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IdentityI have total 16+ yrs experience.
Phase 2-4 trials 5 + yrs (20 studies)
Phase 1-BA/BE trials 7.5+ yrs (more than 500 studies)
Academic experience 3.5 + yrs (teaching MBBS, BDS, Nursing)
Areas of Expertise (Lead a team of 35-40 professionals)
Organization and conduct of Bioequivalence/Bioavailability (PK/PD) studies and Phase I â?? IV studies on generic and NDDS/NCE products of all major therapeutic areas,
Overview of medical writing team (includes study designing, protocol writing, reporting),
Overview of medical affairs/drug safety team (includes medical monitoring, safety evaluation and reporting, medical coding, pharmacovigilance).
Management of registrations of New drugs, Devices including Biologicals and Generics
Expert in managing Clinical operations for Bioequivalence/ Bioavailability studies and Medical monitoring for global clinical research projects for submission to FDA, EMEA, ANVISA, DCGI and TGA.
Part of team while facing various audits of DCGI, ANVISA, FDA, ISO etc. regulatory agencies.
Founding president of Medical Pharmacologists Society (MPS).
Life member of Indian Pharmacologists Society (IPS) and Indian Society of Clinical Research (ISCR).
Reviewer for Indian Journal of Pharmacology (IJP).
J P Nagar,
Bangalore
Certified
