Leveraging the Evolving Bioequivalence Regulatory Landscape to Enhance Product Design & Development

This presentation will outline considerations for product design and characterization.

Register Free: https://www.pharmtech.com/pt_w/bioequivalence-regulatory-landscape

Event Overview:

The regulatory landscape for bioequivalence continues to evolve, leveraging a broader suite of characterization techniques. These not only provide deeper product understanding, but also utility for generic product development as the potential for replacement of costly clinical studies becomes more of a reality. In addition, a holistic approach to product/device design is critical to the success of a generic product. This presentation will outline considerations for product design and characterization.

Key Learning Objectives:

• Understand the current and evolving regulatory pathways
• Learn about product/device design considerations for generic products
• Identify tools and resources that support product-specific characterization

Who Should Attend:

• VPs of R&D within small to mid-sized pharma companies
• Senior scientists within small to mid-sized pharma companies
• C-Suite executives/CTOs/CMOs/CEOs/CSOs within small to mid sized pharma companies

Speakers:

Amanda Jenkins
Director, Pharmaceutical Development
Vectura

Amanda Jenkins is responsible for complex generic and DPI product development programs and has 26 years of experience in pharmaceutical product development, including 22 years of inhaled product development. Amanda joined Vectura in 2002 and has worked on a number of product development programs, spending a significant portion of this time focusing on the development of generic DPIs for the EU and US markets. Amanda holds a BPharm (Hons) degree from the University of Nottingham and a masters degree in Applied Project Management from Northumbria University.

Richard Poole
Director, Pharmaceutical Development
Vectura

Richard Poole leads a center of excellence group at Vectura, with the remit of ensuring best practice in product development is understood and implemented across Vectura’s projects. He has over 20 years’ experience working with inhaled products, with 19 years in product development. Richard has been with Vectura since 2004 and has worked on a range of DPI products at all stages, from feasibility to late-stage generic development for the US market. Richard holds a BSc (Hons) in Pharmacology from Sheffield University.

Andreas Meliniotis
VP, Device Development
Vectura Limited

Andreas Meliniotis is VP of Device Development at Vectura and leads the engineering and device development group (based in Cambridge, UK). With over 20 years’ experience at Vectura, he has led the design and development of several multidose dry powder inhalers as well as nebulizers and connected device technology. Prior to joining Vectura, Andreas worked for Cambridge Design Partnership and The Technology Partnership, developing glucose measurement devices and industrial printing technology, respectively. He is a chartered mechanical engineer and chartered manager, and holds a bachelor’s degree in Mechanical Engineering from the University of Nottingham.

Register Free: https://www.pharmtech.com/pt_w/bioequivalence-regulatory-landscape