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Sadaf Aftab Inamdar, BPharm
Pharmacist of Record
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.