Dr. Kedar Prasad Meena Associate Professor (Pharmaceutics) Department of
Pharmacy Guru Ghasidas Central University Bilaspur C.G. 495009,
M- 9424160514, Ph.D A central University, Guru Ghasidas University, Bilaspur,CG
M. Pharm BIT, Mesra Ranchi University, JH
B. Pharm Rajasthan University, Jaipur
Teaching & Research Experience 20 years. He published 32 research papers in
various national and international journals. He has attended many national and
international conferences, seminars, webinars, FDP, and workshops and Life Member
of the Association of Pharmaceutical Teac hers of India (APTI)
meenapharmaceutics@rediffmail.com
Mr. Ashish Kumar M.Pharm. (Pharmaceutics) Department of Pharmacy Guru
Ghasidas Central University Bilaspur C.G. 495009.
GPAT and GATE Qualified (2022)
ashishkumar92855@gmail.com
UNIT I 12 Hours
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 12 Hours
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 12 Hours
Nonclinical drug development: Global submission of IND, NDA, ANDA. Investigation of medicinal product dossier, (IMPD) and (IB).
UNIT IV 12 Hours
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