Merck Millipore, the Life Science division of Merck, organised the second edition of ‘EMPROVE® Seminar Series’ in Mumbai. The seminar is an endeavour by Merck Millipore to offer the Indian pharmaceutical industry a platform for getting access to the latest trends and developments in the international regulatory arena. This year’s theme, ‘Stability in Turbulent Times’, addresses the challenges faced by the industry.
The seminar was inaugurated by Dr Claus-Dieter Boedecker, Managing Director, Merck [India] and Head – Merck Millipore [India] and Tapan Ray, Former President, – OPPI and Independent Pharmaceutical Industry Analyst & Consultant. Merck Millipore’s eminent panel of internationally reputed speakers equipped the pharma industry to successfully navigate the labyrinth of the global regulatory landscape.
The topics discussed ranged from potential solutions to challenges faced by exporters to regulated markets; stumbling blocks faced while making abbreviated new drug applications and how to overcome them; quality standards and certification available to grade pharma excipients in the current regulatory scenario.
Boedecker said, “Today the pharma industry in India is grappling with challenges owing to an uncertain and ever-changing regulatory environment. It is imperative for our industry to understand, interpret and prepare to meet the challenges of tomorrow. Through the EMPROVE Seminar Series, our focus and commitment is to help customers understand the changing regulatory scenario and negotiate in such market dimensions. With EMPROVE, Merck Millipore establishes itself as leaders in quality and international regulatory compliance.”
Peter Salazar, Head of the Pharm Chemicals Solutions, Merck Millipore [India] and pioneer of the EMPROVE Seminar Series remarked, “The 2013 edition of EMPROVE Seminar Series helps gain better insights into the rapidly evolving global regulatory scenario for improving stability of the pharma industry in such turbulent times. Merck Millipore’s customer-friendly EMPROVE products and services, along with providing regulatory support, offers information on greater product safety, cost and time savings.”
Ray addressed the seminar on ‘Challenges in Pharmaceutical Exports for Regulated Markets and Potential Solutions’. He stated, “I am happy to be associated with the second edition of the EMPROVE Seminar Series. The setbacks on the regulatory front this year have adversely impacted advancements in drug manufacturing processes and technology. In such a scenario, pharma companies will need to focus their attention on appropriate corrective measures in this area sooner and the EMPROVE Seminar Series helps discuss and resolve regulatory challenges and provide solutions to the industry.”
At the seminar, Dr Najib Sehat, Head – Global Regulatory Management, Merck Millipore and Member – EXCiPACT Global Steering Committee spoke on pharmaceutical excipient quality standards and certification in the current regulatory environment. Other experts who spoke at the seminar include Dhiraj Chopra, Associate Director, Dr Reddy’s Laboratories; Amit Bansal, Managing Partner, Resolute IP and Legal Solutions; Meena Kashyap-Shah, Sr Manager – Regulatory Affairs, JB Pharmaceuticals; and Dr Christian Dittrich, Global Marketing Manager – Bioavailability Enhancement, Merck Millipore.
Leading pharmaceutical companies attended the seminar and discussed on the evolving regulatory scenario and tools to expedite the complex process.
EP News Bureau – Mumbai
