Innowacje w lekach generycznych, czyli wszystko co musisz wiedzieć o lekach hybyrydowych / 505 (b)(2) - ścieżka rejestracyjna.
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The Hybrid and 505(b)(2) regulatory pathways can allow pharmaceutical companies to bring improved medicines onto the market while alleviating some of the cost and time associated with traditional innovative development.

Join our panel of industry experts at our next Virtual Innovation Day for a deep dive into case studies and actionable insights for navigating pharmaceutical regulation with innovation.

Attend this Virtual Innovation Day for:

◾ Key considerations in the US 505(b)(2) and EU Hybrid (or alternative) application pathways
◾ Encapsulation solutions for improved formulation and fixed dose combination
◾ Manufacturing equipment to address the challenges linked to multiple product dosing

Event Agenda:
Keys to Success for 505(b)(2) Development
Eric Kendig, VP of Regulatory and Strategy, Camargo

Fixed Drug Combinations (FDCs): “Development strategies up to registration”
Julia Grapinet, MSc, Co-founder & Project Director, J2Fpharma

Dosage form considerations for Hybrid and 505(b)(2) NDA
Frédérique Bordes-Picard, Business Development Director for Innovative Products, Lonza

IMA capsule fillers for multiple dosing
Angelo Airoldi, Product Manager, IMA Active

Amorphous solid dispersions and their potential for life cycle management of a drug product
Karl G. Wagner, Professor of Pharmaceutical Technology and Biopharmacy, University of Bonn

Register here.