Smart Innovation through Hybrid and 505(b)(2) Regulatory Pathways

Virtual Innovation Day

Fill the form to watch now on-demand

First Name:

Last Name:

Business Email:

Company:

Title:

Country:

Privacy Option-Email:

UTM Campaign:

UTM Medium:

UTM Source:

Our panel of industry experts take a deep dive into case studies and actionable insights for navigating pharmaceutical regulation with innovation.

Watch on-demand for:

Key considerations in the US 505(b)(2) and EU Hybrid (or alternative) application pathways

Manufacturing equipment to address the challenges linked to multiple product dosing

Speakers

Keys to Success for 505(b)(2) Development // Eric Kendig, VP of Regulatory Strategy // Camargo

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

Dosage form considerations for Hybrid and 505(b)(2) NDA // Frédérique Bordes-Picard, Business Development Manager, Innovative products // Lonza CHI

IMA capsule fillers for multiple dosing // Angelo Airoldi, Product Manager for Capsule Fillers and Tablet Presses // IMA Active

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

Presented by: