Member of the DIA Board of Directors and also serves as the Co-chair for the DIA Science Policy Advisory Committee. He is an accomplished global life sciences innovation executive with more than 20 years of leadership experience across three multinational corporations, GE Healthcare, Life Technologies, and Terumo BCT, delivering over $500M in career revenue. Palani has a considerable track record in breadth and depth from a medical product development standpoint, and has worked in the areas of drugs, devices, and diagnostics. Palani has a Ph.D. in the field of biological sciences from Northern Illinois University, followed on by a post-doctoral fellowship at the University of Rochester in HIV biology.

C Padmakumar was Co-Founder & Chairman & Managing Director of Terumo Penpol Private Limited. Currently Special Officer, Kerala Medical Technology Consortium; Director, Kerala Lifesciences Industries Parks Private Limited; Director, Padosan Trading Private Limited; and Chief Consultant, C P Consulting.Padmakumar started his career as a Junior Project Executive and worked his way up from the shop floor in India’s first Blood Bag company, Peninsula Polymers Limited (PENPOL). The company is now established as one of the largest manufacturing sites for Blood Bags in the world and is the market leader in India. He was the Chairman of CII Thiruvananthapuram Zone during the period 2011-13. He has also been a member of the CII Kerala State Council.

An influential and data-driven executive professional with a robust background in the Pharmaceutical and Public Health sectors, bringing a unique blend of expertise in leading digital transformation initiatives and leveraging data to guide corporations through complex business changes. Recognized as a thought leader/industry expert in the data, digital health, and AI ecosystem, excelling at understanding industry trends and developing strategic perspectives to guide digital health and AI partnerships and investments. High-level analytical skills and deep expertise in drug development, clinical, safety and regulatory processes, data management, digital innovation, and governance.

Manoj is a seasoned technology leader with 38+ years of international experience in the medical device industry. A Mechanical Engineering graduate from CET Trivandrum with a PG Diploma in Plastics Engineering from CIPET, he began his career at PENPOL, contributing to India’s first blood bag manufacturing facility. Following the Terumo-PENPOL joint venture, he led technology transfer initiatives & held leadership roles across Manufacturing, R&D, Quality, Engineering, & QMS. He later served as Vice President, Global Product Development & Engineering, Terumo Blood and Cell Technologies & whole Time Director, Terumo Penpol Pvt. Ltd. He is also an expert member of ISO Technical Committees & currently chairs the Medical Plastics Committee of IPI

Sinto Poulose is the Founder Director of IQZYME MEDTECH PVT. LTD. He is an MSc. Biochemist having more than 18 Years experience in the IVD field. He is an EU IVDR Implementation Specialist, who is Lead Auditor of ISO 13485:2016 and ISO 9001:2015. Sinto take care of Turnkey Clean Room Consultation for IVD Manufacturing units as per cGMP requirements in accordance with WHO-PQ & EU IVDR.

Chetan Makam is General Manager, Global Blood Solutions at Terumo Blood and Cell Technologies and Managing Director & Board Chair of Terumo Penpol Pvt. Ltd. He leads global strategy and innovation across blood collection, processing, transfusion and services, advancing integrated donor to patient solutions and connected care networks. Since 2018 he has transformed global service capabilities across 150+ countries, shaping “Services Ecosystem” and “Beyond Equipment” strategies to deliver holistic value. With 20+ years in regulated global medical device markets, Chetan serves on the boards of Hemex Health and the Global Blood Fund. Based in Colorado, he is an avid reader and amateur numismatist.

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

Himanshu Baid is the Managing Director of Poly Medicure Ltd (Polymed). Mr Baid embarked on a journey to revolutionize the healthcare industry & founded Polymed in 1995. Under his leadership, the company has consistently delivered sustainable growth and operational excellence. His vision is rooted in providing innovative, safe, and quality healthcare solutions, contributing to a healthier world. He was honoured with the prestigious Ernst & Young Entrepreneur of the Year Award in the Healthcare & Life Sciences category in 2024. He holds key positions in various industry bodies as the Sr Vice President, NATHEALTH, Co-Chair, FICCI Medical Devices Committee, Patron Member –AHPI & Life-time member of Export Promotion Council of Medical Devices.

Dr. Anju Gopan is a medical expert with 25+ years of experience, including two decades in oncology and nearly 13 years in oncology clinical research. She currently serves as Medical Director – Oncology & Hematology at IQVIA, Medical Sciences and Strategy, Asia, guiding complex cancer trials across the region and globally. Trained at KMC Mangalore and RCC Trivandrum, with additional exposure in cancer epidemiology at IARC/WHO, Lyon, she brings strong clinical and scientific expertise. She has led multiple oncology advisory boards and is an active member and speaker at oncology forums, including HBA. Her interests include cancer prevention, women’s health, yoga, wellness, and early cancer awareness.

Dr. Pooja Jani is a Medical Officer at the U.S. FDA who was most recently detailed to the FDA India Office as an Acting International Relations Specialist. Previously, she served as deputy on the Diagnostic Data Program in CDRH, providing strategic oversight and program management for COVID-19 digital diagnostics initiatives.Prior to joining FDA in 2022, Dr. Jani spent 13 years in diverse local public health leadership roles spanning health systems innovation, emergency preparedness and response, and population health program implementation. Dr. Jani earned her MD from the Medical College of Georgia and completed her Preventive Medicine residency and MPH at the University of North Carolina-Chapel Hill.

I am the Founder & CEO of Neujin Solutions, a regulatory affairs and quality assurance consultancy serving medical device and IVD manufacturers in India and globally. I spent 13 years with a European Notified Body as an Assessor, Auditor, and Trainer, evaluating medical devices and manufacturing systems. My team has supported 50+ clients and delivered 100+ regulatory submissions across areas including IVDs, cardiac stents, ophthalmic implants, orthopaedics, and contraceptives. My expertise includes QMS, clinical evaluation, risk management, and usability engineering. I hold degrees from BITS Pilani and IIM Indore.

With over 15+ years of pioneering experience in Data, Analytics, and Research, Adarsh Srivastava leads IVD Data Insights - Data, Analytics & Research at Roche Diagnostics. Known for his strategic insight, Adarsh has driven the creation of resilient and innovative data analytics solutions that have transformed healthcare operations and decision-making. A passionate advocate for ethics in Artificial Intelligence, Adarsh has been at the forefront of establishing a robust infrastructure and fostering a culture of competency in ethical AI. He has championed the integration of ethical considerations into AI development, ensuring transparency, fairness, and accountability in AI systems.

Sreejith is currently Director–RAQA at Stryker Global Technology Centre, India, with over 25 years of experience in the medical device industry across Stryker, GE Healthcare, and BPL Healthcare. His expertise spans process engineering, product quality, quality assurance, and regulatory affairs. He has led multiple FDA inspections, MDSAP audits, and global regulatory audits. Passionate about making healthcare safer and accessible, he has supported global product registrations and certifications including MDSAP, ISO 13485, CE, ISO 27001, and ISO 17025. He is also a Lead Auditor for ISO 13485:2016 and ISO 9001:2015.

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

Director - IQzyme Medtech Pvt Ltd, Member-Anusandhan National Research Foundation (ANRF),"MAHA MedTech Mission" Task Force Committee. WHO PQ & regulatory intelligence advocacy and mentorship with extensive experience in regulatory testing of biologics, in vitro diagnostics (IVDs), medtech innovation across public health laboratories, incubators, and national reference laboratories. Proven track record in strengthening local manufacturing, technology transfer, quality systems for diagnostics and biotechnology derived therapeutics, including COVID-19 diagnostics & emergency response, process automations, LIMS, QMS, EQAAS etc. Adept at guiding startups, manufacturers, and government agencies on WHO Prequalification, Emergency Use Listing (EUL)

B Harikrishnan, working as General Manager at Terumo Penpol Pvt Ltd is an accomplished medical device professional with over 32 years experience in medical device manufacturing sector across Production, Quality assurance, Quality systems, Engineering management, Process automation, PVC processing, Sterilization, Supplier management and Project Management.

Dr Mrutyunjay Suar is the Director General of Industry-Institute-Innovation Interface at KIIT University, Bhubaneswar, CEO, KIIT Technology Business Incubator (KIIT-TBI) and the Chairman of Bhubaneswar City Knowledge Innovation Cluster Foundation (BCKIC), an initiative of the office of the Principal Scientific Adviser (PSA) to the Govt of India. An entrepreneurial professor with PhD in Molecular Microbiology from University of Delhi and postdoc from Institute of Microbiology, ETH Zurich. Under his leadership, KIIT-TBI nurtured 460+ start-ups in last 15 years, created 10000+ jobs and established Centre of Excellence in incubation in the area of Digital Health, Diagnostics & Precision agriculture, supported by DST, Govt of India.

Srihariraju Manthena is an Electronics & Communication Engineering professional with an MBA in Systems & Operations and over 25 years of experience across Aerospace, Defence Electronics, and Medical Device industries. He is an IRCA Certified Lead Assessor for ISO 9001 & ISO 13485, MDSAP Assessor, and qualified Medical Device QMS Tutor. Currently serving as Service Delivery Manager – Regulatory Services at BSI India, he has extensive expertise in Quality Assurance, Regulatory Affairs, Manufacturing Operations, and Medical Device Assessments. He has conducted 1200+ audit man-days and worked with leading global organizations across medical devices, aerospace, telecom, and engineering sectors

Anil Raj is Head of Process and Equipment Engineering at SFO Technologies, the flagship company of NeST Group, established in 1990 in southern India. With nearly 29 years at SFO and a B.Tech in Electronics & Communication Engineering, he has led the development of advanced manufacturing processes for complex electronics and high-level assemblies across Medical, Aerospace, Defence, Transportation, and Industrial sectors for global companies including GE, Philips, Siemens, Thales, Rafael, and IAI. He is also an active member of IPC’s Standards Development Committee and has led Lean, Six Sigma, and TQM initiatives across manufacturing lines.

Dr. MiRa Jacobs is the Head of Digital Health for the MHRA. Prior to joining the MHRA, she worked for the US FDA, most recently as the Director of the Division of Digital Health Policy in the Digital Health Center of Excellence. She earned her doctorate in biomedical engineering. In her civil service roles, Dr. Jacobs has been a key enabler of innovative policy development in medical software and AI space, including Predetermined Change Control Plans and the Good Machine Learning Practice Guiding Principles. She also served as the US FDA’s co-chair of the International Medical Device Regulator’s Forum’s SaMD Working Group.

Sarada is a graduate engineer from CET Trivandrum with a PG Certificate in Business Management from XLRI, Jamshedpur. A professional member of ASQ, she holds certifications including Certified Manager of Quality/Operational Excellence and Certified Medical Device Auditor. With 30+ years of experience across Operations, Product Design, Marketing, Customer Care, and Quality, she currently heads the Quality function as General Manager–Quality at Terumo Penpol Pvt. Ltd. A Senior IEEE member, she served as Chair, IEEE Kerala Section (2020–21) and has received prestigious recognitions including the IEEE Region 10 Women in Engineering Award and Terumo excellence awards.

Dr Deepa Arora, CEO of CLINEXEL, has 3 decades of experience in leadership positions in large pharma in Clinical Research and Safety Monitoring. Due to her extensive experience, she understands the regulatory requirements and business needs of regulated and semi-regulated markets and can accordingly organize customized, tailor-made solutions for Clinical Development & Clinical Research activities for pharma & emerging biotech. CLINEXEL is a full- service Clinical Research Organization with presence in India and the USA. Dr. Deepa has built a strong team at CLINEXEL with expertise spanning across NCEs, NBEs, cell therapy, biosimilars, and repurposed drugs, and provides services to the Sponsors from India, the USA, and Europe.

Wil Vargas, MEM, AStd is an Aerospace Engineer at the U.S. FDA, Center for Devices and Radiological Health (CDRH). He holds a bachelor’s degree from NYU Tandon School of Engineering and a Master’s in Engineering Management from George Washington University. With 25+ years of IT experience across multiple sectors, he has spent the last 12 years in healthcare advancing and harmonizing global voluntary consensus standards through organizations including MITRE, AAMI, and ASCO. Since joining the FDA/CDRH Digital Health Center of Excellence in 2021, he has been serving as an International Policy Analyst in the Office of the Center Director at CDRH.

Alberto Ganan Jimenez is a Pharmacist and a Biochemist and holds a PhD on Molecular and Cell Biology from University of Zaragoza (Spain). After working in Pharmaceutical Industry in Business Intelligence positions, Alberto joined the EMA in 2006 as a Product Lead in the Quality of Medicines Office. In 2013, he was appointed Head of Procedures office and since 2022 he is leading the Committees and Quality Assurance Department. This department hosts the secretariat of the Scientific Committees and Working Parties and the Expert panels on Medical devices, provides quality assurance on regulatory and labelling aspects of medicines and is responsible for the procedural management of minor variations and validation of initial MAAs.

Stephanie Shedd, B.S., RAC is a Biomedical Engineer at the U.S. FDA’s Center for Devices and Radiological Health (CDRH). She earned her bachelor’s degree magna cum laude in Bioengineering from the University of Pittsburgh. From 2005 to 2023, she served as a lead reviewer in OPEQ, focusing on pre- and post-market review of spinal devices, including intervertebral fusion cages and pediatric devices. She has been recognized for her review of a novel anterior non-fusion device for adolescent idiopathic scoliosis and for mentoring new employees. She currently serves as an International Policy Analyst in the Office of the Center Director at CDRH.