Team members from R&D, new product development, drug discovery. respiratory product development, regulatory, manufacturing team took part in the event
Generic Respiratory Drug Development 2017 conference was recently held in Mumbai. The conference was consecrated by Directors of Alliance India, Brian Nunes and Faisal Sheikh. Express Pharma was one of the media partners for the event.
The key note presentation was given by Dr Gur Jai Pal Singh, Head – Cipla Respiratory Center of Excellence. The conference was also attended by Dr Guirag Poochikian – EX FDA, President – Poochikian Consulting, Mark Copley, Sales Director, Copley Scientific, Tim Freeman, MD, Freeman Technology and team members from R&D, new product development, drug discovery. respiratory product development, regulatory, manufacturing team.
Dr Singh addressed the delegates on evolution of the regulatory landscape, regulatory pathways for drug approval, approval process for new drug applications. He also discussed about the current regulatory paradigm for approval of generic inhalation products, in vitro evaluations.
Dr K Bangarurajan, Deputy Drugs Controller talked about the India regulatory requirement on respiratory product development and licensing requirements for product development and commercialisation. He also talked about the functions of CDSCO and various regulatory authorities in India.
Prof Ambikanand Misra, Department of Pharmacy, The Maharaja Sayajirao University of Baroda, spoke on critical attributes in development of dry powder inhaler.
Dr Manju Misra, Professor, NIPER Ahmedabad articulated about the urgent requirement of respiratory products in India because of the increasing pollution level. She also talked about various new methodologies to develop cost effective formulations targeting Indian population and discussed on formulation development strategies of respiratory product considering Indian context.
Dr Jaideep Gogtay, CMO, Cipla addressed about how COPD has become a third biggest threat to human life. Shital Kumar Joshi, Senior Manager, Ansys Software, focussed on state-of-the-art CFD simulation methods for development of an inhaler, simulation in healthcare industry etc.
Mark Copley, MD, Copley Scientific, spoke about the recent innovation on respiratory product analysis, which has clinical relevance on in vitro testing method and also explained about the regulatory expectations on product development and analysis.
Dr Rakshit Trivedi, Senior Principal Scientist, Glenmark Pharma talked about analytical tests and techniques to characterise pressurised metered dose inhalers their formulation challenges, analytical Challenges, FDA CMC specifications etc.
Dr Amrita Bajaj, Professor, SVKM’s Dr. Bhanuben Nanavati College of Pharmacy spoke about various novel formulation strategies for developing products for pulmonary drug delivery, such as particle engineering, pulmosols, porous particles, pulmospheres. She also explained the advantages of this technology over the conventional technology through various animal and human models. She spoke about various technologies such as gamma scintigraphy, scanning
electron microscopy, plethysmography, spirometry to characterise the formulation.
Dr Kapileswar Swain, Sr VP Formulation & Research, Wockhardt spoke about applying human factors and usability engineering to medical devices. He also spoke of USFDA guidance on applying human factors and usability engineering to medical devices.
The final presentation was addressed by Bharat Gangakhedekar, CEO, Marathwada Auto Cluster and Guruprasad Rao, Director & Mentor (Leadership Team) – Imaginarium India, where the importance of 3D printing was addressed.