The seminar series is an initiative to create a platform for the industry to discuss and disseminate information as well as develop strategies for the pharma sector’s growth
The 2016 chapter of the Emprove Seminar Series was recently held in Mumbai. The seminar witnessed the presence of experts from the industry as speakers and panelists. ‘Enabling Informed Risk Assessment’ was the theme for the year. The seminar series is an initiative to create a platform for the industry to discuss, debate and disseminate information as well as develop strategies for the future of the pharma industry.
Welcoming the distinguished speakers and the audience to the 5th edition of the EMPROVE Seminar Series, Peter Salazar, Head of the Process Solutions Business, Merck, said, “The milestones in regulatory affairs are changing very fast and so the objective of this seminar, ‘Enabling Informed Risk Assessment’ fits well into the need of the hour. The seriousness towards risk assessment has increased over the past few years.
Sushrut Kulkarni, Senior Vice President and Head Pharmaceutical Technology Center, Zydus Cadila in his inaugural speech highlighted that risk assessment covers two main aspects. They are risk to patient and business risk. Different regulatory bodies have different expectations and the requirements in regulatory today have become similar to that required for NDAs.
Dr Najib Sehat, Head-Global Regulatory Management, Merck – Life Science Business talked on the topic ‘EU Guidelines on the formalised risk assessment for ascertaining the appropriate GMP for pharma excipients.’
He said, “The European directive 2011/62/EU, known as the ‘Falsified Medicine Directive’ requires that the pharma manufacturer has to perform a formalised risk assessment and has to verify the appropriate GMP for excipients.”
Dr Anjali Apte-Deshpande, Director/ Founder, Central Dogma presented studies on recombinant protein production in E Coli with auto inducing medium.
Dr Nishodh Saxena, Vice President (Head Quality and Regulatory), Jubilant Life Sciences was also one of the speakers. In his presentation, he said, “In the pharma industry, every product and every process is associated with risks to the patient’s health. To maintain product quality throughout the product life cycle, a considerable amount of time and resources are allocated.” He presented practical ways to analyse the risks to the quality system and provided guidance to achieve efficient quality management as well as compliance through quality risk management.
Michael Payne, Senior Technical Bio safety Consultant, Merck Millipore, spoke on the importance of risk assessment in clinical trials. He said , “It is important that robust decisions on quality and scaling are made as soon as possible to avoid unwelcome surprises in the middle of clinical trials”.
The event concluded with a presentation by Ivy Louis, Founder, Vienni Training and Consulting. Louis dealt with the topic ‘Quality & Culture –The Interchangeable Ingredient’. She highlighted how the culture of the organisation has a huge impact on the quality of work among the employees and how quality and culture are two sides of the same coin.
EP News Bureau – Mumbai
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