NDA Partners announced today that it has been invited by UBM India to design and conduct two premier workshop events for the India pharmaceutical industry addressing the topic of data integrity, reliability and quality metrics. The workshops, which will take place in Mumbai on October 18 and Hyderabad on October 20, 2016, are designed to provide information to help India pharma companies better understand and address critical quality issues faced by manufacturers. Approximately 200 senior professionals from India Pharma companies are expected to attend.
Dr. G. N. Singh, the Drug Controller General of India (DCGI), head of the Central Drugs Standard Control Organization (CDSCO), the national drug regulatory authority in India and Dr. Mathew Thomas, Country Director at the US FDA Office in New Delhi, India have been invited to deliver their remarks at these workshops. Individual sessions will be conducted by NDA Partners senior Expert Consultants including Roger Williams, MD, Philip Goliber, PhD, Brian Harvey, MD, PhD, and Srini Srinivasan, PhD, as well as industry speakers from India. Dr. Williams is a Partner in the firm and former Chief Executive Officer and Chair of the Council of Experts, US Pharmacopeial Convention (USP); Director, FDA Office of Generic Drugs; and Deputy Center Director, FDA Office of Pharmaceutical Sciences. Dr. Goliber, also a Partner, was formerly Vice President Strategy & Portfolio at UCB Pharma SA, following a thirty year industry career as a Pharmaceutical Sciences executive. Dr. Harvey is a senior Expert Consultant and former Director, Division of Gastroenterology Products, FDA CDER, and Deputy Director, FDA Office of Drug Evaluation 5. Dr. Srini Srinivasan is a senior Expert Consultant and former Executive Vice President and Chief Science Officer, USP, Washington DC; Managing Director, USP India; Chief of USP Global sites; and Vice President of Global Verification Programs.
“We look forward to contributing to the further development and quality of the Indian pharmaceutical industry and are pleased to collaborate with UBM India on this timely and important topic”, said NDA Partners Chief Executive Officer Earle Martin. “We believe that our Expert Consultants can play an important role in assisting companies in India with their efforts to introduce consistent quality products into Western markets.”
UBM India is India's leading exhibition organizer. The firm provides the pharma industry with platforms that bring together buyers and sellers from around the world, through a portfolio of exhibitions, content led conferences, and seminars. UBM India hosts more than 25 large scale exhibitions and 40 conferences across the country every year, thereby enabling trade across multiple industry verticals. A UBM Asia Company, UBM India has offices in Mumbai, New Delhi, Bangalore and Chennai. UBM Asia is owned by UBM plc which is listed on the London Stock Exchange. UBM Asia is the leading exhibition organizer in Asia and the biggest commercial organizer in mainland China, India and Malaysia. For further details, please visit ubmindia.in.
About NDA Partners
NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.
Earle Martin, Chief Executive Officer