WEBINAR – From Guidance to Practice: Navigating Revised FDA PSGs for Inhaled Products
Join us for a webinar exploring recent updates to FDA Product-Specific Guidances and their impact on generic inhaled product development.
FDA Product-Specific Guidances provide an important framework for demonstrating bioequivalence and shaping the development of generic orally inhaled drug products. Recent revisions introduce new considerations for in vitro testing, study design and the evidence required to support regulatory submissions.
This webinar will explore what has changed, why these updates matter and how they may influence development strategies. Attendees will gain practical insight into revised in vitro testing expectations, the design of effective studies, and the configuration and operation of recommended test systems.
To register, please select a date/time by clicking on the links below:
Wednesday 28th October; 9:00-9:45am GMT
Wednesday 28th October; 5:00-5:45pm GMT
About the Presenter
James Taylor | Product Support Specialist
James Taylor is the Product Support Specialist at Copley Scientific, where he provides practical guidance and support to customers working with orally inhaled and nasal drug products, OINDPs.
With hands-on experience in pharmaceutical laboratory testing, James has worked across a broad range of quality control activities within GMP-compliant environments, including commercial and stability testing. His experience includes a particular focus on aerodynamic particle size distribution (APSD) measurement and delivered dose uniformity (DDU) testing, alongside crossover and ruggedness studies. Drawing on this laboratory experience, James has developed a strong understanding of the practical challenges behind OINDP testing.
James works closely with customers to provide technical guidance, training and support across a range of OINDP testing activities, supporting the effective application of testing methods and helping laboratories navigate relevant regulatory requirements.
