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.

Senior management professional and entrepreneur with 30+ years of experience in drug development and epidemiology; Founding member/founder of two companies.Pharmaceutical industry experience spans across Clinical Development, Pharmacovigilance, Scientific Writing, RWE and HEOR; experience includes setting up and building expertise and operations in these areas.Currently responsible for clinical development and RWE practice in NTT DATA’s Life Sciences Consulting organization

Sanish is the R&D Director at Johnson & Johnson Innovative Medicine, India, and a former President & Executive Committee Member of the Indian Society for Clinical Research (ISCR), India's leading clinical research organization. A trained Clinical Pharmacologist (MD, DM) and Fellow of ACCP, USA, he brings about 18 years of experience in the pharmaceutical industry, spanning Clinical Development, Clinical Pharmacology, Medical Affairs, and New Product Strategy across India and Emerging Markets. He is passionate about advancing clinical research education, integrating ethics into clinical trials, and driving innovation in rare disease development.

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.

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.

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.

Gaurav holds a PhD in Biotechnology (University of Pune) and an MBA (BITS Pilani). With 25+ years in academia and healthcare, he specializes in R&D, regulatory planning, and lifecycle management. Since 2021, he has led Parexel Bengaluru’s 350+ Global Regulatory Affairs team. Previously, he held senior roles at IQVIA, INC Research, Biocon, Clinigene, and Avesthagen. An ISCR Executive Committee member (2023-25), he chaired its South Chapter (2019-23) and Regulatory Council (2009-19). He received ISCR’s “President Award” (2019, 2020) and “Hall of Fame” Award (2018). He also chairs Narayana Health’s Academic Ethics Committee. A GCP expert, he has trained professionals for 12+ years and published 10 research papers.

With around 26 years of experience in Pharma & 6 in the Clinical Research industries, Dr. Qayum Mukaddam has been on both the sides of the table (viz Sponsor & CRO). He passed his MBBS from T N Medical College & MD in Pharmacology from Grant Medical College & Sir J J Group of Hospitals, Mumbai.He had the opportunity to be in Indian as well as MNC Pharma organisations, gaining valuable experience in Medical Affairs, Regulatory, Clinical Research, Pharmacovigilance & Compliance.He enjoys interacting with young mind,s be it fresh medical graduates aspiring to make their mark in the Healthcare industry or colleagues from Sales and Marketing in the Industry.

A Pharmaceutical Physician With 27 years of industry experience, Dr. Viraj Suvarna has held leadership roles including Country Medical Director, Roche Pharma India; VP & Head Medical at Biocon Biologics, Lupin, and DRL; President Medical at Eris Lifesciences; Medical Director at Boehringer Ingelheim; and Head Medical Operations at Pfizer. He is an accredited speaker (MMC), Section Editor (PICR), peer reviewer, author of 50+ publications, and former ISCR EC member and OPPI/EFPIA committee member. He topped MD Pharmacology at GMC, with academic distinctions in MBBS and holds an MSc in Pharmaceutical Medicine from Hibernia University.

Suraj is a seasoned professional with over 19 years in clinical research, adept at managing trials across various phases and setups. His expertise includes designing Case Report Forms (CRFs) and transitioning from paper-based to electronic systems. He has led multiple studies, overseen drug safety projects, and managed a global team of 350+ professionals. At GSK, Suraj heads the service delivery unit, managing Functional Service Providers (FSPs), delivery, operations, performance tracking, training, and access management. Known for his innovative approach, he excels in navigating complexities and meeting critical timelines. Suraj also enjoys classical music, traditional painting, traveling, reading, and listening to music.

Clinical Research Professional with 27+ years of experience across pharma, academia, and government. Began career as a CRA at AstraZeneca India, later holding leadership roles at MSD, Bharat Serums & Vaccines, and THSTI (Govt. of India). Currently serves as General Secretary of the Indian Society for Clinical Research (ISCR) and Adjunct Visiting Faculty at Manipal College of Pharmaceutical Sciences. Holds an M.Pharm in Pharmacology, an Executive MBA from IIM Lucknow, and a Doctorate in Business Administration from SSBM, Geneva.

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.

Head of Clinical Data Management, Sanofi; Steering Committee Member & Co-Chair, SCDM India. Expert in global operations, inspection readiness & innovative tools. Passionate leader driving impactful change, mentoring teams & advancing healthcare through data.

Abhinav has Masters' degree in Pharmacy and a Pharma MBA degree.Over 14+ years in end-to-end patient safety experience, including ICSR management, safety and risk management, database implementation and migrations.Heading PV practice that includes Process Compliance Review and Analysis (PCRA), SME vertical; having worked across entire safety service lines. Managed delivery, quality, compliance and transitions for multiple projects across various therapeutic areas including oncology, orphan drugs, biologics (vaccines and other biologics), CGT, generics and innovator products

Dr. Subrat is a qualified medical physician with an M.D. in Pharmacology from Seth G.S. Medical College, Mumbai University. He brings over 23 years of experience in Medical Affairs, Clinical Research, and Pharmacovigilance. Currently Regional Director, Medical Affairs (Women’s Health) for Asia Pacific, Eastern Europe, Middle East, and Africa, he has led numerous cross-functional medical projects. A published author and speaker, his expertise spans Women’s Health, Oncology, Respiratory, Dermatology, Analgesics, and Anti-microbials. He is also a Fellow of the MSD Global Fellowship Project with JHPIEGO.

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.

Allwyn has over two decades of experience in Lifesciences and Clinical Trials, with expertise spanning Data Acquisition, Data Management, and Statistical Programming. Currently, he serves as a Product Owner at Saama, focusing on Agentic AI-powered data lake and data transformation solutions for pharmaceutical and clinical research organizations. He is particularly passionate about integrating GenAI-based automation into daily processes to accelerate clinical trial submissions. His recent work includes spearheading GenAI solutions for Statistical Programming deliverables such as SDTM, ADaM, and TFLs, as well as Medical Writing deliverables like CSR and Patient Narratives, and Data Management use cases such as Centralized Sample Tracking.

Arnab Sengupta, VP at Novo Nordisk, brings 20 years’ global experience in clinical research, leading data science, AI-driven innovation, and workforce transformation to accelerate data-to-decision and improve patient outcomes. Aligned with the moto "patients are waiting", he aspires and leads with clear vision, people focus and business solutions.

Currently serving as Vice President – Customer Excellence at ArisGlobal, I bring over a decade of leadership experience in pharmacovigilance (PV), healthcare, and life sciences technology. My career spans strategic roles at global organizations including Foresight - IQVIA, Pinnaxis where I have led high-impact initiatives across product, services, and delivery. Known for a strong commercial mindset and strategic vision, I specialize in driving customer-centric growth, scaling complex programs, and delivering business value at the intersection of technology and healthcare.

Dr. Mohammed Baseer Ahmed is an accomplished pharmacovigilance executive with over 20 years of experience spanning the entire product lifecycle—from Phase 1 clinical development to product sunset. He has held leadership roles in organizations ranging from large pharmaceutical companies to ultra-rare disease biotech companies. He has led global pharmacovigilance operations and driven key initiatives including safety system modernization and vendor transitions. Dr. Ahmed has successfully guided teams through high-stakes regulatory inspections and complex safety challenges.

Ex-EVP Lupin Ltd, headed global clinical development before retirement in 2023. Worked for Sanofi, Reliance Clinical Research Services, Novartis, Fulford & started his career with Glaxo after his MD from Grant Medical College in Mumbai. Profiled in a book by Tata McGraw-Hill “Thought Leaders” amongst 22 corporate leaders from different sectors of corporate India published in 2000.

A dental surgeon by training, Dr. Arati Borkar joined DiagnoSearch Life Sciences in 1999 as a Quality Manager for Central Laboratory operations and gained rich cross-functional experience over her 25 years tenure, having worked in various areas of the organization. She currently heads the Quality Assurance team. Dr. Borkar is actively involved in designing and conducting various in-house and external training programs and has extensive experience as an independent auditor for investigational sites and analytical laboratories across the world.

Dr. Siva is a physician with an MBA and holds a Lean Six Sigma Green Belt. He heads the signal and risk management along with Gen AI for safety at Indegene. He has led various automation initiatives using RPA, AI, and GenAI for diverse use cases. His expertise encompasses the full range of pharmacovigilance activities, from case processing to risk management. Throughout his career, he has collaborated with numerous CROs and leading pharmaceutical firms, including Viatris and Teva Pharmaceuticals. Additionally, Dr. Siva is a frequent speaker at both local and international pharmacovigilance conferences. He serves on the Board of Studies at Chitkara University, where he contributes to curriculum development and delivers guest lectures.

I am a result-driven regulatory expert with over 16 years of experience in biologics and pharmaceutical drug development and approval with specializing in core regulatory CMC and lifecycle management. I hold a master’s degree in Bio-medical Genetics. In my current role as Regulatory Manager, I am managing multiple clients and dealing with major submissions of the vaccines in the developmental pipeline as well as the life cycle management of the mature vaccine products in the market.My experience covers a wide range of regulatory activities, including strategy development, submission preparation, and agency interactions across multiple regulated and nonregulated markets.

Dr Rashmi Hegde is currently Executive Vice President Medical at GSK India. Dr Hegde is a Paediatrician by training and has vast experience with the International Pharmaceutical companies.She has been associated for over 2 decades with several global Pharmaceutical companies such as Abbott, Solvay, Wockhardt, Piramal, Novartis and Cipla. Dr Hegde has led Medical Affairs, Medico-Marketing, Medical Strategy, Clinical Operations, Regulatory, Pharmacovigilance and Medical Scientific Liaison for both Pharmaceutical and Biotechnology companies.

Decisive, results-oriented, transformational and passionate medical affairs and clinical research professional, Dr Sadhna Joglekar is the Head of Global Drug Development (GDD) Centre in India for Novartis. She is also a member of the NGSC (Novartis Global Service Center) Board in India. As Head of GDD in India, Sadhna leads the creation and implementation of the overall long-term vision and strategic priorities for GDD India that will enable growth for all GDD functions in India. She also plays a key role in facilitating cultural changes that empower GDD India associates to realize their full potential and have a big impact on patients.

Alok Khettry is a seasoned business leader with 38 years in the pharma and biotech industry, known for driving transformation and building future leaders. Most recently as COO – India at Bharat Serums and Vaccines (BSV), he played a key role in BSV’s successful transformation, including Advent’s exit and acquisition by Mankind Pharma. Previously, in a 35-year career at Sanofi across India and Southeast Asia, Alok led high-performing teams, expanded patient access, and delivered sustainable growth. Named Sanofi’s “Talent Champion for Asia-Pacific & Japan,” he is passionate about coaching, digital innovation, and advancing healthcare.

Ashwini Mathur is Executive Director at Onesto Consulting, based in Dublin, advising pharma companies, research organizations like the Gates Foundation, and institutes such as RCSI Dublin. With 30+ years in clinical research, he holds a PhD in Biostatistics (UC Berkeley), Executive MBA (IIM Bangalore), and Master’s in Mathematics (IIT Delhi). Formerly Head of R&D Ireland-UK at Novartis, he has 35+ publications, 2 book chapters, and 150+ presentations. He is past President of the Indian Association for Statistics in Clinical Trials and former Secretary of the International Biometrics Society. Ashwini also mentors Ayurveda research and is adjunct faculty at institutes in India and Ireland.

José is an expert in the field of Pharmacovigilance and Drug Safety. He has experience both from the Regulatory (Danish Medicines Agency), and from the Pharmaceutical Industry, where he has been responsible for Pharmacovigilance IT systems, databases and electronic transmissions. He has been training EVWeb and XEVMPD training courses since 2004, and collaborates in the development of these training courses. He provides also EU QPPV services and local QPPV services in Spain for Pharmaceutical Companies.

Raghav is Head of Pharmacovigilance for SEA at Takeda, based in Singapore, with a passion for Patient Safety, innovation, and value creation. He leads regional PV strategy, fostering cross-functional partnerships aligned with company goals and emerging trends. Previously, he held senior PV roles at Ipsen (MEA/Eurasia), AbbVie, and Lundbeck across APAC, with deep expertise in diverse regulatory landscapes. With a strong track record in team building and strategic leadership, he brings broad experience in PV, clinical research, and project management. Raghav holds a Master’s in Clinical Pharmacy from the College of Pharmaceutical Sciences, Manipal, India.

Niyati has an impressive 19 years of experience in regulatory affairs and product development across Drugs and Biologics. She is a seasoned expert in crafting global regulatory strategies, especially for biosimilars. Her deep expertise spans: Pre and post approval planning and processes, Strategic product development, Complex submissions including IND, IMPD, BLA, NDA, and MAA. As a head of department, she develops and executes plans for clients to navigate through the diverse and demanding regulatory requirements, providing expert consultation and support throughout the drug development and commercialization lifecycle. Her proficiency has been instrumental to support successful commercial product launch and distribution.

Mr. Gregory Smith is the Director of the India Office in the FDA’s Office of Global Policy and Strategy (OGPS). With over 12 years at the FDA, he previously led CDER’s Special Projects Staff and worked as a regulatory project manager in CVM’s Office of New Animal Drug Evaluation. He specializes in complex scientific, regulatory, legislative, and operational issues, including user-fee negotiation, supply chain assessment, and portfolio management. Mr. Smith also has experience in clinical trial management, risk evaluation, and post-marketing surveillance. He is a certified project and portfolio management professional and graduated from the University of Maryland, College Park.

Shreenath (Shree) Sreenivas currently leads Research and Development Business Insights and Technology, India at Bristol Myers Squibb in Hyderabad. He holds a B.Sc. (Hons.) and M.Sc. in Industrial Chemistry from IIT Kharagpur and an Executive MBA from ISB, Hyderabad. Shree is a seasoned science and technology leader with over 22 years’ of global experience. With a “patient first” mindset, he spearheads AI innovation, clinical transformation, organizational excellence and R&D strategy across life sciences and pharma.

Dr Mrutyunjay Suar is the Director General of Industry-Institute-Innovation Interface at KIIT University, Bhubaneswar, CEO, KIIT Technology Business Incubator (KIIT-TBI) and the Chairman of Bhubaneswar City Knowledge Innovation Cluster Foundation (BCKIC), an initiative of the office of the Principal Scientific Adviser (PSA) to the Govt of India. An entrepreneurial professor with PhD in Molecular Microbiology from University of Delhi and postdoc from Institute of Microbiology, ETH Zurich. Under his leadership, KIIT-TBI nurtured 460+ start-ups in last 15 years, created 10000+ jobs and established Centre of Excellence in incubation in the area of Digital Health, Diagnostics & Precision agriculture, supported by DST, Govt of India.

Dr Chitra is a pharmacovigilance (PV) and clinical research professional with over 24 years’ experience through unique combination of quality/compliance and operational leadership.Her core strength has been in leading PV/GCP compliance and Quality Assurance projects and always striving for PV/GCP inspection readiness.Since 2021, she transitioned from heading quality assurance for PV and GCP to heading pharmacovigilance (Drug Safety and Risk Management-DSRM) operations at Lupin Limited leveraging her QA expertise.Chitra started her career in Academics in Clinical Pharmacology at KEM Hospital, Mumbai. Prior to joining Lupin, she has worked in various capacities in Pfizer, BMS and ADAMAS Consulting.

With over 25 years of experience in strategic global clinical study management and operations, Partha heads a large, geographically dispersed team at Syngene International Limited. He is instrumental in steering operations to execute complex clinical trials across different domains, including pharmaceutical, biosimilar, therapeutic equivalence or epidemiology, medical device to food & nutritional products.He worked as an integral member of the core operations team in his earlier company and handled several regulatory inspections, including USFDA, EMA and WHO, with a favorable outcome. He is also one of the Experts of the Project Monitoring Committee overseeing progress of Ophthalmology Clinical Trial Network funder by DBT and BIRAC.

Dr. Srirupa Das, a Pharmaceutical Physician with 24 years of experience, has held leadership roles including Country Medical Director, and APAC Lead for Global Scientific Affairs at Johnson and Johnson MedTech; Country Medical Director at Abbott India Ltd. Her expertise spans Clinical Development, Medical and Regulatory Affairs, Portfolio Strategy, and Governance. She has managed proprietary, specialty and established portfolios; domestic and global markets. She has driven brand leadership through innovative evidence strategies and contributed to healthcare policy shaping in India.Dr. Das holds an MD in Pharmacology, and a postgraduate diploma in marketing from NMIMS, Mumbai.

Avisek is a seasoned leader in the Life Sciences industry, bringing close to 18 years of experience in global program management, and pharmacovigilance operations. He is currently serving as an Engagement Delivery Leader at Cognizant. He has successfully led large-scale transformation initiatives for leading biopharmaceutical organizations, with a strong focus on compliance, operational excellence, and talent development. He is an alumnus of Cranfield University (UK), and XLRI, and has delivered invited talks in more than 10 academic conferences, spanning premier institutions and universities.

With over 25 years of progressive experience in the clinical research industry, Charu Gautam is a seasoned leader with deep expertise in the design, execution, and oversight of Phase I–IV clinical trials across multiple therapeutic areas. Her career spans global pharmaceutical companies , CROs, and academics, where she has consistently driven excellence in clinical development, medical strategy, and operational delivery.Charu brings a unique blend of scientific acumen and strategic foresight, having led cross-functional teams in complex, multi-regional studies.Charu is recognized for her ability to navigate complex clinical landscapes, mentor emerging leaders, and deliver results that advance both scientific knowledge and patient care.

Dr. Jaideep A. Gogtay is the Global Chief Medical Officer at Cipla Ltd, where he has served for over three decades. A medical graduate from Grant Medical College and M.D. in Pharmacology from Seth GS Medical College & KEM Hospital, he leads global medical affairs, clinical development (India), and pharmacovigilance. He has contributed to the development and launch of several drugs, especially in HIV/AIDS, infectious diseases, and respiratory medicine. He has led Phase 2–4 clinical trials and helped establish the Chest Research Foundation. Dr. Gogtay has over 60 publications and 100+ conference presentations.

Dr Mahesh Iyer, PhD, is Head of Biometrics and Data Sciences at BMS India with 25+ years in R&D across Pfizer, Novartis, BI, and Parexel. At Pfizer, he led Stats, AI/ML, Digital Sciences, and Innovation (India-Philippines). He also served as VP at Parexel, co-founded Sineflex Solutions LLP, and led the BIRAC-funded med-tech accelerator at IIIT Hyderabad. Mahesh mentors med-tech startups, fosters industry-academia ties, and initiated a part-time Ph.D. program at Novartis. He is Past-President of IASCT and IISA (India Chapter) and was named among India’s Top-100 AI leaders. A certified coach in emotional intelligence and assessments, he holds a Ph.D. in Statistics from Temple University, Philadelphia.

She is a qualified medical physician, MD in Pharmacology, from Seth GS Medical college and KEM Hospital, University of Mumbai, India. She is a Diplomate of the National Board, in Pharmacology (DNB) as also holds a Master’s degree in Pharmaceutical Medicine, from the University of Hibernia, Dublin, Ireland (MSc).She has more than 18 years of experience in the pharmaceutical industry in Medical Affairs, Clinical Research & Development, Health economics and Pharmacovigilance. She currently heads the Medical function at GSK India as the Executive Vice president Medical Affairs, handling their General Medicine, Specialty, Vaccines portfolio and Pharmacovigilance.

John Praveen is an accomplished Pharmacovigilance and Medical Writing professional with 17+ years of experience across product safety, including pharmacovigilance, device vigilance, hemovigilance, and cosmetovigilance. As Associate Vice President, he leads global PV/MW portfolio delivery and shared services, driving strategy and transformation across geographies. He serves as National Secretary and Board Member of SCRM and is on the Editorial Board of the Journal of Patient Safety & Epidemiology. John holds degrees in Biological Sciences, Microbiology/Immunology, and management from IIM Lucknow.

Yogananth Rajendran is a distinguished leader in the field of Biologics Regulatory Affairs, currently serving as the Vice President of Global Regulatory Affairs at Kashiv Biosciences. He has played a pivotal role in securing the global authorization of biologics, biosimilars, cell and gene therapy products. Prior to his role at Kashiv Biosciences, he held key positions at Immuneel Therapeutics, Zydus, Intas, Lupin, Julphar, and Biocon.

Dr. Anupama is a physician and researcher with 25+ years of clinical research experience across drugs, devices, and biosimilars in all phases of development. One of India’s first Phase 1 NCE investigators, she is Founder & SME at Arkus Research, advising pharma, CROs, and health tech startups globally on clinical strategy, medical affairs, and GxP compliance. A GCP evangelist and advocate for rational, risk-based QMS, she has contributed to Indian GCP (2005), mentors teams, and serves on academic and startup advisory boards. She is also a PhD guide and peer reviewer for IJP and Scientific Reports.

Accomplished leader in medical affairs with over 20 years of experience, including more than a decade as head of medical affairs in pharmaceuticals, biotech, and patient care. He possesses extensive expertise in various domains, such as medical affairs, clinical research, regulatory affairs, medical governance, and pharmacovigilance, at global, regional, and national levels. He is a strategic and forward-thinking medical affairs leader capable of developing departmental vision and aligning strategic objectives to achieve it. Passionate and driven, with a deep-seated belief in developing the next generation of leaders and fostering talent pipelines.

Dr. Pranav Sikka, the Global Head of Safety Signal Detection and MedDRA Query Management at Novartis, oversees the signal detection for Novartis products. Dr. Sikka is a highly qualified physician with a postgraduate degree in Pharmacology and Pharmaceutical Regulatory Affairs. Over the course of his illustrious career, he has amassed 16 years of professional experience, including 13 years solely dedicated to pharmacovigilance. His expertise in pharmacovigilance is particularly pronounced in the area of core signal management activities, which he has focused on for the past 12 years.

Gurpreet Singh is Vice President, Managing Director Integrated Safety at IQVIA. Based in UK, he has 18 years' experience in Pharma Industry of which 16+ years have been in Global Drug Development. He has had the opportunity to work with some top global companies like Cognizant, Tata Consultancy, Novartis and Parexel. At Novartis he was the Global Head of PV Operations managing all Global PV activities. At Parexel he was the Senior Director PV Operations responsible for managing PV projects of top Global Pharma and Biotech companies. Gurpreet is a certified Six Sigma and Project Management Professional. He has interest in Digital Transformation and Organization Culture and has led various projects during his tenure in the Pharma Industry.

Bijal is a postgraduate in Biochemistry has been working with TCS for more than 18 yrs in Clinical Data Management domain. She has rich experience in managing study set-up, conduct and close-out of clinical trials across TAs including Cardiovascular, Immune inflammation, Autoimmune, and Respiratory spanning across all phases of clinical trials. She has managed complex clinical studies including megatrials with 15000+ subjects and RWE. She has been instrumental in pivoting key roles like Lead Data Manager, SDTM data manager by providing operational excellence and enhanced customer experience.

Shehnaz started her clinical research career with Pfizer India in 1997, as a CRA. She then moved to Data Management followed by Head Quality Standards for the Pfizer India Medical Department. Post Pfizer, Shehnaz worked as an independent audit consultant, until 2013 when she joined ADAMAS as Head for the Asia-Pacific region. She has conducted over 170 GCP audits globally and has been instrumental in launching ADAMAS Insights, a data visualization tool.

Ms. Lakshmi Achuta is a quality and compliance specialist with three decades of experience providing strategic advisory services in the biotech, pharmaceutical & medical devices sectors for strategy, quality (GLP, GCP, GMP, ISO), compliance and skill enhancement having worked in Biotechnology, Biopharmaceutical, Clinical Research (CRO), Contract Research and Manufacturing Services (CRAMS) industries with increasing responsibilities. She has previously worked in the Biocon Group for 26 years at Biocon & Syngene. She has been awarded the Hall of Fame Award by the Indian Society for Clinical Research for her contributions.

With over 25 years in the pharmaceutical industry, Dr. Artem Andrianov is a leading expert in clinical data quality and biostatistics. As the CEO of Cyntegrity, he specializes in data-driven risk management in clinical trials. His academic background includes a Ph.D. in Mathematical Modelling and an Executive MBA. Dr. Andrianov co-founded Cyntegrity in 2013, focusing on advancing RBQM. His specialized knowledge spans Spirometry, ECG, Oncology, ePROs, and clinical data management. Committed to making clinical trials safer and more reliable, Dr. Andrianov is a key figure in the evolution of RBQM.

Global leader in medication safety, currently president of the International Society of Pharmacovigilance (ISoP), an institution with presence in 100 countries, whose mission is to improve the medication safety worldly.Pharmacist, Epidemiologist, Ms Pharmaceutical Care, MSc Education. With more than 20 years of experience, she is an international consultant and lecturer in pharmacovigilance, safe use of medications and medical devices, patient safety, patient education, leadership and communication. She was president of the Colombian Pharmacovigilance Association for 5 years, founding member and Co-chair of the ISoP Special Interest Group (SIG) "Medication errors. Currently Pharmacy Career Director in Pontificia Universidad Javeriana.

Dr. Pankaj Gupta is Senior Director, Medical Affairs at Pfizer India, with broad experience across medical affairs, public health, pharma marketing, and clinical practice. He holds an MBBS and MD from Grant Medical College and Seth GS Medical College, Mumbai, a Fellowship in Clinical Sciences, and management training from XLRI Jamshedpur. Passionate about transforming clinical practice for better patient access and outcomes, Dr. Gupta brings deep expertise in strategic medical affairs, clinical research, integrated evidence generation, market access, and healthcare system partnerships.

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.

Dr. Kacker is a Pharmacologist by training, having completed his PhD in Pharmacology from All India Institute of Medical Sciences in India. Dr. Kacker switched his interests from academia to pharmaceutical industry more than 18 years ago, and has managed the Regulatory and Pharmacovigilance functions at global organizations. Dr. Kacker is a co-founder of APCER Life Sciences, having started the company out of UK more than 11 years ago. In his current role he operates as the Managing Director and Global Technical Head of APCER. Dr. Kacker has been a Qualified Person/Person Responsible for Pharmacovigilance with experience of more than 17 years as EU-QPPV and in his current role he does operate as the EU-QPPV for some of APCER’s clients.

Rajendra Kumar Kasi is Vice President and Global Head of Pharmacovigilance, with over two decades of leadership in the pharmaceutical industry. He has led global PV transformations, built agile teams, and implemented technology-driven safety systems. Rajendra has successfully navigated integrations, inspections, and restructuring while maintaining compliance and advancing patient safety. A recognized speaker and thought leader, he advocates for digital innovation, evolving regulations, and the future of safety science. Passionate about mentoring, he champions PV as a catalyst for innovation, trust, and sustainable healthcare.

Healthcare industry leader with 20+ years of global experience in drug development and digital health technologies (DHTs). Expertise in biostatistics, RWE and regulatory. Drove industry innovation through TransCelerate Biopharma, Digital Therapeutics Alliance and Roche’s digital innovation hub Startup Creasphere. Previous work experience includes Merck (Philadelphia), Genentech (South San Francisco), Roche (Santa Clara) and an internship at Pfizer (Ann Arbor). Holds Ph.D. in Statistics (UC-Santa Barbara) and M.Sc. in Applied Statistics and Informatics (IIT-Bombay). Recently relocated to Pune, India.

Sujit has over 20 years of experience within pharma services. His journey has been through global delivery, eClinical operations and operational excellence. He has worked with top Pharma companies and ITES service organizations Viz. Pfizer, J&J, Cognizant and TCS across Clinical Operations, Data management and Data transformation. He has managed teams across all phases of clinical trials and multiple therapeutic areas. He has a 11 Yr. old Son, and enjoys photography and sports during his free time. At present, Sujit is Sr. Director Operations with IQVIA Digital Products and Services.

Dr. Sundaresh K.N is an independent consultant specializing in global clinical trial patient recruitment and retention strategies. He leverages Process driven technology and AI enabled functionalities to deliver precision outreach and personalized patient engagement at scale. With expertise in patient journey mapping, omnichannel campaigns, real-world data integration and technology, Dr. Sundaresh plays a key role in positioning Indegene as a technology-first, patient-centric leader in clinical trial services. With over 20 years of experience in public health, healthcare IT, ITES, and CME, he also founded crocareers, a learning initiative that has trained over 3,000 clinical research professionals, including CRAs and CRCs.

A seasoned doctorpreneur with 25+ years in the pharma industry, spanning medical affairs, clinical research, PV, regulatory, health tech, AI, and digital therapeutics. He established the NIDHI health tech incubator at IIPH Gandhinagar and built four innovative, evidence-based digital platforms to improve patient outcomes. A Harvard-certified expert in innovation, team building, and crisis management, he blends medical expertise with business acumen. Passionate about leveraging technology to advance healthcare, he continues to drive innovation and impact across the industry.

Mr. Abdul Rahim, based in Bangalore, has been a key figure in healthcare IT since 2001. He has led the development of safety databases, risk detection systems, and end-to-end management tools. A co-founder of MedSight, which pioneered the big data-driven MedSight Sapphire platform (later acquired by ARIS Global), he now heads ALWIS Solutions. At ALWIS, he drives innovation in pharmacovigilance through AI and automation, with products like ReTrans Enterprise, ReGenX, ZiCapPro, and ZiSmart. Passionate about mentoring, Rahim also enjoys traveling and spending quality time with his family.

Angshuman Sarkar is a distinguished statistician with a career spanning academia and the pharmaceutical industry. He holds a PhD in Statistics and began his professional journey as an Assistant Professor of Visva-Bharati University (a central university, India), teaching graduate and post-graduate students, and supervising PhD candidates is Statistics. During his decade-long academic tenure, he published numerous papers in international journals, contributing to areas such as Design of Experiments, Analysis of Mixture Response Variables, Robust Inference, and Missing Data Analyses. His research established him as a thought leader in statistical methodologies.

Dr Gursharan Singh, General Manager, Biocon Biologics, Bangalore, brings two decades of global experience in clinical development, medical affairs, and strategic consulting across biosimilars, complex generics, NCEs, NBEs, and ATMPs for multiple regulatory agencies, including US FDA, EMA, PMDA, CDSCO, RosMinzDrav, ANVISA, COFEPRIS, Health Canada, TGA, etc., with prior leadership roles at Dr Reddy’s Laboratories, Hyderabad, UDG Healthcare, and Ranbaxy Labs Limited, Gurgaon.

She is a Industry leader with over 30 years of experience in biopharma R&D, clinical research, business operations and account management.She has consistent track record of above target financial, employee and customer metrics.She has delivered exponential and sustainable growth in various businesses and functions.She has Re-established drug development and clinical research in India through stakeholder advocacy.Past President (2013-17 and current EC member) of The Indian Society for Clinical Research (ISCR), the nodal professional body in India for clinical research professionals.Positioned India and Asia successfully as innovation hubs – internally and externally.

With more than 18 yrs experience including PV industry and clinical practice, Prasad in his current role as VP, Drug Safety & PV with Syneos Health is managing specific PV operation in India, Japan and China. He is involved in setting up and managing PV operations, developing strategies for growth, PV processes management during his career in various organizations.

Dr. Padma V. Devarajan is Advisor and Chair Professor, SIES School of Pharmaceutical Sciences, Mumbai. She was formerly Professor and Dean at the Institute of Chemical Technology Mumbai. She is Chair of the National Innovation and Startup Policy 2024 Revision Committee for Higher Education Institutions, President of Society for Pharmaceutical Dissolution Science, Fellow of the Maharashtra Academy of Sciences and represented India in the ISO working group on Health, Safety and Environmental aspects of nanotechnologies. She has >100 publications, many granted patents, licensed technologies, with products commercialized in India, UK and Europe. Her recent accolade is the Woman Scientist Award 2024 of the Controlled Release Society Inc. USA.

Firasatullah Syed is a Principal Solutions Consultant at Oracle Life Sciences with over 15 years of experience in the pharmaceutical industry, specializing in Clinical Research and Pharmacovigilance. His career spans roles in both clinical operations and pharmacovigilance across a global Contract Research Organization (CRO) and a leading multinational pharmaceutical company. At Oracle, Firasat focuses on building strong customer relationships and driving value by identifying business challenges in clinical research and offering meaningful insights into how Oracle’s Life Sciences solutions can address them.

Nithya Gogtay, MD, DNB, DNB [Clinical Pharmacology], PhD, FRCP Professor & Head - Department of Clinical Pharmacology Seth GS Medical College & KEM Hospital, Mumbai 30 plus years of clinical research experience First woman Editor, Jr of Postgraduate Medicine Chairperson, Hinduja Hospital Ethics Committee

Dr. Ashish Indani, a globally recognized medical device expert, combines over 25 years of clinical research expertise with cutting-edge innovations in AI, blockchain, and nanotechnology. A physician with an MBA in Clinical Trial Management, he holds 20+patents and has authored 200+ publications spanning medical devices, clinical methodologies, and Vedic literature. Awarded the State Award and President’s Scout and Prestigious BackbuckAward, Dr. Indani is a sought-after speaker at international forums and Tedx, driving transformative advancements in life sciences and digital health solutions.

Dr. Phillip Nguyen is a physician and policy staffer at the US FDA’s India Office, having previously worked on FDA’s biomedical research monitoring program. Before FDA, Dr. Nguyen’s experience spanned working in the nonprofit sector on regulatory systems strengthening, supply chains, and pharmaceutical quality standards with multilateral organizations. A former Assistant Professor of the Georgetown University School of Medicine, Dr. Nguyen holds a medical doctorate from Tufts University, and a bachelor’s in Molecular & Cell Biology, cum laude, from Harvard University.

Joydeep Sengupta is a seasoned leader with two decades of experience in Clinical Research, Pharmacovigilance, Quality Assurance and Regulatory Affairs. Joydeep collaborated with various pharma companies like Novo Nordisk, Novartis, Aurobindo, Sun Pharma and also with solution providers like IQVIA, Fortrea and Cognizant, in the last two decades. He has led large teams across geographies and has expertise in conducting audits and facing regulatory inspections. In his present assignment he is working with Curateq Biologics (Aurobindo Pharma Company) as General Manager and Global Head of Pharmacovigilance.

Dr. Swashraya Shah graduated in Medicine during the year 1989 and post-graduated in MD (Pharmacology) in 1995 from one of the premier institutions of India - Grant Medical College, Sir J. J. Group of Hospitals, Mumbai. Currently, he is associated with Bharat Serums & Vaccines Ltd as Chief Medical Officer since 2020. He has over thirty years of rich professional experience both in academic & clinical arena spread across various leading pharmaceutical companies for the country, region and global role. Prior to this he worked for MSD Pharmaceuticals Pvt. Ltd. for ten years starting from October 2007 as Senior Director Medical Affairs & Alembic Pharmaceuticals Ltd in 2019.

Anuprita Sheth is a senior life sciences leader with 25+ years of global experience across pharma, biotech, and CROs. She specializes in strategic outsourcing, vendor management, and performance analytics across the drug development lifecycle. Currently, she leads global vendor oversight for R&D and medical safety, managing a multi-million-dollar portfolio across APAC, EMEA, and the Americas. She has held leadership roles at Amgen, BMS, Cognizant, and Pfizer, and pioneered Amgen’s vendor liaison model. Anuprita holds a Master’s in Statistics, a PG Diploma in Business Management, and a Strategic Management credential from IIM Ahmedabad. She is also a recognized speaker and mentor in the industry.

Accomplished Board Leader and Senior Executive with 39+ years of experience across healthcare, FMCG, and PE-backed enterprises in Asia-Pacific. Proven leadership as Chairman, Independent Director, and Senior Advisor to Fortune 100 firms. Currently Non-Executive Chairman at Appasamy Associates and Independent Director at HDFC Trustee. Former Executive Chairman of Suven Pharma and President of OPPI (2017–2020). Recognized for driving governance, cross-border partnerships, and transformation. Honored with Lifetime Achievement Award (2024), Michael Porter Award, and Economic Times’ Most Promising Asian Leader.

Deepti is M.Pharm (Gold Medalist) & PMP® with 20+ yrs in Clinical Research, Site Excellence, PM & QA. Expert in transforming research-naïve hospitals, managing 80+ trials, audits, and patient recruitment. Skilled in SOPs, GxP, stakeholder engagement, and capacity building across 150+ sites in India.

Vivek Kalagara, with 26+ years in technology and innovation, is a visionary leader transforming Life Sciences and Healthcare through AI and Data Science. Before founding Datafoundry in 2016, he held leadership roles at top pharmaceutical firms, driving data-driven strategies to accelerate drug discovery and improve patient outcomes. At Datafoundry, he champions AI/ML to address complex challenges—streamlining clinical research, enhancing real-world evidence, and advancing patient-centric solutions. A passionate AI evangelist, he promotes ethical, accessible, and impactful innovation guided by Patient-Centricity, Customer Focus, and Employee Delight.

Dr. Kunal Khanna, PhD, is the Founder and Director of EffecMed Private Limited. He has developed advanced medical technologies including GBR membranes, bone void fillers, resorbable screws, and customized implants, holding multiple patents in design and material innovation. He led the first successful translation of an implantable technology from IIT Bombay lab to hospitals and to the market, improving healthcare in India. Dr. Khanna has received several honors, including the Canada India Healthcare Innovation Award (2021) and BIRAC BIG grant (2013). His work has been featured in The Times of India for creating India’s first biodegradable bone screws.

Divakar has 20+ yrs of GCP, GLP & GMP QA experience.He has Handled multiple regulatory inspections - including 25+ FDA inspections for CT, BA/BE & In-vitro BE. Conducted wide variety of audits including Investigator sites, BA/BE & clinical trial CROs, BA Labs, CDM, IWRS, part 11 compliance audits in 10+ countries.

Viswanadh (Vishy) is a Vice President at Parexel Biotech with over 25 years of experience in the pharmaceutical and life sciences industries, primarily in CROs across the pharma value chain. Vishy specializes in strategy, business development, and talent development. He holds a Master's degree in Veterinary Medicine, specializing in Cardiovascular Physiology, and has completed a Senior Management Program from IIM Kolkata. At DIA, Vishy brings a fresh perspective on empowering future clinical talent and provides insights for tomorrow's research leaders.

Member of the DIA Board of Directors and also serves as the Co-chair for the DIA Science Policy Advisory Committee. He is an accomplished global life sciences innovation executive with more than 20 years of leadership experience across three multinational corporations, GE Healthcare, Life Technologies, and Terumo BCT, delivering over $500M in career revenue. Palani has a considerable track record in breadth and depth from a medical product development standpoint, and has worked in the areas of drugs, devices, and diagnostics. Palani has a Ph.D. in the field of biological sciences from Northern Illinois University, followed on by a post-doctoral fellowship at the University of Rochester in HIV biology.

Ram Prasanna is a business leader in Real World Evidence (RWE) and Health Economics & Outcomes Research (HEOR) with 20+ years in the pharma domain. At EVERSANA APAC, he leads project management and client engagement for RWE & HEOR services. Previously, he worked at GSK, Sanofi, Baxter, Frost & Sullivan, SIRO Clinpharm, and IQVIA, focusing on clinical research, HEOR project management, client engagement, and business development. Experienced in client liaison, observational studies, data analytics, market research, and health economic projects, Ram has supported pharma clients across APAC, US, EU, and Middle East. He holds MSc degrees in Health Economics & Pharmacoeconomics and Biotechnology, plus an IIM certification in Sales & Marketing.

Dr. Aniket serves as the Country Safety Lead at Pfizer India’s Drug Safety Unit, overseeing pharmacovigilance activities across India and neighboring region countries. He brings over 16 years of experience in Pharmacovigilance, including prior roles at Amgen and also has 4 years of clinical practice experience. Leads the Pharmacovigilance Task Force at the Organisation of Pharmaceutical Producers of India (OPPI). Active member of the Pharmacovigilance Council at the Indian Society for Clinical Research (ISCR). Honored twice with the ‘ISCR Hall of Fame’ award for outstanding contributions to pharmacovigilance. Speaker at multiple ISCR PV Council events and the Regional Workshop on Pharmacovigilance organized by IPC, NCC-PvPI.

Dr. Anju Agarwal is working as Global Director, Global Patient Safety at ADVANZ PHARMA. She has over 28 years of professional experience. She is a dentist by profession having spent more than17 years in the pharmaceutical industry in both core pharma as well as CROs. She is passionate about bringing an impact to patient safety by her work. She has hands on experience in setting up and management of pharmacovigilance department and safety database in various organizations.She believes in bringing an impact to PV processes by streamlining with support from technology. Leveraging the best of both worlds technical and subject matter is key to bring in most efficient and lean PV systems.

Medical professional with a background in medical rehabilitation sciences (NIOH, Kolkata), postgraduation in neurosciences (BYL Nair Hospital, Mumbai), and management education from IIM Calcutta. She brings 22 years of experience in the health and pharma sectors, including 18+ years in pharmacovigilance. She has worked with Novartis and Dr. Reddy’s, and currently serves as VP & Global Head of PV at Mankind Pharma, where she has led the setup of global PV systems. Her expertise spans global regulatory compliance and over a decade of experience in biosimilar drug safety across geographies.