Textbook on Regulatory Affairs for M. Pharm

Description

Textbook on Regulatory Affairs for M. Pharm By Kedar Prasad Meena, Ashish Kumar

CONTENTS : UNIT I – Documentation in the pharmaceutical industry: Master formula record, DMF Drug master File
Distribution records. Generic drugs product development introduction, Hatch-Waxman Act and amendments, CRF (CODE OF FEDERAL REGULATION),
ANDA regulatory approval process, NDA approval process, BE and drug product assessment, in-vivo, scale-up process approval changes, postmarketing surveillance, outsourcing BA and BE to CRO.
Regulatory requirement for product approval: API, biologics, novel, therapies obtaining NDA, ANDA for generic drugs ways means US registration
for foreign drugs.
UNIT II – CMC, post-approval regulatory affairs, Regulation for combination products and medical devices. CTD and ECTD format, Regulatory requirement of
EU, MHRA, TGA, and row Countries.
UNIT III – Nonclinical drug development: Global submission of IND, NDA, ANDA. Investigation of medicinal product dossier, (IMPD) and (IB).
UNIT IV – Clinical trials: Developing clinical protocols. Institutional review board/ independent ethical committee Formulation
and working procedure informed consent process and procedures. HIPAA new, requirement to clinical study
process, pharmacovigilance safety monitoring in clinical trials.