| Ajit Singh, Chairman, ACG Worldwide and Dr Bernd Renger, Chairman, European Qualified Persons Association light the traditional Indian lamp to inaugurate the ‘EMPROVE Seminar Series’ organised by Merck Millipore [India] in Mumbai, while Peter Salazar, Head of the Pharm-Chem Solutions, Merck Millipore [India] and Kashmira Billimoria, Merck Millipore [India] look on |
Merck Millipore [India], a division of Merck KGaA, Darmstadt, Germany, recently flagged off the ‘EMPROVE Seminar Series’ in Mumbai. EMPROVE is a proprietary service from Merck Millipore which combines product quality with user-related documentation simplifying rigorous regulatory work for the pharmaceutical industry. The inaugural seminar on ‘Evolving Trends in Regulations in the US and EU’ consisted of a panel of eminent speakers of international repute.
Panelists who addressed key issues in regulations included Ajit Singh, Chairman, ACG Worldwide, who spoke on the ‘Current Trends in the Pharmaceutical Industry with respect to Indian and International Regulations’. Dr Bernd Renger, Chairman, European Qualified Persons Association addressed the seminar on ‘Challenges for Regulatory Compliance for the EU’. Leading pharma companies were present to exchange notes and have discussions on the evolving regulatory scenario and tools to expedite the complex process.
Introducing the seminar Peter Salazar, Head of the Pharm-Chem Solutions, Merck Millipore [India], said, “The regulatory landscape is changing and it is imperative for our industry to understand, interpret and prepare to meet the challenges of tomorrow. Merck Millipore has an extensive range of tools designed to support its clients during all stages of the drug manufacturing process from research to industrial-scale production and quality control. The EMPROVE Seminar Series is an endeavour by Merck Millipore [India] to give back to the industry by bringing together under one roof experts from different fields to predict and better prepare for the future.”
Salazar further added, “With EMPROVE, we have established ourselves as leaders in quality and international regulatory compliance. The ever-increasing requirement for regulatory compliances often impacts the product costs. Merck Millipore’s customer-friendly EMPROVE offers benefits such as greater product safety, cost and time savings, and regulatory support through tailor-made documentation.”
EMPROVE offers comprehensive dossiers and documents needed for the intended usage of raw materials in three different product lines. Since its introduction in 2005, the EMPROVE portfolio is continuously growing and consists of several hundred products.
The EMPROVE seminar also saw reputed spokespersons like Chandrashekar Deo, Consultant – Quality and GMP who provided an overview of ‘The Changing Environment for Regulatory Compliance in the US’; P Manoj Kumar, Assistant Vice President R&D, Mylan Laboratories who spoke on ‘Developing Complex Parenteral Dosage Forms – A Generic Perspective’; Dr Sandeep Tiwari, Regional Technical Manager, South Asia, Colorcon Asia who spoke at length on ‘Examining the Impact of Excipient Variability on QbD’, and Dr Ulrich Reichert, Head of Regulatory Experts and Customer Audits, Merck Millipore who gave insights into ‘Elemental Impurities – Perspective as per ICH/EU/US’.
EP News Bureau