Venue: Holiday Inn & Suites Dubai Science Park, an IHG Hotel, Dubai, UAE.
IHG Hotel, Dubai Science Park, Dubai, UAE.
CEO & Owner
Pharsafer
Associate Director & Global Head - PV
Emcure Pharma
Global Head – PV
Alkem Laboratories
Vice President & Global Head - PV
Glenmark Pharma
Global Director - Global Patient Safety
Amgen
Deputy Site Head and
Medical Review TA Head
– Patient Safety
Bristol Myers Squibb
Chief Scientific Advisor
Pivot Path
Sr. Vice President & Co-Founder
Techsol Lifesciences
CEO and Co-Founder
SafeVig Solutions
Global Senior Pharmacovigilance Auditor
Sandoz
Founder & Director
Rhyme Life Sciences
Country Head – Global Business Operations
Cosette Pharmaceuticals
Sr. Pharmacovigilance Associate
Pharmacovigilance Programme of India (PvPI), Government of India
Director
Drug Safety & Global PV Regional Head – Asia Pasific. MSD
Director - Global Patient Safety
Amgen
Sr. Vice President
Biomatrix Healthcare
Global Head of Pharmacovigilance
Lupin
VP & Head – Medical Services, Pharmacovigilance and New Product Development
Centaur Pharmaceuticals
Technology Evangelist
Veeva Systems
General Manager – Pharmacovigilance,
Marksans Pharma
Global Head - Medical Assessment Compliance and Digitalization
Dr. Reddy's Laboratories
Mentor, Researcher, Author
& Public Health Advocate
Head of Pharmacovigilance
Zydus Lifesciences
Sr. Vice President – Late Phase Operations
Lambda Therapeutic Research Ltd.
Head – Pharmacovigilance
Cipla Ltd.
Founder
Pvigilant Health - Dubai
PharSafer is a Global CRO specialising in all aspects of Clinical & Post Marketing Safety; Medical Affairs; Regulatory Strategy; Auditing; Training; IT Informatics & Development. Established for over 20 years; PharSafer has a wealth of experienced individuals in the Company able to help clients in all areas of vigilance – from case processing to signal detection and from drugs to devices to vaccines; biologics; advanced therapies and cosmetics.
Techsol Life Sciences is an integrated clinical development, medical affairs and post-marketing surveillance business solutions provider to global biopharmaceutical, medical device, food, and nutraceuticals companies. With our commitment to bringing novel treatments and therapies faster to market, we deliver regulatory compliant clinical research services, GxP technology consulting solutions in combination with our unified SaaS platforms.
Using our deep-domain scientific expertise and technology innovation, we help sponsors to reduce time-to-market, save costs, and realize maximum value, across pharmaceutical and medical device business functions through clinical research, compliance oversight, insights generation, digitalization and GxP process automation.
Pivot Path is a life sciences solutioning organization that integrates technology, platforms and pharma domain expertise to deliver transformative outcomes for customers across the globe.
With a team of over 500 pharma experts, we serve 60+ clients across five continents, covering the entire life sciences value chain. Our capabilities span a comprehensive range of services, including global pharmacovigilance, clinical operations, intellectual property rights, quality and digital compliance, IT and people & digital services—enabling organizations accelerate innovation and drive sustainable, meaningful growth.
SafeVig Solutions is a forward-thinking, globally recognized organization that stands at the intersection of life sciences and cutting-edge technology, offering specialized solutions to pharmaceutical and biotechnology companies. With a primary focus on advancing pharmacovigilance, SafeVig leverages a robust combination of Automation, Artificial Intelligence (AI), Machine Learning (ML), and Blockchain to transform operational processes and resolve functional challenges within the industry.
Since its inception, SafeVig has continually evolved its suite of services and technologies, enabling organizations to move beyond traditional compliance-based models and take full ownership of patient safety.
SafeVig’s comprehensive solutions not only streamline and enhance pharmacovigilance operations but also bring exponential improvements in efficiency, achieving up to a 10X increase through the intelligent use of technology. With an unwavering commitment to synergy, quality, and innovation, SafeVig Solutions has become a trusted partner for global organizations, empowering them to adapt to regulatory demands with speed, accuracy, and enhanced safety oversight.
Rhyme Life Sciences Private Limited(RLS) is established in 2017 with the determination and commitment to offer the Pharmaceutical industry with the solutions which are innovative, and compliance driven thereby meeting the regulatory expectations. We committed to deliver accurate, timely and cost-effective services throughout the regulated markets. We are team comprising of experienced professional including physicians, pharmacists, life science graduates and post graduates. Team is well acquainted with the regulatory needs including but not limited to USFDA, EMA, TGA, CDSCO and others. We are assertive and confident to have ‘know how’ We are proud to highlight our expertise in handling USFDA and MHRA inspections.
Our services:
Vizen Life Sciences is a global pharmacovigilance and regulatory services partner, combining deep PV expertise with a validated, technology-driven delivery model. Headquartered in Hyderabad with a delivery presence in Prague, Vizen supports the safety profile of over 1,000+ products across India, the EU, the UK, and beyond, and serves as the EU QPPV, UK QPPV, and local PV contact for clients in jurisdictions including the EAEU, GCC, Australia, and China.
Our end-to-end capabilities span ICSR case processing, aggregate reporting, signal management, medical literature monitoring, MICC services, and PSMF authorship — powered by an integrated technology stack including AI-supported literature monitoring, an intelligent Case Intake Module, the validated Clinevo Safety database, an integrated MICC platform with CloudTalk telephony, E2B(R3) gateway submissions to FAERS and EudraVigilance, and integration pathways into Oracle Argus and ArisGlobal.
Built on inspection-ready operations and a single-partner delivery model, Vizen helps clients consolidate vendors, accelerate compliance cycles, and stay ahead of evolving regulatory expectations.
Navatio Pharma is a leading pharmaceutical services company dedicated to providing top-tier solutions in pharmacovigilance, regulatory operations, and medical information. With a firm focus on ensuring compliance and fostering innovation, Navatio Pharma offers specialized services that help pharmaceutical and biotech companies navigate the complexities of drug safety, regulatory requirements, and medical inquiries on a global scale.
Our expert-driven approach guarantees the accurate, timely, and efficient handling of critical drug safety processes, enabling our clients to manage product safety effectively. We support pharmaceutical companies with comprehensive pharmacovigilance services that monitor, assess, and report the safety of drugs throughout their lifecycle.
In addition to pharmacovigilance, Navatio Pharma provides robust regulatory operations services, ensuring that our clients meet global regulatory standards and requirements for drug approval and market entry. Our medical information services address client queries with reliable, scientifically accurate responses, supporting healthcare professionals and patients alike.
With a commitment to client-centric service, Navatio Pharma’s global reach is reinforced through offices in the USA and India, allowing us to deliver services that meet local and international standards. Our continued expansion and dedication to innovation make us a trusted partner in the pharmaceutical and biotech industries, helping clients maintain compliance and achieve success in a rapidly evolving market.
4C Pharma Solutions is established and operated by Physicians and Subject Matter Experts experienced in Clinical Research, Pharmacovigilance and Regulatory Affairs. It is one of the fastest growing global service provider organizations headquartered in the United States. The service spectrum spans Pharmacovigilance/Drug Safety, Devices, Biologics, Consumer Care products, Nutraceuticals & Cannabis products, Regulatory Affairs, Medical Writing, Argus Safety Database Hosting, Maintenance, Support and Training.
4C is focused on delivering quality services at an optimized cost to suit clients’ budget. We are ISO 9001 and 27001 certified with fully validated in-house Oracle Argus Safety installed on cloud for quick deployment and high availability. We provide quality support for Argus at drastically reduced costs facilitating companies to focus on R&D and other tasks without extensive technology overheads.
We have an exemplary team of healthcare and IT professionals, well-established facilities, processes and systems capable of providing end to end support in Dossiers (CTD/eCTD/NeeS) preparation, publishing, validation, submissions, Labeling, Artworks, Medical Information Call Center, Literature Search, Case Processing, Signal Detection, Aggregate Reports, Risk Management Plans, Pharmacovigilance SOPs preparation, System setup and Training. 4C team also has expertise on multiple safety and regulatory applications to accommodate any requirement.
Synapmed is an AI-native pharmacovigilance and drug safety organization combining scientific expertise, regulated operations, and proprietary AI platforms to support global life sciences companies. The company delivers end-to-end pharmacovigilance, medical information, literature monitoring, signal detection, aggregate reporting, regulatory intelligence, and safety operations through a technology-enabled operating model. Synapmed’s multidisciplinary teams include physicians, pharmacists, life-science specialists, and AI engineers working within validated, inspection-ready environments. Our AI platforms are designed with human-in-the-loop governance, full auditability, explainability, traceability, and regulatory compliance, enabling scalable automation while maintaining scientific rigor, quality oversight, and global regulatory adherence across safety workflows.
By partnering with us, you can position your brand at the forefront of the pharmaceutical landscape and gain invaluable exposure to a highly targeted and influential audience.
Partnering with the Drug Safety Symposium is a strategic investment, to explore partnership opportunities and discuss customized packages, please contact us at [email protected]
Gateway of India
Juhu Beach
Prithvi Cafe
Jehangir Art Gallery
Marine Drive
Siddhivinayak Temple
Haji Ali Dargah
Mount Mary Church
Elephanta Caves
Kanheri Caves
Dr. Graeme Ladds has been involved in Drug Safety for the last 35 years holding senior positions in a number of top ten Pharma. As CEO of PharSafer Graeme has established a global Company looking after the safety of many different client product types and has overseen over 100 Regulatory Inspections globally, and understands intimately the requirements for operating a compliant safety system in order to protect patients properly and quickly satisfying the regulations.
Bringing over 21 years of experience across pharmacovigilance, clinical research, and medical practice, Dr. Neha Vala is a trained medical professional with strong grounding in clinical pharmacology, GCP, and global PV guidelines, she has end-to-end expertise in risk management planning, signal management, and benefit–risk evaluation. Dr. Vala has successfully established and scaled pharmacovigilance functions for multiple organisations and has led numerous regulatory inspections, including USFDA, MHRA, EU authorities, Health Canada, and DCGI. She is also an active speaker at national and international pharmacovigilance forums.
I have been with Alkem Laboratories Ltd, Mumbai, for the past 13 years in various roles and am currently serving as the Head of Global Pharmacovigilance.
With 25 years of experience spanning both academic and industrial roles, I have played a key role in establishing an in-house Pharmacovigilance department that adheres to stringent regulatory standards and processes. This has supported our global pharmacovigilance operations through the development and implementation of comprehensive safety monitoring systems, risk management plans, and regulatory compliance strategies.
In the past five years, I have successfully led my team through three major regulatory inspections for Pharmacovigilance by the USFDA, TGA-Australia, and MoH-Kazakhstan. These inspections required meticulous preparation and a deep understanding of regulatory requirements, affirming the robustness and effectiveness of our pharmacovigilance practice
Dr. Rajendra Kasi is a healthcare professional with more than 2 decades of experience in clinical and drug safety arenas. He is the Vice-president and Global Head of Pharmacovigilance at Glenmark Pharmaceuticals Ltd. Before joining Glenmark, he worked with reputed pharmaceutical companies like Zydus Cadila and Mylan Laboratories, etc. He was pivotal in establishing Pharmacovigilance units from scratch to hatch level for major pharmaceutical players in India. He believes quality consciousness, keeping oneself up-to-date with the latest happenings in the industry, and embracing and adopting new technologies in the domain are the key factors to ensure regulatory compliance.
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. 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. He serves on the Board of Studies at Chitkara University, where he contributes to curriculum development and delivers guest lectures. Dr. Siva is on the Advisory Boards of GAADs, PharmaNow, and PharmaFocus Asia & EU. Furthermore, he mentors FFE scholarship recipients and acts as a medical assessor for Arogya World.
Dr. Vikram K is the Deputy Site Head and Medical Review TA Head – Patient Safety at Bristol Myers Squibb, based in Hyderabad. With over 20 years of experience across hospitals, pharma, CROs, and BPOs, he has built and mentored high-performing pharmacovigilance teams while ensuring compliance with global regulatory standards. His expertise spans medical review, large-scale study oversight, and inspection readiness, having successfully led multiple audits including USFDA, MHRA, and SwissMedic. Prior to this, he was with Eli Lilly, driving medical review capabilities. Vikram holds an MBBS, a Diploma in Diabetology, an MBA from ISB, and certifications from IIM-A and Johns Hopkins.
Dr Gopal Muralidharan is the Chief Scientific Advisor at Pivot Path a role he has taken over after his recent retirement from Arcolab as Global Head of Pharmacovigilance and Clinical Operations. His 35+ years of experience, includes his close to 15-year stint in both pre-clinical and clinical research areas in the USA, with American Cyanamid (Lederle Laboratories, USA) and Wyeth Research (presently Pfizer, USA). He returned to India in 2003 as President and CSO of Lotus Labs, Bangalore. As an entrepreneur, he set up a CRO and has worked extensively in Clinical, Non-Clinical and bioanalytical areas of drug development programs across various therapeutic areas not only for NMEs (NDAs, including 505b2) but also for Generic molecules (ANDAs), with quality and integrity serving as the cornerstone of his successful contributions. He led the transformation of the pharmacovigilance program at Arcolab.
On the academic front, he served as an Adjunct Faculty at Manipal College of Pharmaceutical Sciences, Manipal University and was also a research guide to post-graduate students at the Rajiv Gandhi University of Health Sciences, Bangalore.
He has made several scientific presentations in national and international forums and has also been involved in several scientific deliberations with regulatory authorities worldwide. He has served as a consultant to the Tropical Disease Research program of the World Health Organization and is a member of several international professional organizations.
Dr Muralidharan has a Ph.D. in Drug Metabolism and Pharmacokinetics from the University of Saskatchewan, Canada.
Sriram heads the Digital Transformation practice at Techsol Life Sciences with 20+ years of experience across Clinical, Quality, Medical Affairs, and Pharmacovigilance. He specializes in delivering compliant, technology-driven solutions that enable end-to-end digital transformation aligned with global regulatory standards.
Ms. Sridivya Palacharla is the CEO and Co-Founder of SafeVig Solutions, with over 15 years of experience in clinical research and pharmacovigilance. She has extensive expertise in building quality-driven and inspection-ready healthcare solutions for pharmaceutical and biotech companies. Through SafeVig, she is focused on delivering end-to-end pharmacovigilance, clinical research, and regulatory services. She is also passionate about empowering women, mentoring young professionals, and driving innovation in healthcare and patient safety.
Dr. Manoj Swaminathan is a seasoned pharmacovigilance leader with over two decades of experience spanning patient care, public health, and global drug safety. A public health physician by training and a GxP auditor by discipline, he has led large-scale pharmacovigilance and medical information functions across global markets, managing safety operations in over 100 countries.
Currently serving as Global Senior Pharmacovigilance Auditor at Sandoz, Dr. Swaminathan brings deep expertise in GVP auditing, compliance strategy, gap assessments, and inspection readiness. His experience includes leading pharmacovigilance transformations, supporting mergers and acquisitions, and driving digital initiatives, including AI/ML applications in patient safety.
Having held leadership roles at organisations such as Piramal Pharma and Sun Pharma, he combines operational depth with strategic insight. A passionate trainer and speaker, he continues to shape the next generation of pharmacovigilance professionals globally.
Dr. Abhay Chimankar is a globally recognized physician and pharmacovigilance leader with over 20 years of extensive experience in drug safety, pharmacovigilance, medical writing, clinical trials, BA/BE monitoring, and auditing. He brings deep expertise in the practical implementation of global regulatory guidelines, particularly the EU GVP Modules.
Known for his strategic leadership and operational excellence, Dr. Chimankar has successfully streamlined pharmacovigilance operations and delivered significant business value through efficient planning, execution, and compliance-focused systems. He is widely respected as a pharmacovigilance auditor with substantial experience handling USFDA and MHRA inspections.
During the pandemic, he conducted one of the highest numbers of pharmacovigilance audits, further strengthening his reputation as a trusted industry expert. He is also among the few third-party auditors to directly interact with Health Authorities.
A sought-after national and international speaker, panelist, and moderator, Dr. Chimankar regularly contributes to leading pharmacovigilance conferences and industry forums. Today, he is regarded as one of India’s top pharmacovigilance consultants, known for his practical insights, regulatory expertise, and commitment to advancing drug safety standards globally.
Girish brings more than two decades of global leadership experience in the CDMO and pharmaceutical industry. He holds a PhD in Chemical Engineering along with an MBA in Strategy and Finance, and currently serves as Country Head – Global Business Operations at Cosette Pharmaceuticals. In this role, he leads strategic growth initiatives across digital transformation, supply chain, regulatory affairs, pharmacovigilance, and operational excellence, while closely collaborating with the US headquarters.
He has a strong track record in building and scaling businesses, managing P&L responsibilities, and translating innovation into sustainable commercial success. A certified Six Sigma Black Belt, Girish has led multiple initiatives spanning system optimization, product development, commercialization, smart manufacturing, and sustainability. He is also passionate about developing high-performing teams and fostering a culture focused on execution, innovation, and measurable business impact.
Dr. Dharini Boopathi is a pharmacovigilance professional with over a decade of experience in drug safety, adverse drug reaction (ADR) monitoring, and public health awareness. Currently serving as a Senior Pharmacovigilance Associate with the Pharmacovigilance Programme of India (PvPI) at the Indian Pharmacopoeia Commission, she plays a key role in strengthening pharmacovigilance activities across Tamil Nadu and Puducherry.
A Pharm.D graduate with a Postgraduate Diploma in Pharmacovigilance from JSS College of Pharmacy, Ooty, Dr. Dharini has been actively associated with PvPI since 2015, contributing to the growth and expansion of India’s national pharmacovigilance ecosystem. Her work involves coordinating with Adverse Drug Reaction Monitoring Centres (AMCs), healthcare institutions, and professional bodies including IMA, IPA, and INA to promote ADR reporting and patient safety initiatives.
Passionate about creating awareness among healthcare professionals and the public, she has led numerous educational and outreach programmes focused on strengthening the culture of drug safety reporting in India. Dr. Dharini is also a recognized speaker and resource person, having delivered presentations at more than 30 state and national conferences. In addition, she has contributed to over 20 journal articles and pharmaceutical publications, reflecting her commitment to advancing pharmacovigilance knowledge and practice.
Dr. Jamal Baig, M. Pharm, Ph.D. (Pharmacology), is the Multi-Country Safety Head for South Asia & Indo-China at Sanofi India since November 2021, with over 16 years of experience. He previously served as the PV Head at MSD Pharmaceuticals for 11+ years and as a Team Leader at Pfizer Drug and Safety PV Process at Wipro Ltd. He has held various industry positions, including Chair of the PV Council at ISCR and member of the PV Task Force at OPPI. Dr. Baig has played a leading role in developing PV guidelines in India and is a frequent speaker at national and international PV events.
Dr. Mukesh Gori, with extensive experience in global patient safety and pharmacovigilance, serves as Director at Novartis. He excels in executing strategic visions, managing external relationships, and ensuring QMS compliance in supplier selection, qualification, and management. His responsibilities include overseeing contract management, third-party risk, governance, transitions, and budget planning for outsourcing. Mukesh facilitates leadership-level communication, providing strategic advice on Alliance operations and contributing to the Pharmacovigilance System Master File (PSMF).
He leads governance forums, manages issues, escalations, and transitions, and ensures adherence to global SOPs. Mukesh has created RFP documents, conducted vendor due diligence, and managed audits, CAPAs, and QMS processes. As a people manager, he emphasizes team retention, training, and diversity. Before Novartis, he led Operations and Vendor Management in Drug Safety at Cipla Pharma, overseeing biosimilar management and regulatory inspections.
Mukesh’s expertise in pharmacovigilance strategy and operations positions him as a leader committed to driving excellence, effective communication, and a culture of quality and compliance in all his professional endeavours.
Dr. Vipin Sethi is a seasoned pharmaceutical leader with over 25 years of experience spanning pharmacovigilance, medical affairs, portfolio management, regulatory compliance, and international business. Throughout his career, he has held leadership positions with renowned organizations including LG Life Sciences, Mega Lifesciences, Cadila Pharmaceuticals, and Biomatrix Healthcare.
With extensive expertise in global pharmacovigilance regulations and operational excellence, Dr. Sethi has successfully established and led PV functions, developed in-house safety teams and systems, and guided organizations in building robust compliance frameworks aligned with international regulatory expectations.
A medical professional by training, he brings a unique ability to bridge scientific understanding with business and operational strategy. His experience includes managing outsourced and in-house pharmacovigilance models, leading inspection and audit readiness initiatives, and driving cross-functional collaboration across global markets.
Known for his practical approach, leadership capabilities, and strong problem-solving mindset, Dr. Sethi has consistently delivered successful outcomes in highly regulated and dynamic environments. His ability to balance compliance, operational efficiency, and business objectives has made him a respected leader within the pharmaceutical industry.
Dr Mangesh Kulkarni is a physician (MD) with experience over 25 years in Clinical R&D and has worked extensively in Clinical Pharmacology studies and Pharmacovigilance; especially worked in Immunology and Oncology. He has performed leadership roles at various functional and strategic levels in pharma MNCs, CROs and IT enabled companies. He is currently the Global Head of Pharmacovigilance at Lupin Ltd, based out of Mumbai.
Dr. Mayuresh Kiran is an accomplished clinical pharmacologist and pharmaceutical leader with extensive experience spanning medical services, pharmacovigilance, clinical research, and new product development. Holding qualifications in MBBS, MD (Pharmacology), and DM (Clinical Pharmacology), he brings a strong blend of scientific expertise, clinical insight, and strategic leadership to the pharmaceutical industry.
Associated with Centaur Pharmaceuticals for over 14 years, Dr. Kiran currently serves as Vice President and Head of Medical Services, Pharmacovigilance, and New Product Development, where he plays a pivotal role in driving medical strategy, patient safety initiatives, and innovation across the organization’s portfolio.
Prior to joining the industry, he served as an Assistant Professor in the Department of Pharmacology in Mumbai, contributing to medical education and research. An active researcher and thought leader, Dr. Kiran has authored and co-authored more than 65 publications in reputed international indexed journals and has been involved in over 30 clinical trials, including studies involving a New Chemical Entity (NCE).
A sought-after speaker at national and international conferences, Dr. Kiran is widely recognized for his expertise in clinical pharmacology, pharmacovigilance, and drug development. His contributions continue to support the advancement of patient safety, evidence-based medicine, and innovation within the pharmaceutical industry.
Umesh Khadela is a seasoned enterprise technology advisor with over 10 years of experience helping global Life Sciences organizations evaluate, select, and implement digital transformation and enterprise software solutions. Over the years, he has worked closely with senior executives across Quality, Regulatory, and R&D functions, helping them navigate complex technology adoption challenges, drive organizational alignment, and achieve measurable business outcomes.
He specializes in bridging business and technology conversations by enabling leadership teams to define the right transformation strategy, establish meaningful success KPIs, and accelerate value realization from enterprise platforms and digital initiatives.
Dr. Chaitanya Kulkarni is a seasoned pharmacovigilance leader with over 18 years of experience in global drug safety, regulatory compliance, safety systems, and operational excellence. Throughout his career, he has successfully led the design, implementation, and transformation of pharmacovigilance functions, helping organizations build robust, inspection-ready safety ecosystems aligned with global regulatory expectations.
At Marksans Pharma, Dr. Kulkarni provides strategic leadership for global safety operations, combining deep regulatory expertise with operational oversight to ensure patient safety remains at the heart of business decision-making. He has a proven track record of establishing in-house pharmacovigilance departments from the ground up, including organizational design, talent acquisition, process development, and SOP implementation.
An expert in global pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP), he has led complex safety database implementations and large-scale data migration projects, enabling organizations to improve compliance, efficiency, and scalability. His expertise extends to regulatory intelligence, inspection readiness, quality systems, and the development of sustainable operating models for growing pharmaceutical organizations.
Known for his collaborative leadership style, Dr. Kulkarni is passionate about mentoring teams, building cross-functional partnerships, and driving continuous improvement across the pharmacovigilance landscape. His ability to translate complex regulatory requirements into practical, business-focused solutions has earned him recognition as a respected leader in the field of drug safety and patient protection.
With over 16 years of deep-rooted experience in pharmacovigilance, Dr. Kabil Kalathingal is a seasoned leader recognized for his strategic vision and operational excellence across global drug safety landscapes. His expertise spans end-to-end PV operations, including the management of ICSRs, aggregate reports, risk management plans (RMPs), signal detection, and quality assurance.
Dr. Kalathingal has played a pivotal role in computer system validation (CSV) for PV systems and is a strong advocate for integrating regulatory compliance with technological advancement. Known for his ability to harmonize global regulatory expectations with regional execution, he brings sharp insights into PV systems governance, audit readiness, and continuous improvement.
Currently leading high-impact pharmacovigilance initiatives, Dr. Kalathingal continues to shape smarter, risk-based safety frameworks that align with the evolving demands of the pharmaceutical industry.
Dr. Nilima Kshirsagar is one of India’s most distinguished physician-scientists, clinical pharmacologists, and public health leaders, with an illustrious career spanning over four decades in clinical research, pharmacology, drug development, patient safety, and healthcare policy. Widely recognized for her pioneering contributions to evidence-based medicine and rational use of medicines, she has played a transformative role in advancing clinical pharmacology and research standards in India.
Throughout her career, Dr. Kshirsagar has held several prestigious academic, advisory, and leadership positions, contributing significantly to national and international initiatives in healthcare, medical research, and regulatory science. She has been closely associated with the development of ethical and scientific frameworks for clinical research, strengthening pharmacovigilance systems, and promoting patient-centric healthcare practices.
Currently associated with P. D. Hinduja National Hospital & Medical Research Centre, Mumbai, Dr. Kshirsagar serves on multiple national and international research, ethics, and advisory committees. She has also contributed extensively to policy development, capacity building, and scientific governance across healthcare institutions and research organizations.
A Fellow of several esteemed professional bodies, including the Royal College of Physicians (UK), the American College of Clinical Pharmacology (USA), the National Academy of Sciences, India (FNAS), and the National Academy of Medical Sciences (FNAMS), she is internationally respected for her contributions to clinical pharmacology and translational medicine.
Dr. Kshirsagar has authored numerous scientific publications, mentored generations of clinicians and researchers, and served as a guiding force in advancing high-quality clinical research in India. Her contributions have been recognized through multiple awards, honors, and leadership appointments, reflecting her lifelong commitment to scientific excellence, patient safety, public health, and innovation.
A highly sought-after speaker at global forums, Dr. Kshirsagar continues to shape conversations around clinical research, pharmacovigilance, regulatory science, and the future of healthcare. Her unique ability to bridge academia, clinical practice, public health, and industry perspectives makes her one of the most influential voices in the Indian healthcare ecosystem today.
Dr. Patel bringing over 18 years of experience in drug safety and pharmacovigilance across pharmaceutical organizations and global service businesses. He has extensive expertise in managing end-to-end PV operations, regulatory compliance, and safety system oversight across diverse markets.
Devang has successfully led and managed multiple regulatory inspections by global health authorities, demonstrating strong capabilities in audit readiness and compliance excellence. His experience across both sponsor and service environments provides him with a well-rounded perspective on operational challenges, governance, and scalable pharmacovigilance practices.
Dr. Pranjal P. Bordoloi brings over two decades of diverse experience in clinical research, pharmacovigilance, regulatory affairs, and strategic operations across the pharmaceutical, biotechnology, and CRO sectors. His career is marked by a strong integration of scientific acumen and operational leadership, with a consistent track record of driving global clinical development programs.
Throughout his career, Dr. Bordoloi has successfully led more than 100 clinical trials spanning Phases I to IV, including NCEs, ANDA, and Biosimilar studies. His therapeutic expertise spans a wide range of indications, and he has extensive experience navigating regulatory frameworks across India, the US, EU, and other international markets.
Dr. Bordoloi holds an MBBS from Assam Medical College, an MD in Pharmacology from Gauhati Medical College, a PGDBM from the Assam Institute of Management, and has completed an Advanced Program in Strategy Management from IIM, Kolkata.
Currently at Lambda, Dr. Bordoloi leads cross-functional teams encompassing clinical operations, medical affairs, regulatory, pharmacovigilance, and data management and biostatistics. A recognized thought leader, Dr. Bordoloi is a frequent speaker at national and international conferences, where he shares insights on clinical trial management, biosimilars, and pharmacovigilance.
Dr. Prasad Deshmukh leads Global Pharmacovigilance (PV) operations at Cipla Ltd., overseeing PV activities across all regions. His role focuses on establishing and strengthening regional PV systems and fostering collaboration with cross-functional stakeholders to ensure compliance and operational excellence.
With over two decades of experience in pharmacovigilance and project management, Dr. Deshmukh brings a rich blend of clinical practice and industry expertise, having worked with BPOs, CROs, and pharmaceutical companies. His global exposure includes significant contributions to PV initiatives in regions such as Japan and China.
Throughout his career, he has successfully led cross-functional teams to implement and deliver complex PV projects. A passionate learner and mentor, Dr. Deshmukh is deeply committed to coaching and professional development. Outside of work, he enjoys reading and following sports.
Dr. Ahmed Hegazy is a seasoned physician and pharmaceutical medicine expert with over 27 years of extensive experience across sales, medical affairs, marketing, training, and pharmacovigilance in the pharmaceutical industry. He holds a Master’s degree in Pharmaceutical Medicine with First Class Honours for his thesis on Adverse Drug Reactions in the Middle East—recognized with distinction, presented at ISoP 2017, and published in Drug Safety.
His academic journey is enriched with certifications from prestigious institutions including George Washington University (Neurology), Columbia University (Immunology and Transplantation), the Royal College of Physicians (GCP & Clinical Research), Uppsala Monitoring Centre (Pharmacovigilance), and more. He also holds a Mini MBA, and diplomas in Medical Quality and Hospital Management. Additionally, he is an ISO 9001:2015 Lead Auditor (IRCA-accredited) and a Lean Six Sigma Green Belt holder.
Dr. Hegazy served as Head of Global Patient Safety at Merck for seven years, overseeing PV operations across 82 countries with a team across eight nations. His Medical Affairs leadership spans 12+ years across various therapeutic areas, including neurology, oncology, endocrinology, immunology, and infectious diseases.
He is currently the Founder of Pvigilant Health, based in Dubai, and operates as an Executive Consultant in Medical Affairs and Pharmacovigilance for local and global firms. A respected thought leader, he regularly chairs, moderates, and speaks at conferences and trains regulatory bodies, academic institutions, and industry professionals worldwide.
