Remix education
Uncategorized

Regulatory Affairs Notes / MCQs / PPT / PDF

by Remix education00

Regulatory Affairs Unit:- 1 Notes

Unit NoUnit Topic ListDownload Link
1Documentation in Pharmaceutical industry: Master formula record, DMF (Drug Master File), distribution records.Click Here
1Generic drugs product development Introduction, Hatch- Waxman act and amendmentsClick Here
1CFR (CODE OF FEDERAL REGULATION)Click Here
1Generic drugs product developmentClick Here
1drug product performance, in-vitroClick Here
1ANDA regulatory approval process, NDA approval processClick Here
1ANDA regulatory approval process, NDA approval processClick Here
1ANDA regulatory approval process, NDA approval processClick Here
1BE and drug product assessment, in -vivo, scale up process approval changes, post marketing surveillance, outsourcing BA and BE to CRO.Click Here
1BE and drug product assessment, in -vivoClick Here
1Regulatory requirement for product approval: API, biologics, novel, therapies obtaining NDA, ANDA for generic drugs ways and means of US registration for foreign drugsClick Here
1Regulatory requirement for product approval: API, biologics, novel, therapiesClick Here

Regulatory Affairs Unit:- 2 Notes

Unit NoUnit Topic ListDownload Link
2CMC, post approval regulatory affairs.Click Here
2Regulation for combination Products and medical devices.Click Here
2CTD and ECTD formatClick Here
2CTD and ECTD formatClick Here
2CTD and ECTD formatClick Here
2CTD and ECTD formatClick Here
2industry and FDA liaison.Click Here
2ICH – Guidelines of ICH-Q, S E, M. Click Here
2ICH – Guidelines of ICH-Q, S E, M. Click Here
2Regulatory requirements of EU, MHRA, TGA and ROW countries.Click Here
2Regulatory requirements of EU Click Here
2Regulatory requirements of TGAClick Here
2Regulatory requirements of TGA Click Here

Regulatory Affairs Unit:- 3 Notes

Unit NoUnit Topic ListDownload Link
3Non clinical drug development: Global submission of IND, NDA, ANDA.Click Here
3Non clinical drug development: Global submission of IND, NDA, ANDA.Click Here
3Non clinical drug development: Global submission of IND, NDA, ANDA.Click Here
3Non clinical drug development: Global submission of IND, NDA, ANDA.Click Here
3Investigation of medicinal products dossier, dossier (IMPD)Click Here
3Investigation of medicinal products dossier, dossier (IMPD)Click Here
3and investigator brochure (IB).Click Here
3and investigator brochure (IB).Click Here

Regulatory Affairs Unit:- 4 Notes

Unit NoUnit Topic ListDownload Link
4Clinical trials: Developing clinical trial protocols.Click Here
4Institutional review board/ independent ethics committee Formulation and working proceduresClick Here
4Institutional review board/ independent ethics committee Formulation and working proceduresClick Here
4informed Consent process and procedures.Click Here
4HIPAA- new, requirement to clinical study processClick Here
4pharmacovigilance safety monitoring in clinical trials.Click Here
4Clinical TrialsClick Here

Regulatory Affairs Extra Notes

Sr. NoTopic ListDownload Link
1Regulatory science BookClick Here
2Unit-5 Pharmaceutical Regulatory Science hand made notesClick Here
3concept and parameter of optimizationClick Here
4DRUG-EXCIPIENT INTERACTIONS DIFFERENT METHODSClick Here
5Physiological and formulation of parentralClick Here
6MANUFACTURING AND EVALUATION OF PARENTERALSClick Here
7Calibration of Dissolution ApparatusClick Here
8Emulsions And Suspensions,smedds Preparation And StabilityClick Here
9KINETICS OF STABILITY STABILITY TESTINGClick Here
10Modern Pharmaceutics (MAT103T) GTU SEM – 1 IMP QUESTIONSClick Here
11Parenterals Large And Small Volume ParentalClick Here
12Optimization Techniques In Pharmaceutical Formulation And ProcessingClick Here

Regulatory Affairs Extra Notes

Very useful app for students Explore all types of academic content in one platform.