The Indian Drug Manufacturers Association (IDMA) is organizing a one-day seminar on 'Filing Strategies for Regulated Markets' at Sunville, Worli in Mumbai on June 22. Drug Controller General of India Dr M Venkateshwarlu will inaugurate the seminar.
Several prominent persons in the Indian pharmaceutical regulatory scenario will be present in the seminar to deliver their views on vital topics related to pharma industry and its regulation. The subject of the seminar is very relevant as India is now in the forefront of filing a large number of ANDA with US FDA and this trend is growing. Many leading companies including medium size companies are also now eager to file ANDA to get approval from US FDA.
With the growing generic market in US and other countries the importance of filing ANDA and related documents like DMF, CTD etc. is growing. This seminar is aimed to guide and provide basic information to the young executives working in regulatory division of a company.
Dr Paranjothy Kanni, professor of pharmaceutics at Al-Ameen College of Pharmacy, Bangalore, and adviser to Pharmaceutical companies will deliver speech on "New Drug Approval Process- An Update", while Dr Darshan Makhey- Head of Quality India, Hospira Inc will speak on "New Drug Applications- NDA's".
Antony Raj Gomes, senior director - quality control formulations, Dr Reddys Laboratories will speak on "Analytical Challenges in Filing" and K S Babu - DGM, drug regulatory affairs and compliance, Wockhardt Ltd will speak on " Bio equivalence section of ANDA". Suchitra Tiwari manager - regulatory affairs J B Chemicals & Pharmaceuticals Ltd will provide information on "e - CTD Filing". Narayan Gad- chief executive - formulations, Panacea Biotec Ltd will also share his information in the seminar.