Value-Added Medicines: From Development to Approval

Discover how to effectively develop and secure regulatory approval for value-added medicines in Europe and the US. Hear directly from industry experts sharing real-world experiences and actionable insights to guide your journey from development to market.

Register Free: https://www.pharmtech.com/pte_w/value-added-medicine

In the rapidly evolving pharmaceutical landscape, value-added medicines (VAMs) are emerging as pivotal solutions that optimize patient outcomes and health care efficiency. These innovative products, which include reformulated, repurposed, or combined therapies, enhance existing medications’ efficacy, safety, and convenience.

1. Regulatory frameworks and pathways in Europe:

• Understanding the European regulatory environment for VAMs.
• Navigating regulatory challenges and opportunities.
• Case studies illustrating successful regulatory strategies and approvals within Europe.

2. Development strategies:

• Key considerations in the development of VAMs, including formulation science, clinical trial design, and patient-centric approaches.
• Innovations in drug delivery systems and their impact on the development process.

This webinar will include examples of successful developments of value-added medicines in Europe.

This webinar aims to provide an in-depth exploration of the key regulatory and development aspects of value-added medicines, with a focus on the European context.

An expert panel, comprising regulatory affairs specialists and pharmaceutical developers, will share their experiences and best practices.

Key Learning Objectives:

• Gain insights into the key regulatory frameworks and pathways for value-added medicines and 505(b)(2).
• Explore essential considerations for successful VAM development.
• Learn from expert case studies and best practices to navigate the regulatory landscape through VAMs and 505(b)(2)

Who Should Attend:

• Business development managers
• Regulatory affairs managers
• Clinical development managers
• Commercial strategy managers
• Managing directors
• Research and development directors
• Product development scientists
• Heads of outsourcing
• Suppliers’ evaluation managers
• Innovation and development managers
• Product portfolio managers
• Strategic planning managers
• Project managers
• Formulation managers
• Analytical chemistry managers

To learn more about Adragos Pharma visit: https://adragos-pharma.com/

Speakers:

John Kytariolos
Head of Clinical & Scientific Affairs
Adragos Athens

John Kytariolos holds BSc, MSc, and PhD degrees in pharmacy with a focus on biopharmaceutics and pharmacokinetics. For the past 11 years, he has led the clinical development department at Adragos Athens, and has over 15 years of experience in the generic drug industry. Kytariolos has successfully overseen over 100 bioequivalence and bioavailability studies, contributing to numerous regulatory submissions. He specializes in value-added medicines, pediatric formulations, and complex generics. Kytariolos is experienced in bioequivalence studies for highly variable drug products, dissolution studies, and in-vitro in-vivo correlation (IVIVC). He has also participated in key meetings with European regulatory agencies, including the European Medicines Agency.

Konstantinos Apostolou
Senior Manager for R&D
Adragos Athens

Konstantinos Apostolou, MSc, PhD, is the senior manager for R&D at Adragos Athens, with 20 years of professional experience. He holds MSc and PhD degrees in pharmaceutical analysis from the University of Athens. His work focuses on developing analytical tools for formulation development and evaluating data for informed decision-making. Initially, Apostolou specialized in mass spectrometric analysis of biological samples for bioequivalence studies. For the past 13 years, he has been a key member of Adragos Athens, sharing his expertise in analytical and formulation development.

Register Free: https://www.pharmtech.com/pte_w/value-added-medicine