Dr. Sarah McMullen is the Country Director for the FDA India Office. Her professional experience has included analytical method development and testing for multiple FDA-regulated commodities, establishment inspections, import operations and policy, and foreign office service. Her FDA career has spanned over 20 years working as a chemist, tissue residue specialist, consumer safety officer, and leader. The last nine years of her experience has focused on international arenas including import operations and foreign office service. Dr. McMullen has a Doctor of Philosophy in inorganic chemistry and a Bachelor of Science in chemistry from Emory University.

Dr. Sudheendra is the Senior Technical Advisor for drugs. Prior to joining FDA India Office, Sudheendra worked for a Contract Research Organization as Head – Quality Assurance [GCP]. Sudheendra has about 20 years of experience in Clinical Research, Quality Assurance, and Quality Management Systems. He has audited more than 450 Bioequivalence Studies and audits of different therapeutic drugs. He also has exposure to different regulatory agencies. Sudheendra holds a Ph.D. in Biochemistry from Gulbarga University, Karnataka.

Dr. Cho is the Director of the Division of Generic Drug Study Integrity, Office of Study Integrity and Surveillance in FDA. She leads bioequivalence/bioavailability inspection programs and oversees compliance evaluation, enforcement strategies, and international collaborations.

Barbara Wright currently serves as the Supervisor of the Foreign Inspection Cadre within FDA’s Office of Bioresearch Monitoring Operations. She is responsible for the assignment and oversight of international inspections covering BA/BE, GCP, GLP, and PV compliance programs. Barbara was selected for this position at the formation of the cadre in 2018, after spending 28 years of as a field Investigator and Specialist in Bioresearch Monitoring inspections.

Sarah Ibrahim is the Associate Director for Stakeholder and Global Engagement in the OGD/ CDER at the U.S. Food and Drug Administration (FDA). Dr. Ibrahim develops OGD strategies to address identified and emerging regulatory challenges in relation to the international nature of the generic drug industry. She established OGD’s current global affairs program, the generic drug cluster which is the first generic drug forum that involves the word leading regulatory agencies. In collaboration with other CDER and FDA offices, she supports stakeholder engagement concerning issues related to globalization of the generic pharmaceutical supply and harmonization of regulatory approaches for generic drugs.

Dr. Nilufer Tampal is the Acting Associate Director for Scientific Quality in OGD’s Office of Bioequivalence. In this role, She develops strategies and oversees implementation of data quality and the scientific integrity of bioequivalence data submitted in Abbreviated New Drug Applications (ANDAs). She provides expertise in utilization of advanced analytic data tools supporting ANDA reviews. As a leading senior expert within the Office of Bioequivalence for international harmonization efforts regarding bioequivalence in ANDAs, she serves as the Rapporteur for the International Council for Harmonization (ICH) Generic Drug Discussion Group.

Dr. Rubina has regulatory experience of more than 21 years, working in Central Drugs Standard Control Organisation (CDSCO), the National Regulatory Authority of India in various capacities as head of zones , head of division of import registration, new drug, quality assurance of vaccines . She started her career in CDSCO as Drugs inspectors conducting GMP, GCP, GLP inspections.She has five years experience of working in production of Injectable drugs prior to joining CDSCO. Presently working in CDSCO (HQ), New Delhi looking after International Co-operation and prior to this she was working as zonal head, Deputy Drugs Controller (I) in CDSCO (West Zone) comprising of the states of Maharastra, Goa, Daman, Silvassa, DNH and Chattisgarh.

Lisbeth has been a GCP and pharmacovigilance inspector at the Danish Medicines Agency.Since 2006. Prior to that, she has experience from an authority perspective on regulatory affairs and authorisation of clinical trial protocols, from a research and hospital perspective (Clinical pharmacology at a University Hospital in Denmark) and from working in the medicinal industry as a GCP auditor. Lisbeth is part of the EU GCP Inspectors’ Working Group and of the sub group who drafted the EU Guideline on computerised systems and electronic data in clinical trials. She represents EU as the topic lead in the ICH E6 R3 revision.

Stephen Vinter is Operations Manager for the GLPMA and Laboratories Group for the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Prior to joining the Agency in 2012, Stephen worked in Operations Management at a Contract Research Organisation. Stephen has also worked in the manufacturing sector and is a Chartered Chemist and Chartered Quality Professional. In his role as a Lead Senior Inspector, Stephen conducts GCP, Bioequivalence and GLP inspections of organisations in the UK and overseas. Stephen is the Head of the UK Good Laboratory Practice Monitoring Authority.

A Clinician and Researcher, Dr Anupama Ramkumar is the principal consultant and CEO of Arkus Research Pvt. Ltd, a clinical consulting company engaged with pharmaceutical companies and CROs worldwide.With over 26 years of medical experience and 22 years of experience in Clinical Research Industry she bridges the field of medicine and pharmacology effectively and is a sought after clinical development and GCP expert as well as technical strategy advisor for pharma companies and research units. Her forte lies in demystifying GCP to build practical and effective Quality management systems for regulated drug development with a focus on compliance and operational excellence.

Ib Alstrup is a Medicines Inspector, GxP IT, with the Danish Medicines Agency and an EMA expert. With a background as a SW, tester and IT QA from the industry; he has specific focus on inspection of regulated parties’ validation and safe operation of computerised systems throughout all GxP areas.

Dr. Bonapace is the Director of the Division of New Drug Study Integrity in the Office of Study Integrity and Surveillance, Center for Drug Evaluation and Research, US FDA. He is responsible for the planning and conduct of inspections by the GLP Team and two BA/BE Teams and communicating data reliability recommendations to CDER review divisions.

Janete has been conducting bioresearch monitoring (BIMO) inspections in India since 2015 and has been with USFDA since 2009. She holds an MPH in Epidemiology, a Masters in Biomedical Science and a Bachelor’s degree in Biology/Pre-Med. Prior to FDA she worked in private industry as a Research Associate with major chemical, pharmaceutical and food firms.

LCDR Malik Imam, PharmD, is the Deputy Director of the Office of Regulatory Operations (ORO) in CDER’s Office of Generic Drugs (OGD). In collaboration with ORO’s Director, they are responsible for the Immediate Office, three divisions, and the Controls Correspondence Program. The three Divisions under their purview are the Division of Project Management (DPM), the Division of Filing Review (DFR), and the Division of Labeling Review (DLR). Before his current role, Malik spent ten years in the Division of Labeling Review, leading efforts to update generic labeling with critical new safety information. Prior to joining the agency, he worked in several pharmacy fields, including manufacturing, compounding, and long-term care.

Dr. Victoria Keck is a Lead Toxicologist in FDA’s Office of Generic Drugs Division of Pharmacology/Toxicology Review (DPTR). She has worked for DPTR since 2015. Dr. Keck leads pharmacology/toxicology reviews of Drug Master Files and Abbreviated New Drug Applications.

Ms. Long is a Consumer Safety Officer focusing on BIMO. Courtney Long joined the FDA in February of 2002 and prior to joining the India Office had worked in Providence, Rhode Island; San Diego, California; and Falls Church, Virginia. She has conducted inspections covering food, medical devices, blood, plasma, human reproductive tissue, and all areas of bioresearch; and participated in multiple health fraud investigations.

Dr. Mada joined the FDA in 2008 as Clinical Pharmacologist in the Office of Clinical Pharmacology. Later moved to Office of Scientific Investigations, Office of Compliance, and is currently a Senior Pharmacologist in OSIS, OTS. Dr. Mada received bachelor’s, master’s, and Ph.D. in Pharmaceutical Sciences and Pharmacology. Completed Post-Doctoral Research in Temple University School of Medicine. Prior to FDA, and was a Research Assistant Professor in the University of Pittsburgh School of Pharmacy. Dr. Mada’s regulatory experience includes evaluation of bioanalysis for BA/BE and PK studies submitted under INDs, NDAs, BLAs and ANDAs. He conducted several onsite audits of clinical and bioanalytical facilities across the globe.

Dr. Venugopal G Somani is the Drugs Controller General of India (DCGI) since July 2019. Dr. V.G. Somani did his MPharm and PhD in Pharmaceutical Sciences from Nagpur University, India. Earlier he worked as a Joint Drugs Controller (India) in CDSCO heading the Divisions of Regulation of Medical Devices & In vitro Diagnostics, Stem cells & Blood Products, New Drugs (which are Subsequent & Fixed Dose Combination), He has also worked as Joint Drugs Controller (India) heading the divisions of Biologicals, Clinical Trial, New Drugs and Cosmetics, Enforcements for several years. He was primarily involved in dossier assessment, monitoring, and framing of proposals for amendments in Rules, policies, and guidelines.

Emma Whale is a Senior GCP & GLP Inspector for the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Prior to joining the Agency in July 2008, Emma worked for eight years as a GLP Auditor and Deputy GLP Quality Manager with experience in both Sponsor Organisations and Contract Research Organisations. Emma has also worked in histopathology for a large agrochemical company and she has an honours degree in Biomedical Sciences. In her role as a Senior Inspector, Emma conducts inspections of both GCP and GLP commercial and non-commercial organisations in the UK and overseas inspections of organisations conducting Bioequivalence studies.

Dr. Zhang has conducted, coordinated and reviewed comprehensive BIMO clinical and analytical inspections covering BA/BE, PK, PD, immunogenicity and animal rule studies in support of NDA, ANDA, BLA and IND applications. Before joining the FDA, Dr. Zhang completed a postdoc fellowship at Johns Hopkins University. She has a Ph.D. in Cellular & Molecular Pharmacology and a B.S. in Pharmacy.

Investigator Gunn is an FDA Specialist in the Bioresearch Monitoring program and an officer in the United States Public Health Service. He has been with the FDA and USPHS for 12 years and currently serves as a member of the BIMO Foreign Cadre where he conducts inspections of drug, biologic, and device trials conducted at locations outside the US at the trial site and sponsor level. Prior to joining the FDA, he began his career in laboratory research developing molecular methods for the detection of arboviruses in the environment and moved into clinical research in 2000 where he started as a research coordinator.

Dr Kshirsagar was former acting Vice-Chancellor at the State Health Science University, and also Dean Director of medical education and research, and Prof. Head Clinical Pharmacology G.S. Medical College KEM hospital, Parel, Mumbai and at T. N. Medical College Mumbai, President of the Indian Pharmacology Society and Infectious Disease Society, India, Chairman Academic Committee AIIMS. Govt. of India, Delhi.She has won many awards besides being an University topper, gold medalist, B.C. Roy National Award, Vasvik Award for industrial research, developing and patenting liposomal drug delivery system, Mayor’s award three times.

Dr. Dawn Olenjack is a Bioresearch Monitoring Specialist assigned to FDA’s Dedicated Foreign Inspection Cadre. In her 13 years with the Agency, she has performed inspections of drug, device, biologic and clinical research firms across the US and in 16 countries. She is also responsible for providing training to FDA investigators and industry on the agency’s regulatory oversight of clinical research. She holds a Doctor of Chiropractic Degree and Bachelor of Science in Human Biology.

Dr Anand Eswaraiah has overall 20 years of academic and industry experience. Has completed his MD Pharmacology from A.I.I.M.S, New Delhi; MBBS from Bangalore Medical College, Bangalore, Executive General Management (EGMP) from IIM Bangalore.In his current role, he is responsible for oversight and leadership for the clinical operations function, execution of global Phase 1 – 3 trials to meet marketing authorization requirement of biosimilar products across various regions sucAVPh as US, EU, Japan etc. He is responsible for managing the governance of outsourced projects, interacts with various cross-functional teams like Project management, Clinical/Medical Science, Quality, Regulatory, SCM, and others.

Aparna has over 19 years of experience in regulated bioanalytical assays supporting large molecule drug development. She is specialized in developing/transferring and validating Immunoassay methods in support of preclinical and clinical trials for PK, PD, and Immunogenicity endpoints as per USFDA and EMA guidelines. She has worked on assays for diverse classes of large molecules that include novel biologics, biosimilars, and vaccines.She also works closely with her team, partners, collaborators, and clients to design and validate assays fit for their scientific and clinical safety, efficacy interpretation purposes.In her current role, She is also responsible for driving scientific and growth strategies for the laboratory.

Dr Kumar Prabhash Professor & HOD, Medical Oncology has clinical trial experience as a Prinicpal investigator in Phase II, Phase III and Phase IV oncology trials. Participated in 40-50 trials till date. He has been an investigator as PI and Co-PI in research projects. Also, has been an PI in more than 15 Pharma projects. He is a member of IAP, ISMPO, ICON, MHG & many more. He has collaborative projects with ACTREC scientists, BARC, Hyderabad University and other departments in TMH. He has also been invited as a speaker at ASCO,2015, WCLC, 2016, Oration at ISSLC, 2015 & many more.

Hasan A. Irier is a Senior Pharmacologist in Office of Study Integrity and Surveillance (OSIS) in US FDA. He conducts BA/BE inspections in support of ANDAs, NDAs, and BLAs. Dr. Irier received his PhD in Pharmacology from Emory University, Atlanta GA. Dr. Irier joined to US FDA in 2014.