Dr. Shiva Murthy N:MBBS - VIMS, Bellary - 1997MD Pharmacology - VIMS, Bellary - 2001. MBA – SMU – 2012Total 21+ yrs experiencePhase 2-4 trials – 5 + yrsPhase 1-BA/BE trials – 7.5+ yrsAcademic experience – 11 + yrsAreas of Expertise (Lead a team of 35-40 professionals)Organization and conduct of Bioequivalence/Bioavailability (PK/PD) studies and Phase I – IV studies on generic and NDDS/NCE products of all major therapeutic areas, Overview of medical writing (includes study designing, protocol writing, reporting), Overview of medical affairs (includes medical monitoring, safety evaluation and reporting, medical coding, pharmacovigilance). Management of registrations of New drugs, Devices including Biologicals and GenericsExpert 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 Karnataka Society of Medical Pharmacologists(KSMP),Life member of Indian Pharmacologists Society (IPS) and Indian Society of Clinical Research (ISCR). Managing Editor of JPADR, Reviewer for Indian Journal of Pharmacology (IJP). Worked as the advisory board member for Clinical Trial Magnifier (CTM), an online journal published by Clinical Trials Center, The University of Hong Kong.
Listed skills include Clinical Development, Clinical Research, Gcp, Medical Affairs, and 19 others.