Navakanth B.
Manager, Global Medical Affairs at Dr.Reddys Laboratories Ltd
- Role
- Manager at Dr. Reddy's Laboratories
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Navakanth B.
M.Pharm (Pharmacology) having 15 years experience in Medical writing, Pharmacovigilance and Clinical research
Experience
Manager
Dec 2019 — Present · Hyderabad, IN
Medico-Regulatory Documents: Review of CTD Modules- Nonclinical overview and summaries (Module 2.4, 2.6 & 4) and clinical overview and summaries (Module 2.5, 2.7 & 5), addendum to clinical overview (ACO) and other regulatory documents as per regulatory authority guidelines Preparation of Investigator Brochure (IB), Clinical study reports (CSR), Informed consent Form (ICF) and Case Report Forms (CRF), Executive summaries and Medical Target product profile (TPP). Preparation of presentations and dossiers for SEC and technical committee meetings Preparation of medical rational, product write-ups, bio-waiver justification and literature support to various regulatory authorities Support to fresh filing via MRP/DCP/National Procedures at European countries Response to queries raised by Regulatory Agencies throughout the life cycle of productLabelling documents: Review of prescribing information (PI)/product information, summary of medicinal product characteristics (SmPCs), product monograph and patient information leaflets (PILs) to various regulatory authorities Preparation/review of Core data sheets (CCDS/CCSI) Preparation/updation of PI’s/SmPCs for pharmacovigilance Timely monitor the various health authority platforms for safety updates, validate and implementation in to the labelling documents (e.g, PRAC, CMDh, MHRA, FDA updates)Supporting Life Cycle & Portfolio Management Initiatives: Proposal for differentiated products, super generics and super-super generics. New product evaluations Medical rationales for fixed dose combinations, new drug delivery systems, product proposals & generation of target product profile.
Education
Raghavendra Institute of Pharmaceutical Education & Research, Anantapur
B.Pharm
2003 — 2007
Annamalai University
M.Pharmacy
2007 — 2009
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