Sadaf Aftab Inamdar, BPharm

Pune, India
Role: 
Staff
Pharmacist of Record
Sadaf Aftab Inamdar, BPharm

I am currently working in the capacity of Pharmacy Manager/Pharmacist of Record at B J Government Medical College CRS, Pune. I am B. Pharm and well qualified with 21 years of experience in clinical Research and have an expertise in my field. I have been managing IND and non-IND DAIDS sponsored clinical trials and providing pharmaceutical support within a highly regulated research environment. My experience includes Study Product Management, Supervision and training of the pharmacy staff, Establishment and implementation of internal policies and procedures, Confidentiality, Informed Consent Verification, Study Product information (Package Inserts/Investigator’s Brochures), maintaining scientific integrity of blinded studies, QA/QC management, Inventory Control, Randomization procedures, Study Products preparation and dispensing, Counseling the study participants regarding the study treatment, Study drug adherence monitoring, completing Case Report Forms (CRFs), Record keeping and the Study Product Destruction. I am knowledgeable of and follow all local and country’s applicable laws and regulations governing the practice of pharmacy and study product management. I am also responsible for preparing the applications for the in-country Drug Regulatory Authority DCGI and attending monthly study specific calls. 

I am knowledgeable of all the protocols being conducted at our site and is well trained in Good Clinical Practices and Human Subjects Protection. I have been associated with BJGMC site since 2001 where I worked in SWEN study from 2001 until 2006. I have managed to conduct various DAIDS protocols namely IMPAACT P1060, P1070, PROMISE, P1078, P2010 and for ACTG A5207, A5225, A5274, A5273, A5288, A5349 respectively. Currently I am working on P1108, P2005, , A5332, A5300B/I2300B/Phoenix, A5362 and also managing various other non DAIDS studies at site.

I am currently serving as an International Co-Vice Chair of PDISC of SMCCC. I have also served two consecutive terms as an International Committee member on the Adults Clinical Trial Group (ACTG) Pharmacy Subcommittee for a period from 2009 –2014 , two terms on Pharmacy Working Group of PDISC of SMCCC and have also served as a member on IMPAACT Pharmacy Resource Committee in the past. 

Increasing Market and Public Health Outcomes Through Scaling Up Affordable Access Models of Short Course Preventive Therapy for TB (IMPAACT4TB)

Post Date: 
2019-12-17
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Primary Objective: This study is being conducted in Brazil, Cambodia, China, Ethiopia, Ghana, Haiti, India, Indonesia, Kenya, Malawi, Mozambique, South Africa, Tanzania, and Zimbabwe. The overall goal is to reduce TB incidence among (1) people living with HIV who are on antiretroviral therapy, and...

BWI CTU: Baltimore-Washington-India Clinical Trials Unit

Post Date: 
2007-02-02
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Comprising clinical trial sites at Johns Hopkins Medicine in Baltimore, Whitman Walker Health in Washington, DC, and the BJGMC-CCGHE collaboration in Pune, India, the Baltimore-Washington-India Clinical Trials Unit (BWI-CTU) is one of only 25 international HIV/TB clinical trial sites funded by the...

Mother-to-Child Transmission (MTCT) of HIV: India SWEN Study

Post Date: 
2002-06-07
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This study was officially terminated August 2018. Primary and secondary analyses of the India SWEN study, an NIH-funded phase III randomized controlled trial of an extended nevirapine prophylaxis regimen among 783 HIV-infected pregnant women and their...

Intestinal barrier dysfunction and microbial translocation in HIV-infected pregnant women is associated with preterm birth

Post Date: 
2018-03-24
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Publication: 
Clinical Infectious Diseases
Our results show select immune markers can identify women at higher risk for PTB in HIV-1-infected populations and suggest modulating gut barrier integrity and microbial translocation may affect PTB.

Extended-dose nevirapine to 6 weeks of age for infants to prevent HIV transmission via breastfeeding in Ethiopia, India, and Uganda: an analysis of three randomized controlled trials

Post Date: 
2009-07-26
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Publication: 
The Lancet
Background: UNICEF/WHO recommends that infants born to HIV-infected mothers who do not have access to acceptable, feasible, affordable, sustainable, and safe replacement feeding should be exclusively breastfed for at least 6 months. The aim of three trials in Ethiopia, India, and Uganda was...

Up Close: Sadaf Inamdar

Post Date: 
2016-07-01
The integrity of clinical trials relies on pharmacological expertise. The pharmacy at the BJGMC site is in capable hands.