Head, Bioavailability and Bioequivalence
Sun Pharma
Dr Arshad H. Khuroo graduated from Jamia Hamdard, did his post-graduation in pharmacy operations, followed by his Ph. D. in pharmaceutical sciences, from BIT, Ranchi. He started his career as a Bio-analyst and currently is heading bioavailability and bioequivalence (BA and BE) function in SUN Pharmaceuticals India Limited. Dr Arshad has 30 years of remarkable experience in conduct of BA/BE studies for the domestic and international markets and has faced more than 100 national and international regulatory inspections till date. He is author/co-author of nearly 100 publications in reputed international journals and has also written a book entitled, “Echoes of experience, 30 insights from life’s journey.”
Head, Global Clinical Operations,
Cliantha Research
Dr. Domadia has 20+ years of experience in CRO & Pharmaceutical industry. With Cliantha Research, he is associated for more than 8 years. Dr. Domadia’s experience includes early clinical development (BA/BE), Phase I (NCE), Experimental, Proof of Concept, Biosimilars, , Glucose Clamp studies, Patient Based PK studies, Clinical endpoint studies, Late Phase Studies, Pharmacovigilance (PV) and Biometric operations (PK, STAT and DM) with rich mix of leadership, and operations.
Dr. Domadia is an excellent operational strategist, and a judicious decision maker with intuitive and articulate vision. He is accountable for overall strategy and execution of business plans for the Late Phase Global Clinical Operations at Cliantha. Dr. Domadia has built & lead the team of more than 300+ scientist in CROs and streamline the various operational activities as per the regulatory requirements. He has successfully managed 100+ regulatory inspections for early & late phase including US FDA, MHRA, MCC, MHCW, ANVISA and DCGI at Cliantha.
Geena Malhotra is Cipla’s Global Chief Technology Officer since January 2020 and is a member of its Management Council. She also fronts the Company’s Devices and Diagnostics Centre of Excellence, Sustainability agenda and Compliance drive.
Prior to her current role, she has led Manufacturing Operations as well as Integrated Product Development with the Company. Having joined Cipla in 1986, for well over three decades now, Geena has been an integral pillar of Research & Development and a key driver of Cipla’s Respiratory Innovation Engine. She spearheaded the Company’s use of cutting-edge technology platforms, equipment, drug-device combinations and targeted drug delivery dosage forms, in order to fulfill unmet patient needs. She also has to her credit, many patents in the areas of formulation development and technology in solid oral dosage forms, topical delivery systems and inhalation medical devices.
Geena has been instrumental in driving Cipla’s transformation towards becoming a digitally agile company as well as reimagining its operations across the value chain through initiatives like the adoption of Industry 4.0.
Under Geena’s leadership on the ESG front, Cipla has won several recognitions pertaining to Sustainability and Occupational Health & Safety. The Company ranked as one of the most sustainable healthcare companies in the Dow Jones Sustainability Emerging Markets Index 2021. Cipla was also conferred with the Frost & Sullivan and TERI's Sustainability 4.0 Awards 2021. These accolades are testimony to Cipla's continuous efforts in the sustainability space as a leader in the pharma industry.
Geena holds an Executive MBA degree from the University of Washington, St. Louis. She has also completed her Bachelor’s in Pharmacy from Mumbai.
Greg Smith is the Director of the India Office in the FDA’s Office of Global Policy and Strategy (OGPS). His FDA career spans over 12+ years working as the director of CDER’s Special Projects Staff in the Office of Executive Programs and as a regulatory project manager in CVM’s Office of New Animal Drug Evaluation. He specialized in complex and mission-critical scientific, regulatory, legislative, and operational issues including user-fee negotiation, supply chain assessment, legislative implementation, organization-wide governance, and portfolio management. His professional experience includes project management of clinical trials, risk evaluation and mitigation strategies, post marketing, and surveillance initiatives for a global contract research organization (CRO). Mr. Smith is a certified project and portfolio management professional and graduated from the University of Maryland, College Park
Consumer Safety Officer (Pharmaceuticals),
India Office US FDA
Guerlain Ulysse is a Consumer Safety Officer (CSO) within US FDA’s India Office. Since 2015, he has held the role of CSO for the New Jersey District Office and Drug Specialist for Office of Regulatory Affairs (ORA). He has also completed details as a supervisor and as part of U.S FDA Dedicated Foreign Drug Cadre conducting various international drug inspections. He holds a M.S degree in Biotechnology from the University of Maryland Global Campus. He has also completed his Bachelor of Science degree from the University of Michigan, Ann Arbor and has co-authored scientific publications in the field of biomedicine and biotechnology.
Dr Himanshu Gadgil, CEO of Enzene Biosciences Ltd. Under his leadership, Enzene transformed from a startup biotech into a multi-vertical, multi-site biopharmaceutical enterprise. Previously, he served as Sr. Vice President at Intas Pharmaceutical Ltd., where he revitalized the commercial product pipeline by successfully launching numerous biosimilar products across various global markets. During his stint in the US, he led different facets of process and product development at Amgen spearheading IND, BLA and Market authorizations of various blockbuster biotech products. Early in his career, he joined Waters Corporation, pioneering QBD methodologies that enabled multi-attribute characterization in biopharmaceuticals. Himanshu holds a PhD in Biochemistry from the University of Tennessee and has authored over 50 publications and patents, showcasing his leadership and innovation in science.
Deputy General Manager, Formulation R&D
Sun Pharma Industries
Industries have started moving the point-of-analysis from the laboratory to process. PAT not only detects the issues early, it also supports Statistical Process Control (SPC) through real-time monitoring and optimization, and improves Quality by Design (QbD) with better process understanding and risk management. Although the concept of PAT is known for decade, the implementation still remains a challenge, thus demanding more experience and knowledge-sharing. R Kalaiselvan is serving as General Manger (FRD) in Sun Pharma Industries Ltd. His work profile includes formulation development (modified release generics and new products), process scale-up & technology transfer. PAT is his area of interest to achieve the consistency in quality and has co-authored the guidance on process analytical tool published by IPA. He would share the fundamentals and interpretation of results with case study examples in this webinar.
Kellia Hicks, Level II, Drug Specialist is Senior global regulator with the U.S. Food and Drug Administration (FDA) where she has played a pivotal role in ensuring the safety, efficacy, and quality of medical products available to consumers both in the US and abroad. Her contributions have positively impacted patient safety on a global scale. With 15 years of domestic and international regulatory operations and regulatory compliance experience with the FDA, she has established herself as a Subject Matter Expert (SME) in the complex landscape of sterile and non-sterile pharmaceutical manufacturing operations, pharmaceutical quality, and regulatory compliance.
In addition to her regulatory work, she engages in, and is passionate about capacity building, fostering collaboration, and knowledge-sharing within the pharmaceutical industry. She frequently serves as a SME speaker and panelist at conferences and workshops with both the private industry and international government stakeholders, where she shares her insights on emerging regulatory trends, best practices in regulatory compliance, and the evolving global regulatory landscape.
Kellia holds of Master of Public Health and a Bachelor of Science in Biology, minoring in Psychology. She is honored to join this conference as a Panelist, where she looks forward to sharing her knowledge, insights, and experiences with industry experts and stakeholders to foster collaboration and innovation in the area of global regulatory drug compliance.
Head, Global Quality and Pharmacovigilance
Dr Reddy's Laboratories
Mr. Krishna Venkatesh is the Global Head of Quality & Pharmacovigilance. Mr. Venkatesh has over 28 years of experience in the pharmaceutical industry and has been with our company for 14 years. His experiences span across areas of product development, process engineering, technology transfer and manufacturing operations. Prior to joining our company, he worked with Barr Pharmaceuticals and Teva in the United States. Mr. Venkatesh holds an MS degree in Pharmaceutics from University of Mississippi and a B. Pharm degree from BITS Pilani.
President & Head - Pharmaceutical Technology Center (PTC)
Zydus Lifesciences Limited
Mr. M. E. Kannan leads the formulation Research and Development organisation, Pharmaceutical Technology Center (PTC) at Zydus Lifesciences Ltd., Ahmedabad.
Mr Kannan is an alumni of Dr. H. S. Gour Vishwavidyalaya (formerly known as Sagar University). He has been part of R&D organization’s over the last 25 years in various capacities with increasing responsibilities over the years.
His current roles and responsibilities include conceptualization of project strategies, resourcing, product development, scale-up, regulatory submissions and approvals & overall management of the research and development organization. He leads multiple teams comprising of scientists from varied scientific disciplines.
In the area of oral solid dosage forms, he is instrumental in developing many complex modified release dosage forms in the technology area such as matrix, reservoir, multi particulate, solid dispersions etc. He has wide experience in scaling up these technologies to commercial scale. He is also engaged in the research of different dosage forms viz. parenteral, topical, pulmonary and transdermal dosage forms. He has many patents and publications in the field of pharmaceutical research.
Deputy Director, Office of Policy for Pharmaceutical
Quality, OPQ, CDER
USFDA
Commander (CDR) Mahesh Ramanadham is the Deputy Director for the Office of Policy for Pharmaceutical Quality, within FDA’s Center for Drug Evaluation and Research, Office of Pharmaceutical Quality (OPQ). He joined the FDA in November 2009 after graduating with his Doctor of Pharmacy degree from the University of Maryland and his M.B.A. from the University of Baltimore. Within FDA, he has served in leadership roles in the Office of Compliance and the Office of Pharmaceutical Manufacturing Assessment within OPQ. Prior to joining FDA, CDR Ramanadham had experience in solid oral dosage manufacturing ranging from OTC products to schedule II narcotics. Outside of FDA, CDR Ramanadham continues to practice pharmacy in the community setting to maintain perspective on the clinical relevancy and impact of FDA’s efforts in pharmaceutical quality.
Nilesh Gupta is the Managing Director and member of the board of Lupin. He is a Chemical Engineer from the Institute of Chemical Technology, Mumbai and an MBA from the Wharton School, Philadelphia.
As Managing Director of Lupin, Mr. Gupta co-leads the Company and has helped establish Lupin’s research platforms, expanded its manufacturing operations and strengthened its quality standards. Mr. Gupta is also responsible for the Company's R&D and technical operations in India, and leads the Company’s Quality and Supply Chain functions, in addition to the commercial function for the India, API and Asia Pacific regions which are close to half of the company’s global revenues of USD 2.5 billion.
Prashant Sharma is a part of Zydus Senior Leadership Team and manages Group Manufacturing & Operations for Formulations & API at Zydus Cadila. He has been in business roles for over 3 decades and managed Global Supply Chain, Human Resources, Corporate Communications &
Operations portfolios in MNCs and Global Indian organizations.
He believes that Learning Agility & Formative Experiences shape a leader. The foundation for both is a keen desire to keep learning & challenging oneself, taking risks and building teams that perform better than oneself.
Pravin Kulkarni is a seasoned quality professional, with 25 years of enriching experience within pharmaceutical domain. He has worked at various Senior leadership roles with reputed pharma companies covering multiple dosage forms, API, products and technologies. Currently, Pravin is working as Head- Global Quality Sustainability, Training and Quality Culture, Sun Pharma. His previous assignments include major pharmaceuticals companies like Biocon Biologics, Emcure, Mylan and Wockhardt at leadership level. He is a postgraduate in Microbiology. Certified IIM-A, six sigma and lead auditor professional. His pharmaceutical industry career encompasses a breadth of experience in the area of Quality Management System, Remediation, Corporate Quality, Quality Culture, Sustainable Quality Compliance, Sterility Assurance, Microbiology, IT-QA and Operational excellence.
Drug Controller General of India
Government of India
Dr Rajeev Singh Raghuvanshi has completed his Bachelors and Masters from IIT-BHU (Formerly IT-BHU), Varanasi and PhD from National Institute of Immunology, New Delhi. His PhD work is in the area of Extended Release Formulation of Vaccines, a project conceptualized to help reduce the number of injections required to be given for complete immunization. He has also done ISB-Kellogg Global Advanced Management Program.
After working for 7 yrs at National Institute of Immunology, New Delhi, Dr Rajeev moved to join the leading Indian multinational, Ranbaxy Laboratories Ltd., where he worked for development, registration and launch of NDDS, Generics and Branded Generics for various global markets. After having spent 12 years with Ranbaxy, he moved to another Indian Multinational, Dr Reddy’s Laboratories Ltd, Hyderabad. In his 11 years of stay with Dr Reddy’s Labs, first eight years was in development of 505b(2) NDA products for US market. In this role, he successfully led the CMC team to get 6 products approved in 1st review cycle by USFDA. During this tenure, he had the opportunity of multiple face to face interactions with USFDA, MHRA and agencies from South Korea, Sweden, Romania etc. Last three years at Dr Reddy’s has been in a different role of establishing an R & D Team for markets like India, China, Russia and other Emerging Markets in the space of Pharmaceutical Product Innovation / Differentiation, registration and launches. He is widely travelled throughout the world and has worked with team members and partners in countries like USA, UK, China, Russia, South Africa, Romania, Sweden, Canada, France, Australia and Japan.
Dr Raghuvanshi’s expertise lies in dosage form design and development, mainly in the domain of pharmaceutical innovation. He has been involved in development of different kind of products like Oral Solids, Oral liquids, Topicals, Injections, Nasal Sprays, Auto-injectors, Sublingual, Mouth Dissolve, Extended Release and Delayed Release for global markets. More than 200 products developed by him and his teams are currently being sold in India, US Europe and Emerging Markets. Dr Raghuvanshi has 14 granted US patents along with more than 250 published PCTs and Indian Patents. He has more than 25 publications in peer reviewed journals and has co-authored 6 chapters in books. He has been visiting faculty at NIPER – Hyderabad and IIT-BHU and has taught students of NIPER-Mohali. He is a regular speaker at different International and National conferences on Pharmaceutical Innovation. For his contribution, Dr Reddy’s Labs has twice awarded him with “Dr Reddy’s Excellence Award”.
Leadership development has been his passion and many of his team members mentored by him are holding leadership roles in Indian and global pharmaceutical companies.
After a very successful career with corporate pharma, he decided to do something completely different which is socially more impactful. Of many possibilities, he chose to work with Govt. of India and joined Govt’s Ministry of Health and Family Welfare, as Secretary-cum-Scientific Director of Indian Pharmacopoeia Commission on 16 Feb’21. In a short stint of 2 yrs, he changed the face of IPC and bought multiple long lasting changes impacting quality standards for medicines being sold in India. Cultural shift to more open and receptive organization scaling up the Impurity Standards inventory, harmonization of quality specification with ICH and other global standards, increasing user base for IP and IPRS, PDG membership for IP, international recognitions and scaling up of Pharmacovigilane and Materiovigilance program of India are some of them.
Govt of India has now been given him the responsibility of Drugs Controller General of India. He joined the new position of 23rd Feb 2023 and working towards changing the way Indian pharmaceutical regulation is looked in this country and beyond.
Head, Development Quality Assurance
Dr Reddy’s Laboratories
Rajendra Madhukar Bandgar - Head of Development, Preclinical and Clinical Quality Assurance at Dr. Ready’s Laboratories Limited, Hyderabad.
Mr. Rajendra has around 28 Years of experience in different functions of Pharmaceutical Industry. In his previous assignments, he has worked with Lupin Limited, Wockhardt Biotech, Orchid Healthcare and Emcure Pharmaceuticals.
He has experience in the Pharmaceutical Industry in Analytical Research, Quality Management of Preclinical, Clinical, Pharmacovigilance and Drug Substance and Drug Product Development, Technology transfers and Regulatory affairs. Expertise in interpretation and implementation of new regulatory guidelines, risk assessment and failure investigations and Quality Management System of Drug Device Combination Products. Received Platinum Crystal Award from USP in 2017 for highest contribution to USP. He has been invited to deliver lectures at various Universities, Colleges and USP workshop.
Mr. Rajendra Bandgar is Post Graduate in Chemistry from Shivaji University Kolhapur.
Rajeev Kumar Sinha is Cipla’s Global Chief Manufacturing Officer since April 2024 and is also member of its Management Council. Prior to this, he was the Joint President & Global Head Formulations Operations at Cipla.
Rajeev is an accomplished leader with over thirty-five plus years of rich experience in the Operations & Supply Chain domain across diverse industries such as Chemical, FMCG, Foods & Beverages and Pharmaceuticals. Before joining Cipla, Rajeev has worked with ICI India Limited (Explosives Division), Hindustan Unilever Limited , ICI India Limited (Paints Division), Cadbury India Limited, PepsiCo and Glenmark.
At Cipla, Rajeev led Global Operations Strategy & Excellence, Manufacturing science & Technology, Formulations Manufacturing Operations and API Manufacturing Operations. He has been pivotal in driving Cipla’s transformation towards becoming a digitally agile company while reimagining its operations across the value chain.
Rajeev strengthened manufacturing operations through focused initiatives on - Manufacturing Science & Technology, Digital Advanced Analytics and Automation, Occupational Health & Safety and Environment Sustainability, Engineering Asset Care, Technology for Manufacturing & Project Management, Operations Excellence - embedding a culture of Lean Six Sigma and driving continuous improvement in the area of people capability and business processes to meet the evolving statutory, product regulatory and control environment expectations.
He holds a Bachelor of Technology degree in Mechanical Engineering from IIT Kanpur
Ex-Vice President of Engineering
Sun Pharma Industries and Founder, Eco-vita
Rajendra Kumar Das - A Mechanical Engineer with MBA from IIM Nagpur & Advance Diploma in Industrial Safety.
Enthusiastic, versatile, high-energy leader having over 28 years of extensive experience in Planning, Designing, Green field and brown Project, Operation and Maintenance of large-scale Pharmaceutical Industries, Engineering Operations, Validation, Automation, Facility Management, Utility and EHS.
His expertise lies in end-to-end facility creation and management of large-scale pharmaceutical industry with hands on experience and expertise in HVAC (Heating, Ventilation and Air Conditioning) as per GMP requirements. His interest lies in Energy Conservation, Water Conservation, Sustainability, Digitalization for betterment of the organization and Society as whole. He has been very active in reducing power, fuel, water for the organizations he worked for and was successful in it. He believes in society development and in turn nation development through individual’s efforts towards sustainable development. He carries his kin interest in people development with values and integrity and always in search of opportunity for doing something for society for Nation Building.
Passionate about new technologies, Green sustainable solutions, Energy Saving, Lean manufacturing, Automation and digitalization and new market development.
Instrumental in materializing/accomplishing numbers of reputed Greenfield and Brownfield projects with strategies and right interpretation of business requirements.
An active member in IPA Quality Forum, member of ISHARE, ISPE and other industrial technical forums.
Senior Technical Advisor
Indian Pharmaceutical Alliance
Dr Rajiv Desai is the Senior Technical Advisor at the Indian Pharmaceutical Alliance. He formerly headed the Corporate Quality Management at Lupin Ltd in India.
Dr Rajiv Desai has around 30 years of experience in Pharmaceutical Industry. In his previous assignments, he has worked as heads of Corporate Quality Management at Dr Reddys, Mylan, Piramal and Alembic Pharmaceuticals. He started his career with Ciba Geigy (now Novartis) in R&D and Technology transfer in India and Switzerland.
His experience in the Pharmaceutical Industry spreads across basic research, Technology transfers, Quality Management and Regulatory affairs.
Selected as an US Pharmacopeia Expert committee between 2010 and 2015. He has been invited to deliver lectures at various international and national scientific forums. He has actively worked on several board of studies of reputed universities in India for short term teaching assignments and syllabus revision programs for post graduate courses. At UDCT, he was appointed as visiting faculty, under the Daiichi Karkaria memorial endowment faculty program for the year 2013 - 2014.
Dr Rajiv Desai, has a Ph.D from UDCT ( now ICT) in Pharmaceutical Chemistry and a post graduate degree in Management from NMIMS.
Ruth Moore, Ph.D., has worked with FDA for 10 years as a CMC Reviewer performing assessment of manufacturing process and control strategy, inspections and CGMP compliance of manufacturing facilities for BLAs, NDAs and ANDAs. Prior to FDA she spent 16 years in technical and executive management roles in the private sector pharmaceutical industry, overseeing analytical methods development and validation to support process development, process performance qualification and quality control for release and stability testing of drug substances and drug products. She serves as a subject matter expert (SME) on Data Integrity (DI) and CGMP Compliance, collaboratively working with CDER Office of Compliance (OC) and Office of Pharmaceutical Quality (OPQ) to perform risk assessment of DI-violative firms in relation to marketed products and pending applications. In this role she evaluates third-party auditors’ protocols and reports, firms’ CAPAs, and proposed remediation of data in marketing applications.
S. M. Mudda is a Pharmacy graduate with a Postgraduate Diploma in Management Studies. He has more than 45 years of wide experience in pharmaceutical industry covering all aspects of pharmaceutical manufacturing and Quality Management. He was associated with Micro Labs Limitedfor more than 30 years and served them as Executive Director Technical and operations and later as Director Global
Strategies.
He is the Founder Managing Director of Misom Labs Limited, Malta (Europe), an EU GMP Licensed Pharmaceutical Testing Laboratory and Batch Certification company.
He is actively associated with IDMA and is Chairman of Regulatory Affairs Committee.
He is also serving as Technical Advisor and Leadership Mentor to many leading Indian Companies.
Former President – NSF Health Sciences (India & Asia Pacific) representing NSF International UK, a Global GMP Consulting and Education company in Asia Pacific Region.
Program Director, and Faculty, NSF UK, Advanced Program in Pharmaceutical Quality Management, an MBA style 10 months program offered in collaboration with Indian Drug Manufacturers’ Association(IDMA) for the senior executives of the industry.
KEY STRENGTHS
Technical and Strategic leadership for Design and Operation of Pharmaceutical manufacturing plants consistent with global Standards for Operations and Quality Excellence
Design & implementation of best-in-class Pharmaceutical Quality Management System for consistent implementation of Good Manufacturing Practices (GMPs) harmonized with the global requirements
Well-connected with the national & global thought leaders in the areas of PharmaceuticalQuality Management and CGMP Regulation
Has hosted 70+ GMP inspections conducted by leading regulatory agencies such as USFDA, European Agencies, MHRA etc. Specialized in creating global remediation plan for long-term and sustainable CAPAs thereby helping companies in averting regulatory actions.
Sam has joined NSF from a long career history with the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Department of Health & Social Care (DHSC). The majority of Sam’s career has been spent in a variety of roles at the MHRA. Before joining the DHSC, Sam was Chief Quality and Access Officer at the MHRA with accountability for regulatory activities across the UK supply chain, including Inspectorate (all GxPs), Enforcement, Licensing, Clinical Trials, Pharmacopoeia & pre-market Medical Device activities. Sam also brings extensive experience of crisis management, having led national and international scale incidents, and was the Executive lead for the MHRA’s response to the recent pandemic.
Sam has a doctorate in chemistry from the University of Reading and has also completed an MBA at Warwick University.
Senior Technical Advisor
Indian Pharmaceutical Alliance
Education :- Post graduate degree in Pharmacy alongwith Diploma in Business Management &. Certification in general management from IIM Ahmedabad
Experience :- Total experience of 42 years in managing pharmaceutical manufacturing
Currently he is supporting the activities of Quality Forum of Indian Pharmaceutical Alliance as Senior Technical Advisor.
Earlier he was Managing Director – Zydus Hospira Oncology P.Ltd., (ZHOPL) - A joint venture company of Zydus & Pfizer for Manufacturing and distributing sterile oncological injectables. This company exports Oncology injectables to 61 countries including USA, Japan & Europe with highest regulatory compliance and quality standards.(August 2016 till December 2019)
Prior to this job he was responsible for all the global manufacturing functions of Zydus Cadila from February’2001 till July’2016 as President Global Manufacturing. He was also a member of Executive Committee of Zydus.
His previous experience includes working in reputed companies FDC, Cipla, Cynamid and Sun Pharma in various capacities and departments.
Secretary General
Indian Pharmaceutical Alliance (IPA)
Sudarshan has a strong passion for healthcare and the education sector. He is currently the Secretary General of the Indian Pharmaceutical Alliance (IPA), Senior Advisor with APAX Partners and the Chairman of the Indian Institute of Health Management and Research (IIHMR), Jaipur. He also serves as a Board Member of Abbott India, Healthium (APAX Portfolio), Sunshine Holdings PLC and various educational institutions.
Sudarshan is on the Advisory Committee of the Biotechnology Ignition Grant, Government of India and a Visiting Faculty at the Indian Institute of Management Ahmedabad (IIM A). He is a Certified Executive Coach from the Coaching Foundation of India.
Sudarshan has a rich healthcare business experience of over 45 years and has contributed to shaping healthcare policy and improving access to healthcare in India. He has held several leadership positions in Abbott, J&J, Boots and leading Indian companies and last served as the Managing Director at Abbott Healthcare Solutions. His experience spans across Pharmaceutical, OTC, Hospital, Diagnostic and Nutrition businesses. He has been associated with over 30 brands which are among the top 300 in the Indian pharmaceutical market. He also served as Chairman of the Life Sciences Skill Sector Development Council (LSSSDC) of India under the Ministry of Skill Development & Entrepreneurship. He is the first Indian recipient of the Global Chairman’s Award at Abbott.
Sudarshan is an alumnus of St. Stephens College, Delhi and Indian Institute of Management, Ahmedabad (IIM A).
Vipul Doshi is responsible for the Quality and compliance function (API and drug formulation, Biologics , Vaccines, Research activity) and Regulatory Function of the Company with regard to Dossier filing, obtaining Regulatory approach for all markets which includes India, US, Europe & EMB. He is also responsible for Pharmacovigilance, EHS and API R&D.
He has distinguished career of over 30 years in the Pharmaceutical industry in India, and most of it is in the area of Quality and Regulatory Affairs functions of APIs, Finished Dosages involving Sterile and non-sterile products, Biologicals, New Chemical Entities and have helped Industry to benefit from his expertise in his chosen field.
He has successfully built robust Quality Systems in ever evolving Regulated Market requirements at Sun Pharma during his 23 long years there. He has represented these Companies in technical discussion with International Regulatory agencies, and often found simple solutions to complex Compliance problems. He has developed motivated teams wherever he has worked, and has been a good trainer, guide and motivator to all those who have worked with him.
22 October 2024 - 23 October 2024 
Virtual
