Vivek is a Partner in the Delhi office of McKinsey & Company. He is a leader in McKinsey’s Pharmaceutical Operations & Quality practice in India. Having worked extensively in developed and emerging markets, Vivek has served several pharmaceutical companies on improving their operations by helping them adopting best practices across manufacturing, supply chain, quality and R&D.

Vivek has been associated with IPA Quality Forum since its inception. He has worked with executives from IPA QF member companies to define best practices in several areas including Process Validation, Investigation and Quality metrics.

Prior to joining McKinsey, Vivek used to work with ITC Ltd. in the Manufacturing function. He is an MBA from India School of Business, Hyderabad and B.Tech in Electrical Engineering from IIT Kanpur.

Umang Vohra joined Cipla in 2015, and has been Managing Director and Global Chief Executive Officer of Cipla since September 2016. After gaining degrees in engineering, marketing and finance, Umang worked with Eicher Motors, PepsiCo and Dr. Reddy's. Through his previous roles in India and the US, he has built a distinguished career with deep understanding and experience in various aspects of the global pharmaceutical business.

As Cipla's MD & GCEO, Umang's priorities have been Cipla's strategic growth, defining and executing Cipla's roadmap to maintain momentum in home markets whilst strengthening its presence in other regions, consolidating its core focus areas, augmenting capability, and building the right organisation. Recognised as an action-oriented industry leader, Umang is a firm believer in the power of agile business models, disruptive technologies, data-driven analytics and a future-ready workforce with a view to making a difference to the lives of patients.

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.

Samir Mehta is Chairman of Torrent Pharmaceuticals Ltd and Vice Chairman of the Torrent Group. Born in 1963, after his post-graduation in management studies, Mr Mehta delved into the nascent businesses of Torrent Group in 1986 and over the years has ably guided its well strategized growth with his analytical and professional approach.

Under his leadership, Torrent Pharma took several strategic initiatives, including forays into new therapies and geographies, large investments in product development infrastructure and capabilities, building state-of-the-art manufacturing facilities and inorganic growth through acquisitions, thus establishing Torrent as one of India’s fast growing and well respected Pharma majors. His emphasis on organisation design, execution and operational efficiencies has built a strong and globally competitive business platform in Torrent Pharma.

Dr. Sharvil Patel is the Managing Director of Cadila Healthcare Ltd., one of the leading global healthcare providers and the 4th largest pharmaceutical company in India and officiates as the Chairman on the Board of Zydus Wellness Ltd. (ZWL), the listed entity of the Zydus group that spearheads the group’s presence in the fast growing consumer healthcare market. ZWL recently acquired Heinz India’s business including the brands Complan, Glucon D, Nycil and Sampriti Ghee.

With a specialisation in Chemical and Pharmaceutical Sciences from the University of Sunderland, UK and a doctorate also from the same university for his research work in Breast Cancer at Johns Hopkins, Bayview Medical Centre, USA.

Dr. Sharvil Patel spearheads organization-wide initiatives including Quest - the quality excellence programme and champions innovation in bringing new products to the market, new technologies, new patient-centric approaches and differentiated strategies to create a future-ready organisation.

He was conferred the ‘40 Under 40 Most Influential Asians’ Award by the Asian Business & Social Forum 2018 (ABSF) and the Young Business Leader ’40 under Forty’ Award by ET Now in 2017.

Dr. R. K. Vats is the Additional Secretary to the Government of India and currently handling the works related to food and drugs administration in the Ministry of Health & Family welfare, Government of India, along with administration of Central Government Health Scheme as Director General and e-health programmes. He has handled works related to Health & Family Welfare Department in the State Government also. He has experience of working as Financial Adviser in the Ministry of Urban Development, in addition to the field experience of Revenue Administration in the Districts and Secretariat of the State Government. He is a Medical professional by education and experience of working in Radiotherapy Department for 3 years before joining the administration. Recently, initiatives of the Ministry of Health in policy related to the use of drugs, medical devices and food standards are his priority concerns. Very recently, benchmarking exercise of national regulator was carried out by WHO in India in which the national regulator achieved the desired grades. Guidelines concerning clinical trials have also been streamlined for ease of doing business in India. He is looking forward for valuable interaction with the participants.

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.

Mark Birse joined the MHRA in 2002 and is currently the Head of the Inspectorate which comprises of over 70 Inspectors. Mark is a chemistry graduate with an MSc in pharmaceutical sciences. He previously worked in the pharmaceutical industry for over 10 years in a variety of roles including process technology, new product introduction and quality assurance and he is eligible to be named as a Qualified Person under Directive 2001/83/EC.

Kartik is an Expert Associate Partner in the Mumbai office of McKinsey and Company. He is a leader in the Global Quality, Compliance and Remediation service line in Asia. Kartik works on quality and operations topics across industries with a focus on the Pharmaceuticals sector. He is passionate about quality and works with companies, industry associations and other stakeholders on a range of quality and compliance topics.

Kartik has been associated with the IPA Quality Forum (IPA QF) since inception and has been closely involved with the team of executives of IPA QF member companies which developed the data reliability guidelines. Kartik is an MBA from IIM Ahmedabad and Btech/Mtech from IIT Madras.

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.

Howard Sklamberg is a partner at Akin Gump Strauss Hauer & Feld LLP. From 2014-April 2017, Howard served as USFDA’s Deputy Commissioner for Global Regulatory Operations and Policy, where he oversaw the Office of Regulatory Affairs and the Office of International Programs. He led or co-led many quality and safety efforts (including inspection modernization and program alignment) and the negotiation and implementation of GDUFA and GDUFA II. Howard directed FDA’s multilateral initiatives and its overseas offices. Howard also served as Direction of CDER’s Office of Compliance and Deputy Associate Commissioner for Regulatory Affairs.

Mr. Glenn Saldanha is the Chairman & Managing Director of Glenmark Pharmaceuticals Ltd. He joined in 1998 as Director and took over as Managing Director & CEO in 2001.

As Chairman & Managing Director of the Company, Mr. Saldanha oversees all operations of the organization. During his tenure, he transformed Glenmark into a truly global organization with revenue over a billion dollar and commercial presence in over 80 countries. Under his leadership, Glenmark has evolved from an Indian branded generics business, into a research-driven and innovation-led organization. Mr. Saldanha’s vision is to discover, develop and take to market India's first innovative drug for the entire world.

Mr. Saldanha holds a bachelor’s degree in pharmacy from Mumbai University and is an MBA from the Leonard Stern School of Business at New York University. Prior to Glenmark, he has worked with Eli Lily, USA and PriceWater House Coopers, USA.

Director of Inspection, Enforcement & Standards, Medicines & Healthcare products Regulatory Agency

Gerald Heddell joined the MHRA as Director of the Inspection, Enforcement & Standards Division in 2005. Gerald is a microbiologist who is a Chartered Biologist and a member of the Royal Society of Biology and the Royal Society of Chemistry.

Since leaving the UK National Health Service in 1978, he has worked in a succession of progressively senior roles in manufacturing and quality assurance in the pharmaceutical industry. Gerald has experience in most aspects of pharmaceutical manufacture and control. This has included microbiological development, analytical laboratory management, quality assurance, business development, director of a large steriles manufacturing facility and, most recently, European Quality and Compliance Director for GlaxoSmithKline.

In his current position with the MHRA, Gerald's responsibilities focus on the quality of medicines in the UK and include a comprehensive surveillance, inspection and enforcement programme, the licensing of pharmaceutical manufacturers and wholesalers, defective medicines reporting, unlicensed imports, borderline products, medicines testing and the British Pharmacopoeia.

Dr G N Singh, an alumnus of Banaras Hindu University, has made outstanding contribution to the strengthening and efficient functioning of the Drug Regulatory Systems in India, which has added great value to the prestige and stature of the Indian Pharma Industry.

Dr Singh after his Doctorate in Pharmaceutical Sciences from BHU in 1987, joined and worked for IDPL in their Formulation Plant, Gurgaon from 1989-2002, and as its R&D Head from 2001-02. In between he did his MBA from University of Hull (UK) in 1997, specializing in Human Resource Management, Marketing and Strategic Management. In 2002 he joined the Ministry of Health & Family Welfare as Director of the Indian Pharmacopoeia Laboratory, Ghaziabad. In 2009 he was chosen as the first Secretary-cum-Scientific Director of the newly created Indian Pharmacopoeia Commission (IPC). In 2012, he was given the additional charge of Drug Controller General (India) as Head of CDSCO.

Mr. Dilip G Shah graduated from the premier business school in India, the Indian Institute of Management (IIM), Ahmedabad. He has 52 years of varied experience in the pharmaceutical industry.

Currently, he is the Secretary-General of the Indian Pharmaceutical Alliance, Member of the Expert Review Committee of Access to Medicine (ATM) Index; Member of the CPhI International Advisory Board; and Member of the Board of Advisors of Pharmabiz.com (Weekly). Mr Shah is an independent director on the Boards of Fresenius Kabi Oncology Ltd, Anuh Pharma Ltd Shaily Engineering Plastics Ltd and CEO of Vision Consulting Group; a firm specialized in strategic planning.

Before starting Vision in 1997, he was a Member of the Board of Directors of Pfizer-India for whom he worked for 30 years. He was also Chair of the International Generic Pharmaceutical Alliance (IGPA) for two terms (2005-07) and (2010-11). He was a Member of the Official Indian Delegation to WTO Ministerial Conference at Cancun. He also appeared before the U.S. International Trade Commission (USITC) and testified in Investigation No.332-543 Hearing in Washington DC in 2014.

He has addressed several WTO workshops on TRIPS, WIPO seminars on IPRs and Public Health, WHO meetings on Access to Medicine besides several other international meetings and conferences.

David Keeling is a Senior Partner in McKinsey & Company’s Chicago Office.

David leads McKinsey’s global Pharmaceutical Quality and Operations Practices - a global group of about 300 consultants that focuses on improving operations and quality for biopharma clients. David’s clients are predominantly global leaders in the biopharmaceuticals and medical products industries.

David attended the University of Western Australia, where he received a Bachelor of Engineering degree in electrical engineering with first-class honors. He also holds an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University. Prior to joining McKinsey, David worked in high-tech, where he was responsible for product development, project management, and business management.

David lives in Chicago with his wife and four children.

Bart Janssens is a Senior Partner and Director with the Boston Consulting Group. He has been with the firm for 19 years, has been based in India for the last 14 years.

Bart leads BCG's Healthcare practice in India, and is a core member of BCG's global healthcare practice. He advises many of the leading multinational and generics companies in India, on topics including growth and capital allocation strategy, operational excellence, and organizational effectiveness. In addition, Bart has worked with large hospital chains in India on margin expansion programs.

Bart holds an MBA from The University of Chicago Booth, and an Msc from the Katholieke Universiteit Leuven in Belgium.

Andrei Spinei is a Scientific Administrator at the European Medicines Agency since 2014, working in the area of GMP inspections and is responsible for the management of the EMA Sampling and Testing programme, Quality Defects and GMP Non-Compliance as well as liaison for the EMA in international collaborations on GMP.

Graduated as a Pharmacist from the University of Medicine and Pharmacy in Bucharest, Romania, before joining the European Medicines Agency he has worked for 7 years in the Pharmaceutical Industry in Regulatory Affairs in a broad area of activities.

Assistant Country Director, International Relations Specialist (Drugs), Office of International Programs, India Office, USFDA

Dr. Ademola Daramola serves as the US FDA’s International Relations Specialist focusing on human drugs in India. Prior to joining the India Office, Dr. Daramola served as an expert in drug inspections as well as inspectional and investigative techniques for FDA’s Office of Regulatory Affairs since 2010. He is widely regarded as an expert in data integrity inspectional techniques. He also has several years of pharmaceutical manufacturer experience. Dr. Daramola holds a Doctor of Health Science and a Master of Public Health (MPH) from Nova Southeastern University, a Bachelor of Science in Information Technology from Barry University and a Bachelor of Science in Biochemistry from Ondo State University.”

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.

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.