DSS India – Drug Safety Symposium
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Our Commitment

Your perception is our reality, that’s what makes us different! Here’s what we do to deliver exceptional content.

Global Thought Leadership

Our conference brings together the leading experts, thought leaders and regulators to provide unparalleled insights into the latest trends and challenges shaping the industry.

Interactive Learning

Our unique approach ensures a holistic and engaging experience for our attendees. Our conferences are not just about passive listening; it's about active participation. Gain practical insights and actionable takeaways that you can apply immediately in your role.

Cutting-Edge Technology

Explore the latest technological advancements and software solutions that are transforming pharmacovigilance practices, offering efficiency and compliance.

Regulatory Insights

Gain direct access to regulatory authorities and compliance experts who provide valuable insights into regional and international pharmacovigilance regulations.

Speakers

Founder

Pvigilant Health

Dr. Ahmed Hegazy

 

General Manager

Serum Institute of

India Pvt. Ltd

Dr. Chetanraj G Bhamare

 

Heads Global Pharmacovigilance and Clinical Operations

Arcolab

Dr. Gopal Muralidharan

Multi-Country Safety Head
for South Asia & Indo-China

Sanofi India

Dr. Jamal Baig

Director – Global Patient Safety & Pharmacovigilance,

Amgen

Mr. Mukesh Gori

Global Head – PV

Alkem Laboratories

Dr. Rahul Somani

 

Sr. Vice President

and Medical Director

Hetero

Dr. Shubhadeep Debabrata Sinha

 

Vice President, Global Patient Safety and Clinical Affairs – Amneal

Pharmaceuticals

Dr. Sridhar Yeshamaina

Vice President & Global Head – Pharmacovigilance

Glenmark

Pharmaceuticals  

Rajendra Kasi

Sr. General Manager – Global Head, Pharmacovigilance

Lupin Pharmaceuticals

Dr. Chitra Bargaje

Vice President & Global Head – Pharmacovigilance
Mankind Pharma

Dr. Nitu Sinha

 

Vice President & Head – Pharmacovigilance

CIPLA

Dr. Prasad Deshmukh

 

PV Leader & Consultant

Dr. Siva Kumar Buddha

Sr. Principal Scientific Officer of
Pharmacovigilance Programme of India
Indian Pharmacopoeia Commission

Dr. Jai Prakash

Patient Safety Site Head

& MSAP,

Bristol Myers Squibb

Dr. Retesh Bhumbak

Global Senior GCP/PV Auditor, Novartis

Souvik Chatterjee

President – Medical Affairs and Clinical Research,

Ipca Laboratories Ltd.

Dr. Anil Pareek

 

VP and Head of Global Pharmacovigilance Services

Navitas Life Sciences

Dr. Pushpa Basavanapalli

CEO & Owner

Pharsafer.

Dr. Graeme Ladds

Global Director, Global Patient Safety
ADVANZ PHARMA

Dr. Anju Agarwal

 

Patient Safety & PV, Consultant

Bhageswari Sreeraman

Founder and Director,
Rhyme Life Sciences

Abhay Chimankar

Director of PV Technology,
Navitas Life Sciences

Subash J

Event Partners

GOLD PARTNER

Arcolab is a global life science consulting and technology partner, designed to provide diverse capabilities and services with subject matter experts across domains. Arcolab is ISO 27001 & ISO 27701 certified, assuring customers that the implemented controls are effective and aligned with the highest standards of data security and privacy.
With over 500 employees, we provide services to 30+ clients spanning 5 continents across life science areas, including injectables, APIs, biologics, oral dosages, medical devices and R&D centres. Our expertise spans a comprehensive range of life science services, including global pharmacovigilance, clinical operations, computer system validation, intellectual property rights, IT, quality assurance, people & digital services, and many more.

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SILVER PARTNER

Sarjen Systems is a trusted partner for digital transformation and automation. With over 26 years of experience, our mission revolves around infusing the power of technology into domains like Pharmacovigilance, Clinical & Regulatory for business efficiency.
Our solution portfolio
Pharmacovigilance:

• Safety Database (Drugs, Devices, Vaccines, and Combinational Products)     • Literature Automation
• ICSR Submission     • Automation     • Smart EV     • Triage Automation     • Signal Automation
• Document Management (PADER, SDEA, Reports)

Clinical Research:
• Early & Late Phase Trials     • Regulatory      • eCTD / CTD     • RIMS

Quality:
• Quality Processes     • Document Management (SOPs, Protocols and more)     • Training Management

Consulting:
• Advanced Analytics     • Digital Bots     • AI/ML Based Automations
We have earned the trust of customers in over 50 countries. With a global user base exceeding 75,000.

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EXHIBIT PARTNER

SafeVig Solutions is a technology-driven company specializing in pharmacovigilance (PV) automation and digitalization. Focused on revolutionizing drug safety operations, SafeVig offers next-generation platforms powered by artificial intelligence (AI), machine learning (ML), and natural language processing (NLP). Their flagship solutions streamline critical PV processes, including case processing, signal detection, and risk management, reducing manual effort and ensuring faster, more accurate safety insights. With a strong emphasis on regulatory compliance, inspection readiness, and operational excellence, SafeVig empowers pharmaceutical, biotechnology, and healthcare companies to modernize their pharmacovigilance systems, improve patient safety outcomes, and drive efficiencies across the entire product lifecycle.

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Clinevo Technologies is a global leader in next-gen, cloud-based software for the life sciences industry—trusted by over 200 clients with a 100% retention rate. Our AI-powered Pharmacovigilance Suite—including Safety Database, Signal Detection, Literature Monitoring, and Case Intake—helps pharma, biotech, and CROs automate safety operations, ensure compliance, and enhance decision-making. With deep domain expertise, built-in automation, and modular, scalable solutions, Clinevo empowers safety teams to stay audit-ready, cut costs, and drive operational efficiency. Visit our booth to see how we are redefining drug safety with intelligent automation and AI-driven innovation.

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SESSION PARTNER

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.

Learn More

Navitas Life Sciences is dedicated to expediting global access to improved healthcare to people across the globe. As we build innovative solutions for the future, we are driving better outcomes for drug development and beyond. We believe in Powering Possibilities, enabling life-changing treatments to reach patients faster, safer, and more effectively.

Our comprehensive end-to-end pharmacovigilance services deliver full-service operations with patient safety at the core. Our expert team ensures compliance, risk management, and efficiency in full-service PV operations. With a flexible onshore or offshore model to meet diverse organizational needs, we cover the entire spectrum of PV, backed by a wealth of experience and technological capabilities.

We leverage our extensive industry knowledge and experience to provide advanced end-to-end PV services. With a team of experienced domain experts, we boast unrivalled PV insight facilitated by our industry-leading PV networks—pvnet, pvconnect, pvtech, pvindia, medtechnet, and cmonet—backed by 20+ years of benchmark data.

Leading biopharma companies, many from the top 100, join our safety networks to learn and share with one another in an open environment. Our networks serve as collective platforms, offering learning, benchmarking, forums, and access to the latest industry insights through webcasts, think tanks, community exchange, and working sessions. Together, we address challenges, develop innovative solutions, and explore strategies for enhanced performance and success.

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NETWORKING PARTNER

Vizen Life Sciences – is a global provider of pharmacovigilance and regulatory affairs services, dedicated to supporting pharmaceutical and biotechnology companies in ensuring patient safety and regulatory compliance. Headquartered in India, with a presence across key international markets, Vizen offers end-to-end solutions including QPPV services, safety database setup, case processing, aggregate reporting, risk management, and medical information call centers. Backed by a team of experienced professionals and a commitment to quality, Vizen partners with clients to navigate complex regulatory landscapes efficiently and cost-effectively, delivering tailored services that align with global standards and regional requirements.

Learn More

Media Partners

PAST EVENT PARTNERS

PRICING

INR 50000*

+ 18% GST applicable

USD 1800*

+ 18% GST applicable

* Pricing is applicable for Pharma Manufacturing companies only.

Partners

Why Partner at Drug Safety Symposium – India Chapter?

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.

Unparalleled Visibility

Benefit from our extensive marketing efforts, including online promotion, social media campaigns, email marketing, and partnerships with industry associations.

Networking and Collaboration

Identify new business opportunities, collaborations, and partnerships that can drive growth and innovation in your organization by forging strategic alliances.

Thought Leadership

Showcase your organization's expertise by sponsoring a speaking session or panel discussion, allowing you to share insights and thought leadership.

Customized Sponsorship Packages

We offer flexible sponsorship packages that can be customized to meet your specific marketing and branding objectives. Choose from various sponsorship tiers, each offering unique benefits and levels of exposure.

Partnering with the Drug Safety Symposium is a strategic investment, to explore sponsorship opportunities and discuss customized packages, please contact us at [email protected]

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Dr. Ahmed Hegazy

Founder, Pvigilant Health - Dubai

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.

Drug discovery and development, Ethics, Biostatistics, Research Methodology, Regulatory Affairs, Medical Affairs, and Pharmacovigilance. His current position is Head of Global Patient Safety for Intercontinental Region (Africa, Middle East, Turkey, Russia and CIS) at Merck. I am based in Dubai, UAE and my team members are based in 7 hubs / locations across the region.

Dr. Chetanraj G Bhamare

Dy. QPPV (Asst GM) - Clinical Research & PV,
Serum Institute of India

Dr. Chetanraj G Bhamare, is a Clinical Pharmacologist with over 13 years of experience in clinical research and pharmacovigilance. He has an MBBS and post-graduation – MD in Clinical Pharmacology and Therapeutics.  Currently, he is working in the world’s largest manufacturer of vaccines, Serum Institute of India Pvt. Ltd. (SIIPL), Pune in the capacity of Safety Physician.

Since 2015, he has been working with Serum Institute of India Pvt Ltd and involved in end-to-end pharmacovigilance activities of all vaccines, biologicals, and clinical development.

He has many national and international publications to add to his credit. He is a member of the Indian Society for Clinical Research (ISCR) Pharmacovigilance Council and of the Developing Countries Vaccine Manufacturers Network (DCVMN) Pharmacovigilance Working Group.

Dr. Gopal Muralidharan

Heads Global Pharmacovigilance and Clinical Operations, Arcolab

Dr. Gopal Muralidharan heads the global pharmacovigilance and clinical operations team at Arcolab. With over 35 years of experience, he has worked in both pre-clinical and clinical research areas in the USA, for almost 15 years with American Cyanamid (Lederle Laboratories, USA) and Wyeth Research (presently Pfizer, USA). He later returned to India 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.

Dr. Jamal Baig, M. Pharm

Multi-Country Safety Head for South Asia & Indo-China Sanofi India

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.

Mr. Mukesh Gori

Director – Global Patient Safety, Amgen

Dr. Mukesh Gori is a seasoned pharmacovigilance leader with over 18 years of experience, bringing a distinctive blend of clinical expertise and operational acumen to the pharmaceutical industry. A physician trained in alternate medicine, Dr. Gori has successfully navigated roles spanning PV strategy, safety operations, and global outsourcing.

His extensive background includes leading large-scale pharmacovigilance integrations during mergers and acquisitions, managing multi-country regulatory inspections, and designing end-to-end safety systems that align with evolving compliance demands. At Novartis, he plays a pivotal role in shaping PV delivery models that integrate innovation, efficiency, and quality across global teams.

With a career built on cross-functional leadership and a commitment to patient safety, Dr. Gori continues to influence how safety science is practiced and advanced in global settings.

 

.

Dr. Rahul Somani

Global Head – PV, Alkem Laboratories

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. Shubhadeep Debabrata Sinha

Senior Vice President and Medical Director, Hetero

Dr. Shubhadeep D. Sinha is a seasoned pharmaceutical leader and practicing physician with over 23 years of global experience across clinical development, pharmacovigilance, and medical affairs. Currently serving as Senior Vice President and Head of Global Operations at Hetero Group of Pharmaceuticals, he leads clinical trials, pharmacovigilance, medical writing, medico-regulatory functions, and product ideation for generics, biologics, and discovery molecules.

Prior to Hetero, Dr. Sinha held leadership roles at renowned organizations including Dr. Reddy’s, Glenmark, Accenture, Vimta Labs, and Indigene Alquest. His clinical development work spans a broad portfolio—from NCEs in HIV and oncology to biosimilars like Rituximab, Trastuzumab, and Tenecteplase, and generics across key therapeutic areas such as COVID-19, Hepatitis-C, cardiology, and rheumatology.

He has established and scaled global pharmacovigilance systems at multiple firms, successfully navigating USFDA and international regulatory inspections. Dr. Sinha is also a board-certified practicing physician specializing in infectious diseases and diabetology.

An accomplished academic, he has published 30 peer-reviewed articles, authored two books, and contributes as adjunct faculty at KMC Manipal and IGIMS Patna. His blend of strategic leadership and clinical insight positions him as a key voice in shaping modern drug safety and development.

Dr. Sridhar Yeshamaina

Vice President, Global Patient Safety and Clinical Affairs – Amneal Pharmaceuticals
Global Pharmacovigilance Lead | Clinical R&D Expert | Drug Development Strategist

Dr. Sridhar Yeshamaina brings over two decades of distinguished experience in Global Clinical Research & Development and Pharmacovigilance, spanning a wide array of therapeutic areas in the pharmaceutical and biopharmaceutical sectors. He has served in senior leadership roles at globally respected organizations such as Hetero, Novartis, Wockhardt, Bharat Serums, Vivo Bio, SciTech, and GVK. He is currently the Vice President, Global Patient Safety and Clinical Affairs at Amneal Pharmaceuticals, where he leads global pharmacovigilance and clinical development strategies.

A trained pharmacologist from Jawaharlal Nehru Medical College (JNMC), Dr. Sridhar holds a Doctorate in Clinical Pharmacology and Therapeutics from the Nizam’s Institute of Medical Sciences (NIMS); PG Diploma in Neurology from The Barts and the London Hospital, UK; Masters in Global Business Management from Indian Institute of Management (IIM). His career covers the full spectrum of drug development—ranging from early preclinical research to advanced clinical strategy—with core strengths in drug safety, early-phase development, and dose-ranging studies, including novel dosage forms.

Dr. Sridhar has been instrumental in building and scaling Pharmacovigilance systems in the pharma industry. He has led multidisciplinary teams to achieve critical regulatory milestones across clinical development stages, with a stellar record in GVP and GCP inspections conducted by USFDA, EMA, Health Canada, BPOM Indonesia, SAPHRA South Africa, and other authorities—frequently earning zero observations.

He is credited with the development and validation of non-invasive human pharmacological models for clinical drug screening and has played a key role in the successful development of five New Chemical Entities (NCEs) and two New Biological Entities (NBEs) that are now commercially marketed.

A prolific contributor to the scientific and regulatory community, Dr. Sridhar has authored 45 publications, delivered over 100 presentations, and is a regular invited speaker at major national and international platforms, including FIP, IPC, IPS, ISMS, and ISCR etc. He also serves as the Scientific Convenor of the Indian Pharmaceutical Congress (IPC) and is the Honorary Secretary of the Industrial Division of Indian Pharmaceutical Association (IPA).

His contributions have been widely recognized with numerous accolades, including:

  • U.K. Seth National Award for Best Clinical Research (2008)
  • Medical Scientific Award (2009)
  • Industry Above and Beyond Award in Clinical Research (2011)
  • Novartis Excellence Award in Clinical Innovation (2013)
  • GCP Inspector Certification – DGHS, Ministry of Health and Family Welfare, GOI (2023)
  • Certified Trainer for GVP Inspectors – CDSCO/PVPI (2023)
  • WEECE Clinical Innovation Award (2023)
  • HYBIZ Healthcare Trailblazer Award (2023)
  • Global Pharma’s Strategic Innovation Leader Award (2024)
  • …and multiple Above & Beyond Awards for leadership in R&D excellence

Dr. Sridhar is known for his scientific rigor, strategic insight, and collaborative spirit, and continues to shape the future of global drug development with a deep commitment to innovation, quality, and patient safety.

Mr. Rajendra Kasi

Vice President & Global Head – Pharmacovigilance, Glenmark Pharmaceuticals

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 played a pivotal role 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. Chitra Bargaje

Senior General Manager – Global Head, Pharmacovigilance, Lupin Pharmaceuticals

Dr. Chitra Bargaje is a seasoned pharmacovigilance and clinical research professional with over two decades of global experience across the pharmaceutical industry. Currently serving as the Global Head of Pharmacovigilance at Lupin Pharmaceuticals, she brings deep expertise in PV operations, compliance strategy, and quality management systems.

Chitra began her career in academia, teaching Clinical Pharmacology at the prestigious KEM Hospital, Mumbai. Her industry journey includes significant leadership roles at Pfizer, Bristol Myers Squibb (BMS), and ADAMAS Consulting, where she led complex global PV and GCP audit programs. An ISO-certified lead auditor, Chitra has conducted compliance audits in numerous regulatory jurisdictions, helping organizations build inspection-ready PV systems rooted in operational excellence.

In 2021, she transitioned from her QA leadership role to spearhead pharmacovigilance operations at Lupin, where she continues to integrate quality-first thinking into global safety strategies. A recognized thought leader, Chitra is a member of MRQA, a life member of ISCR, and actively contributes to various PV and quality councils.

Dr. Nitu Sinha

Vice President & Global Head – Pharmacovigilance, Mankind Pharma.

Dr. Nitu Sinha is a seasoned leader in Pharmacovigilance (PV) with over two decades of experience across the pharmaceutical, biotech, and technology sectors. As Vice President and Global Head of Pharmacovigilance at Mankind Pharma, she drives innovation and transformation in safety operations, integrating advanced automation and AI to enable regulatory compliance, efficiency, and patient safety.

Nitu’s expertise spans end-to-end safety strategy, regulatory intelligence, safety data analytics, medical review, and signal detection. She has played a pivotal role in designing and implementing next-generation safety platforms that are scalable, intelligent, and future-ready. Her visionary leadership has helped top global life sciences organizations transition to modern safety ecosystems, embracing technology to improve outcomes while reducing operational burden.

An advocate for industry collaboration, Nitu regularly contributes to global discussions on the future of pharmacovigilance through conferences, thought leadership, and strategic partnerships. She is known for bridging the gap between scientific safety practices and emerging digital capabilities, ensuring that innovation is both impactful and compliant.

With a background in clinical medicine and an MBA in Healthcare Management, Nitu combines medical insight with business acumen, making her a valuable voice in shaping the future of drug safety.

She is passionate about patient-centric approaches, operational excellence, and mentoring the next generation of PV professionals. Her contributions continue to shape the evolving landscape of global pharmacovigilance.

Dr. Prasad Deshmukh

Head – Pharmacovigilance, Cipla Ltd.

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. Siva Kumar Buddha

PV Leader & Consultant

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. JAI PRAKASH

Senior Principal Scientific Officer & Officer-in-Charge National Coordination Centre Pharmacovigilance Programme of India at Indian Pharmacopoeia Commission.

Dr. Jai Prakash has done B. Pharm. and M. Pharm. (Pharmacology) from College of Pharmacy (now Delhi Institute of Pharmaceutical Sciences and Research, New Delhi, India) and Doctorate from the Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), New Delhi, India. At present, he is Senior Principal Scientific Officer and Officer-in-Charge, National Coordination Centre for Pharmacovigilance Programme of India at Indian Pharmacopoeia Commission (IPC), Ministry of Health & Family Welfare, Govt. of India, Ghaziabad. He was also the Secretary-cum-Scientific Director, IPC. He has overall more than 20 years of experience in the area of teaching, research, pharmacovigilance, pharmacopoeia and formulary science. He was temporary advisor /expert for WHO’s Expert Committees, Geneva, Switzerland. He was the member of Institutional Human Ethics Committee, National Institute of Biologicals, Noida, member of Core Group/Expert Committee for Revision of National List of Essential
Medicines, 2011, 2015, 2022, member of CDSCO Expert Committee on Draize Test. member of National Expert Committee for Allergens and member of International Society of Pharmacovigilance. He is also the member of Multidisciplinary Expert Committee of National Pharmaceutical Pricing Authority, New Delhi. He has made several presentations in National and International conferences. He has many national and international publications and book chapters to his credit.

Prior to joining as Senior Principal Scientific Officer, he served as Principal Scientific Officer and Senior Scientific Officer in IPC, Senior Scientific Officer Grade I (Pharmacology) in Central Indian Pharmacopoeia Laboratory (CIPL), Lecturer in Meerabai Polytechnic, Govt. of NCT of Delhi etc. He has several publications to his credit in books (16 chapters), national and international journals of repute (23 national and 19 international publications). He is the recipient of Ms Geeta Mittal Medal for Basic Research in the field of Oncology for being the best postgraduate at AIIMS, Servier Young Investigator’s Award and Certificate of Merit in M. Pharm.

Dr. Retesh Bhumbak

Patient Safety Site Head & MSAP, Bristol Myers Squibb

Dr. Retesh Bhumbak brings over 24 years of diverse experience across global pharmaceutical companies, CROs, and business process services, with deep expertise in pharmacovigilance operations and regulatory compliance. Currently serving as the Patient Safety Site Head and Medical Safety Assessment Program (MSAP) Lead at Bristol Myers Squibb, he plays a strategic role in overseeing global safety processes and cross-functional collaborations.

Prior to his current role, Dr. Retesh led the establishment of a full-service global pharmacovigilance hub and has successfully spearheaded over 25 regulatory PV inspections worldwide. Notably, under his leadership, Aurobindo Pharma’s PV unit became the first-ever pharmacovigilance center outside the UK to be inspected by the MHRA, setting a precedent in global compliance excellence.

Dr. Retesh holds an MBBS and MD from the esteemed Maulana Azad Medical College, New Delhi—one of India’s premier medical institutions. His depth of experience and leadership across safety science, regulatory strategy, and operational transformation make him a valuable contributor to India’s evolving PV landscape.

Souvik Chatterjee

Global Senior GCP/PV Auditor, Novartis.

With two decades of experience in end-to-end Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP), and Computerized System Validation (CSV), Souvik has an extensive background in digital transformation within GxP systems in the GCP and PV domains. He specializes in regulatory compliance, pharmacovigilance delivery, and audit/inspection. Over the years, he has hosted and participated in more than 15 regulatory inspections, including those by US-FDA, MHRA, EMA, BfArM, Dutch Health Authority, and TGA. Additionally, I have been involved in over 200 internal and external GVP/GCP/CSV audits, covering pre-qualification, routine, sponsor, partner, vendor, Computer System Validation, due-diligence, investigator site, country clinical development, mock-preapproval inspection, and baseline audits. He is a certified PMI-PMP (waterfall and agile/Scrum project management), Agile practitioner, and Lean and Six Sigma Black Belt professional with a focus on business transformation projects. His passion lies in the evolving fields of artificial intelligence and machine learning within the GCP/PV domains, and he brings strategic insights to maintain GxP requirements in computerized systems.

Dr. Anil Pareek

President – Medical Affairs and Clinical Research,
Ipca Laboratories Ltd.

Dr. Anil Pareek is a distinguished physician and clinical research leader with over 40 years of experience spanning clinical practice, drug development, and medical affairs. A postgraduate in Internal Medicine from the esteemed Topiwala National Medical College and Nair Hospital, Mumbai, Dr. Pareek has also served as faculty there and held the position of Consultant Physician with the Ministry of Health, Saudi Arabia.

Currently serving as President – Medical Affairs and Clinical Research at Ipca Laboratories Ltd., he has played a pioneering role in several major clinical research breakthroughs. Notably, he conceptualized the role of low-dose Chlorthalidone (6.25 mg) in hypertension management—findings that were published in the Journal of the American College of Cardiology (JACC) and cited in Braunwald’s Heart Disease.

He has also been at the forefront of drug repurposing, including the use of Hydroxychloroquine in metabolic disorders and the approval of the first anti-inflammatory drug for type II diabetes.

Dr. Pareek has authored over 130 publications in peer-reviewed journals across diverse therapeutic areas including diabetes, hypertension, pain management, and inflammation. His work continues to shape evidence-based treatment strategies and set new benchmarks in clinical innovation.

Dr. Pushpa Basavanapalli

Vice President and Head of Global Pharmacovigilance Services, Navitas Life Sciences

Dr. Pushpa Basavanapalli is the Vice President and Head of Global Pharmacovigilance Services at Navitas Life Sciences, bringing 18 years of expertise in the field. She oversees end-to-end global pharmacovigilance operations, ensuring regulatory compliance and strategic execution. Known for her ability to build strong client relationships, she has successfully led numerous high-impact projects.

Dr. Graeme Ladds

CEO & Owner, Pharsafer.

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.

 

Dr. Anju Agarwal

Global Director, Global Patient Safety
ADVANZ PHARMA

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.

In her current role she also manages toxicology and preclinical studies. She has very successfully steered through due diligence and integration activities over recent years.

Bhageswari Sreeraman

Patient Safety & PV, Consultant.

Life sciences professional with 15 years of diverse experience across Pharmacovigilance, Regulatory Intelligence, Clinical Research, and Public Health. Deep functional expertise in patient safety operations, global compliance frameworks, and automation-led digital transformation across drug, device, and vaccine portfolios. Most recently, at 3Analytics, led product development for AI-driven PV automation solutions, focusing on regulatory intelligence, literature surveillance, signal management, and compliance innovation. Previous roles at ICON Plc and Tata Consultancy Services involved leadership in PV compliance analytics, alliance management, and clinical trial safety. With an eMBA from IIT Bombay and a Gold Medal in Microbiology from VIT, recognized for integrating subject matter expertise with technology to streamline safety operations and enhance regulatory outcomes.

Subash J

Director of PV Technology at Navitas Life Sciences

Subash J is the Director of PV Technology at Navitas Life Sciences, bringing over 17 years of experience. A recognized expert in safety database implementation, upgrades, data migration, and integration, he has successfully led multiple Oracle Argus projects across global clients. At Navitas, Subash heads the Safety Technology practice and is the architect behind safetyREADY®, our proprietary pharmacovigilance solution suite. He is committed to building custom PV solutions that improve operational efficiency and minimize risks in pharmacovigilance.