What will this webinar address?
In the rapidly evolving pharmaceutical landscape, value-added medicines (VAMs) are emerging as pivotal solutions to optimize patient outcomes and healthcare efficiency.
This webinar aims to provide an in-depth exploration of the key regulatory and development aspects of value-added medicines, with a focus on both the European and U.S. contexts. Our expert panel features John Kytariolos, Head of Clinical & Scientific Affairs at Adragos Athens, and Konstantinos Apostolou, Senior Manager for R&D at Adragos Athens, who will share their experiences and best practices to help professionals across drug development, regulatory, and market access roles align their strategies with evolving regulatory expectations and patient needs.
In this webinar, you will learn:
- Understanding the USA and the European regulatory environment for VAMs
- Navigating regulatory challenges and identifying opportunities
- Case studies illustrating successful regulatory strategies and approvals within Europe
- Key considerations in the development of VAMs, including formulation science, clinical trial design, and patient-centric approaches
- Best practices for clinical development and bioequivalence testing to ensure safety and efficacy compared to originator drugs
- The role of CDMOs in accelerating development, optimizing manufacturing, and supporting regulatory success
With a BSc, MSc, and PhD in Pharmacy specializing in Biopharmaceutics and Pharmacokinetics, John has been at the helm of the Clinical Development department at Adragos Athens for the past 11 years, accumulating over 15 years of experience in the Generic Drug Industry.
Konstantinos studied Chemistry, pursuing an MSc and a PhD in the field of pharmaceutical analysis at the University of Athens. His work focuses on developing suitable analytical tools that provide reliable research data in the field of formulation development, with an overall professional experience of about 20 years.
This webinar is brought to you by
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60 minutes
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Free