface between the pharmaceutical company and the regulatory agencies in order to ensure public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
During 1950s, multiple tragedies i.e. sulfanilamide elixir, vaccine tragedy and thalidomide tragedy have resulted in substantial increase of legislations for drug products quality, safety

Long-Answer Questions:
1. Write a note on ICH guidelines.
2. Explain the principles of TQM and QBD.
3. Write about the six sigma concepts.
4. Define OOS. How will you find out the possible OOS in the results? Explain.
5. Write the basic principles of ISO 9000. Explain ISO 9000 series in detail. Write a note
on requirements of ISO 9000 Series.
6. What is EMS? Write the basic working principle of ISO 14000 series. What are the
advantages of it?
7. Write a short note on GLP and NABL.