INDIAN SOCIETY FOR CLINICAL RESEARCH
13th Annual Conference Beyond New Regulations- Increasing Participation and Enhancing Patient Safety January 24-25, 2020, Mumbai
Track I – Clinical Operations Speakers Profile
Insert Program Date Insert Program Title 1 Dr. Chirag Trivedi Sr. Director and Head of Clinical Study Unit India and South East Asia Cluster, Sanofi President, ISCR
Work Experience: Am currently working in Sanofi as Sr. Director and Head of Clinical Study Unit India and South East Asia Cluster - overseeing clinical studies in India, Singapore, Malaysia, Thailand, Indonesia, Philippines, Bangladesh, Sri Lanka and Vietnam. Have been with Sanofi since May 2006 and have handled various roles and responsibilities in these years. Prior to Sanofi, have worked in a CRO and prior to that, in a Central Lab. Since April 2017, am the President of Indian Society for Clinical Research (ISCR). As a Society, ISCR brings together all those who are engaged in clinical research activities in India and provides a forum for exchange of information and learning. ISCR aims to build awareness of clinical research as a specialty in India and to facilitate its growth in the country while helping to evolve the highest standards of quality and ethics. Experienced in the fields of Clinical Research, Clinical Quality Assurance, Medical Excellence, Pharmacovigilance, Bioavailability & Bioequivalence Studies, and Business Development. Educational Qualification: Ph.D. in Pharmacology Additional information: Have been nominated as an external examiner by the University of Mumbai for the Ph.D. (Tech.) and for Masters in Pharmaceutical Sciences Examination (speciality – Pharmacology) for evaluating research thesis. Have been a Speaker at various national and International conferences Dr. Sanish Davis, MD DM FCP, R&D Director, GCO, Janssen Pharmaceuticals, India Hon. General Secretary, ISCR Dr. Sanish Davis has been with Janssen since Sept 2019. He has dual responsibilities in the Janssen India organization. He is responsible for providing oversight to the Clinical studies that are being conducted in India either as part of the global clinical studies or Phase IV post approval commitment studies. He also drives the Portfolio prioritization process for Janssen India for which he works closely with the commercial, Medical, Regulatory and R&D organizations across India and APAC (APSSO, APMS). In his previous assignment with Covance he was responsible for providing medical and scientific leadership and strategic guidance for clinical development programs and medical monitoring for ongoing clinical trials, as well as medical advice to the drug safety service and clinical operations teams. In that role, he has been involved in providing Medical & Scientific Affairs capabilities for running Phase I-III clinical trials in CV, Metabolic areas and other Therapeutic Areas e.g. Opthalamology, Rare Disease, Oncology, Immunology etc. Prior to joining Covance he was Director, Clinical Pharmacology for Merck/SUN JV where he drove Early clinical development programs for innovative generics/FDCs in the dyslipidemia/hypertension therapeutic area. As a Cardiovascular Research Physician in Pfizer, before he joined Merck, he provided leadership for both Clinical Research and Medical Affairs for anti- hypertensive and lipid metabolic products. He is a thought leader in the Clinical Research Industry in India and is currently the General Secretary of Indian Society for Clinical Research (ISCR) – an organization of ~40 accredited R&D companies who are conducting regulated clinical trials in India. He is conversant and in sync with the regulatory and ethical changes for conducting clinical trials in India. He also has good experience in presenting and defending clinical trial project applications with ICMR and DCGI (MoH) in India as well as other emerging market regulatory agencies. Dr. Davis completed his medical degree (MD) and Clinical Pharmacology training (DM) at Seth GS Medical College & KEM Hospital, Mumbai, India. He is a Fellow of the American College of Clinical Pharmacology. Dr. Seema Pai, Director & Head - India for Global Site and Study Operations (GSSO) , Clinical Development & Operations, Global Product Development, Pfizer Treasurer, ISCR She is responsible for clinical trial delivery for global and local clinical trials placed in India. She is on the leadership for AsiaAfME & on the global extended leadership team for GSSO. Dr.Pai is an office bearer & treasurer for the Indian Society for Clinical Research from 2018 onwards. She is the Scientific Committee Chairperson for ISCR & is an active member of the DIA in India & works closely with the Clinical Development Services Agency for supporting several activities of the Department of Biotechnology in India. Dr. Pai was responsible for India, Thailand, Vietnam and Philippines for clinical trial delivery in her previous role at Pfizer. She was responsible as the asset director for oncology assets like Lorlatinib, Crizotinib, C366 as well as vaccines like Prevnar, RSV until end of 2018. She has also served as an practicing oncopathologist at tertiary care hospitals, ethics committee member, medical writer and editor for key publication houses at the start of her career and then worked in clinical development extensively holding the roles of medical monitor, safety physician, oncology protocol development expert for an Indian CRO & local pharmaceutical company (SiroClinpharm) following which she was the Senior Director & Head - Clinical Development Division of a Japanese Pharmaceutical Company in India – Daiichi Sankyo for over 8 years where she was responsible for India Cluster & Australia. She has been instrumental in overseeing the largest, longest cardiovascular program in Venous Thromboembolism & Atrial Fibrillation - ‘Edoxaban’ which had 2 large phase 3 cardiovascular studies enrolling over more than 1200 patients in India and has provided leadership for establishment of the oncology, and frontier areas portfolio development at Daiichi Sankyo India. She has completed her MBBS from Grant Medical College, Sir J J Group of Hospitals, Mumbai followed by her MD (Path) from T.N.Medical College, Nair Hospital, University of Mumbai. She has worked in clinical research and pharmaceutical industry for >16 years. Thus, during her career, Dr. Pai has worked in all phases of clinical trials from IND to NDA for various compounds in the areas of oncology, cardiology and metabolic diseases. She has several published papers in journals of national and international repute. Dr. V G Somani Drugs Controller General (India), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India He is Drugs Controller General (India), under Dte.GHS, MoH&FW, Government of India. He has done M. Pharm, PhD in Pharmaceutical Sciences. He is Chairman of WHO’s Member State Mechanism (MSM) of 194 countries on substandard and falsified medical products at Geneva, Switzerland vide World Health Assembly (WHA) resolution 65.19 which is very important platform to safeguard Global interest for making a quality affordable generic medicines acceptable in the world. He is working in CDSCO in Drugs Regulation for last 22 years and having vast experience in the field of GMP, GCP, GRP, GDP, GLP, Dossier Review etc. and he has also worked on all the posts in the hierarchy of CDSCO. He has been involved in training various national regulatory guidelines like guidelines on similar biologics and contributed to various WHO guidelines on Drugs, Devices &Vaccine related issues. His focus areas are Simplification of regulation and access to quality medical products through Good Regulatory Practices & strengthening of Drug Regulatory system. He is a well-known speaker and trainer of various national and international/ WHO scientific bodies and was awarded merit scholarship/fellowships by the Government since schooling days till completion of his P Kedar Nayak Global Clinical Development Manager/Study Delivery lead Global Clinical Sciences and Delivery Global Clinical Operations @ GlaxoSmithKline (GSK)
Am currently working in GSK as Global Clinical Development Manager/Study Delivery lead as a part of the global clinical matrix team for HIV studies. Started with GSK India in 1996 as a medical representative for critical care, anti-infectives and Asthma care products including being part of asthma task force for a novel device. Subsequently moved to Clinical Operations in 2004, since then have been holding a variety of clinical research roles of increasing seniority starting from CRA, Local study Manager, Clinical Research Manager, Head of Clinical Operations -Vietnam, India and then recently as Area Manager - Area Manager - In-Country Clinical Operations - India, Russia, Africa.
Handled different responsibilities across diverse therapy areas primarily Oncology, Respiratory, Infectious diseases. As Area Manager for RMEA in addition to my role for Russia, South Africa, have been responsible for overseeing clinical studies being done in partnership with strategic partners (CRO) within AP countries namely India, Singapore, Malaysia, HK, Thailand, Taiwan, Turkey Philippines, Vietnam & NZ. Have also worked with India Medtronic for a brief period between 2006-2009 as Manager -Clinical Studies and then re-joined GSK as a Clinical Research Manager (Oncology) in 2010.
Head of Clinical Operations -Vietnam between 2013-2015 Chair – Western Since April 2017, am the Chair of the Western Chapter of Indian Society for Clinical Research (ISCR). As a Chair for the West Chapter, my passion is to create a forum for fellow colleagues to step up , Chapter, ISCR. exchange information and thus learning between all of us who are active & passionate about CR within the region with a sole objective towards the ISCR goal to build awareness, capacity and capability of clinical research. Chair – Local Experienced in the fields of Clinical Research, Clinical Quality, Risk Based Monitoring. Organising Educational Qualification: MSc. MBA th Additional information : committee- 13 ◦ Have been a Core member of the RBM Regional Board (Representing EMAP & J) & Led RBM Annual ISCR Champion Network for EMAP & J region to ensure that LOC activities in the region are aligned with the overall Global/Regional RBM business plan and priorities. Conference 2020 ◦ MBA with specialization in Human Resources Management from NMIMS. Key Note Speaker Dr. Gagandeep Kang Executive Director, Translational Health Science Technology Institute (THSTI) Professor Kang is the Executive Director, Translational Health Science Technology Institute (THSTI), an autonomous institute of the Department of Biotechnology (DBT). Prior to joining DBT, Prof. Kang was Professor and Head of the Wellcome Trust Research Laboratory, and the Division of Gastrointestinal Sciences at the Christian Medical College (CMC) in Vellore. Professor Kang has built a strong inter-disciplinary research program that uses careful and detailed field epidemiology with molecular tools for characterization of infectious agents and host response to infection to understand and change factors that affect transmission, development and prevention of enteric infections and their sequelae. Observational, interventional and mechanistic studies on enteric infection and nutrition have demonstrated the complex relationships between gut function and physical and cognitive development. Based first at an outstanding medical college and now at the THSTI, she has established a strong training program for students and young faculty in clinical translational medicine aiming to build a cadre of clinical researchers studying relevant problems in India. She is a member of the WHO's Product Development Vaccine Advisory Committee Global Advisory Committee and chairs the Immunization Technical Advisory Group for the WHO’s South East Asian Region. She serves or has served on the scientific advisory committee of several national and international institutions, including the Wellcome Trust, UK, the DBT-Wellcome Trust India Alliance, the International Vaccine Institute and the International Center for Genetic Engineering and Biotechnology. Dr. Urmila Thatte Professor and Head at the Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai
Dr. Urmila Thatte is Professor and Head at the Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai. She has an M.D. and Ph.D. in Pharmacology from the University of Mumbai, a Diplomate of the National Board of Examinations, New Delhi, in Clinical Pharmacology and is a Fellow of National Academy of Medical Sciences, New Delhi. Dr. Thatte is a Member of the Subject Expert Committees (Govt. of India) for review of new drug applications and the Expert Committee set up by the Ministry of Health and Family Welfare for deciding compensation for Research Related Injury. She also serves on Scientific Advisory committees as a Clinical Pharmacology expert of the ICMR. Dr. Thatte is the Member Secretary, Forum for Ethical Review Committees in the India (FERCI), Chair of the Signal Review Panel, Pharmacovigilance Programme of India, member of the WHO Expert Advisory Panel on Drug Evaluation and Asia-Pacific Consortium, International Society of Pharmacoeconomics and Outcomes Research (ISPOR). Dr. Thatte serves on the National Ethics Committee of NACO and chairs the Ethics Committees of the Bombay Hospital. She also serves on the Institutional Ethics Committee of KEM Hospital as well as on the Independent Ethics Committee, Mumbai. Having won several prizes at the undergraduate level, her team’s research work has been recognised by the prizes they have won in scientific conferences. Dr. Thatte has been awarded the prestigious Dr. KN Udupa Award for Excellence in research in Ayurveda by IASTAM. She was conferred the “Excellence in Drug Research Award” (Traditional Medicine) by the Central Drug Research Institute, the prestigious Dr. BN Ghosh Oration of the Indian Pharmacological Society on the topic “Herbal Drug Development – Opportunities and Challenges” and the Dr. Faroque Abdullah Oration of SMS Medical College, Jaipur on “Ethical Issues in Clinical Research”. She has over 220 Publications in National and International Journals including 8 books and 20 chapters in various books on clinical pharmacology to her credit. Dr. Thatte was the Clinical Pharmacology Section Editor for Clinical Pharmacology for the API (Association of Physicians of India) Textbook of Medicine published in 2008. Dr. Thatte is in the core team that authored the 2017 edition of the ICMR Ethical Guidelines for Biomedical Research. Dr. Sripad Banavali Director Academics Tata Memorial Hospital, Dr. Shripad Banavali has completed his MD Internal medicine in 1986 and underwent 3 years Adult Oncology training at TMH under able guidance of Dr S H Advani. Then He spent nearly 8 years in the U.S. doing research on various aspects of leukemia including work at St Jude Children Research Hospital which is considered the “Mecca” of pediatric oncology. Then came back and joined TMH. At present, he is the head of Medical Oncology at TMH. Since accepting the responsibility of the medical oncology dept in India’s largest and most advanced cancer hospital, Dr Banavali has embraced a revolutionary approach to cancer treatment known as metronomic therapy. He has more than 200 scientific publications in various peer reviewed journals to his credit. Dr Banavali is Oncology SEC member for past few years as well. Suneela Thatte Vice President & Head, R & D Solutions, IQVIA India
Suneela is an industry leader with extensive experience in clinical research, operations, business operations and account management with a more than 25 year stint in the biopharma industry. Currently serving as Vice President and Head R & D Solutions, IQVIA India, Suneela is responsible for IQVIA’s Clinical Development business in India. She also supports IQVIAs’ Regulatory strategy and is responsible for engagements with industry bodies and associations. Suneela joined IQVIA (formerly Quintiles) as Clinical Team Leader in 1998 and has, over the last 19 years, worked in various leadership positions. Suneela began her career as Assistant Manager, Medical Information Service at Unichem Laboratories and later moved to Rhone Poulenc as Clinical Research Associate in the Medical Services Division before she joined IQVIA in 1998. Suneela holds a Master of Pharmaceutical Sciences degree from Mumbai University and a Master of Business Administration from New Port University, California, Mumbai Chapter. She is the Past President (2013–17) of the Indian Society for Clinical Research (ISCR), the nodal professional body in India for clinical research professionals. It was during her tenure that ISCR, as a body representing all the stakeholders in clinical research, got wide recognition within India – including that of Indian regulatory authorities – and abroad. Suneela is an active member of the Clinical Trials Committees of several industry associations such as Confederation of Indian Industries (CII), Organization of Pharmaceutical Producers of India (OPPI), Advisory Council for Developing Human Resources for Pharmaceutical Industry where she is a Task Force member. She has also published papers in medical journals. Suneela is the recipient of Healthcare Businesswoman’s Association Luminary Award for 2017. In February 2019, she has been honored by The Indian Society for Clinical Research with a Lifetime Achievement Award for Notable Contribution to Clinical Research Fraternity – Industry. Dr. Suresh Menon Chief Scientific Officer, Novartis India Limited
Dr. Suresh Menon is an alumni of the Grant Medical College & J.J. Group of Hospitals in Mumbai Has been associated with the Indian Pharmaceutical Industry for more than 3 decades and has worked in a number of Indian as well as multi-national companies (including USV, Piramal, Schering Plough and Organon). Currently with Novartis (for the last 15 years+), heading the Medical Function as Chief Scientific Officer (CSO). Is well networked in the Pharma industry and, in addition to being the Chair of the Medical- Regulatory Committee of OPPI, is also an Executive Committee Member of the Indian Society for Clinical Research (ISCR). Was also a past President of the ISCR. Dr. Menon has more than 30 publications in peer reviewed journals to his credit. Dr.(Prof) Asita D’silva University of Kelaniya, Sri Lanka
Professor Asita de Silva has held many positions in academic medicine over the last 26 years. He is a Clinical Pharmacologist and is currently Senior Professor of Pharmacology at the Faculty of Medicine, University of Kelaniya, Sri Lanka. He is also Director of the Clinical Trials Unit in the same institution. Prof de Silva graduated MBBS in 1991 from the North Colombo Medical College, Sri Lanka, and had his postgraduate training in clinical pharmacology at the Radcliffe Infirmary in Oxford. He holds a doctorate in Clinical Pharmacology from the University of Oxford and is a Fellow of the Royal College of Physicians, London. Prof de Silva’s research interests have focused on clinical trials in neglected tropical diseases and major non-communicable diseases. He has published more than 60 papers in indexed scientific journals including the New England Journal of Medicine, Lancet, Journal of the American Medical Association, PLoS Medicine, Clinical Science, Lancet Global Health and Stroke, and has delivered many orations and invited lectures. He has received Presidential awards for medical research on numerous occasions and is a recipient of many prestigious research grants including project grants from the Wellcome Trust, Medical Research Council, UK, and the National Health & Medical Research Council in Australia. Prof de Silva recently received the National honour of Vidya Jyothi for his contribution to medical science.
Letitia Robinson Country Director USFDA
Dr. Robinson’s experience includes clinical research, public health legislation and policy development, global health, maternal child health, HIV/AIDS, and managing programs mandated to increase health care access and decrease health care disparities. Letitia has spent over two decades working as a clinician and public health professional with experience throughout the Department of Health and Human Services.
Dr. Robinson has a Doctor of Philosophy in Health Sciences and a Master’s and Bachelor of Science in Nursing. Mr. Anirban Roy Chowdhury Director & Principal Consultant, ARC LifeScience Consulting Group
Anirban Roy Chowdhury is a clinical research professional with about 2 decades of experience in the pharmaceutical industry. He started his career as a CRA in AstraZeneca and most recently he was the Executive Director, Global Clinical Trial Operations at MSD (Merck & Co). He is the Founder Director and Principal Consultant at ARC Life Science Consulting Group, a boutique clinical research consulting firm. He is an Adjunct Visiting Professor at Dept. of Pharmacology, Manipal College of Pharmaceutical Sciences, Manipal. Anirban serves in the Executive Committee of the Indian Society for Clinical Research. Dr. Deepa Bhartiya Head Stem Cell Biology Department, ICMR- National Institute for Research in Reproductive Health
Scientist G and Head, Stem Cell Biology Department, ICMR-NIRRH, Mumbai Did PhD from CDRI, Lucknow and Post-doc at NIH, Bethesda, USA Published extensively on stem cells and oncofertility Have more than 100 published articles on Pubmed Is attached to Mumbai University and several students done PhD under her guidance Major interest of research is on pluripotent stem cells Dr. Savita Rangarajan MD, FRCP, FRCPath Consultant Haematologist University Hospital Southampton NHS Foundation Trust United Kingdom Prerana Medical Sciences & KJ Somaiya Super Speciality Hospital & Research Centre
Savita Rangarajan, MD, FRCP, FRCPath is a Consultant Haematologist at the University Hospital Southampton NHS Foundation Trust and at K J Somaiya Super Speciality Hospital & Research Centre in Mumbai, India. She is the R&D Director of the Clinical Trials & Research Unit in Mumbai. Dr Rangarajan obtained her Undergraduate & Post Graduation degree in Medicine at Lokmanya Tilak Municipal Medical College, Mumbai, India, and further specialty training in Haematology in the United Kingdom. She trained at various teaching hospitals in London as a registrar including the Roya Free Hospital, UCLH, and the Hammersmith Hospital. She was made a Consultant Haematologist at St Thomas’ Hospital in 2000, which is one of the largest Comprehensive Care Centre for Haemostasis & Thrombosis. She developed the Southern Haemophilia Network in Wessex and established a vey successful Clinical Trials Unit at Hampshire Hospitals and was PI/CI in more than 20 Phase I-IV Clinical Trials including Gene Therapy for Haemophilia. Dr Rangarajan is a Fellow of the Royal College of Physicians and the Royal College of Pathologists and is a member of UKHCDO, American Society of Hematology and International Society of Thrombosis and Haemostasis (Co Chair of the Factor VIII, Factor IX and Rare Coagulation Disorders ISTH subcommittee) among others. She has contributed a book chapter on haemophilia and has published widely, with papers appearing in The New England Journal of Medicine, Haemophilia, Journal of Thrombosis and Haemostasis, British Journal of Haematology, Blood Coagulation and Thrombolysis, and Blood, to name a few. Dr Mahesh Iyer Co-Founder, Sineflex Solutions LLP
Mahesh is a co-founder of Sineflex Solutions LLP, a consulting firm focused on enabling and accelerating innovation in the healthcare space. He is also the domain mentor of the BIRAC funded med-tech accelerator located at the Centre for Innovation and Entrepreneurship, IIIT Hyderabad. In this role, Mahesh is responsible for mentoring startups in the medtech space, and helping them scale their products and solutions. Mahesh Iyer has over 20 years of experience in research and development in healthcare. He has been responsible for guiding many products through the development life-cycle. Before co-founding Sineflex Solutions, Mahesh was at Novartis in various roles, including Site Head, Biostatistics at Hyderabad, and Global head for Exploratory Safety and Statistical Analytics. Prior to Novartis, Mahesh worked with Bristol Myers Squibb and Boehringer Ingelheim. Mahesh brings a strong analytical mind-set, deep insights into healthcare development and a proven record of implementing innovative solutions in the healthcare domain. Mahesh is passionate about enhancing industry academia collaboration; he set up one of the first part-time Ph.D. program in Statistics for Novartis associates, teaches at a number of Indian universities and has chaired multiple conferences over the years. He is currently Secretary of the Indian Association for Statistics in Clinical Trials and President of the International Indian Statistical Association, India Chapter. Apart from his functional activities, Mahesh has led various organizational developmental activities and trainings. He is a certified coach in the areas of emotional intelligence, assessment centers, and psychometric evaluations. Mahesh has completed his Ph.D. in Statistics from Temple University, Philadelphia. Shankar Arun Vice President and Head, Parexel Informatics India
As Vice President, Shankar Arun heads Parexel India’s Informatics Business Unit in India which specializes in the areas of Technology, Operations and Clinical Programming. With 24 years of work experience largely devoted to the CRO/IT/KPO functional carve-outs within the Life Sciences segment, Shankar brings in rich expertise developing solutions around EDC, Biostats, and Safety Platforms. Before joining the Life Sciences Industry, he had worked as a consultant in the US for some of the prestigious names like Microsoft (Seattle) and Apple (Cupertino). A Technology Evangelist, Shankar specializes in designing solutions within the Clinical Research space around the framework of “SMAC” (Social Media, Mobility, Analytics and Cloud) and is an active proponent of “Go Digital” models. He also leads Parexel Informatics’ Innovation Initiative which conducts research on the application of Artificial Intelligence and Robotic Process Automation in the field of Clinical Development. Shankar is an active participant in external forums like Cypher Analytics Summit, India Analytics Summit, SCDM, DIA etc where he has presented keynote speeches on topics related to Artificial Intelligence, Machine Learning and IOT. A strong believer in people power, Shankar is focused on mentoring and coaching his teams to maximize their full potential. Dr. Arun Bhatt MD (Med), FICP (India), FICR (UK) Consultant – Clinical Research and Development
Dr Bhatt has extensive experience of over three decades in the Indian pharmaceutical industry in clinical research, drug development, and regulatory affairs. He has managed clinical development of novel molecular entities in diverse therapeutic areas in all clinical development phases. Dr Bhatt has worked as a consultant in pharmaceutical medicine and clinical pharmacology. His past positions held include President, Clininvent Research Private Limited – a CRO, CEO of CMI (India) Private Limited and Medical Director of Novartis India Limited. Dr Bhatt has been active in industry associations and was earlier the President of Indian Society for Clinical Research (ISCR). He is Editor-in-Chief of Perspectives in Clinical Research – the journal of ISCR. In 2009, the Institute of Clinical Research UK nominated Dr Bhatt for the Honorary Fellowship of Institute of Clinical Research. Dr Bhatt is the recipient of Drug Information Association Outstanding Service award 2012 for his immense contributions in his field of specialization. Dr Bhatt was awarded ISCR Special Award 2017 for Notable Contribution to Clinical Research Fraternity in India Dr Bhatt delivered the prestigious Prof U K Sheth Oration in 2013. Dr Bhatt is a qualified assessor for NABH Accreditation for Clinical Trials – sites, investigators and Ethics Committees. Dr Bhatt has more than 150 publications in national and international journals. He runs a regular monthly column on “Good Clinical Practice – Question Answers” and has published a book “Clinical Trials and “Good Clinical Practice in India – Questions and Answers”. Dr Girish Chinnaswamy Associate Professor, Department of Medical Oncology, Tata Memorial Hospital
Girish Chinnaswamy completed his medical school and post graduate training in paediatrics at Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) Pondicherry. He further underwent subspeciality training in paediatric and adolescent oncology at the Royal London and Newcastle Upon Tyne Hospitals in the United Kingdom. He subsequently pursued research in paediatric cancer pharmacology at the Northern Institute of Cancer Research, Newcastle University studying the pharmacokinetics and pharmacogenomics of anticancer drugs in Children. He has previously worked as a faculty in paediatric oncology at Christian Medical college hospital Vellore and is presently working as a consultant at Tata Memorial Hospital. His special interests are paediatric neuro- oncology and bone tumors in children. Dr Sameer Shah Head, Department of Hepatology Institute of Liver Diseases, HPB Surgery and Transplant at the Global hospital
Dr. Samir Shah is the Head, Department of Hepatology Institute of Liver Diseases, HPB Surgery and Transplant at the Global hospital, Mumbai, and visiting consultant to Breach Candy Hospital. He has been awarded the Hargobind Foundation Scholarship and trained in Hepatology and Liver transplant at the Institute of Hepa tology, University College London. He was the first elected Secretary of the Indian Association for Study of the Liver for the period 1995-1997 and has been a Council Member of International Liaison Committee, Asian Pacific Association for the Study of the Liver (APASL). He has been involved with several international clinical trials on new drug development with presentations in international meetings and publications in peer reviewed journals. He has been the driving force to co-ordinate efforts to start a cadaveric organ transplant programme in the country and Mumbai in particular. Member of the Editorial Board of Indian Journal of Gastroenterology, National Advisory Board of the Journal of the Association of Physician of India (JAPI) Editorial Board Member, Journal of Clinical and Experimental Hepatology. Founder Trustee and the Hon.Gen. Secretary of the National Liver Foundation. Founder Member, Coalition to Eradicate Viral Hepatitis in Asia Pacific (CEVHAP). Expert, Core Advisory, Group on Viral Hepatitis, ICMR. Ms Vandana Gupta Founder, V Care Foundation
Driven by the axiom “Together we can and we will conquer cancer”, Vandana was inspired to set up V Care Foundation in 1994 after she successfully conquered cancer. Based on her personal journey of managing cancer, Vandana was determined to fill the gap cancer patients and their caregivers feel as they battle the disease. A strong advocate of patient care and caregiver support, Vandana leads from the forefront to ensure V care Foundation helps them face cancer with hope, confidence and maintain a good quality of life. Vandana is passionate about bringing value to the lives of cancer patients and spends a significant amount of time serving and meeting patients and their families. She is driven by the motivation to ease this difficult emotional and physical journey from diagnosis to treatment for patients.
Vandana acts as a strong advocate for cancer awareness and has presented at several national and international forums on ethical treatment and need of cancer care in India. She has received several accolades for her work and vision. Vandana manages a team of 60 dedicated volunteers and 10 employees, to lead V Care Foundation’s national efforts towards providing emotional assistance, financial aid, nutritional support, paediatric cancer care, palliative care and managing a compassionate medicine assistance program for a multinational company. Today, V Care is associated with voluntary work at Tata Memorial Cancer Hospital & Research Centre, Nanavati Hospital, Leelavati Hospital, Breach Candy Nursing Home and Jaslok Hospital. She has also played a key role in bring global exposure and expertise to V Care Foundation through affiliations with American Cancer Society, International Kidney Cancer Coalition and Lymphoma Coalition.
Vandana has two papers published in the Perspective in Clinical Research in 2013 and 2016 , titled “What I wish every doctor knew: A patient perspective” and “Involvement of general public in biomedical research”. Vandana was also part of the ASCO panel in development and publication of “Secondary prevention of cervical cancer; American society of clinical oncology resource-stratified clinical practical guide 2016”. She has a Masters in English Literature, and a certification in child development. She has the honour of being the first fellow of the International partner program by American Cancer Society. Currently, she is the chairperson of the ethics committee of Breach Candy hospital in Mumbai. Dr Gouri Pantvaidya, MS,DNB,MRCS. Professor, Department of Head & Neck Surgery, TMH
Dr Gouri Pantvaidya, MS,DNB,MRCS. Professor, Department of Head & Neck Surgery, Secretary, Data Safety Monitoring Unit Tata Memorial Hospital, Parel, Mumbai Dr. Partha Gokhale Head Clinical Operations- Boehringer Ingelheim India
Dr. Partha Gokhale is the Head Clinical Operations- Boehringer Ingelheim India. Partha is a medical doctor and has done his post-graduation in Pharmacology. He is a M.D, D.N.B (Pharmacology) and is also a certified lawyer (L.L.B). During the last 18 yrs, Partha has been involved in increasing responsibilities in clinical research from clinical protocol development, medical monitoring to increasing managerial positions in clinical research. He was instrumental in setting up the clinical research departments of Boehringer Ingelheim India Pvt Ltd and assisted in setting up the clinical research department at Wyeth Pharmaceuticals India. Dr Partha Gokhale is the Chair of the Ethics council of Indian Society For Clinical Research. Dr.Durga Gadgil Research Consultant, Tata Memorial Centre
Durga Gadgil, an independent clinical research consultant, is currently working also as a consultant with the Tata Memorial Administrative and Research Council (TRAC). She is the chief coordinator for the two-year MSc in Clinical Research course conducted by the Tata Memorial Centre under the Homi Bhabha National Institute. She is also a GCP Trainer and conducts workshops and seminars for the same. Besides, she is instrumental in setting up the National Cancer Grid Contract Research Organization (NCG CRO) at TMH in 2017, which monitors NCG funded, multicentric studies carried out in India. At present 4 CRAs and one Project Manager report to her in the NCG CRO, who monitor 9 NCG funded Multicentre studies in India. She has 31 years of experience in the pharmaceutical industry and retired in November 2015 as Area Head, Asia Pacific, Regional Medical Monitoring Organization, Pfizer. In this role, she was the line manager for medical monitors based in Australia, India, Singapore, Hong Kong, China, Korea, Taiwan and Philippines. The team was responsible for monitoring all global studies from Phase 2 to 4 for medical aspects, ensuring patient eligibility, protocol adherence, data integrity and quality, in compliance with local and global ethical principles. Durga is a certified NABH assessor for NABH Accreditation Standards for Clinical Trials (Ethics Committee, Investigator, and Clinical Trial Site) During her career span of 30+ years, she has worked in many pharmaceutical companies, all MNCs and one India company. She has experience in all fields related to a medical doctor’s role in the industry, like medico-marketing support, regulatory activities, pharmacovigilance and safety reporting, clinical operations, medical monitoring, auditing and training. Dr Vasee Moorthy WHO, Geneva
Vasee Moorthy (BA MA BMBCh MRCP PhD) is WHO’s global lead for clinical trials policy. In addition he leads a team overseeing work of WHO in Global Health Ethics, quality assurance of evidence-based guidelines, WHO’s international clinical trial registry platform and the WHO Global Observatory on Health R&D. His background is as an infectious disease/internal medicine physician trained at Universities of Cambridge and Oxford, UK, a clinical scientist with a PhD in malaria immunology, a career as a vaccine researcher and experience working at PATH, a product development partnership based in Washington DC. He spent 5 years living and working in sub-Saharan Africa in Kwazulu/Natal and The Gambia, identifying knowledge gaps and conducting research to advance policy and practice. He has been a WHO staff member for 10 years, initially as the malaria vaccine focal point, then head of vaccine development and currently Cross-cutting Lead in WHO’s Science Division. Dr Moorthy has led WHO’s work in clinical trials transparency leading up to the WHO Joint Statement on Public Disclosure of Results from Clinical trials signed by over 20 leading global and national agencies in 2017, including the Indian Council on Medical Research. https://www.who.int/ictrp/results/jointstatement/en/
Dr. Pooja Sharma Senior Scientist and Head, Medanta institute of Education and Research
A gynaecologist and clinical researcher with 18 years of research expertise. Has spearheaded the establishment of two clinical research institutions at Society for Applied Studies and the Medanta Institute of Education and Research, in addition to the Medanta Public Health Initiatives Unit and recently the Medanta Foundation. An investigator who has conducted vaccine trials for Rotavac, Chikv and Japanese Encephalitis. Has special interest in bioethics and has served on several Ethics committees, like those at Medanta, Genebandhu, National Brain research center and the Indian Spinal Injuries center. Works in the area of patient advocacy for research and is founder secretary of PARTAKE (NGO for Patient Awareness of Research and Therapeutic Advancements for Knowledge and Empowerment) and works with several patient support groups towards creating research awareness in patients. Dr. Manjunath K Deputy General Manager Clinical R&D, Zydus Research Center Cadila Healthcare
A pharmaceutical physician with more than 14 years of experience in clinical research/clinical development. The lead role in the medical and scientific affairs of various global clinical development programs for new chemical entities, biosimilars, new drug delivery systems, translational research and generics development. An extensive experience in strategizing and developing the entire global clinical development pathway for drugs in many different therapeutic areas with notable experience in oncology, hepatology and biosimilars development. The lead role in interacting with the global regulatory agencies, specifically the United States food and drug administration, European medicines agency, Medicines and healthcare products regulatory agency, United Kingdom, the Indian council of medical research and the Drug controller general of India. Medical monitoring and safety monitoring experience across early and late phase clinical trials in multiple therapeutic areas. Dr. Sandhya Kamat Head of Dept, Pharmacology, KEM Hospital
Dr. Sandhya Kamat is Professor and Head at the Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai. She has an M.D. in Pharmacology from the University of Mumbai. Dr. Kamat is the Chairperson of the on the Institutional Animal Ethics Committee of the Institute. She also serves on the Institutional Ethics Committees of Nowrosjee Wadia Hospital and Bai Jerbai Wadia Hospital and on the Independent Ethics Committee, Mumbai. She was the member secretary of the Institutional Ethics Committee of Seth GS Medical College & KEM Hospital from 2002-2006 after which she continued to be member till 2011. Dr. Kamat is a founder Member and treasurer of the Forum for Ethical Review Committees in the India (FERCI) Her main areas of research interest include cardiovascular and gastrointestinal pharmacology, herbal medicines and rational use of medicines. She and her team have won several prizes in scientific conferences. Dr. Kamat has undergone training in GCP and ethics and has been a faculty for several workshops on Research Methodology and Ethical Aspects of Research. Dr. Nithya Gogtay Additional Professor in Clinical Pharmacology, KEM Hospital, Mumbai
Currently working as Additional Professor in the Department of Clinical Pharmacology Seth GS Medical College & KEM Hospital, Mumbai (Bombay, India. Have over 100 peer reviewed publications to my credit. Received special training in Pharmacovigilance at the Uppsala Monitoring Centre, Sweden in 1996 and Bioethics at the Thammasat University, Thailand in 2005. Also trained in biostatistics through training programs of the NIH USA and Christian Medical College, Vellore, India from 2000-2010. Serves on the Editorial board of the Journal of Association of Physicians of India and has been the past Editor [2012-2016] of the Journal of Postgraduate Medicine. Have done 25 GCP clinical studies and guided 10 Masters students and is guiding 3 PhD students. Also serves on the boards of several IRBs in the city. Dr. Sameer Bakhshi Department of Medical Oncology Dr. B. R. A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
• Professor, Department of Medical Oncology, Dr. BRA Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi
• Faculty since 2002 at AIIMS
• Ex-Member Secretary of AIIMS Ethics Committee • SEC Member for CDSCO Oncology Related Drugs • Areas of interest: Leukemias, Sarcomas and Supportive Care in Cancer
• Published more than 350 peer review articles Dr. Sujeet Rajan Consultant Respiratory Physician, Interstitial Lung Diseases/ILD Clinic, Bombay Hospital Institute of Medical Sciences and Bhatia Hospital
Sujeet Rajan is a respiratory Physician who graduated from the Grant Medical College in 1989 and Post-graduated in respiratory medicine from the Seth. GS Medical College and KEM Hospital in 1994. He Joined the Bhatia Hospital in Mumbai in 1996 and subsequently also joined the Bombay Hospital Institute of Medical Sciences from August of 2000. He has been actively involved in teaching, research and clinical practice at these 2 Hospitals. His areas of interest are interstitial lung disease, airway disease, sleep disorders and patient communication, and he is also in the process of setting up and ILD clinic to run twice a week. He is currently the European Respiratory Society’s National Representative from india and also the Indian Editorial Adviser for the American Journal of Respiratory and Critical Care Medicine, and has 34 publications to his credit Dr. Denis Xavier MBBS, MD, MSc (Clin Epi) Vice-Dean (PG), Professor, Dept. of Pharmacology, St. John's Medical College Head, Division of Clinical Research and Training, St. John's Research Institute St. John's National Academy of Health Sciences
Vice-Dean (PG), Professor of Pharmacology and Head, Div. of Clinical Research at St. John’s Medical College and Research Institute, India.
Vice President of SOCHARA – an NGO for health; 2019 onwards.
Executive Committee member of Indian Society for Clinical Research (ISCR) and National Convener of its Academic Consortium for Clinical Research in India (ACCRI).
Under graduation and post graduation training at St. John’s and a Masters in Clinical Epidemiology at McMaster University, Canada.
Helped set up the Clinical Research Division at St. John’s in 1999 with collaborations in about 180 Centers across India and 2 other Asian countries; to date recruited over 95,000 subjects in over 30 large projects.
He has or is serving on about 25 international research steering committees.
Principal Investigator of the NIH (USA) Center of Excellence to counter chronic diseases (2009-14).
He runs courses in Research Methods, Biostatistics and Evidence Based Medicine since 2009, trained about 2000 from India and 7 other countries in 23 courses.
Received research grants from the NIH (USA), CIHR (Canada), NHMRC (Australia), UK- MRC, Wellcome Trust, ICMR etc.
He has over 120 papers in journals such as the Lancet, NEJM, JAMA, BMJ, Circulation, Eur Heart J, Heart, AHJ, Nature CV, IHJ etc., 6 book chapters and is Section Editor of a cardiology textbook.
Editorial Board of JACC, Nature Cardiology, RUHS and Preventive Cardiology.
Formerly Chairperson of the Narayana Health Academic Ethics Committee and Member of NIMHANS ethics committee.
Task force member of ICMR (4 projects), Advisory Board of BIRAC (DST, Govt. of India)
Delivered invited lectures at ◦ Oxford University, UK; ◦ McMaster University, and University of Toronto, Canada; ◦ Harvard, Stanford, Duke and North Western Universities, USA.
Xavier has also delivered invited lectures at the World Congress of Cardiology, Dubai 2012 (2 lectures), Melbourne Australia 2014 (2 lectures), American Heart Association’s International Stroke Conference, Los Angeles 2016, World Stroke Congress (2016) and American College of Cardiology, New Orleans, USA (2016). Dr. Ramesh Jagannathan MBBS, MD, MSc (Pharm) Clinical Research Consultant, Bengaluru Medical doctor (MBBS) with MD (Pharmacology) from B.J. Medical College and Sassoon Hospitals, Pune and a Master's research degree in Experimental Pharmacology from a Public University Medical School in USA Currently, he is a Clinical Research consultant and has 20 years’ experience in Pharmaceutical Industry, worked in different leadership and managerial roles: • Head-Clinical Development at Biocon Research Ltd.; • Medical Director at Novo Nordisk India Pvt. Ltd.; • Director-Clinical Research, Associate Director-Medical affairs and others at AstraZeneca Pharma India Ltd.; • Head-Clinical Development, Global Medical Affairs, Dr Reddy’s Labs Ltd. Member, Indian Society for Clinical Research (ISCR) since 2009; currently EC member and past South Chapter Head (2014-2018) Has organized and/or contributed as Speaker to over 60 meetings/programmes, including major Conferences (National/Regional) and workshops in Clinical Research He has experience in areas of Commercial (Medical affairs, Medico- marketing) and R&D (Clinical Development, Clinical Trials and Medical Science) roles. Dr. Yashashri Shetty Associate Professor, in the Department of Pharmacology & Therapeutics, Seth GS Medical College & KEM Hospital
Dr Yashashri Shetty is currently working as Associate Professor, in the Department of Pharmacology & Therapeutics, Seth GS Medical College & KEM Hospital. She is being trained at international workshops in rational use of medicines in community, PK – PD modeling, Medical Statistics and Medical writing. She has 16 years of experience of undergraduate and 10 years of post-graduate training. She has 12 years’ experience of being a part of Ethics committee and 5 years as Member Secretary, and now currently working as Joint Member secretary of Institutional Ethics committee II (IEC II), at Seth GS Medical College & KEM Hospital, and member of Institutional Ethics committee II (IEC -II) of Tata memorial Hospital. She and her team had contributed in the Institutional Ethics Committee Accreditation (SIDCER-FERCAP) which was first of his kind in the country as well as in NABH accreditation. She is been a trained International surveyor for Ethics committee and had surveyed 9 Ethics Committees for International FERCAP SIDCER recognition at national as well international level. She is also undergraduate Pharmacology Quiz In-charge from last 10 years and her team has won nearby 9 state level quizzes. She is one of the authors of the chapter “Ethical review process” in ICMR 2017 guidelines. She is author of 6 manuals the subjects ranging from Standard Operating Procedure of ethics committee, manuals on prescription writing, SLOs in Pharmacology’ and “Neuropharmacology” She is a recipient of 31 awards for her research in the field of pharmacology and research ethics including the prestigious Achari Award at national level and 2 papers at international forum. She has experience of working as Investigator in many animal studies and clinical studies in the area of Rational use of Medicines, Pharmacoeconomics, Research Ethics and neuropharmacology. She has over 70 publications in peer reviewed journals. Ms Indu Nambiar Senior Manager – Local Pharmacovigilance / LPVM, Boehringer Ingelheim
Ms. Indu Nambiar, is a Home Science Graduate with Majors in Nutrition. She pursued her P. G Diploma in Dietetics, and is a registered Dietician. Currently holds the position of Head - Pharmacovigilance at Boehringer Ingelheim India Pvt. Ltd. She started her career in the Pharmacovigilance field in 2006, when she joined Novartis India Ltd. as Executive – Drug safety & Epidemiology (DS&E) and was associated with Novartis for the next 5 years. She is a life time member of ISCR and was instrumental in the formation of the PV working Group within ISCR in 2014. She was the Co-Chair for the PV council from its inception for 4 years (2015 – 2019). Has been awarded for her consistency in being compliant to the ever changing regulations and received accolades from her Global PV team for innovations within the function. She has been a resource person in several National and International Pharmacovigilance conferences. Sachin Mangalvedhekar Associate Director, Novartis
Sachin Mangalvedhekar is an Associate Director with Novartis based out of Hyderabad. He has been with the QA department of Novartis since 2015. In this role Sachin is a Data Integrity Lead for GDD Hyderabad and drives quality capability development through several training programs and supports audits, self-inspections and anytime inspection readiness. Sachin began his career as a clinical pharmacist, followed by CRA role where he worked with CROs and GlaxoSmithKline Mumbai for close to 5 years. In a career spanning over 20 years, Sachin has performed various roles such as project manager, senior project manager in SIRO ClinPharm and also head of clinical operations group at Sun Pharma Advanced Research Company Limited (SPARC). Sachin is a lifetime member of FERCI- Forum for Ethical Committee Review in India (FERCI) and RQA – Research Quality Association. By qualification, Sachin is a pharmacist with B Pharm and M Tech in Pharma Operations and Management from BITS Pilani. Given his passion for quality and training, Sachin has trained/ mentored more than 150 associates, led 3 regulatory inspections, several audits and has 7 publications in the field of pharmacovigilance. In his free time, Sachin likes to spend time with his family that comprises his wife Chitra who is into clinical research training and daughter Saisha who is in grade 8. He also gives career guidance to new as well as experienced associates. Suhail Ali , Executive Director – Clinical Delivery, PRA Health sciences, Singapore.
Clinical Research Professional with more than 18 years of global experience. Currently leading the Clinical Delivery group of PRA for Asia. He has wide and varied operational and therapeutic experience having worked in Clinical Project Management, Clinical Operations, Team management and Regional Leadership across Global pharma, Biotech and CRO companies. He has served as a global lead on many Clinical Development Programs bringing novel drugs and vaccines to market.
He has worked in a broad range of therapeutic areas including Oncology, Immunotherapies, Pediatrics, Metabolic Disorders, Anti- infectives, Nephrology and Psychiatry. Holds a Masters in Pharmacy, is also a Board Certified Medical Affairs Specialist, and an executive board and founding member of Association of Pharmaceutical Medicine, Singapore (APMS).’ Dr.Rohini Hawaldar Tata Memorial Hospital, Mumbai
Joined TMH in 1986 as Software Programmer First one to Use Personal Computer With basic knowledge of Statistics, used to analyze the clinical data of the patients Graphical Presentation Clinical Audits Received the fellowship for training in Clinical Trials at CRC, London UK & NIH, US (1995) CRS was established in 1997 at TMH Retrospective and Prospective studies were planned First RCT was planned in 1998 Many investigator initiated clinical trials planned and executed Pharma sponsored studies started Initiated Evidence Based Management conferences Team of TCs and Statisticians appointed in 2004 Clinical Research Methodology course initiated TMC Research Administrative Council(TRAC) formed in 2007 Since 2009, coordinating the functions of TRAC Guiding PIs for writing Protocols, designing ICFs & CRFs Training for TCs and IEC Members on SOPs National and international Accreditation of the IECs Extending support to establish Research Facilities at TMC’s satellite Centres Partha Chatterjee Head of Clinical Research, CTS and in charge of Clinical Operations, Siro ClinPharm
Mr. Partha Chatterjee is the Head of Clinical Research, CTS and in charge of Clinical Operations at Siro. Mr. Chatterjee joined Siro Clinpharm in 1998 as a Clinical Research Associate and slowly grew up the ladder to lead the global clinical operations panning across 10 countries. His knowledge and expertise has been pivotal in managing numerous key clinical trials across multiple therapeutic areas such as oncology, nephrology, endocrinology, infectious diseases etc. His leadership has facilitated the Clinical Operations team to successfully execute complex clinical trials across diverse domains like Epidemiology, Medical Devices, and Food & Nutritional products. It has also allowed for Siro¹s diversification into new arenas like the booming FMCG sector. A post-graduate in Microbiology from the Institute of Science, Partha is an influential member of the Indian Society of Clinical Research. He has been actively involved in the drive to transform the Indian Clinical Research scenario and his contributions and suggestions have been crucial in shaping the way forward. Nidhi Rathi Lakra Associate Director, Project Leadership, IQVIA India
Nidhi, Associate Director, IQVIA has more than 20 years of professional experience including 16 years in international clinical research & drug development. Currently she works as Line Manager and Project Oversight at IQVIA, Global Project Leadership. As a Line Manager she manages team of highly experienced global project managers who work with the clients and internal teams to help successfully lead & deliver projects. She started her clinical research journey as a Study Coordinator at an investigator site and thereon joined IQVIA (legacy Quintiles) in 2004 as a CRA. With her sharp acumen on operational excellence and quality focus she augmented her clinical management experience from CRA to Clinical Team Leader, Project Manager, Program Manager and subsequently Line Manager and Oversight. In her earlier role, as a Clinical and Project Lead she managed several regional and global studies across all regions in different therapeutic areas, with particular interest and experience in cardio-vascular & immunology indication. Nidhi counts her experience to lead a large full service biosimilar program in Rheumatoid Arthritis across more than 30 countries in US and European region as well as leading one of the largest cardiovascular program in Venous Thromboembolism in India, as significant in her journey as global Project Manager.
Nidhi holds Master’s degree in “Food and Nutrition” and another Masters from “National Institute of Nutrition” in “Applied Nutrition” and has worked at various hospitals as a dietician before her entry in clinical research. With her inclination towards patient care, management, health and fitness she is extremely proud and happy to be a Clinical Research professional. Nidhi strongly believes in replicating experience and creating strong and capable successors. She drives culture of operational excellence and innovation which are critical for success and have outstanding client experience. Dr. Rubina Bose Dy. Drug Controller CDSCO, West Zone
Doctorate in Pharmacy, M Pharm, B Pharm from Jadavpur University, Kolkata. She has Regulatory experience of more than 20 years, working in Central Drugs Standard Control Organisation in various capacities as head of division, zonal head, Assistant Drugs Controller , Drugs inspectors. She has five years experience of working in production of Injectable drugs prior to joining CDSCO Presently working as Deputy Drugs Controller (I) in CDSCO (West Zone). Worked as Deputy Drugs Controller (India) in CDSCO (HQ), MoHFW, DGHS, Govt. of India in the Divisions of new drug, import registration, quality assurance of vaccines. Worked in WHO Prequalification vaccine assessment team as Technical officer for four months at WHO(HQ), Geneva and participated in vaccine dossier assessment, and inspection of vaccine manufacturer as a prequalification team member and also participated in other WHO meetings, guidance preparation activities. Working as WHO expert in various national and international Advanced Good Manufacturing Practices (GMP) Training of inspectors in countries like China, Thailand, Indonesia, Vietnam, Iran etc Working as WHO expert for developing GMP guidelines of biologicals, Good Regulatory Practices guideline, National Regulatory Authorities (NRA) assessment tools and nominated to represent Govt of India in various WHO meetings/training at Geneva, USA, Tunisia, China, Turkey etc. to contribute in the development of various guidelines Worked as the WHO focal point for NRA assessment of vaccines, GMP inspection of vaccine manufacturing facilities and implementation of Institutional Development Plan including capacity building and training of Inspectors in GMP, GCP, dossier review, pharmacovigilance and development of various guidelines Participated in the NRA assessment of vaccines by WHO in 2009, 2012 and 2017 when Indian NRA was declared functional by WHO.