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SELECTBIO Conferences Quality, Compliance & Audit in Clinical Trials

Ashish Mungantiwar's Biography

Ashish Mungantiwar, President, Macleods Pharmaceuticals Ltd

Dr. Ashish Mungantiwar, is currently working as President -Medical Services in Macleods Pharmaceuticals Ltd. R and D centre. He heads Bioequivalence, Medical Services, Clinical Trials, Pharmacovigilance and Domestic Formulation Development. He has a rich experience of 20 years in the Pharma field.
Dr. Ashish completed his PhD in Pharmacology from Bombay College of Pharmacy, Mumbai. He has served as a study director for more than 2000 BA/ BE studies (invivo and invitro BE studies). Conducted BE studies on oral solids, Inhaler and Invitro binding studies. Also overseen bioequivalence study on topical product (Vaso constriction study)
Dr. Ashish supervises the activities of clinical, bio-analytical, PK and statistical section of Bioequivalence Department.
He has successfully handled more than 25 regulatory inspections like USFDA, WHO, UKMHRA, ANVISA (Brazil), MCC (South Africa), IDA (Netherlands), GLP Compliance monitoring authority – Thailand, CDSCO (India), DCGI and various consultant audits.
As Head of Pharmacovigilance, he ensures “Benefit – Risk Management of all Macleods Pharmaceuticals drugs throughout their life cycle and ensures all required pharmacovigilance obligations.
He has obtained various new drug approvals from DCGI for first time launch in India.
He also plays a vital role in new product selection for Domestic and Regulated Market.
As Head – Clinical Trials he has successfully completed various multicentric Phase III clinical trial studies for various therapeutic segments.
He has been invited as Speaker in various International and Indian Conferences.
He has more than 25 publications. He also has a chapter in the book – Scientific Basis of Ayurveda therapies, Ed. Dr. Mishra, CRC press, Washington, pg 63-81, 2004.
Dr. Ashish has been granted three patents.
Two students have completed PhD under his guidance and three students are pursuing.

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eCTD with CDISC: Regulatory Requirements

Thursday, 12 April 2018 at 15:10

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