Dr. Vivek Ahuja is a physician-turned pharmaceutical leader with 25 years of experience across pharmacovigilance, clinical research, public health, and technology. In 2005 he pioneered pharmacovigilance in India by establishing the first global PV unit at Ranbaxy. He is Executive Vice President at EVERSANA leading global pharmacovigilance, with prior leadership roles at Sun Pharma, ArisGlobal, Baxter, and PATH. He holds an MBBS (GMC Chandigarh), MD (AIIMS New Delhi) and MBA (MDI Gurgaon). He co-authored the Pharmacovigilance Programme of India (2010) and supported PV systems in Nepal, Bangladesh, and China. An international speaker, he advocates simplifying pharmacovigilance through practical innovation.

Gurpreet Singh is currently the Chief Business Officer, Pharmacovigilance & Clinical, Pivot Path. He is based in UK and has 20+ years' experience in the Pharma Industry. During these years he has also held Leadership positions with top Global companies like 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 also has keen interest in Digital Transformation and Organization Culture.

Nitu Sinha is a healthcare and pharmacovigilance professional with a degree in Medical Rehabilitation Sciences from NIOH Kolkata, a postgraduate degree in Neurosciences from BYL Nair Hospital, Mumbai, an MSc in Clinical Research and Regulatory Affairs from Manipal, and management education from IIM Calcutta. A Lean Six Sigma Black Belt, she has 25 years of experience in the healthcare and pharmaceutical sectors, including 19 years in pharmacovigilance. Having spent 17 years with Novartis and Dr. Reddy’s, she currently serves as VP & Head of Global Pharmacovigilance at Mankind Pharma and Head of PV for Bharat Serum & Vaccines. She has extensive experience in global PV systems, regulatory compliance, and biosimilar drug safety.

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.

Dr Avinash is currently the Vice President and head of global pharmacovigilance at Cipla. He has 20 plus years of total experience. He has worked with innovator and generic pharmaceutical companies as well as with pharmacovigilance service providers enabling him to have a holistic view of the PV operations.

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.

Dr. Kausik Maiti is a physician-scientist with over two decades of experience spanning clinical medicine, pharmacovigilance, and regulatory strategy. He leads a global team of 300+ clinicians and safety experts across all therapeutic areas and is a recognized thought leader and speaker at DIA, WDSC, ASCO, ASH, and other global forums. He actively drives AI-enabled transformation initiatives to advance patient-centric, data-driven safety, and signal management.

Sumati Randeo, is a globally acclaimed architect of healthcare regulation with over 30 years’ leadership across APAC, India and international markets. An industry trailblazer, she honed her expertise at MedTech and pharma powerhouses like Abbott, Danaher and Roche. From spearheading policy reforms alongside the WHO and European Commission to orchestrating complex clinical trial strategies, she empowers pharma, MedTech and government agencies to harmonize regulations, accelerate market access and champion patient-centric innovation.

Sanjeev Sachdeva is the Global Head, - Advisory and Business Process Services, Life Sciences, Tata Consultancy Services. Sanjeev is responsible for Life Sciences business transformation, research & innovation, advisory and future investments strategy and roadmap. With over 30+ years of experience in technology and business transformation, he assists customers in their transformation journey by adopting innovation technologies and processes across the business value chain - R&D, Manufacturing, Supply Chain, Digital Health, Patient Experience transformation, and Commercials. Sanjeev participates in various industry thought leadership platforms/roundtable.

Dr. Retesh is Senior Director, Medical Safety Assessment Program Lead, and Site Head – Patient Safety at Bristol Myers Squibb, Hyderabad, a role he has held since October 2024. With over 24 years of experience across pharmaceutical companies, CROs, and BPS organizations, he has built and mentored high performing teams, strengthened global regulatory compliance, and advanced pharmacovigilance practices. He has played a key leadership role in more than 25 successful regulatory PV inspections, including the first ever MHRA inspection of outside UK pharmacovigilance unit at Aurobindo Pharma. Dr. Retesh holds an MBBS and MD from Maulana Azad Medical College, Delhi.

Ashok serves as General Manager & Executive Director, DIA India, leading strategy, operations, and partnerships across the country. A pharmaceutical physician with 29 years of experience spanning the Indian Army, academia, and leading global pharmaceutical companies, he brings deep expertise in clinical development, medical affairs, regulatory affairs, and drug safety. Prior to joining DIA, Ashok held senior leadership roles at Novartis, Dr. Reddy’s Laboratories, and Themis Medicare, leading complex development programs and cross-functional teams. He holds an MBBS and MD in Pharmacology, with executive education from IIM Calcutta and certification in Pharmaceutical Medicine from the Faculty of Pharmaceutical Medicine, UK.

Dr Shubhadeep Sinha is a senior physician with over 25 years of experience in healthcare, medical research, and pharmaceutical development. He currently serves as Senior Vice President & Medical Director at Hetero Pharmaceuticals, leading global Clinical Trials, Patient Safety, and Medical Affairs operations. Previously, he held leadership roles at Dr. Reddy’s Laboratories, Vimta Labs, Accenture, Glenmark, and other leading organizations. His expertise spans new drugs, biologics, vaccines, and generics across multiple therapeutic areas. He has established and led global pharmacovigilance functions and successfully supported over 100 international regulatory inspections.

Director & Chief, Surgical Gastroenterology, GI Oncology & Minimally Invasive Surgery, AIG Hospitals, Hyderabad. Pioneer in Hepato-Pancreato-Biliary (HPB) Surgery, Dr. G. V. Rao, MBBS, MS, MAMS, FRCS (Hon.) and NOTES (Natural Orifice Translumenal Endoscopic Surgery). Padma Shri Awardee for distinguished contributions to Medicine. Recipient of the Parliamentary Gold Medal for outstanding contributions to Gastroenterology. Honorary Fellow, Royal College of Surgeons & Physicians of Glasgow (FRCS). Internationally recognized for surgical innovation, research excellence, and advancing GI surgery in India

Dr Shukla has completed his M.S (Pharm) from NIPER-K in 2011 & earned his doctorate in Toxicology from CSIR-Indian Institute of Toxicology, Lucknow in 2016. He joined IPC in early 2017 and associated with the MvPI since 2018. He is currently working towards ensuring safe use of medical device in Indian population and development of a robust safety surveillance system for medical devices and IVDs. He has organized numerous national and international level training programmes for the professionals of medical device industries, healthcare professionals and regulatory authorities to enhance the knowledge, practice and compliance to the safety of medical devices and IVDs.

Dr. M. Vamshi Krishna is a Medical Oncologist and Hematologist with over 12 years of experience in cancer care and treatment. He completed his MBBS and MD in Internal Medicine from JIPMER, followed by oncology training at AIIMS, New Delhi, and a super-specialization in Medical Oncology from Tata Memorial Hospital, Mumbai. He currently serves as Director and Head of the Department of Medical Oncology at AIG Hospitals, Hyderabad. His areas of clinical and research interest include hepatocellular carcinoma (HCC), biliary tract cancers, and supportive cancer care in resource-constrained settings. He has authored several peer-reviewed publications, presented at national and international conferences, and is a member of ESMO and ASCO.

Prachet Mohanty is a Data, Analytics & AI Engineering leader with 22+ years of experience across Life Sciences and Financial Services. At Bristol Myers Squibb, he leads Data, Analytics & AI for Worldwide Patient Safety and Global Regulatory Sciences, delivering GxP-compliant Data Platforms, Data Products and AI-powered solutions that advance Patient Safety and Regulatory Intelligence. Previously, he drove the Enterprise-scale Data Science Platform Transformation program at Bank of America. A U.S. patent holder (Metaverse-enabled Digital Cognitive Twin), TOGAF-certified, RAPS-credentialed, Harvard Medical School HMX Pro Pharmacology trained, with advanced certifications from IIIT Hyderabad and IIM Ahmedabad

Narayanan R. is Head of Product Strategy and Management for the TCS ADD™ suite of platforms at Tata Consultancy Services (TCS), with over two decades of deep domain expertise in Clinical Development and Pharmacovigilance.  Across his career, Narayanan has worked closely with many of the world’s top 20 pharmaceutical companies, incubating innovative technologies and delivering and scaling enterprise platforms across clinical development and pharmacovigilance business functions. Currently, he is focused on agentic AI and AI-native product architectures - designing governed, explainable, and compliant autonomous agents that orchestrate complex scientific and operational processes at scale.

Akila Srinivasan is Director – Patient Safety Project Management at Parexel International Ltd., with over 24 years of experience in the pharmaceutical industry spanning pharmacovigilance operations and project management. She has successfully managed large pharmaceutical and biotech partnerships across the US, Europe, and APAC regions and has been a key contributor to business pursuit initiatives. Akila has trained and mentored global project leaders in project finance and business operations and has authored multiple standard operating procedures. She has also led safety process improvement initiatives, including digital solutions to enhance safety knowledge management and operational efficiency.

Miang is a Pharmacist, MBA. She has more than 26 years of regulatory affairs experience with numbers of medical devices and pharmaceutical companies. Her current position at JNJ Vision is the Regional Regulatory Affairs head, APJ. Miang has a board experience in Regulatory Affairs, Clinical Research, Reimbursement, Government Affairs and Quality Assurance in Asia Pacific including Japan. Prior to Cardinal Health, Miang worked for numbers of healthcare companies (Takeda, Boston Scientific, JNJ, Actelion, Cochlear, Bausch & Lomb, Zimmer Biomet, Alcon & Cardinal Health) in different locations (Bangkok, Hong Kong, Sydney and Singapore).

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.

Dr. Selvakumar Sambandan is a passionate mentor and an accomplished Subject Matter Expert (SME) and a leader in drug safety and pharmacovigilance (PV) with nearly 20 years of PV industry experience. He currently serves as the DGM-PV at Apotex Pharma, GBS Mumbai where he manages large-scale PV operations and drug information functions and manages submissions of ICSR and Aggregate reports for > 3 years. Prior to his leadership role at Apotex, he spent nearly seven years at Cognizant Technology Solutions as a Delivery Manager and Engagement Delivery Lead for PV projects and over nine years at Accenture, serving at various levels and left the organization as an Operations Manager.

Prof. Bikash Medhi is Professor, Department of Pharmacology, PGIMER, Chandigarh, and an internationally recognized leader in pharmacology, clinical research, and pharmacovigilance. He serves as IUPHAR Chairman for Basic & Translational Science, GCP Chairman for the Government of India, and is a member of INSA. He coordinates the PGIMER Pharmacovigilance and Materiovigilance Centre for North India and serves as Regional Coordinator, NADA (North Zone), Ministry of Youth and Sports. An accomplished academic and researcher, he has published over 700 research papers, authored 10 books, and contributed 300 book chapters.

Prashanth serves as Associate Director - Regulatory Affairs, India & ASEAN for Boston Scientific. He holds master’s in biotechnology from VIT University, Vellore and is certified as Lead Auditor in ISO 13485:2003. Prashanth has more than 14+ years of regulatory experience in Medical Device industry. He has worked with Teleflex Medical, Abbott Medical Optics and the Vascular division of Abbott Healthcare Pvt. Ltd. in regulatory roles with increasing responsibility. He is actively engaged in various medical device industry forums such as APACMed, USIBC, Medical Technology Association of India (MTaI) etc. and currently acting as Co-Chair of RA Committee at Medical Technology Association of India (MTaI).

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).

Dr Arunima Sen is a Pharmacovigilance leader with two decades of experience across Medical Affairs, Safety Writing and Pharmacovigilance. Prior to Viatris, she was associated with Bioclinica, MMS Holdings Inc and AstraZeneca. She is a physician by qualification with MD in Pharmacology. Trained in Generative Leadership and Transactional Analysis, Dr. Sen has successfully built and led teams across emerging CROs and global matrix organizations. As part of Viatris' Global Product Safety and Risk Management team, Dr. Sen leads global pharmacovigilance operations and regulatory safety reporting across a diverse product portfolio. A published author in DIA's Global Forum.

Debashish has over 22 years of experience in Global Regulatory Affairs, Intellectual Property Management and Research & Development with Biotech/Biopharma and Vaccine industries. His academic background is in Biotechnology, Business Administration, and Intellectual Property Rights. Debashish has been working with Dr. Reddy’s Laboratories Ltd. for 14 years and his key areas of interest are Biotherapeutics, NBEs and Biosimilars.

Dr. Vasanth Gadipe is Director, Medical Safety Assessment Physician – Solid Tumor Oncology at Bristol Myers Squibb and a global medical safety leader with nearly 20 years of experience in pharmacovigilance, benefit-risk assessment, and regulatory safety governance. He has led global safety activities including signal detection, aggregate safety reporting, risk management planning, and regulatory submissions. Having held leadership roles at BMS, GSK, Sanofi, Novartis, and leading CROs, he has driven cross-functional safety initiatives and strengthened regulatory compliance and operational excellence. Dr. Gadipe holds an MBBS degree, is ECFMG certified, has cleared the FSMB Exam (Connecticut, USA)

Dr. K. Narendran is Deputy Drugs Controller (India) at the CDSCO Zonal Office and Central Drugs Testing Laboratory (CDTL), Hyderabad, under the Ministry of Health & Family Welfare, Government of India. He also serves as Laboratory In-Charge of CDTL Hyderabad, a national statutory drug testing laboratory under the Drug Controller General of India. As CPIO and First Appellate Authority, he oversees RTI-related responsibilities for the Hyderabad zone. With prior postings at Chennai Seaport and Cochin Port, he has extensive experience in drug regulation and import compliance. He is an active contributor to national regulatory forums, including IPC and CII platforms, promoting harmonized pharmacopoeial standards and regulatory excellence.

Inder Sachdeva is a senior Clinical R&D and Pharmacovigilance leader with over 23 years of experience across global drug development and R&D functions. He has led large-scale delivery portfolios, business transformation initiatives, and operating model modernization across CROs, FSP organizations, and pharmaceutical companies. Currently, he serves as Global Safety & Pharmacovigilance Delivery Head at Syneos Health, overseeing strategic accounts and global delivery operations. He also leads capability development across APAC and serves as Site Head for Syneos Gurgaon. A recognized industry speaker, he frequently presents at global forums, including DIA, SCOPE, SCDM, WSDC, Phuse, and ISCR, on PV

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.

He is a Pharmacist with an M.Pharm (Pharmacology) and a Professional Diploma in Clinical Research and Project Management. He is a certified Advanced Post-Marketing Global Auditor, GVP/GCP Auditor, Quality Risk Management professional, and ISO 9001:2015 Lead Auditor. With over 18 years of experience in global pharmaceutical, biotech, and consulting environments, he has expertise across Pharmacovigilance, Drug Safety, Medical Affairs, Regulatory Affairs, Clinical Research, and Quality Assurance. He has conducted 300+ PV audits across Europe, the Americas, APAC, MENA, CIS, and Africa. He is an active member of RQA, DIA, and a lifetime member of the ISCR PV Council, India.

Dr. Anju Agarwal is Global Director, Global Patient Safety at ADVANZ PHARMA, with over 30 years of professional experience and more than 20 years in the pharmaceutical industry across both pharma companies and CROs. A dentist by training, she is passionate about advancing patient safety and has extensive experience in establishing and managing pharmacovigilance departments and safety databases. She advocates leveraging technology to streamline PV processes and build efficient, lean safety systems. In her current role, she also oversees toxicology and preclinical studies and has successfully led due diligence and integration activities. Dr. Agarwal is a frequent speaker and panelist at industry conferences and forums.

MD (Pharmacology) with more than 13.5 years of experience in PV in CRO space. Worked with Global Pharma Clients in leadership roles. Key responsibilities including; change management and set up of end to end PV services; strategic alliance with the clients to ensure successful delivery, meeting regulatory requirements and quality benchmark and; demonstrated thought leadership to bring in process efficiencies and refinements. Led organizational initiatives like diversity and inclusion leadership program and creating talent pool for representation and innovation. Currently working with APCER Life Sciences as VP and Head of Medical Safety; responsible for teams delivering aggregates (all types), signal management and, related ad hoc services.

Dr. Pranjal P. Bordoloi is a seasoned clinical research and pharmacovigilance professional with over 20 years of experience across the pharmaceutical, biotechnology, and CRO sectors. He has successfully led more than 100 Phase I–IV clinical trials, including NCE, ANDA, and biosimilar studies, with expertise spanning rare and orphan diseases. His experience covers clinical research, pharmacovigilance, regulatory affairs, medical affairs, and strategic operations across India, the US, EU, and other global markets. Currently at Lambda, he leads cross-functional teams across clinical operations, regulatory affairs, pharmacovigilance, medical affairs, and data sciences.

Shri Guguloth Ramdhan is a distinguished pharmaceutical regulatory leader with over 27 years of experience in drug control and pharmaceutical regulation in India. He currently serves as Joint Director and State Licensing Authority (SLA), Drugs Control Administration, Telangana, overseeing pharmaceutical licensing, regulatory compliance, enforcement, and public health initiatives across the state. Having served as Drugs Inspector, Assistant Director, Deputy Director, and now Joint Director, he has played a pivotal role in drug quality enforcement, pharmacovigilance promotion, and coordination with CDSCO and DCGI. He has represented Telangana at national forums, including the DIA–US FDA Biosimilars Workshop and Indian Pharmaceutical Congress.

I am Regulatory Affairs and Quality professional with over 17 years of experience in medical devices across India, Southeast Asia, and South Asia. I currently lead Quality Management, Regulatory strategy at Cordis, ensuring timely market access and adherence to global standards. I have strong expertise in medical device regulations, EU MDR transition, product lifecycle management, and risk mitigation. I bring proven leadership, cross-functional collaboration, and strategic regulatory planning capabilities to drive compliance and business growth.

Leading India's PV Function: Championing Patient Safety Through Pharmacovigilance Excellence Country Safety Head India, Sanofi – Spearheading India's pharmacovigilance function with strategic leadership and operational excellence 20+ years of progressive experience in pharmacovigilance, clinical research, and medical safety leadership. Core expertise in PV systems, regulatory compliance, risk management, and clinical trial management. Global leadership – Spearheaded Pharmacovigilance process harmonization across all Sanofi regions; established collaborative networks with Country Safety Heads worldwide. Education: Bachelor of Ayurvedic Medicine & Surgery; Executive MBA – NMIMS Deemed University, Mumbai

Senior Life Sciences Technology Leader with 25+ years of experience in IT and Life Sciences, specializing in Pharmacovigilance and Drug Safety. Expert in driving digital transformation, AI-led innovation (NLP/LLM), and large-scale platform integration for global pharmaceutical organizations. Known for delivering measurable operational and compliance outcomes through scalable, enterprise-grade solutions.

Ankur Borkakoty is a seasoned PV leader and currently serves as Head of Safety Case Processing for Novartis, based in Hyderabad. With extensive expertise in global PV operations, regulatory compliance, and risk management, he plays a pivotal role in ensuring high-quality safety case handling aligned with evolving health authority requirements. He brings a strong focus on process excellence, digital transformation, AI-driven innovation within PV. He has a proven track record of leading large, cross-functional teams and managing global vendor networks to drive efficiency, quality & cost optimization. His strategic mindset, combined with a willingness to embrace calculated risks, enables him to deliver impactful business outcomes.

Dr Kabil is a pharmacovigilance leader with over 16 years of experience across global drug safety and risk management. He currently serves as Global Head – Medical Assessment, Compliance and Digitalization at Dr. Reddy’s Laboratories. Previously, he held leadership positions at Fresenius Kabi and Cipla, overseeing end-to-end pharmacovigilance operations, including ICSR management, aggregate reports, signal detection, risk management plans, PV quality assurance, and computer system validation. He has led multidisciplinary global teams and driven compliance, digitalization, and operational excellence initiatives. His clinical background includes experience across multiple medical specialties, hospital practice, and community medicine.

Rohini is a seasoned pharmacovigilance leader and currently serves as Director, Global Pharmacovigilance Operations at a multinational pharmaceutical organization. With over 20 years of experience across end-to-end PV, she has held leadership roles in leading pharmaceutical companies and global CROs. She oversees global safety data operations, regulatory and partner data exchange, PV IT systems, safety databases, and business support functions. Her expertise includes PV training, transitions, database management, audits, inspections, outsourcing strategies, and building high-performing global teams. Rohini holds a medical degree, an MBA in Operations, and a postgraduate qualification in Clinical Research from Mumbai University.

Preety Sharma is a seasoned Regulatory Affairs and Quality Assurance professional with over 15 years in the medical devices sector. As Head of Regulatory Affairs at Edwards Lifesciences, she leads regulatory strategy and compliance for the Indian subcontinent, ensuring alignment with evolving frameworks and enabling market access for life-saving technologies. Her experience spans Boston Scientific, CDSCO, and Morepen Laboratories, driving excellence, collaboration, and stakeholder engagement. An active contributor to MTAI, FICCI, AdvaMed, and AMCHAM, she advocates patient-centric, harmonized policies.

Dr. Anuja Jawale is currently working as Area Safety Head India and South Asia Cluster at Kenvue managing pharmacovigilance operations for Kenvue products in the region. She has a total of 18 yrs of experience in Pharmacovigilance with experience in managing end to end pharmacovigilance and affiliate activities. In the past she has been associated with organisations like Organon, Abbott, Lupin Ltd., TCS and Sanofi Aventis.

Dr. Sailaja Sayana is Group Head – Medical Safety at Sandoz and a physician with over 25 years of healthcare experience, including extensive global leadership in pharmacovigilance and drug safety. She has previously served as Head – Global Pharmacovigilance at Biocon Biologics and held senior safety leadership roles at Viatris, Strides Pharma, IQVIA, and Sciformix. Her expertise spans end-to-end clinical and post-marketing safety, global regulatory compliance, safety database implementation, automation, quality, and compliance management. She has successfully led international regulatory inspections and audits and is recognized for her strategic leadership, project management, mentoring, and cross-functional collaboration.

Dr. Rama is the APAC Head of Quality and Regulatory at Roche Diagnostics Asia Pacific, leading regional quality and regulatory functions across diagnostics and digital products. She has over 16 years of experience in medical device regulation, quality, and compliance. Prior to Roche, she served as Director, Medical Devices at Singapore’s Health Sciences Authority (HSA), overseeing pre- and post-market regulation. She represented Singapore at IMDRF, GHWP, and ASEAN Medical Device Committee forums. Dr. Rama has contributed to global guidance on Software as a Medical Device (SaMD) and AI in healthcare through IMDRF and WHO initiatives. She holds a PhD from the Faculty of Medicine, National University of Singapore

Dr Sanjeev Srivastav is a physician and senior Signal Management professional at BioNTech, with extensive expertise in pharmacovigilance, pharmacoepidemiology, and the integration of advanced analytics and artificial intelligence into drug safety decision-making. He holds an MD, MBA, MHA, PMP, and a Master’s degree in Artificial Intelligence and Machine Learning, and has led global safety activities across vaccines and oncology. His work bridges medical science, regulation, and technology to advance future-ready pharmacovigilance practice, with a focus on robust signal assessment, regulatory compliance, and technology-enabled safety governance.