Dr. Declan Byrne graduated with a BSc degree in chemistry from Queen’s University Belfast in 1994, where he subsequently did his doctoral studies in the field of synthetic organic chemistry. After 3 years post-doctoral research at the Ecole Europeene de Chimie, Polymers et Materiaux in Strasbourg, he joined the EDQM in 2001 and after spending some time in the Publications department aiding in the elaboration of European Pharmacopoeia monographs, he is currently working for the Certification of Substances Division (DCEP) as a chemical assessor of new CEP applications. Dr. Declan Byrne graduated with a BSc degree in chemistry from Queen’s University Belfast in 1994, where he subsequently did his doctoral studies in the field of synthetic organic chemistry. After 3 years post-doctoral research at the Ecole Europeene de Chimie, Polymers et Materiaux in Strasbourg, he joined the EDQM in 2001 and after spending some time in the Publications department aiding in the elaboration of European Pharmacopoeia monographs, he is currently working for the Certification of Substances Division (DCEP) as a chemical assessor of new CEP applications. Dr. Declan Byrne graduated with a BSc degree in chemistry from Queen’s University Belfast in 1994, where he subsequently did his doctoral studies in the field of synthetic organic chemistry. After 3 years post-doctoral research at the Ecole Europeene de Chimie, Polymers et Materiaux in Strasbourg, he joined the EDQM in 2001 and after spending some time in the Publications department aiding in the elaboration of European Pharmacopoeia monographs, he is currently working for the Certification of Substances Division (DCEP) as a chemical assessor of new CEP applications.

Dilip Shanghvi, 64, is the Managing Director of world's 4th largest and India's top specialty generic pharmaceutical company, Sun Pharmaceutical Industries Ltd. Mr. Shanghvi is also Chairman and Managing Director of Sun Pharma Advanced Research Company Ltd. which is engaged in R&D of new innovative drugs and delivery systems. He is a former President of Indian Pharmaceutical Alliance. Mr. Shanghvi has been conferred with many awards and recognitions including, Padma Shri (Fourth highest civilian award by Govt. of India) in 2016, Forbes Entrepreneur for the year - 2014, Economic Times’ Business Leader of the Year (2014), CNN IBN’s Indian of the Year (Business) (2011), Business India's Businessman of the Year (2011) and Ernst and Young's World Entrepreneur of the Year (2011). He has also been awarded the Economic Times' Entrepreneur of the Year (2008), Business Standard’s CEO of the Year (2008) and CNBC TV 18's First Generation Entrepreneur of the Year (2007).

In 2017, he was made a trustee of the Rhodes Scholarship Program at Oxford University. In January 2018, the Indian government appointed Mr. Shanghvi to the Reserve Bank of India's 21-member central board committee. He is also chairman of the board of governors at Indian Institute of Technology (Bombay). In 2019, Mr. Shanghvi was conferred with an honorary doctorate by the Tel Aviv University, Israel’s largest and most comprehensive institution of higher learning.

Francis Godwin received his undergraduate degree from MIT in Chemical Engineering in 2001. After graduation he worked as a process engineer designing, building, and optimizing chemical plants. He was certified as a Black Belt in Six Sigma performing quality improvement projects and teaching Six Sigma principals. He then worked in pharmaceutical process validation for both batch and continuous processes for APIs and finished dosage manufacturing operations. Later, he managed an analytical chemistry laboratory conducting analyses for production, QA, and research testing. In 2009 he received an MBA from Georgetown University and since then, has been working at FDA in CDER's Office of Compliance. He has served in various functions within compliance, and is currently the Director of the Office of Manufacturing Quality, overseeing regulatory and enforcement actions for both foreign and domestic drug CGMP cases.

Gautam is the Managing Partner of McKinsey’s India Office, based in New Delhi. He is also a cofounder of the McKinsey Asia Centre, a special initiative McKinsey initiative on globalization.

Prior to his appointment as Managing Partner, Gautam led McKinsey’s Organisation Practice in Asia and is one of the leading thinkers behind the Firm’s research and insights on transformational change. His passion lies in helping leading institutions in India become global and world-class companies.

During his 25 year career at McKinsey, he has served a diverse range of clients both at a national and global scale advising them on organisation transformation, leadership development, strategy and governance. Healthcare and Pharma are specific areas of focus for Gautam, while hi-tech / IT and infrastructure sectors also form a significant part of his portfolio.

A chemical engineer from IIT Delhi and a MBA from IIM Ahmedabad, Gautam has CEO Leadership as special interest. He is the founder of the McKinsey Leadership Institute.

Jaidev Rajpal is a Partner in the Delhi Office of McKinsey and Company. Since joining the Firm, he has served clients in Medical Products and Pharma sectors as well as Industry associations on Quality, Compliance and Operational Transformation topics.

He has extensive experience in leading at-scale capability-building transformations in operations across different geographies globally, and leads McKinsey’s Asia Pharma and Medical Products and Operations practices as well as the Quality, Compliance and Remediation Service line.

He has led successful resolution of FDA warning letters in a very short time (~9 months) - through transformative quality-culture-and-capability-building efforts - at multiple leading Asian companies. He has been involved in network-wide Quality transformation at an Asian pharma company to develop and sustain capabilities on ‘any-time audit readiness’ and ‘product robustness’.

Prior to joining McKinsey, Jaidev worked as a practicing clinician. He is a Medical graduate from Grant Medical college, Mumbai, India and holds an MBA from Indian Institute of Management, Kozhikode, India.

Group Manager British Pharmacopoeia & Laboratory Services, Medicines and Healthcare products Regulatory Agency (MHRA)

James Pound joined the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) in 2008. He has worked in a variety of roles within the British Pharmacopoeia (BP) & Laboratory Services Group and in 2017 was promoted to the role of Group Manager and Secretary & Scientific Director of the BP Commission. He is a senior leader within the Agency and has responsibility for both the pharmacopoeia and the Agency's regulatory laboratory testing activities. He holds an honours degree in Chemistry and has previously worked in a variety of roles focused on analytical chemistry for both multinational pharmaceutical manufacturers and independent UK analytical laboratories.

Jay Jariwala is an Assistant Country Director with FDA’s India Office. His primary role is to advise FDA leadership on drug policy issues as it concerns India and collaborate with various internal and external stakeholders to advance FDA’s strategic priorities in India. He is also currently acting as Supervisory Consumer Safety Officer managing all inspections conducted by the India Office. Prior to joining FDA’s India Office, He was a Team Leader in the Office of Manufacturing Quality, Office of Compliance, CDER, where he provided leadership and operational oversight of compliance officers assessing violative establishment inspections and resulting regulatory actions. During his tenure he spearheaded numerous regulatory actions such as warning letters, regulatory meetings, and import alerts. He also participates in inspections as a Subject Matter Expert. He was instrumental in developing various risk-based assessment processes including Warning Letter review procedure currently being utilized. He also represented CDER in Mutual Reliance Initiative in assessing various EU drug inspectorates’ capabilities.

Prior to joining CDER, He spent 7 years in CDRH Office of Compliance where he held positions of increasing responsibilities starting as a compliance officer to a quality system specialist. While at CDRH, he was part of Medical Device Single Audit Program (MDSAP) team which is a collaborative inspection effort between US FDA, Health Canada, Therapeutic Goods Administration of Australia, and ANVISA Brazil. Due to his multi-commodity and multi-center background, he was member of a core group instrumental in developing CGMPs for Combination Products, resulting FDA guidance, and investigator training. He was selected and successfully completed CDER’s Emerging Leader Program (ELP.) He has regularly spoken at various conferences and taught various CGMP related courses on behalf of the Agency.

Jeff Francer is Interim CEO and General Counsel of the Association for Accessible Medicines, where he leads legal and international trade advocacy.

Jeff served as Associate Chief Counsel of the Food and Drug Administration from 2003 to 2005, where he advised agency leaders on issues involving the regulation of drugs and biologics including clinical investigation, manufacturing, promotion, enforcement and legislative matters. After leaving the FDA, Jeff served as Associate General Counsel, U.S. Compliance Officer, and Chief Privacy Officer of Biogen Idec, Inc. At Biogen Idec, he was the primary in-house counsel on FDA issues, fraud and abuse prevention and patient privacy. Jeff was also responsible for overseeing the U.S. corporate compliance program.

Immediately prior to joining AAM, Jeff served as Vice President and Senior Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA) where he was the principal counsel to the association on issues relating to the research, development and regulation of medicines in the U.S. and globally.

Jeff received his A.B. in Public Policy and Economics from Brown University, his M.P.P. from Harvard University, and his J.D. from the University of Virginia. He serves on the Board of Directors of the Food and Drug Law Institute (FDLI) and on the Editorial Advisory Board of the Food and Drug Law Journal.

Johnny began his career in pharmaceuticals in 1982 as an Industrial Microbiologist, later growing to head the compliance and quality operations at several major pharmaceutical manufacturers. Johnny holds a BS in Biology and an MS in Microbiology and brings accomplishments from Duke University, London's British Standards Institute, and Harvard University. Johnny joined Lupin in 2019 as President of Global Quality and Compliance.

Prior to starting his pharmaceutical career, Johnny served in the United States Air Force and was assigned to an Aeromedical Evacuation Squadron.

Since joining McKinsey in 2015, Matthias has served primarily pharmaceutical and medical device clients on a range of operations topics focusing around manufacturing, quality and supply chain. A certified Advanced Analytics translator, Matthias helps clients leverage Digital and Advanced Analytics solutions in their daily operations to unlock next-gen performance.

He has been involved in digital transformation in medical device production to increase capacity through end-to-end digital twin-based scheduling, bottleneck equipment OEE increases and digital DoE line speed increase. He has been a part of the digital transformation in a solids manufacturing site across the entire value chain - deploying 9 use cases to capture significant impact in capacity increase, deviations reduction and lab productivity increase. He specializes in lean transformations at different client sites focusing on the areas of manufacturing, packaging, quality, supply chain and maintenance.

Before joining McKinsey, Matthias worked for the BMW Group in their global Operations Efficiency unit. Matthias holds a Masters in Engineering Physics from the Technical University of Munich, Germany, and the National University of Singapore as well as an MBA from the College des Ingenieurs, Paris.

Dr. Milind has a history of service from 1986 to date, with a modest start as a Research Chemist to significant managerial positions. Dr. Joshi earned his Ph.D. in Analytical Chemistry in 1989 from University of Mumbai. He is recipient of "Outstanding Pharmaceutical Analyst Award 2006" by IDMA. He is Chairman of the United States Pharmacopeia (USP) - South Asia Stakeholder Forum & member of the Nominating Committee of USP. He is member, of several professional organizations including Indian Drug Manufacturers Association (IDMA) where he is member of the Regulatory and Quality & Technical Sub-Committees. Dr. Joshi has published more than 25 scientific articles in the fields of analytical chemistry, bioanalytics & Pharmaceutical Sciences. He is a co-inventor for various Indian & International patents for pharmaceutical specialties including controlled release formulations, herbal formulations & synthesis of bulk drugs. Dr. Milind lives in Thane & enjoys Hindustani Classical music the most among other interests.

Nilesh Deshbandhu Gupta is a Chemical Engineer from the Institute of Chemical Technology, Mumbai and an MBA from the Wharton School, Philadelphia. He has been responsible for transforming and expanding Lupin's research programs globally and strengthening the Company's technical operations. As a part of the apex management, he has been instrumental in formulating and executing the core strategy that has helped Lupin emerge as a global generics and specialty major.

As Managing Director of Lupin, Nilesh Gupta is responsible for the Company's R&D, technical operations including global manufacturing and quality, supply chain as well as the commercial function for the India and Asia Pacific regions, which contribute close to 50% of the company’s global revenues of USD 2.5 billion.

Nilesh along with his sister Vinita Gupta, won the ‘Entrepreneur of the Year Award’ at the Forbes India Leadership Awards in 2016 as well as the Ernst & Young ‘Entrepreneur of the Year Award 2015’ in India.

Mr. Pankaj Patel is the Chairman of Zydus Cadila, an innovation-driven, global healthcare company with operations in more than 50 countries worldwide. With an experience spanning over 40 years in the Indian pharmaceutical industry, Mr. Patel combines both research and techno-commercial expertise.

Mr. Patel has been nominated as a Member of the Mission Steering Group (MSG), the highest policy making and steering body constituted under National Health Mission (NHM) and of the Drug Technical Advisory Board by Ministry of Health & Family Welfare, Govt. of India, New Delhi. He has also been nominated on the reconstituted Court of the Indian Institute of Science for the period 2018-2021. Mr. Patel is also on the Board of Invest India and The Indian Institute of Foreign Trade (IIFT).

Mr. Patel is a Past President of the Federation of Indian Chamber of Commerce & Industry (FICCI).

He is a Member of the Board of Governers of the Indian Institute of Management (IIM), Ahmedabad. He is also the Chairman of the Board of Governers and Society, IIM, Udaipur. Mr. Patel is currently on the Governing Board of The Ahmedabad University and the Chairman of the School of Life Sciences, Ahmedabad University. He is also a Member of the Board of Management of the Narsee Monjee Institute of Management Studies and a Member on the Governing Board of the Gujarat Law Society, Nirma University and the Anant National University, Ahmedabad.

Mr. Pankaj Patel is the Executive Chairman, Vice President and Trustee of the Gujarat Cancer Society and Chairman of the Gujarat Cancer and Research Institute, a Regional Cancer Centre and one of the largest cancer centres of India, reaching out to the needy and underprivileged cancer patients. He also officiates as the Chairman of the Deaf and Mute School, Ahmedabad.

Ranjana has previously held leadership roles in pharmaceutical companies such as Actavis, Endo Pharmaceuticals, Zenith Goldline and Thames Pharmacol.

Ranjana has a Doctorate in Health Administration from the University of Phoenix, USA; an MBA from Dowling College, New York; a Post-Graduate Diploma in Pharmaceutical & Chemical Analysis from Sophia College, Mumbai; and a B.Sc. (Hons) in Chemistry from Mithibai College, Mumbai. She has received training in leadership in pharmaceuticals and biologics at Harvard University.

As a Member of the Management Council at Cipla, Ranjana leads the organisation’s worldwide quality enterprise from the development of a product to its commercialization.

An industry veteran, Ranjana has over three decades of experience in pharma. In 2006, Ranjana received the Rising Star award from the Healthcare Business Association. In 2018, she was recognized as Woman Leader of the Year award at the Future Leaders’ Summit. In 2019, She received the National Healthcare Leadership Women Award presented by Zee Business.

Doctorate in Pharmacy, M Pharm, B Pharm from Jadavpur University, Kolkata.

She has Regulatory experience of more than 20 years, working in Central Drugs Standard Control Organisation in various capacities. She is presently working as Deputy Drugs Controller (I) in CDSCO (West Zone). In the past she has worked as Deputy Drugs Controller (India) in CDSCO (HQ) in the Divisions of new drug, import registration, quality assurance of vaccines. She has worked as a WHO expert for developing GMP guidelines of biologicals, Good Regulatory Practices guideline, National Regulatory Authorities (NRA) assessment tools. She was nominated to represent Govt of India in various WHO meetings/training at Geneva, USA, Tunisia, China, Turkey etc. to contribute in the development of various guidelines. She has worked in WHO Prequalification vaccine assessment team as Technical officer for four months at WHO(HQ), Geneva and participated in vaccine dossier assessment, and inspection of vaccine manufacturer as a prequalification team member.

She has five years experience of working in production of Injectable drugs prior to joining CDSCO.

Samantha is responsible for ensuring the quality of medicines in the UK through a comprehensive inspection programme and the enforcement of medicines legislation. These responsibilities include the licensing of manufacturers and wholesalers, defective medicine reporting, unlicensed imports, borderline products, medicines testing and the publication of the British Pharmacopoeia.

Samantha was appointed to Director of IE&S at the start of 2018. Prior to this Samantha held several roles at the MHRA including Director of Business Transformation, Deputy Director for IE&S, and Scientific Director for the British Pharmacopoeia (BP) Commission and Group Manager for the BP & Laboratory Services. Samantha also worked in the Inspectorate for several years, performing inspections, nationally and overseas. Prior to joining the MHRA, Samantha worked in industry for a number of years.

Samantha studied chemistry (BSc, MSc, PhD) at Reading University, completed an MBA at Warwick University and more recently has completed the Major Project Leadership Academy (MPLA). Samantha is a member of the Royal Society of Chemistry and a Visiting Research Fellow at Reading University, playing an active role promoting public sector opportunities to science graduates.

Samina Vaziralli is the Executive Vice-Chairperson of Cipla, and represents the third generation of the founding family of Cipla. An alumna of the London School of Economics, she has in the past worked in the UK and the US with the leading global firm Goldman Sachs before joining the Cipla leadership team in 2011.

Samina joined Cipla as Executive Director and Global Head - Strategy, M&A and Cipla New Ventures. She has been instrumental in driving the Company’s current transformation agenda. Samina played a key role in successfully incubating and shaping Cipla Health Limited, spearheaded Cipla’s ambitious foray into the US market with strategic acquisitions. Samina has built a top-class leadership pipeline for the Company as it continues to spread its wings globally.

As Executive Vice-Chairperson of Cipla, Samina focuses on board and governance issues, in addition to furthering Cipla’s strategic priorities through key global partnerships, corporate culture, hiring the right talent, and public advocacy.

Today recognized as the promoter face of Cipla, Samina has been feted for her diverse work experience and business knowledge. In 2017, she received the ‘Most Powerful Women in Business’ award from Business Today. In 2018, Forbes named Samina among the top 25 emergent women business leaders in Asia, and Fortune India named her among the most powerful women in business in 2018 and 2019.

Satish Reddy is the Chairman of Dr. Reddy's Laboratories. He joined the company in 1993 and since then has held positions of increasing responsibility. Satish led the organization's transition from a uni- focused manufacturer of APIs (active pharmaceutical ingredients) to a company that moved up the value-chain with a diverse product portfolio of Finished Dosage Formulations. He oversaw the expansion and establishing of a strong footprint for Dr.Reddy's finished dosage products in Russia, CIS countries and other emerging markets.

As an active member of major industry associations and governmental panels, Satish played a key role in shaping policies concerning the pharmaceutical sector as well as the economy, such as policy formulation on India's patent law, drug pricing and important amendments to the Drugs & Cosmetics Act. He is the President of the Indian Pharmaceutical Alliance, a premier industry association of leading research based Indian companies. Satish also chairs the Life Sciences Skill Development Council under The National Skill Development Corporation (NSDC), an organization, working in partnership with various stakeholder groups, to serve and address the skill shortfalls in the Life Sciences Sector across India. He is also the Chairman of the Board of Governors of NIPER Hyderabad and is Deputy Chair of the CII Southern Region. He was a member of the Drugs Technical Advisory Board of India, the Chairman of the Andhra Pradesh Chapter of the Confederation of Indian Industries (CII) and head of its National Committee on Pharmaceuticals. In May 2015, the Ministry of Labour and Employment, Government of India, nominated Satish as Chairman of the Board of Governors of the National Safety Council.

He holds a degree in Chemical Engineering from Osmania University, India, and an M.S. in Medicinal Chemistry from Purdue University, USA, where he received the 2009 Distinguished Alumnus Award from the School of Pharmacy and Pharmaceutical Sciences.

Post graduate degree in Pharmacy alongwith Diploma in Business Management &. Certification in general management from IIM Ahmedabad

Shirish has over 40 years’ experience in managing pharmaceutical manufacturing. Currently he is supporting the activities of Quality Forum of Indian Pharmaceutical Alliance as Senior Technical Advisor. Prior to this, he was Managing Director - Zydus Hospira Oncology P.Ltd., (ZHOPL) for Manufacturing and distributing sterile oncological injectables. He has also held responsibility 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 achievements includes optimizing the operational costs with Lean ways and structured programme across all units of Zydus under the name of ‘SLIM’ Strategic Lean Integrated Manufacturing. He has been instrumental in bringing new technologies like MDI’s / DPI’s / Transdermal Patches / Lyophilization. He was also instrumental in bringing up the new modern plants at Baddi, Sikkim, SEZ and upgrading of the existing plants at Moraiya ,Goa, Nikhho Brazil & Nesher at USA. He conceptualized new design of SEZ -additional capacity for unicellular flows for superior material and manpower movement and avoidance of cross contamination. He led Zydus Manufacturing on the path of automation to reduce human interventions in the processes, EBMR to make Zydus manufacturing fully compliant.

He is also on the governing board of Parenteral Drug Association (PDA-India) and active member of other professional bodies like ISPE, IPA(Quality forum) as well Indian Pharmaceutical Association.

Dr. Stelios Tsinontides is Director of the Office of Pharmaceutical Manufacturing Assessment (OPMA) under the Office of Pharmaceutical Quality (OPQ) in CDER. Dr. Tsinontides has over 25 years of experience in the pharmaceutical industry. OPMA evaluates facilities, process design, and control strategies to assess capabilities of manufacturers to produce quality pharmaceutical and biotechnology products at commercial scale and provides leadership and technical expertise to Agency components internal and external to the Office of Pharmaceutical Quality regarding manufacturing quality issues.

Prior to joining the FDA, Dr. Tsinontides served in senior-level positions in the pharmaceutical industry - most recently as Shire’s Head of Small Molecule (SM) Drug Product Technical Services. His group was responsible for providing scientific and technical expertise for SM Drug Product scale-up and commercial manufacturing activities worldwide, to ensure establishment of commercial robust manufacturing processes and a continuous supply of product to patients.

Dr. Tsinontides holds a B.E. in Chemical Engineering from City College of CUNY and an M.A. and Ph.D. in Chemical Engineering from Princeton University. He’s also studied in the Wharton Management Program at the University of Pennsylvania. Dr. Tsinontides is also a Fellow at the American Institute of Chemical Engineering (AIChE).

Sudarshan has a strong passion for healthcare and the education sector. He is currently the Secretary General of Indian Pharmaceutical Alliance (IPA), Senior Advisor with APAX Partners and is also a Board member of multiple organizations. He has served in several leadership positions over the years and was earlier the Managing Director at Abbott Healthcare Solutions.

Sudarshan has a rich healthcare business experience of over 40 years which includes stints in Abbott, Johnson & Johnson and leading Indian companies. He has got extensive experience in field force management, brand building and overall business operations in healthcare companies. He has been associated with over 30 brands which are among the top 300 in the Indian Pharmaceutical industry. His experience covers Pharmaceutical, OTC, Hospital, Diagnostic & Nutrition business. He has received number of recognitions for his contributions within the company, with academic institutions and with industry associations. He is the first Indian recipient of the Global Chairman’s Award at Abbott.

Sudarshan has also served as Vice President of Organization of Pharmaceuticals Producers of India (OPPI) representing research based pharmaceutical companies. He is currently the member of the Board of Abbott India, Healthium Limited (APAX portfolio company), Zandu Chemicals Limited, PharmEasy, Indian Institute of Health Management Research, Jaipur, member of the Advisory Board of Narsee Monjee University, Mumbai (NMIMS), Board Member of Indian Education Society (IES) and Charter Member of The Indus Entrepreneurs, Mumbai (TiE). He is a Certified Executive Coach from Coaching Foundation of India. He has also contributed in shaping the healthcare policy and improving access to healthcare in India.

Sudarshan is an alumni of St. Stephens College, Delhi and Indian Institute of Management, Ahmedabad.

Susan Schniepp has 40 years of quality assurance experience in the pharma-ceutical industry. She served in leadership roles at Allergy Laboratories, Inc., OsoBio Pharmaceuticals, LLC, Searle, Abbott, and Hospira. She has earned several awards from the PDA, including its Distinguished Author Award, Dis-tinguished Service Award, and Gordon Personeus Award.

Sue’s publications include the book, Understanding the United States Pharma-copeia and the National Formulary: Demystifying the Standards-Setting Pro-cess, for which she was awarded the 2007 PDA’s Distinguished Author Award. She co-edited and contributed to the books Pharmaceutical Outsourc-ing: Quality Management and Project Delivery and SOPs Clear and Simple for Healthcare Manufacturers.

Serving as a volunteer in a number of capacities, she has served on the PDA Board of Directors from 2011- 2013 and from 2016- 2019 and is currently the Chair Elect (2020 - 2022). Sue has served on numerous planning committees, including the PDA/FDA Joint Regulatory Conference Planning Committee since 2002. She is currently working part of the working group writing a tech-nical report relating to manufacturing data integrity issues and participating in PDA’s standard setting activity regarding purchasing controls.

In addition to her PDA activities, Sue is an editorial advisory board member and columnist for Pharmaceutical Technology (since 2007) and BioPharm In-ternational Magazines. She holds a bachelor of science degree in Microbiology from Northern Illinois University.

He is Drugs Controller General (India), under Dte.GHS, MoH&FW, Government of India. He has done M. Pharm, PhD in Pharmaceutical Sciences.

He is Chairman of WHO’s Member State Mechanism (MSM) of 194 countries on substandard and falsified medical products at Geneva, Switzerland vide World Health Assembly (WHA) resolution 65.19 which is very important platform to safeguard Global interest for making a quality affordable generic medicines acceptable in the world.

He is working in CDSCO in Drugs Regulation for last 22 years and having vast experience in the field of GMP, GCP, GRP, GDP, GLP, Dossier Review etc. and he has also worked on all the posts in the hierarchy of CDSCO.

He has been involved in training various national regulatory guidelines like guidelines on similar biologics and contributed to various WHO guidelines on Drugs, Devices &Vaccine related issues.

His focus areas are Simplification of regulation and access to quality medical products through Good Regulatory Practices & strengthening of Drug Regulatory system.

He is a well-known speaker and trainer of various national and international/ WHO scientific bodies and was awarded merit scholarship/fellowships by the Government since schooling days till completion of his PhD.

Vikas Bhadoria is a Senior Partner in McKinsey’s Delhi Office and leads the Pharmaceutical and Medical Products (PMP) practice in India. He also leads McKinsey’s PMP Operations practice in Asia.

During the last 19 years, he has assisted Indian pharma companies in developing and implementing growth strategies, launching and building global businesses, transforming their organisation and culture, building capabilities and developing leaders. He has also led large-scale enterprise transformation and profit improvement programs, supply chain transformations and lean shop floor operations. He has been leading transformations to build a strong and preventive Quality by design culture, helping organisations upgrade their Quality management systems and driving comprehensive remediation efforts for plants dealing with serious Quality challenges.

On the global front, he also serves Multi-National global pharma companies to build strong emerging market strategies and leverage India for outsourcing and offshoring opportunities across the value chain. He has also supported India sourcing engagements for Global pharmacos, distributors and retailers.

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.