Moin is a veteran alumnus with 44 years of work in the Pharma Industry and still counting. He is one of the well-known Pharmacovigilance (PV) professionals in Asia-Pacific having rich hands-on experience of practically every facet of Industrial Pharmacovigilance. He founded PVCON which is a Consulting & Auditing Services firm. He has undergone extensive training in U.S., Germany, France and Singapore to master PV. He is a certified "Lead Auditor"and is closely associated with Govt. Of India's National Pharmacovigilance Program as Advisor and Trainer for DCGI & PVPI staff. Recently, he has been nominated by the International Society of PV to lead its South Asia chapter.

Saket Singh, Vice president Global Pharmacovigilance capability lead overseeing operation for India, APAC, Europe & LAtam with 15yrs of experience in clinical domain, vast experience of handling operations for CDM, SDTM & Core expertise in handling the Pharmacovigilance process across multiple pharmaceutical clients. Expertized skills in leading large sales pursuits, thought leadership, developing strategies for growth, managing cross functional strategies, Pharmacovigilance processes, Audits & Inspection management, process re-engineering, operational excellence Project, Six sigma black belt.

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.

AS VP – Life Cycle Safety, Vijay leads Global Safety Case Processing, Regulatory Reporting and Literature Screening services for IQVIA. Vijay brings broad service delivery experience in life cycle safety across Drugs, Vaccine, Device and Consumer products across end-to-end safety case processing and more recently established global capabilities to support COVID vaccine programs for two of the largest vaccine makers. An early adopter of technology; has successfully deployed multiple tools and BOTs to achieve tangible benefits and optimization in his role. Vijay has over 20 years of service delivery experience in the healthcare industry and is a regular presenter at conferences.

Pharmacist with over 22 years of experience in pharma industry with over 14 years in end to end patient safety experience, including ICSR management, safety and risk management, Database implementation and migrations.Worked across entire safety service lines. Managed Delivery, quality, compliance and transitions for multiple projects across various therapeutic areas including Oncology, Orphan drugs, Biologics (Vaccines and other biologics), generics and innovator products. Managed communications with regulatory agencies, hands on experience managing multiple regulatory inspections like with MHRA, EMA, FDA etc. Experience managing electronic submission gateways, EudraVigilance, xEVMPD etc. Experience overseeing QPPVs and local RPs.

Soumya Padhy has academic experince BSC with Masters in Business Administration.10 years in Pharmaceuticals Business Management & 15 years in Pharmacovigilance and Drug Safety Quality and Operations Management. Heading Full Service Safety Operations in India with a 240+ team. He is providing PV Business consulting to external stakeholders and clients in PAREXEL. He believes in “Collaboration and Knowledge sharing” as keys to progress in Life & Business.                                                 

Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. In this capacity, he is involved in both the premarket and postmarket regulation of drugs and therapeutic biologics, and in the implementation of the drug safety provisions of the Food and Drug Administration Amendments Act and other initiatives.

Dr. Anish Desai is a trained Clinical Pharmacologist and Pharmaceutical Physician with 3 decades of experience in Academia, Research, and Healthcare industry with proven leadership skills, strong business acumen, and a deep understanding of the Healthcare System, including Pharmaceutical, Nutraceutical & Medical device industry. He has been recognized for driving positive change, delivering solutions, developing talent and nurturing strong relationships with external stakeholders. ‘IntelliMed Healthcare Solutions’ is a Healthcare startup launched by him with an intent to focus on strategic medical affairs for business growth, thereby infusing science into business.

E. Stewart Geary, MD, is Global Safety Officer at Eisai Co., Ltd. He is a Councilor of the Japanese Association of Pharmaceutical Medicine and serves on the Editorial Advisory Board for the Journal of Pharmaceutical Medicine. A member of CIOMS XII, he also served on the CIOMS VII Working Group on the Development Safety Update Report, CIOMS VIII on Signal Detection, CIOMS on Standardized MedDRA Queries, CIOMS IX on Medicinal Product Risk Management and CIOMS Working Group on Drug-Induced Liver Injury. Dr. Geary is a DIA Fellow, a Fellow of the Academy of Physicians in Clinical Research and an IFAPP Global Fellow in Medicines Development. He earned a BA from Harvard and MD from Stanford Medical School.

Dr Kshirsagar was former acting Vice-Chancellor at the State Health Science University, and also Dean Director of medical education and research, and Prof. Head Clinical Pharmacology G.S. Medical College KEM hospital, Parel, Mumbai and at T. N. Medical College Mumbai, President of the Indian Pharmacology Society and Infectious Disease Society, India, Chairman Academic Committee AIIMS. Govt. of India, Delhi.She has won many awards besides being an University topper, gold medalist, B.C. Roy National Award, Vasvik Award for industrial research, developing and patenting liposomal drug delivery system, Mayor’s award three times.

Jamal has 15 years of work experience in various capacities.Head of Pharmacovigilance country operations in India, Sri Lanka, Nepal, Bhutan Bangladesh, Maldives , Vietnam, Cambodia & Laos at Sanofi India – From Nov 2022. Previous positions held are PV Country Head at MSD Pharmaceuticals Pvt for 11 years. Team Leader, Pfizer Drug and Safety PV Process with Wipro Ltd. Lecturer NIPER, Govt of India. Industry Positions: Chairman of PV Council ISCR (India Society For Clinical Research) – Oct 2021- to till date. PV Task force OPPI. India PV update lead - EFPI. Leading role in development of PV guidelines for MAH in India released by CDSCO-NCC-PvPI in Sep 2017.Invited faculty at NCC-PvPI both for AMCs and PV Program.

Dr. Chetanraj G Bhamare, is a Clinical Pharmacologist with more than 10 years of experience in the field of clinical research and pharmacovigilance. He did his graduation as MBBS and post-graduation as MD in Clinical Pharmacology and Therapeutics from Govt. Medical College in Maharashtra, India. 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 is working with Serum Institute of India Pvt Ltd and is involved in end to end pharmacovigilance activities of all vaccines and biologicals as well as clinical development. He has many national and international publications to add to his credit.

MSc Qualified Quality professional graduate with BSc in Pharmaceuticals Sciences from Kingston University and MSc in PV and Pharmacoepidemiology from the EU2P (Consortium of EU universities).I joined Jazz during the lockdown period in the UK to head the R&D Audits and Inspections team in July 2020. My team is global supporting the Early Development, Clinical and PV system related Audit & Inspection activities reporting into Global Quality. I have been in the pharmaceutical industry for 20+ years. I started my career on a manufacturing plant working on process development, optimization and validation at Eli Lilly & Co and then moved into more R&D quality operation roles at Shire (now known as Takeda).

Rie Matsui is Senior Director, Regional Labeling Head for APAC, International Labeling Group, Global Regulatory Science, Pfizer Japan. She is also the Head, External Engagements for ILG. She is the founder of Asia Labeling Hub at Pfizer that has created various local label updates for more than 25 countries in Asia. She was a member of the Advisory Council of DIA Japan until 2020 and received the DIA Japan regional award in 2015. Her papers were published in scientific journals such as Therapeutic Innovation & Regulatory Science. She is the vice chair of the 2021 DIA Japan Annual Meeting Program Committee. She received DIA Global Inspire Award Connector in 2022. She is teaching at Keio University and Chiba University and is a pharmacist.

Dr. Ramprasad Polana leads the AI/ML automation technology team at ArisGlobal. His responsibilities include identifying significant AI/ML opportunities in all areas of pharmacovigilance and developing models to realize the full potential of AI/ML technologies.Prior to ArisGlobal, he has 28 years of software product development experience in various leadership roles. His industry experience includes projects involving Cognitive Technologies at Innominds and multiple startups in Bangalore, and before that developing Business Intelligence products at MicroStrategy, USA and Beijing R&D centres, and Image Recognition projects for NASA , USA and CMC Ltd, India.

A graduate in medicine from University of Calcutta, Sujit did his MD and DM in clinical pharmacology from the Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh. He has more than 15 years of experience in clinical practice, academic research and pharmacovigilance. He has worked across different disease areas including critical care, diabetes, ophthalmology, neuroscience and neglected tropical diseases. After joining Novartis, Sujit has rapidly taken on growing responsibilities on variety of projects including digital and automation projects within the organization.

Amit Bagla has been in industry for 21 years across various roles in global organizations. During last more than 9 years with IQVIA, Amit has many achievements to his credit. He has been leading service delivery for a portfolio of PV programs & large strategic accounts spread across multiple hubs, has established unique service offerings like Medical Devices Centre of Excellence, expanded training formats based on the principles of adult learning, and led several process efficiency initiatives. Amit is an Innovation driver with an ability to spot and turn opportunities to competitive advantage. Amit holds MBA, is certified Project Management Professional (PMP) & finds his calm amidst books, meditation and self-reflection.

Saikat has more than 20 years of experience in IT / ITES industry driving strategic global programs for Fortune 500 clients. Strong knowledge and expertise in the Life Sciences domain and has rich experience in driving Global operations & outsourcing models having worked with Health & Life Sciences clients / engagements in USA, UK, Ireland and Asia. Currently, he is the Global Head of Life Sciences Digital Operations Business of Wipro. A visionary leader spearheading few transformative solutions in the Life Sciences space, advocating changes to improvement business value meter of Life Sciences Clients.

Madhur is Director of Real World Evidence and Market Access at Labcorp Drug Development.He has worked across global and regional roles in the pharmaceutical industry. He is a market access and pricing strategist with health economics and outcomes research background. His career has spanned across Europe and Asia working for various life science companies (including J&J, Lundbeck & LEO Pharma). He possesses experience with all major payers and health technology assessment (HTA) bodies across Europe, North America, Middle East and Asia Pacific.

Mr Abdul Rahim is from the Garden City of India, Bangalore. He is in the healthcare IT industry since 2001 and has played pivotal role of developing tools like ARISg, agXchange, agBRM, agBalance amongst others, right from inception period to production lifecycle.His start-up venture 'MedSight' laid the foundation for the next generation integrated risk management solution 'MedSight Sapphire' using BigData, which was later acquired by ARIS Global. His latest venture is AWLIS - an Aliteware Integral Solution that primarily focuses on automation of safety and pharmacovigilance activities with Artificial Intelligence to increase the accuracy and reduced cost to the company.

Manoj is a Pharmacovigilance Expert who is extremely passionate about Safe Medicines for Public Health. He has over 16 years of experience in Patient care, Public health, and Pharmacovigilance. He has been in leadership roles in various pharma companies, including Sun Pharma and Piramal Pharma. He is presently associated as a Founder-Director with VigiServe Foundation, a not-for-profit organization in the field of Pharmacovigilance.

Overall corporate experience of more than 16 years which spans over clinical trials and post marketing drug safety. Have been involved in more than 70+ trials across Phase I to Phase IV and BA/BE studies covering various therapeutic areas – Immunology, Cardiology, Oncology, Dermatology. Currently I am Sr. Medical Director at Labcorp and am responsible for the entire MSO team across the post marketing drug safety domain. Current experience spans across a broad range of therapies covering the consumer products, devices and drugs.

Dr. Rubina has regulatory experience of more than 21 years, working in Central Drugs Standard Control Organisation (CDSCO), the National Regulatory Authority of India in various capacities as head of zones , head of division of import registration, new drug, quality assurance of vaccines . She started her career in CDSCO as Drugs inspectors conducting GMP, GCP, GLP inspections.She has five years experience of working in production of Injectable drugs prior to joining CDSCO. Presently working in CDSCO (HQ), New Delhi looking after International Co-operation and prior to this she was working as zonal head, Deputy Drugs Controller (I) in CDSCO (West Zone) comprising of the states of Maharastra, Goa, Daman, Silvassa, DNH and Chattisgarh.

Stephen Fairweather has spent over 15 years at Parexel implementing innovative technology solutions for pharmacovigilance. Having led global teams in operations and systems administration for Parexel’s top safety partnerships, he now focuses on advancing capabilities in PV automation.

Hope is a Vice President- Global Safety Operations with Parexel. She has over 18 years of experience working in CRO and Healthcare industries. She has background in Nursing and Public Health. Currently she is located in Boston, Massachusetts, US. Oversights Global Safety Operations.

Started career in Academics in Clinical Pharmacology at KEM Hospital and then moved to corporate and worked with Pfizer, BMS in Clinical Research Quality Assurance. GCP and PV Auditor with ADAMAS Consulting. 20 years of experience in Pharma industry with over 15 years experience in Clinical Research and Pharmacovigilance Quality Assurance. Has conducted audits in more than 35 countries across Asia-pacific, Europe and America.Hosted/prepared clients for health authority inspections in GCP and PV. Authored and contributed for articles in ISCR and RQA journals. Lead and conducted workshops in CAPA and PV. Invited speaker for certificate courses in PV and GCP. MD (Ayurveda), ISO Lead Auditor, MRQA and life member of ISCR.

Asad has more than 18 years of leadership experience within the CRO, pharma, med-device, and biotech spaces.His experience spans safety and PVG operations, clinical laboratories, strategic planning, governance, strategic partnerships as well as technology and innovation. He has led numerous large-scale transformation efforts bringing in organizational change through tight focus on operational benefit and financial discipline. His key focus areas at Syneos is the technology enablement of all our safety and PVG services in partnership with our customers.He is particularly interested in leveraging innovative automation technologies, data integration frameworks and direct to patient/reporter functionality to deliver clinical end-goals.