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.

Dr. Bahadursingh has been a co-chair of the DIA PV India conference for the past 5 years and brings more than 25 years of experience in Pharmacovigilance and Medical Affairs to the table. His well-recognized breadth of experience affords him a unique perspective and expertise in developing comprehensive solutions to the most pressing challenges in pharmacovigilance and drug safety. He joined the pharma industry from clinical practice, after which he was assigned multi-disciplinary leadership roles of increasing responsibility central to ensuring patient safety and regulatory compliance both regionally and globally first at Eisai, Co., Ltd.’s Tokyo headquarters then at MSD Japan, ArisGlobal LLC and Syneos.

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.

Ritu Jaswal Vice President- Pharmacovigilance Operations has experience of more than 18 years in Parexel. She practiced dentistry for 5 years before moving to the CRO world. Involved in winning and take off of more than 25 PV projects. Leading a team of over 2500 staff globally. GMBA for Mohali and Chandigarh offices for Parexel. She likes gardening, reading fiction, listening to music and cooking.

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.

Dr. Jhonas is the Regional Safety Officer in Asia Pacific Region for Johnson & Johnson MedTech. He is a licensed physician and a licensed pharmacist; he holds a Doctor of Medicine degree from the University of the Philippines, Manila and a Bachelor of Science degree in Pharmacy from the University of Santo Tomas. He has over 10 years of Medical Safety experience in both Consumer & Device Sectors of J&J’s Office of the Chief Medical Officer. In his current role, he is responsible for the medical safety oversight, coordination and mitigation strategies of all medical device safety-related matters in the region, including the support and management of reported medical device complaints, AEs and malfunctions.

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.

Decisive, results-oriented, transformational and passionate medical affairs and clinical research professional, Dr Sadhna Joglekar is the Head of Global Drug Development (GDD) Centre in India for Novartis. She is also a member of the NGSC (Novartis Global Service Center) Board in India. As Head of GDD in India, Sadhna leads the creation and implementation of the overall long-term vision and strategic priorities for GDD India that will enable growth for all GDD functions in India. She also plays a key role in facilitating cultural changes that empower GDD India associates to realize their full potential and have a big impact on patients.

Joanne has BSC in Finance, MBA in International Finance. She has been Global Head of Safety Services – Overseeing global operations of 3100 employees and Member of the Clinical Development Leadership Team. Thought Leader in Outsourcing Strategies (RA and PV), Organizational and Resource Optimization Strategies, Innovation and Partnership Engagements. Over 25 years of experience working in Biopharmaceutical, CRO and Healthcare industries. Former Parexel India Country Leader - Overseeing operations across all PAREXEL India locations encompassing 5000+ employees.

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.

Mohammed Baseer Ahmed is currently Executive Director- Global Pharmacovigilance at Ionis Pharmaceutical. He has over 15 years of experience in Pharmacovigilance Operations. He is a dentist by training and masters in clinical research with extensive experience in managing PV operations spanning across geographies while working at large pharmaceuticals, small biotech and innovative rare disease companies going through different stages of drug development and marketing. He lives currently in Massachusetts with his wife and children.

Sanjay is a Senior Executive in Accenture’s Applied Intelligence practice focusing on PV Analytics & AI/ML based insights, Safety Signal Detection and Safety RWD/ RWE data management. He has deep expertise in Cloud-based Solutions, Life Sciences R&D Digital Transformation, Data and Technology Architecture & Analytics and is based out of Florham Park, NJ, USA. He is a certified AWS & GCP Solution Architect. He has completed his PhD from Northwestern University, Evanston, USA.

Over 25 years of experience in the pharma industry and 6 and a half years in CDSCO-INDIA as a consultant New Drugs reporting to the Drugs controller general of India. Mostly involved in pharmacovigilance of new drugs and old drugs,SAE causality assessment and compensation determination ;inspection of CRO’s,hospitals and pharma company’s for determination of ethical conduct of clinical studies and GCP and making of pharmacovigilance related SOP. Presently consultant to IPC As Medical consultant for SIGNAL Review and Materialovigilance .

I have a total of sixteen years’ experience handling diverse portfolios consisting of twelve years in pharmacovigilance and two years each in clinical trials and in clinical practice. For the last six plus years have been in AstraZeneca, initially as a Global safety Physician in an individual contributor role, later on moved into people management/leadership role where I am currently serving.I am a clinical pharmacologist holding MD, DNB and other clinical research & scientific writing diploma certificates. I have experience of working in AstraZeneca, Novartis, Johnson & Johnson and Lotus Labs, have completed Postgraduate Diploma in Clinical Research and certificate course in Scientific Writing and Creation of Essential Documents.

Sanjay moved in 2019 to India from USA as the EVP, India Country Head & Board of Director, he is responsible to develop strategic direction & provide the leadership and vision necessary to grow the 6,000 plus India organization. He also is the Parexel’s Global Head of Safety Business Unit and Clinical supplies & Logistics business which also includes the global distributions centers & infrastructure. He lived & worked in 8 countries & 4 continents, Sanjay brings over +23 years of experience in Global P&L management, Logistics & Supply chain management, Sales & Marketing, M&A's, Operations & People management.

Aman Wasan is a thought leader within Pharmacovigilance and currently works as Senior Vice President at ArisGlobal. Aman previously served as Vice President of ArisGlobal’s Safety Business Unit responsible for the development of ArisGlobal’s Next Gen-Cognitive Automation enabled Safety Platform. Previously, Aman has held senior leadership positions managing End-End Pharmacovigilance processes at different Global organizations.

Dr Bhatt has extensive experience of over three decades in the Indian pharmaceutical industry in clinical research, drug development, and regulatory affairs. He has managed clinical development of novel molecular entities in diverse therapeutic areas in all clinical development phases. He has worked as a consultant in pharmaceutical medicine and clinical pharmacology. His past positions held include President, Clininvent Research Private Limited – a CRO, CEO of CMI (India) Private Limited and Medical Director of Novartis India Limited. He has been active in industry associations and was earlier the President of Indian Society for Clinical Research (ISCR). He is Editor-in-Chief of Perspectives in Clinical Research – the journal of ISCR.

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.

Ashish is Senior Manager at Stryker neurovascular and has over 21 years of Clinical Research and Digital Innovation experience in Medical Devices. As a principal scientist in TCS, He has been the part of world’s first Artificial Intelligence based pharmacovigilance processing system development and deployment. He has invented the Nano technology-oriented solution for breath-based detection of cancers and infections and has extended the technology for recreation of as auto adjusting mask, detection of pathogens on nonliving surfaces, circulating air and Sewage water. He has worked on Digital Heart, Digital Nose and AI based preclinical to clinical translation of medical device safety and performance data.

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.

Dr Mangesh is MD physician with over 14 years of experience in Clinical Drug Development, Pharmacovigilance and Medical Affairs from diverse set-ups such as Academia, Contract Research Organization (CRO), Pharmaceutical and IT Industry. In his current role as Head of Safety Operations in the Drug Safety & Epidemiology at Novartis Healthcare Pvt Limited, Hyderabad, he is responsible for global ICSRs and Aggregate safety report submissions

Dnyaneshwar or Dnyan (better known as Dan in indistry circle) is a qualified physician of Indian origin, with total experience of more than 17 years. His first encounter with PhV occured during pursuing masters training at a WHO zonal center for Indian National Pharmacovigilance program (KEM hospital, Mumbai; 2007-08).He has worked across PhV business models [academia (KEM), vendor (TCS, Accenture), and sponsor-both developmental (AZ, UCB and BI) and post marketing (Sun /Taro and Glenmark)] since then. He is a qualified PV-QA auditor and a clinical trial medical monitor, has worked (as well as working) as EU-QPPV.

A Dentist with Masters in Clinical Research having close to 12+ years of rich work experience both as a Dentist and a Pharmacovigilance Lead. She has earned her BDS from Rajiv Gandhi University; and had her clinical practice for a couple of years until she moved completely into Clinical Research. Kirstan joined Indegene in June 2021; currently she leads and manages day to day operations of the Case Processing Team under Safety Solutions within Indegene. Her involvement lies in providing directional leadership to project teams, driving various strategic initiatives and implementing process improvement initiative across domains.

Medical professional with graduation in medical rehabilitation sciences from NIOH, Kolkata with postgraduate degree in neurosciences from BYL Nair hospital, Mumbai and management education from IIM Calcutta. She has 17 years of working experience in health sector and pharmaceutical Industry including 15 years of experience in pharmacovigilance. Global pharmacovigilance experience includes ensuring operational performance to meets regulatory requirements and Pharmacovigilance obligations across all geographies. She has more than a decade of experience in handling Biosimilar Drug Safety.

Sachin is currently working as Associate Director, PSS with Labcorp Drug Development, India. He is M-Pharm in Pharmacology by qualification and has over 16 years of industrial experience including 12 years from various domains of Pharmacovigilance. He has expertise in managing large scale global operations to provide end to end case processing for large pharma clients across various therapeutic areas including Oncology, Biologics (Vaccines, Other biologics) and OTC drugs.

Gurumurthaih SS has a decade experience in Pharmacovigilance (PV) with expertise in PV, Regulatory labelling and Project management. He has Masters in Industrial Pharmacy from Rajiv Gandhi University of Health Sciences, Bengaluru. He started his career with IQVIA Bengaluru and worked with multi-national organizations like Cognizant and Syneos Health prior to Indegene. An experienced operations manager, has hands on experience in PV ICSR and literature screening and project management with multitasking with the great track record of setting up of multiple new projects effectively in PV, regulatory labeling and medical writing.

Naila Haris is a pharmacovigilance professional at the Safety and Aggregate Reporting Analytics department at IQVIA. With 11 years of industry experience, Naila currently manages a team of aggregate report writers. She also maintains oversight of benefit risk assessment reports and risk management plans for various clients. Naila holds Master’s in pharmacology from Manipal University.

Rawya is currently the Director of Medical & Regulatory Affairs Department with more than 20 years of successful experience in Julphar, where she leads both functions of Regulatory & Medical Affairs Department. Optimize interdisciplinary understanding and teamwork across the group(s) and integrate Regulatory and Medical activities with those of other departments, ensuring timely and quality submission and Health Authority Interactions. She is also in charge of the Global Drug Safety Surveillance Division, all Pharmacovigilance compliance and safety surveillance activities, quality management to maintain audit readiness of Julphar office internal procedures.

Thomas Nisslein, DVM, PhD, is a licensed veterinarian who studied at University of Munich, Germany. He obtained his PhD in developing a rabies vaccine in a continuous cell culture system at University of Goettingen, Germany and received his Board Certificate 'Veterinary Virology' from the German Primate Centre, Goettingen, Germany. After industry positions in Preclinical Research and Development in the fields of Immunology, and Endocrinology he joined the Global Pharmacovigilance Department of Abbott Laboratories in Hannover, Germany where he held positions of increasing responsibilities. Currently he holds the positions of Global Head of Pharmacovigilance and European Union Qualified Person for Pharmacovigilance.

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

Dr. Urmila Thatte MD (Pharmacology), DNB (Clinical Pharmacology), PhD (Clinical Pharmacology) FNAMS.Listed among the top 2% scientists in the world based on citation of papers of rational use of drugs in developing countries, Pharmacogenetics, Therapeutic Drug Monitoring. The key achievements are: Core team for National Ethical guidelines for Biomedical and Health Research Involving Human Participants, Developed Training modules on GCP and Advanced GCP, National DSMB Guidelines for the DCGI and WHO, Nation wide course on GCP for investigators, ethics Committee members, sponsors and Regulators. More than 300 Publications in National and International Journals including 10 books.

Dr. Deka is a Physician by training and spent 7 years in clinic in the departments of Medicine, Surgery, Accident & Emergency and Orthopedics in India & abroad. Having worked in pharmacovigilance and drug safety for more than 14 years, he has gained experience in areas including signal detection, benefit- risk assessment, risk management & mitigation planning and various process improvement initiatives.In his current role at Amgen, he is responsible for early development molecules, primarily t-cell engagers, targeting solid tumors. As a member of the drug development team, he provides strategic leadership towards evidence generation and maintaining an up-to-date safety profile of the molecule, with support from development & safety teams.

With more than 18 yrs experience including PV industry and clinical practice, Prasad in his current role as VP, Drug Safety & PV with Syneos Health is managing specific PV operation in India, Japan and China. He is involved in setting up and managing PV operations, developing strategies for growth, PV processes management during his career in various organizations.

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

Kausik Maiti is an MD with over 2 decades of experience in Clinical Medicine and Pharmaceutical Industry. Currently, Dr. Maiti leads Safety Physicians, Independent Scientific Data Review Committees, and Signal Management businesses. His team consists of over 300 highly qualified professionals spread across the globe. As part of Global Safety Services leadership, he provides strategic inputs to the business and lead the assigned business functions, client accounts and key initiatives. He provides scientific expertise and contributes to pre-sales activities & PV Consulting. He leads Thought Leadership initiatives for the business unit and drives innovation, research, and technology initiatives in partnership with stakeholders.

Raghav has over 20 years of experience in pharmaceutical industry and over 15 years in Pharmacovigilance and leadership role. Prior to Ipsen, Raghav was Director and head of regional PV for APAC, ANZ in Abbvie and in Allergan based in Singapore. He started his PV career from Lundbeck where over the 12 years, apart from establishing regional PV setup for Lundbeck in APAC, he also established case processing unit which managed around 40% of global safety cases for Lundbeck from Singapore. Raghav also worked in clinical research, project management in his initial days in Pharma industry. His newfound passion is application of AI and ML in PV.