DIA India is organizing the CMC (Chemistry Manufacturing and Controls) Conference titled ‘Converting Science into Regulatory Submission' on February 10-11, 2012 at the Country Inn, Ahmedabad.
Chemistry, Manufacturing and Controls (CMC) is one of the three areas that health authorities consider for the review and approval of drug applications. Effective CMC strategies and execution may reduce regulatory burden, enable shorter review times, and support post approval maintenance.
This is an annual event organized by DIA in India. The key objective of the two-day event would be to make the participants thorough on the regulatory submissions. At the end of the conference, the delegates will be able to describe key concepts in the business, technical and execution applications of regulatory CMC. They will be able to demonstrate process understanding, risk assessment and quality systems. Further, they will be able to understand the importance and emerging trends in electronic submissions and document maintenance. Besides, the conference over the two days will make the participants adept in product knowledge into effective regulatory submission content and enhance their organizations’ current strategies for success in technical regulatory filings, stated Kaushik Desai, director DIA India.
All attendees will receive a DIA certificate of attendance at the conclusion of the event.
The keynote address will be delivered by Pankaj R Patel, chairman and managing director, Zydus Cadila. The sessions will be co-chaired by H. G. Koshia, Commissioner, FDCA, Gujarat and Nandkumar Chodankar, Group CEO, Pharma Business, Excel Industries Limited.
The conference will be addressed by industry leaders including Aniruddha Vaidya, director, Analytical Solutions; Pratibha Pilgaonkar, founder and CEO, Rubicon; Dr Mukesh Gohel, director, Postgraduate Studies in the School of Life Sciences, Ahmedabad University; K Anand, chief operating officer, Famycare; Rajinder Singh, director, Regulatory Affairs, Ranbaxy; Alpesh Patel, vice president Regulatory Affairs, Amneal Pharmaceuticals; G Gurudatta, COO and director, Semler Research; Vinay Nayak, president, Alembic Pharma; Dr A Ramkishan, Asst. Drugs Controller (I), Zonal Office, Ahmedabad CDSCO; Rajiv Desai, president, Quality, Dishman Pharmaceuticals; Bhavesh Patel, general manager - FnD, Astron Research; R R Tuljapurkar, senior vice president - Quality, Zydus Cadila; Antony Raj Gomes, senior vice president, Mylan; and Sanjay Kapadiya, Head - QA & RC, Apotex.
At the inaugural, Aniruddha Vaidya will speak on Analytical Method Development during product development; Pratibha Pilgaonkar will speak on Product Development Strategy based on QBD Principles; Dr Mukesh Gohel will delve into the Design of Experiment; K Anand will speak on Challenges of CMC and Manufacturing: Indian Perspective; and Rajinder Singh would address on Deficiencies identified by Regulatory application.