Regulatory Affairs | Regulatory requirements for drug approval | industrial pharmacy 7th sem unit 3

Regulatory Affairs | Regulatory requirements for drug approval | industrial pharmacy 7th sem unit 3
In this video we cover
1. Regulatory affairs
2. Historical overview of regulatory affairs
3. Regulatory authorities
4. Role of regulatory affairs department
5. Responsibilities of regulatory affairs professionals
6. Regulatory requirements for drug approval
7. Drug development team
8. Non clinical drug development
9. Drug metabolism and toxicology
10. General consideration of IND application
11. Investigators brochure
12. New drug application NDA
13. Clinical research and bioeuivalence studies
14. Clinical research protocols
15. Biostatistics in Pharmaceutical Product Development
16. Data Presentation for FDA Submissions
17. Management of Clinical Studies
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Regulatory affairs
Historical overview of regulatory affairs
Regulatory authorities
Role of regulatory affairs department
Responsibilities of regulatory affairs professionals
Regulatory requirements for drug approval
Drug development team
Non clinical drug development
Drug metabolism and toxicology
General consideration of IND application
Investigators brochure
New drug application NDA
Clinical research and bioeuivalence studies
Clinical research protocols
Biostatistics in Pharmaceutical Product Development
Data Presentation for FDA Submissions
Management of Clinical Studies
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#Regulatory_requirements_for_drug_approval,
#Drug_development_team,
#Non_clinical_drug_development,
#Drug_metabolism_and_toxicology,
#General_consideration_of_IND_application,
#Investigators_brochure,
#New_drug_application_NDA,
#Clinical_research_and_bioeuivalence_studies,
#Clinical_research_protocols,
#Biostatistics_in_Pharmaceutical_Product_Development,
#Data_Presentation_for_FDA_Submissions,
#Management_of_Clinical_Studies,
#Industrial_pharmacy_7th_sem,
#Depth_of_biology,
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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.