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Novotel Mumbai Juhu Beach

2024 年 09 月 24 日 8:00 上午 - 2024 年 09 月 25 日 6:00 下午

Balraj Sahni Marg, Juhu Beach, Mumbai 400049, India

DIA India Annual Meeting 2024

Confluence of Care: Pharmacovigilance, Clinical Innovation, Regulatory Sciences, and Medical Devices Elevating Patient Safety

讲演嘉宾

Moin  Don

Moin Don

Founder and CEO, PVCON Consulting, Lead: South Asia Chapter (ISoP),, International Society of Pharmacovigilance (ISoP), India

Moin is a veteran alumnus with 44 years of work in the Pharma Industry and still counting. He is one of the well-known Pharmacovigilance (PV) professionals in Asia-Pacific, having rich hands-on experience of practically every facet of Industrial Pharmacovigilance. He founded PVCON which is a Consulting & Auditing Services firm. He has undergone extensive training in U.S., Germany, France and Singapore to master PV. He is a certified "Lead Auditor"and is closely associated with Govt. Of India's National Pharmacovigilance Program as Advisor and Trainer for DCGI & PVPI staff. Recently, he has been nominated by the International Society of PV to lead its South Asia chapter.

Ashish  Indani

Ashish Indani

Senior Manager – Clinical Affairs Neurovascular, Stryker Global Technology Center, India

Ashish is Senior Manager at Stryker neurovascular and has over 21 years of Clinical Research and Digital Innovation experience in Medical Devices. As a principal scientist in TCS, He has been the part of world’s first Artificial Intelligence based pharmacovigilance processing system development and deployment. He has invented the Nano technology-oriented solution for breath-based detection of cancers and infections and has extended the technology for recreation of as auto adjusting mask, detection of pathogens on nonliving surfaces, circulating air and Sewage water. He has worked on Digital Heart, Digital Nose and AI based preclinical to clinical translation of medical device safety and performance data.

Fahd  Khan

Fahd Khan

Head Business Development - APAC, Emmes, India

Fahd is a seasoned marketing and business development professional with a wealth of experience spanning 17 years. Throughout his career, he has gained expertise in a variety of areas, including marketing strategy, sales, account management, pre-sales, and bid management. He has worked across a range of industries, including BPOs, pharmaceuticals, IT, life sciences, and healthcare, and has a proven track record of successfully managing businesses in a variety of regions, including Europe, North America, the Middle East, Asia Pacific, and Central Asia. Fahd is known for his strong communication skills and the ability to effectively lead a diverse team.

Prashant  Joshi, RPh

Prashant Joshi, RPh

Executive Director - Drug Safety, Fortrea, India

Pharmacist with over 25 years in the pharma industry, including 16+ years in end-to-end patient safety. Expertise spans ICSR management, safety and risk management, and database implementation. Currently leading PharmacoVigilance (ICSR) practice across safety service lines. Proven track record in delivering quality, compliance, and transitions for projects in oncology, orphan drugs, biologics, cell & gene therapy, generics, and innovator molecules. Experienced in regulatory communications and inspections (MHRA, EMA, FDA). Skilled in managing electronic submission gateways, EudraVigilance, and overseeing QPPVs and local RPs.

Ritu  Jaswal

Ritu Jaswal

Vice President - Pharmacovigilance Operations, Parexel, India

Ritu Jaswal Vice President- Pharmacovigilance Operations has experience of more than 18 years in Parexel. She practiced dentistry for 5 years before moving to the CRO world. Involved in winning and take off of more than 25 PV projects. Leading a team of over 2500 staff globally. GMBA for Mohali and Chandigarh offices for Parexel. She likes gardening, reading fiction, listening to music and cooking.

Shadab  Makhdoomi

Shadab Makhdoomi

Vice President, Accenture Life Sciences, India

I, Shadab am working as an Associate Vice President at Accenture Life Sciences R&D Operations within the Pharmacovigilance domain having close to 15 years of industry rich experience and helped multiple Europe and US based pharmaceutical companies in carrying out their Pharmacovigilance services with core expertise in Operational Management, Strategic Management, Stakeholder Management, Resource Management and Automation. By qualification, I have successfully completed my Bachelors in Dentistry with a Post Graduate diploma in Clinical Research. The most exciting part about my job is that is seamlessly aligns to my mission of making this world a better and safer place to live.

Sonica Sachdeva Batra, MD

Sonica Sachdeva Batra, MD

Associate Vice President Enterprise Medical Head- Regulatory Solutions, Indegene, India

I am an MD physician by training, with 20 years of experience in drug development and medical and scientific affairs. I am presently AVP and Global Head for Medical Affairs and Regulatory at a global technology enabled healthcare solutions provider. I have led many successful global Regulatory Authority engagements across the globe, for developed as well as the Rest of the World- emerging/ developing countries, enabling clinical development plans, strategies, marketing authorisations and post approval compliances for various products including biosimilars. I have a keen interest and experience in enhancing medical value add and scientific information dissemination for medicinal products, in the peri approval and post approval space.

J Vijay  Venkatraman, MD, MBA

J Vijay Venkatraman, MD, MBA

Managing Director and CEO, Oviya MedSafe, India

Dr J Vijay is the Founder, MD & CEO of Oviya MedSafe, a global Pharmacovigilance consulting & Drug Safety services providing company based in India and the United Kingdom. He is the first Indian to have received the Fellowship of the Pharmaceutical Information & Pharmacovigilance Association (PIPA), UK. He has been the India Regional Editor of Global Forum, a DIA publication, since 2017. He served as Chair of the Pharmacovigilance Council of the Indian Society for Clinical Research (ISCR) since the Council’s inception in 2015 until 2019. He was the Chairman of the Indian Medical Association (IMA) Headquarters Standing Committee for Pharmacovigilance for 2021. He is a recipient of IMA’s Leadership Excellence Award.

Vijay  Bhargav

Vijay Bhargav

Vice President, Lifecycle Safety, IQVIA, India

AS VP – Life Cycle Safety, Vijay leads Global Safety Case Processing, Regulatory Reporting and Literature Screening services for IQVIA. Vijay brings broad service delivery experience in life cycle safety across Drugs, Vaccine, Device and Consumer products across end-to-end safety case processing and more recently established global capabilities to support COVID vaccine programs for two of the largest vaccine makers. An early adopter of technology; has successfully deployed multiple tools and BOTs to achieve tangible benefits and optimization in his role. Vijay has over 20 years of service delivery experience in the healthcare industry and is a regular presenter at conferences.

Swapnali  Raut

Swapnali Raut

Director, Clinical Operations, Global Monitoring and Site Engagement (GMASE), Global Clinical Operations Development – R&D, GSK, India

Drug development professional with 24 years in clinical research strategy and operations. Holds a Masters in Pharmacy and MS in Pharmaceutical Medicine. Certified clinical research trainer since 2004 with extensive experience in training. Roles include Clinical Research Associate, Project Manager, and Director at GSK, Pfizer, and Parexel.

Pramod  Kashid

Pramod Kashid

CEO, Expecto Health Science, Singapore

Dr. Pramod Kashid is a distinguished professional in the global clinical research and drug development industry, renowned for his expertise in cardiovascular and oncology clinical development as well as adaptive trial design strategies. With a wealth of experience in leading and expanding CRO business in the APAC region, Dr. Kashid is driven by a deep passion for improving the lives of patients by expediting the drug development process and ensuring timely access to innovative therapies. His commitment to making a difference in the healthcare industry is unwavering, as he continues to strive towards making new treatments accessible to those in need.

Manjusha  Rajarshi

Manjusha Rajarshi

Founder Regulus Healthcare, Partner at roots-simplified Research and Consulting LLP, India

Dr. Manjusha Rajarshi has over 30 years in the Pharma industry. She holds an M.Pharm, Ph.D., Diplomas in IPR, and a PG Diploma in Health Promotion from PHFI, New Delhi. Starting as a management trainee at B. Braun, she advanced through Unichem, Aventis Pasteur, Bayer, and Servier India, specializing in regulatory affairs, clinical research, patents, and trademarks. Currently, she is a freelance consultant and runs REGULUS HEALTHCARE in Mumbai. She is also a Partner at Roots-simplified Research and Consulting LLP, focusing on health research programs, scientific content, and strategic consulting, with several original research papers to her credit.

Manish  Paliwal

Manish Paliwal

Director, Regulatory Affairs, Pfizer, Inc., India

Omprakash  Sadhwani

Omprakash Sadhwani

Ex-Joint Commissioner (HQ) and Drugs Controller, Maharashtra Food and Drug Administration, India

30 years of experience in enforcement of drug laws with expertise in detection and investigation of contravention cases. Best Drug Control Officer of India – All India Drug Control Officers’ Confederation – 2010. Gaurav Puraskar – Government of Maharashtra – 2008. Represented India in multiple national and international pharmaceutical forums. WHO GMP audits for 28 years and WHO GMP certificate audit review and Certification Authority for 8 years. As per WHO TRS 823-Issued more than 240 WHO GMP certificates to manufacturers and 140 loan licensees every 2 to 3 years. Issued more than ten thousand COPPs. Former Secretary of All India Drug Control Officers’ Confederation (AIDCOC).

Priyadarshini  Arambam

Priyadarshini Arambam

General Manager Clinical Research Operations, Academic and Research Department, Batra Hospital and Medical Research Center, India

Susan  Korah

Susan Korah

Delivery Head- Healthcare and MedTech,, Tata Consultancy Services, India

Susan is a Healthcare Professional with over 25 years of operational & strategic experience across the entire Clinical Development value chain and Healthcare ecosystem. She has worked across - pharmaceuticals, life sciences, and healthcare BPOs, and has a proven track record of successfully managing businesses in various geographies including Europe, North America and APAC regions. Susan has liaised with regulatory agencies and has hands-on experience in managing multiple regulatory inspections with MHRA, EMA and US FDA. Susan has Master’s Degree in Pharmacy , specialized in Clinical Pharmacology. She is a Certified -Six Sigma Black Belt and LEAN Professional and a certified Workplace COACH.

Sachin  Mangalvedhekar

Sachin Mangalvedhekar

VP GCP and PV Quality, Glenmark Pharmaceuticals, India

Sachin, a clinical research professional, began his career in 1997 as a clinical pharmacist at KEM Hospital, Mumbai. With over 25 years of experience, he has worked in renowned companies like GSK and Novartis. Currently Head of Clinical and PV QA at Glenmark, he has led multiple GCP and PV inspections. Sachin holds BPharm and MTech degrees from BITS Pilani, mentors over 150 associates, and is committed to ethics in clinical research.

Ankita  Arora

Ankita Arora

Sr. Director, Safety and PV, Syneos Health, India

Himanshu  Bhatnagar, MD

Himanshu Bhatnagar, MD

Associate Medical Director, Parexel International , India

Himanshu Bhatnagar is an Ophthalmic surgeon with over a decade’s clinical experience, and nine years of experience in pharmacovigilance. During these years he has worked extensively in drug safety as a Brand Safety Physician, including activities such as Signal Detection & Management, RMP and IB updates, aggregate reports, Clinical Study Reports, and label updates. He is an SME and is involved in mentoring teams in Signal Management Activities and has created training curricula for people starting out in medical writing roles. He also heads a team of product safety leads working for a major pharmaceutical company.

Ankur  Joshi

Ankur Joshi

Senior Medical Information Manager, ProPharma , India

Ankur is a seasoned Medical Information (MI) and Pharmacovigilance (PV) professional with over a decade of experience. He has a proven track record in delivering comprehensive medical information services, leading complex projects, and fostering high-performance teams. His expertise in MI and PV Operations, Project Management, Team Leadership, and Continuous Improvement has empowered him to drive exceptional outcomes for leading pharmaceutical companies. With a solid foundation in operational and project management methodologies, and a relentless pursuit of excellence, Ankur is passionate about leveraging AI to revolutionize medical information and enhance patient safety.

Kiran  Kandula

Kiran Kandula

Senior Director, Pharmacovigilance, ProPharma, India

Debashis  Das

Debashis Das

Medical/Clinical Affairs, Training & Education Leader - APAC, Medtronic, India

Dr. Debashis Das has over 20 years of experience in the healthcare industry and currently serves as the Medical Affairs Leader for Medtronic Diabetes in the Asia Pacific region, including Australia, Japan, and Greater China. He is a Consultant Physician and Diabetologist in Mumbai and an advisor to BIRAC, Ministry of Science & Technology, Govt. of India, for medical technology and digital health start-ups. He also mentors healthcare innovation at institutions like IIT Bombay, TISS Mumbai, ISB Hyderabad, and others. Previously, he was the India Head of Healthcare & Life Sciences at the UK’s Department for International Trade.

Alok  Dhawan

Alok Dhawan

Director, Centre of Biomedical Research, India

Professor Alok Dhawan is the Director of the Centre of BioMedical Research, Lucknow. He has served as Director of CSIR-Indian Institute of Toxicology Research (2015-2020) and CSIR-Central Drug Research Institute. He was the Founding Director of the Institute of Life Sciences at Ahmedabad University. He earned his Ph.D. in Biochemistry from the University of Lucknow and a D.Sc. from the University of Bradford, UK. He has established several toxicology areas at CSIR-IITR and contributed to national guidelines for Nanopharmaceuticals and Nano-Agri products. He is a Fellow of various academies and societies and has over 150 publications, 7 patents, and an h-index of 59.

E. Stewart  Geary, MD

E. Stewart Geary, MD

MD, Global Safety Officer, Eisai Co., Ltd., Japan

E. Stewart Geary, MD, is Global Safety Officer at Eisai Co., Ltd. He is a Councilor of the Japanese Association of Pharmaceutical Medicine and serves on the Editorial Advisory Board for the Journal of Pharmaceutical Medicine. A member of CIOMS XII, he also served on the CIOMS VII Working Group on the Development Safety Update Report, CIOMS VIII on Signal Detection, CIOMS on Standardized MedDRA Queries, CIOMS IX on Medicinal Product Risk Management and CIOMS Working Group on Drug-Induced Liver Injury. Dr. Geary is a DIA Fellow, a Fellow of the Academy of Physicians in Clinical Research and an IFAPP Global Fellow in Medicines Development. He earned a BA from Harvard and MD from Stanford Medical School.

Amrit  Gill

Amrit Gill

Global Head – CHC, Consumer Healthcare Division, Sanofi, United States

Amrit Gill, with over 17 years in pharmacovigilance, is Global Head of Pharmacovigilance at Sanofi Consumer Healthcare, based in New Jersey. She oversees PV Operations, QPPV office, Affiliates, and Safety Science, ensuring drug safety and regulatory compliance. Her leadership spans generics, non-prescription meds, combination products, and devices, advancing global safety standards. Amrit leads initiatives in signal & risk management, driving safety data robustness and global regulatory compliance. She mentors professionals and speaks at industry conferences, embodying a commitment to patient wellbeing and safety.

Seema  Jaitly, DrMed

Seema Jaitly, DrMed

Managing Director, United Kingdom

Dr Seema Jaitly qualified in Medicine from Charing Cross and Westminster Medical School in 1992 and worked in general medicine and psychiatry for four years. She has worked in the pharmaceutical industry for over 20 years at CROs, large and small companies spanning clinical research, medical affairs, pharmacovigilance and EU QPPV.

Utkantha  Kulkarni

Utkantha Kulkarni

Sr Manager CDM, KlinEra Global Services, India

Experienced in clinical operations, data management, and medical writing. Interned as a Clinical Trial Monitor and proficient in end-to-end clinical data management. Skilled in therapeutic areas including oncology and immunology. Authored and reviewed regulatory documents, and translated medical content. Certified in Quality Monitoring by J&J. Worked with tools like Medidata and Veeva Vault. Recognized by Mahindra & Mahindra and awarded for process improvement and quality. Former visiting faculty at ICRI, Dysmec, and KlinEducate.

Sachin  Patil

Sachin Patil

Director and Head Project Management, Expecto Health Science Private Limited, India

Sachin Patil is the Director and Head of Project Management at Expecto Health Science, a leading CRO in Singapore. With over 19 years of experience in the Asia Pacific region, he has held key roles at Medpace and Novartis. Sachin holds a Master of Pharmacy in Pharmacology from NMIMS University, Mumbai, and a Postgraduate Diploma in Clinical Research from the Bombay College of Pharmacy. At Expecto Health Science, he ensures successful project delivery and client satisfaction, driving the company's growth and excellence in the industry.

Murali  Poduval

Murali Poduval

Domain Consultant- Lifesciences Engineering, Tata Consultancy Services, India

Experienced orthopedic surgeon with over 25 years in tertiary-level hospitals in India. Former Professor and Head of Orthopedics at JIPMER, a national institution. Specializes in hip and knee joint replacement . Currently Senior consultant Lifesciences Enginnering at Tata Consultancy Services at Mumbai. Associate Editor for the Indian Journal of Orthopedics and Chief Editor of Medscape Orthopedics. Published widely in peer-reviewed journals. Research interests include deep learning in orthopedic imaging, gait analysis, recovery insights, medical device development, and digital health innovation.

Representative Invited

Representative Invited

Central Drugs Standard Control Organization, India

Syed Ziaur Rahman, DrMed, MD

Syed Ziaur Rahman, DrMed, MD

HOD Dept of Pharmacology, Jawaharlal Nehru Medical College, AMU Aligarh, India

Dr. Syed Ziaur Rahman, Professor & Chairman of Pharmacology at JNMC, AMU, has over 20 years of research experience. He has authored 7 books, 17 chapters, and 200+ research papers. An active scholar, he has delivered 200+ lectures, edited 11 periodicals, attended 80 workshops, and presented at 195 conferences. He introduced the concept of Pharmacoenvironmentology and leads both AMC-PvPI and MDMC-MvPI at JNMC. Currently, he serves as National Secretary for the Society of Pharmacovigilance, India.

Anika  Rana

Anika Rana

Head Medical Safety Assessment and ESP Engagement , Novartis, India

Anika Khokha Rana is a senior Life Sciences leader with 22 years of experience in Drug Safety and Pharmacovigilance leading cross functional global teams. In current role, she heads the medical function at Novartis Hyderabad. She is a Paediatrician with PG in Clinical Research and Data Management.

Sakshi  Rastogi

Sakshi Rastogi

Sr. Director, Life Sciences COE, NTT Data, India

With over 23 years in the Life Sciences industry, Dr. Rastogi is a seasoned physician dedicated to patient safety and quality outcomes. After practicing Gynecology for six years, she transitioned to various roles in pharma and biotech. She has worked with CROs, KPOs, and IT companies, leveraging Design Thinking for solution proposals and client presentations. An accomplished speaker, Dr. Rastogi has presented on Pharmacovigilance and Personalized Medicine and authored several white papers. At NTTDATA, she leads the Pharma CoE, driving innovation and client-centric solutions.

Renu  Sharma

Renu Sharma

Senior Director Pharmacovigilance Operations, Parexel, India

Renu Sharma is currently working as a Senior Director, Pharmacovigilance Operations at Parexel International Chandigarh, India. She is a dermatologist by qualification. She started her journey with this organization ~15 years back. She has a clinical background in the field of Dermatology but because of her interest in PV she got associated with this field. During her tenure, she has successfully worked with multiple pharma clients providing support as a medical professional and managing end-to-end PV processes and operations. She believes in the fact that working in the drug safety field is a huge responsibility and is an absolute commitment towards patient safety. She wants to contribute to this field in every possible way.

G N Singh

G N Singh

(Former Drug Controller General of India), Advisor to Honorable Chief Minister of Uttar Pradesh, India

Bhumi  Vyas

Bhumi Vyas

Director, Clinvigilant Research Private Limited, India

Bhumi Vyas, Founder of Clinvigilant Research Pvt Ltd, has over two decades of experience in Clinical Research. With a Master's in sciences, she started in pharmaceuticals before moving to Clinical Research. At a leading Indian CRO, she led Quality Assurance and navigated over 50 regulatory inspections. Bhumi founded Clinvigilant in 2017 to enhance clinical trials with digital solutions.

Jamal Anwar Baig, PhD

Jamal Anwar Baig, PhD

Multi Country Safety Head – South Asia & Indo-China (Vietnam), Sanofi, India

Jamal Baig has 17 years of experience in pharmacovigilance, currently serving as Director & Head of PV Operations, South Asia & Indochina at Sanofi India since Nov 2021. Former PV Head at MSD Pharmaceuticals for 11+ years and Team Leader at Pfizer (Wipro). He was a lecturer at NIPER and Chair of the PV Council (ISCR), and played a key role in developing PV guidelines for India (CDSCO-NCC-PvPI, 2017). An invited faculty at NCC-PvPI, he regularly speaks at national and international PV events, including DIA, ISCR, and FICCI. Speaker at the World Drug Safety Congress (Boston 2023, Amsterdam 2024), and on the Scientific Organising Committee for ISCR's 17th & 18th Annual Conference.

Naveen  Chhabra

Naveen Chhabra

Senior Medical Safety Lead, Novartis, India

Dr Naveen is a gold medalist physician with experienced (more than a decade) in medical safety, clinical trials, and risk management. Currently, Naveen is working as medical safety lead, in Global drug department, Novartis. Prior to joining Novartis, Naveen has worked with various CROs/BPOs in various roles including global safety physician and project manager.

Srirupa  Das

Srirupa Das

Country Medical Director, Johnson & Johnson Private Limited, India

Dr Srirupa Das, MD and PGDMM, NMIMS Mumbai is a seasoned medical leader with 23 years of experience in clinical practice and Medical Affairs. She excels in strategic medical affairs, evidence generation, and policy shaping. Currently, she is Country Medical Director at Johnson & Johnson MedTech India and leads APAC Process Optimization for Global Scientific Affairs. Previously she was Medical Director at Abbott India, and had roles at Sun Pharma, Lupin and Fresenius Kabi.

D.R.  Gahane

D.R. Gahane

Joint commissioner, Maharashtra State FDA, India

Sakharam  Garale

Sakharam Garale

Founder & CEO, Renovare’ Healthcare Solutions, India

Mangesh  Kulkarni, MD

Mangesh Kulkarni, MD

Global Head – Drug Safety, Tata Consultancy Services, India

Dr Mangesh Kulkarni is a Post Graduate Physician MD with 23 years of experience in Pharma R&D and Medical Affairs from diverse set-ups such as MNC Pharma, CRO, Academia and IT industry. He has handled various leadership roles at the functional, operational and business consulting levels for large scale global business units/functions. In his current role, he heads the Global Pharmacovigilance at Tata Consultancy Services.

Rajesh  Kumawat

Rajesh Kumawat

Head of Medical Services and Clinical Development, Himalaya Wellness Company , India

Dr. Rajesh Kumawat is head of Medical Services & Clinical Development at Himalaya Wellness Company, Bengaluru, with over 25 years of experience. He completed his MBBS at J.L.N. Medical College, Ajmer, and MD in Pharmacology at SMS Medical College, Jaipur. Dr. Kumawat has 20 years of pharma industry experience, including roles at Lupin, Fresenius Oncology, and Ranbaxy. He has expertise in clinical development, pharmacovigilance, and regulatory coordination. Currently, he oversees medical and clinical development for Himalaya's global products and ensures pharmacovigilance compliance. He has numerous publications and has presented at many conferences.

Kiran  Marthak

Kiran Marthak

Director, Medical Affairs, Phase 1 and Regulatory Affairs , Veeda Clinical Research Limited, India

Dr. Kiran Marthak is an acclaimed leader in Indian Clinical Research industry having four decades of phase 1 studies experience. He held senior leadership positions in Novartis, GSK, Pfizer & Ranbaxy in the past and contributed towards shaping up industry regulations including New Clinical Trial Rules, 2019.

Pravin  Nath

Pravin Nath

Founder and CEO, Ultragenic Research and Technologies, India

After co-founding two organizations in the Pharmacovigilance domain over two decades, I aim to address the industry's pressing needs using new-age tech tools. As Founder and CEO of Ultragenic, our vision is to positively impact patient safety outcomes. We develop agile, scalable, and cost-efficient PV technology solutions using AI, Machine Learning, and Robotics, serving both large and small organizations globally.

Asmita  Nimkar

Asmita Nimkar

Director, Nimkar 360 Pharma LLP, India

Dr. Asmita Nimkar is a freelance pharma professional with a Master’s in Microbiology, a Ph.D. in Analytical Chemistry, and an MBA in HR. A Six Sigma Black Belt and ISO auditor, she teaches and mentors at various institutions. With 30 years of industry experience at Sanofi, Servier, and JB Chemicals, she has expertise in regulatory affairs, clinical research, and more. Passionate about AI/ML and skill development, she also counsels students and supports industry-academia collaborations. As a philanthropist, she and her husband enhance education and sustainability in Maharashtra.

Amit  Patil, PharmD

Amit Patil, PharmD

Sr. Manager, Regulatory Affairs, Pfizer Limited, India

Dr. Amit Patil has 16 years of experience in Pharmaceutical Regulatory Affairs and Clinical Trials. He is the Senior Manager of Global Regulatory Sciences at Pfizer Limited in Mumbai, where he leads regulatory strategies for vaccines, oncology, and established medicines. Amit specializes in product and clinical trial registrations for India and South Asia. As a key member of the OPPI e-labelling workstream, he contributes to industry standards and expert committee meetings. His achievements include global awards for regulatory support in vaccine projects and excellence in fast-tracking product registrations.

John  Praveen

John Praveen

AVP – Pharmacovigilance and Medical Writing, Portfolio Delivery Lead, Accenture, India

John is an accomplished PV and MW professional with over 15 years in Product Safety (Pharmacovigilance, Medical Device Vigilance, Hemovigilance, and Cosmetovigilance). As Associate VP at Accenture, he oversees PV/MW Services and leads the Veeva Safety PV Practice. He has established end-to-end capabilities in various safety domains. John has published articles on Gen AI, Machine Learning in PV, and Cosmetovigilance. He holds degrees in Biological Science, Microbiology & Immunology, Medical Entomology, Medical Genetics, and management from IIM Lucknow, and is certified as an Accenture Business Advisory Expert.

Pallavi  Singh

Pallavi Singh

Associate Project Manager,, Abbott, India

Pallavi Singh, a Clinical Project Manager with over 14 years of experience, excels in leading multi-site clinical trials in the Medical Device sector. With expertise in project coordination, regulatory compliance, and cross-functional team management, she consistently delivers projects on time and within budget. Pallavi holds a Master's in Clinical Research and is committed to advancing clinical research and improving patient outcomes.

Aman  Wasan

Aman Wasan

CEO, ArisGlobal, United States

Aman Wasan is the CEO of ArisGlobal. Aman is a Scientist by training with a degree in Human Genomics. He has a deep knowledge of the Life Sciences industry, a well-established background in global leadership roles, and an expert in operational management and commercial leadership. Prior to taking the role of CEO, Aman served as Chief Commercial Officer for ArisGlobal, where he managed our commercial business and significantly scaled revenue. Since joining ArisGlobal in 2018, Aman has excelled in six different positions, including that of Head of Pharmacovigilance. Before joining the ArisGlobal team, Aman worked for Bioclinica as the company’s Global Head of Safety and Regulatory Services.

Pankajkumar  Chhatrala

Pankajkumar Chhatrala

Founder, CEO, Orthoheal, India

Dr Pankaj is an innovator, inventor, researcher and entrepreneur. He is the co-founder of OrthoHeal and also the inventor of the revolutionary FlexiOH® technology that allows washable and ventilated orthopedic immobilization for post-fracture healing. His curiosity, passion, and enthusiasm for medical innovations that can improve lives at large scale outrank any other accreditation to his persona. Dr Pankaj is a medical professional with Bachelors in Medicine (MBBS) and a Masters in Medical Science & Technology (MMST) from IIT-Kharagpur. His entrepreneurial venture OrthoHeal based in Gujarat (India) & Dallas (USA) is constantly engaged in newer innovations and research to help human lives get better, free from pain and profoundly healthy.

Siddharth  Jain

Siddharth Jain

CEO and Medical Device Regulatory Advisor, Symbiorph Clinical Trialogy, India

Jayant  Kumar

Jayant Kumar

Deputy Drug Controller, CDSCO, India

Dr. Jayant Kumar, a pharmacy graduate from MIT Muzaffarpur, holds a master's and Ph.D. in Pharmaceutical Regulatory Affairs from JSS College of Pharmacy, Mysore. With over 7 years of experience, he has served in various capacities in pharmaceutical organizations, including Drugs Inspector and ADC (I) at CDSCO. His responsibilities spanned blood banks, vaccines, medical devices, and inspections for COPP. He has also served as Deputy Drugs Controller (India) and Zonal Head of CDSCO, Ahmedabad. Currently, he is the Deputy Drugs Controller (India) at CDSCO's West Zonal Office, Mumbai. He has participated in key regulatory discussions and international conferences.

Krishna  Kumar

Krishna Kumar

Associate VP, LifeSciences R&D Operations, Accenture Services Pvt. Ltd., India

Krishna Kumar (KK) is a seasoned PV professional and leader at Accenture’s Life Sciences R&D with a B.Sc in Biotechnology, M.Sc in Clinical Research, PGDPM, and LSSBB. With 17+ years in clinical research, specializing in PV for 15 years, he excels in process reengineering, PV operations, stakeholder management, and transitions. Currently, he is the PV innovation lead and Japan PV work capability lead (India based), managing PV automation projects and multiple PV accounts.

Vinod  Mattoo

Vinod Mattoo

Executive Director, DiagnoSearch Life Sciences, India

Dr. Mattoo completed his MBBS from Government Medical College, Srinagar, and his MD and DM from PGIMER, Chandigarh. With over three decades in the pharmaceutical industry, he started at Wockhardt in 1990, then joined Eli Lilly, followed by roles at BMS and Amgen. He is now Executive Director at DiagnoSearch Life Sciences. Dr. Mattoo has extensive experience in regulatory and medical affairs, has published widely, and received a Lifetime Achievement Award from ISCR.

Rajiv  Nath

Rajiv Nath

Chairman, Association of Indian Medical Device Industry (AIMED), India

President of the All India Syringes & Needles Mfg. Association (AISNMA), board member at Kalam Institute of Healthcare Technology, and chair of the ICMED Certification Technical Committee. Member of the National Medical Device Promotion Council, Expert Advisory Groups for BDTD and CDSCO, and Steering Committee on National Biodesign.

Maharukh  Rustomjee

Maharukh Rustomjee

Managing Partner, Amaterasu Lifesciences LLP, India

Maharukh is a seasoned pharmaceutical design scientist and entrepreneur with 39 years of experience. With a Master’s in Pharmacy from ICT, Mumbai, she is the Founder and Chief Scientist at Amaterasu Lifesciences LLP, recognized by "Startup India." She has a background in drug delivery innovations and has co-founded Rubicon Research. Maharukh is known for her mentorship and contributions to the pharmaceutical industry, holding numerous patents and co-editing a book on Pharmaceutical Development.

Ritu  Singal

Ritu Singal

Global Program Safety Lead, Novartis, India

Ritu, based in Hyderabad, has over 13 years of experience in Patient Safety. She started her pharmaceutical career at APCER Pharma, Delhi, and later joined Novartis, Hyderabad, in 2014, focusing on Oncology safety. Ritu is currently a Global Program Safety Lead in Onco-hematology. She holds a medical degree from Kasturba Medical College and an MD in Pharmacology from Government Medical College, Patiala. Married with a 13-year-old son, Ritu enjoys reading and traveling.

Thirumalai Velu   Swaminathan

Thirumalai Velu Swaminathan

Director, India & South Asia-Regulatory Affairs & Pharmacovigilance , Galderma India PVt Limited, India

Dr. Velu, a qualified physician, has versatile experience in Regulatory Affairs, Clinical Research, Medical, and Pharmacovigilance. After post-graduation from Christian Medical College, Vellore, he worked in Clinical Pharmacology on a WHO project. He joined Torrent Research Centre, leading clinical research and setting up PV operations, facing successful USFDA & ANVISA audits. At Accenture, he led medical research for Wyeth, then at Orchid Pharma, he managed BE studies and pharmacovigilance, facing a successful USFDA PV audit. At Allergan, he headed Regulatory Affairs & PV for India & South Asia, managing new drug and device filings. He then led scientific affairs at Philip Morris India.

Preeti  Verma

Preeti Verma

Senior Director, Solution Architect Leader, Business Development,, Qinecsa Solutions , United States

Preeti, a qualified Gynaecologist and Pharmacovigilance Physician, has over nineteen years of experience in clinical practice and pharmacovigilance. She is experienced in obstetrics, gynaecology, oncology, respiratory, endocrinology, infections, psychiatry, and neurology. Familiar with CIOMS, GVP Modules, and FDA guidances, she assists clients with process gap analysis, CAPA implementation, and developing compliant pharmacovigilance processes. At Qinecsa, she is Associate VP, Services Solutions, PV Operations, working closely with business development and delivery teams. Preeti holds a medical degree and specialization in Obstetrics and Gynaecology.

Anupam  Chhabra

Anupam Chhabra

Head of Medical Affairs, Immuneel Therapeutics Private Limited, India

Dr Anupam Chhabra leads the Medical Affairs department at Immuneel Therapeutics, Bengaluru, a company specializing in advanced CAR-T cell therapy. With a decade of expertise in hemato-oncology and immunology, Dr. Anupam is pioneering the application of innovative cancer immunotherapy in clinical settings. He is spearheading strategic efforts to ensure the safe and efficient implementation of CAR-T cell therapies, working closely with researchers and healthcare professionals in India.

Pavan  Choudary

Pavan Choudary

Chairman, MTaI (Medical Technology Association of India), India

Anish  Desai

Anish Desai

Founder & CEO, IntelliMed Healthcare Solutions, India

Dr. Anish Desai is a trained Clinical Pharmacologist and Pharmaceutical Physician with 3 decades of experience in Academia, Research, and Healthcare industry with proven leadership skills, strong business acumen, and a deep understanding of the Healthcare System, including Pharmaceutical, Nutraceutical & Medical device industry. He has been recognized for driving positive change, delivering solutions, developing talent and nurturing strong relationships with external stakeholders. ‘IntelliMed Healthcare Solutions’ is a Healthcare startup launched by him with an intent to focus on strategic medical affairs for business growth, thereby infusing science into business.

Bharati  Jajoo

Bharati Jajoo

Chief at BodyDynamics & Ergonomic Consultant, BodyDynamics, India

Dr. Bharati Jajoo, with over 25 years of experience, is an expert in office ergonomics and the Chief of "Body Dynamics," a Bangalore-based firm. She is an OTR and CEAS, AOEAS specialist, known for enhancing employee health globally. Dr. Jajoo has published extensively, presented internationally, and contributed to a book on ergonomic design.

Mohit  Mhatre

Mohit Mhatre

Digital Health Delivery Lead, GSK, India

I hold a Bachelor's in Ayurvedic Medicine and Surgery from Mumbai, India, and have a Professional Diploma in Clinical Research. With over 15 years in the Life Sciences industry, I specialize in Project Management across Digital Health, Clinical Data Management, and Medical Coding. Currently, I am a Digital Health Delivery Lead at GSK, India, focusing on integrating Digital Health into clinical trials. I am passionate about learning new technologies and enjoy spending time with my kids and exploring new cuisines while traveling.

Gaurav  Shah

Gaurav Shah

Deputy General Manager, Product Safety and Risk Management, Viatris Laboratories Ltd, India

Umesh  Suryawanshi

Umesh Suryawanshi

Global Pharmacovigilance Physician, Colgate Palmolive India Ltd, India

Umesh Suryawanshi, MBBS, is a medical professional with over 14 years of experience in healthcare, including 4+ years in clinical practice and nearly 10 years in pharmacovigilance. As Assistant Manager of Global Pharmacovigilance at Colgate-Palmolive India Limited, he handles ICSRs, collaborates with EU and ROW teams on Cosmetovigilance and regulatory queries. Umesh enjoys sports and music.

Ashokkumar  Thakkar

Ashokkumar Thakkar

Head of Clinical Research, Meril Life Sciences Pvt. Ltd., India

An accomplished leader in clinical strategies & medical device trials. Specialized in early-stage first-in-human and pre-market trials for medical device start-ups. Expertise in regulatory affairs, clinical evaluation reports, and cross-functional leadership.

Laxmana Kumar  Jakkala, PhD

Laxmana Kumar Jakkala, PhD

Senior Vice President, Clinical & Regulatory, Techsol Life Sciences, United States

Dr. Laxman Jakkala, VP of the Clinical & MedTech Division at Techsol Lifesciences, has over 20 years of experience as a Clinical and Regulatory expert in Medical Devices and Biopharma. He has led regulatory inspections and global audits with USFDA, WHO, DCGI, and EMA. Specializing in EU MDR/IVDR remediation, CE marking, and ISO 13485/14155 implementation, he excels in product registrations, clinical trial applications, 510(k), PMA, GUDID, EUDAMED, medical device labeling, CER, PER, and PMCF studies. Dr. Jakkala is also key in developing regulatory strategies, launching products, and building industry relationships.

Gaurang  Shah

Gaurang Shah

Proprietor, GAURANG SHAH & ASSOCIATES, India

Gaurang Shah is a Fellow Member of ICAI, holds a Diploma in Information System Audit (ISA-ICAI), and is a commerce graduate from Mumbai University. He has a PG Diploma in Business Management from NMIMS and a certification in Masters of Business Finance from ICAI. With over 30 years of experience, he has held senior positions in business consulting, investment banking, KPO, and IT. He has managed advisory assignments in business restructuring, planning, due diligence, valuations, M&A, and fundraising. His expertise spans various industries, including airlines, real estate, pharma, and more. Currently, he practices as a CA with his firm, Gaurang Shah & Associates.

Kamal  Shahani

Kamal Shahani

Managing Director, Cliniminds, India

Kamal Shahani is a seasoned professional with 30+ years in healthcare and life sciences. As Managing Director of Tenet Health Edutech Pvt. Ltd., he oversees health science services, education, and training. He also manages Think-i and CRQA, and founded Mediminds, offering consulting solutions. His career includes senior roles at Allied Research International, Cetero Research, Dr. Lal Path Labs, Gribbles Pathology, and the Australian Trade & Investment Commission. He holds degrees in commerce, an MBA, and a Post Graduate in International Trade.

Mamta  Sharma

Mamta Sharma

Director Regulatory Affairs, PAREXEL, India

Seasoned Regulatory Affairs Leader with 25+ years in pharma and CRO industries, including 14 years at Parexel. Leads 140+ professionals across India, APAC, and EU. Expert in Indian regulations for CTAs, drug development, and MAAs. Speaker at DIA and RAPS; active ISCR member.

Bhawana Saddy Awasthy

Bhawana Saddy Awasthy

General Manager India, Vice President Medical & Scientific Management, Syneos Health, India

Clinical Oncologist with 29 years of clinical and research experience. At Syneos Health for 13+ years, led large phase III trials, and presented protocols to regulatory agencies (DCGI, FDA). Extensive expertise in Phase I-IV studies in oncology (Immuno-oncology, biosimilars, solid tumors, multiple myeloma), neurosciences, infectious diseases, antivirals, and vaccines. Skilled in developing oncology trials and managing medical teams. Serving as General Manager for India (4000+ employees) since 2023. Experienced in bioavailability, bioequivalence studies, and management of solid tumors, lymphomas, and multiple myeloma. Published in peer-reviewed journals.

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