Mark Copley, Sales Director at Copley Scientific, will be presenting as one of the industry experts at the two-day Generic Respiratory Drug Development Symposium.
Mr Copley is presenting on the topic of “Improving the clinical relevance of in vitro testing methods for orally inhaled products (OIPs).”
The symposium is due to take place from 19–20 January 2017 at Hotel Meluha The Fern, Mumbai, India.
This inaugural conference brings together the generic respiratory drugs community to discuss advances relating to generic inhalation and nasal spray drugs — an area experiencing continued growth as blockbuster inhalation products come off patent.
Presentations at the event cover a wide range of topics, including analytical method development, Quality by Design (QbD) approaches, regulatory requirements and manufacturing challenges.
“In vitro test methods are widely used to assess the performance of generic OIP drug delivery, to ensure product consistency and to support claims of bioequivalence” explains Mr Copley.
“Understanding and improving the clinical relevance of these methods is an important issue for the industry and Copley Scientific is delighted to have been invited to present at the Generic Respiratory Drug Development Symposium on this topic. Indian based pharmaceutical companies are highly active within this sector and I am looking forward to interacting with key executives in global R&D, product development, drug discovery, regulatory and manufacturing roles.”
Alongside Mark Copley, speakers include Dr Gur Jai Pal Singh (Head, Cipla Respiratory Center of Excellence) and Dr Guirag Poochikian (President, Poochikian Consulting and former US FDA Associate Director for Regulatory Science).