The symposium will take place on January 19 and 20, 2017
Generic Respiratory Drug Development Symposium will be held in Mumbai on January 19 and 20, 2017. Team members from R&D, new product development, drug discovery, respiratory product development, regulatory, manufacturing team etc will attend the symposium.
Dr Gur Jai Pal Singh, Ex US FDA, Head – Cipla Respiratory Center of Excellence will be the keynote speaker. Others who will take part in the symposium are Dr Guirag Poochikian – EX FDA, President, Poochikian Pharma Consulting, Mark Copley, Sales Director, Copley Scientific, Tim Freeman, MD, Freeman Technology, Dr Keshav Deo, Advisor, API, Dr Jaideep Gogtay, CMO, Cipla, Dr Kapileswar Swain, Sr VP Formulation Development & Research, Wockhardt, Prof Ambikanandan Misra, Professor of Pharmacy, The Maharaja Sayajirao University of Baroda, Dr Rakshit Trivedi Senior Principal Scientist – Analytical Development, Glenmark Pharmaceuticals, Prof Kiran Kalia, Director, NIPER – Ahmedabad, Shitalkumar Joshi, Senior Manager, Ansys Software.
Discussions will be held on the following topics on the first day. They are ‘Approval of inhalation drug products: A US regulatory perspective’, ‘CMC requirements and complexities in the US approval of respiratory drug products’, Critical attributes in development of dry powder inhalers,’ ‘Generic respiratory product development,’ ‘Analytical techniques on generic respiratory product analysis to meet regulatory expectations,’ ‘State-of-the-art simulation methods on developing inhaler.’
On the second day, the following topics will be discussed. They are: ‘Regulatory challenges in the development of generic dry powder inhaler development,’ ‘Manufacturing challenges of respiratory products to meet process validation guidelines,’ ‘Dry powder inhaler in-vitro device robustness study,’ ‘Micromeritic properties of Raw materials which influence on the product performance,’ ‘Analytical test and technique to characterise pressurised metered dose inhaler (pMDI).’
Express Pharma is the media partner for the symposium.