In line with its mission to find solutions to issues and challenges across the global drug development industry, DIA recently hosted its 5th Regulatory Conference in Mumbai, with the theme, ‘Evolving Global Regulatory Environment’. The conference saw regulators, regulatory professionals, and academia take active part in interactive sessions on manufacturing and quality control, testing and packaging
In his keynote address, Rajiv Malik, President Mylan Inc, US spoke about the current gaps between industry and health authorities. Malik said, “While industry’s active engagement with health authorities and proactive pursuit of partnerships has resulted in development of new regulatory pathways and significantly impact on existing pathways, the industry’s work is not done. There are important gaps in the regulatory landscape on which the industry can and is partnering with the health authorities to address. Doing so is a mutual interest of the industry and of FDA and other regulatory authorities, both of which share the common goal of increasing patient access and bringing high quality, affordable, safe, and effective medications to patients as quickly as possible.”
The session on ‘Evolving Regulatory Review Processes— Transparency/ Timeliness/ Predictability’, was chaired by Arun Mishra, Director, Global Regulatory Affairs (Emerging Markets and Asia-Pacific), GlaxoSmithKline, UK and speakers included Lawrence Liberti, Executive Director, Centre for Innovation in Regulatory Science (CIRS), UK and Prisha Patel, Portfolio Manager, Centre for Innovation in Regulatory Science (CIRS), UK. It was noted that although regulatory agencies across the world share a common goal; to provide safe, effective and quality medicine to their people; regulatory requirement, review processes and timelines however vary from one agency to another. Regulatory agencies in the established markets (e.g. Europe, the US, Japan, Australia etc) are continuously evolving their review processes and practices to bring more predictability and quality in their regulatory review processes.
The session on ‘Negotiating Regulatory Minefields in Drug Development and Registrations in India, Emerging Markets and Developed Markets’, was chaired by Alberto Grignolo, PhD, Corporate Vice President, Global Strategy, PAREXEL Consulting. It was aimed to compare and contrast the contemporary regulatory challenges existing in India, other important emerging markets and the more developed markets (Japan, the EU and the US), and to identify successful negotiation strategies tailored to each reality. The session concluded with the fact that despite the substantial ‘regulatory convergence’ taking shape around the world today. It is still important to ‘act locally’ to be successful. This session explored how to do so through interactive presentations on ‘Opportunities and Challenges in Working with Regulators in Developed Markets’ by Michael Rozycki, Vice President, Regulatory Affairs Asia Pacific, Allergan China; ‘Opportunities and Challenges in Working with Regulators in India’ by Dr VVS Swaroop Kumar from Incozen and ‘Opportunities & Challenges in working with Regulators in Emerging Markets’ by Raj Long, Senior Regulatory Consultant via telecom from Switzerland
On the concluding day of the conference Zoher T Sihorwala, VP Global Regulatory Affairs, Dr Reddy’s Laboratories, chairing a session on ‘Pharmaceutical Industry and Talent Need—Focus on Drug Regulatory Affairs. He rightly brought out the fact that since the Indian pharma industry is second to the US in terms of number of US FDA approved world class facilities, the question that emerges is whether graduates and postgraduates produced by the pharma institutions meet requirements of the industry, and if not, how do we bridge the gap of what is required by the industry and the one catered by academia.
Dr PG Shrotriya, Chief Executive Officer, Pharmaceutical Consultants, Elite Consultancy Services and Kaushik Ray, Vice President, Human Resources, Dr Reddy’s Laboratories brought to light in their discussion and presentations that academia in India are at a cross road and need support and help to make a road map for future. Human resource development has to be frontal priority for pharmaceutical institutions in the country.
The highlight of the second day of the conference was a heated discussion between distinguished panelists. Deven Parmar, Vice President, Global Clinical Research, Wockhardt; Dr Nandini Kumar, Former Deputy Director General, Senior Grade Co-investigator NIH Project, National Institute of Epidemiology; and Urmila Thatte, Head, Department of Clinical Pharmacology, Seth GS Medical College, Mumbai discussed on ‘Human Subject Protection in Clinical Trials’. The session was chaired by Shoibal Mukherjee, Vice President – Medical, Quintiles. The session assessed patient vulnerabilities and attempted to evaluate the adequacy of systems in place for human subject protection in India. Panelists and members from the audience suggested ways in which systems for human subject protection can be further strengthened. A sense of the house was sought to estimate the level of satisfaction among the audience regarding human subject protection in clinical trials underway in the country.
Among the topics that were addressed at this year’s two-day conclave were an in-depth account and analysis of the regulatory environments in the EU, US and emerging markets with particular emphasis on biosimilars and generics as well as the strategies and processes required to achieve global regulatory compliance. Key insights were provided into the crucial pharmacovigilance space and the growing options and potential for a career in drug regulatory affairs.
EP News Bureau — Mumbai
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