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.

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.