Virtual Innovation Day

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


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Virtual Innovation Day

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 
  • Encapsulation solutions for improved formulation and fixed dose combination
  • Manufacturing equipment to address the challenges linked to multiple product dosing


  • 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:

Universitat BONN

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