Harmonizing the Clinical Requirements for LABA/ICS Combinations in the USA and Europe

The podium presentations and discussion were recorded on May 23 at RDD Europe 2013 in Berlin, Germany to provide a perspective on Harmonizing the Clinical Requirements for LABA/ICS Combinations between the USA and Europe.

This session provides an overview of the transatlantic differences in clinical testing requirements for LABA/ICS combinations including perspectives from regulators and industry. It ends with a panel discussion chaired by Leslie Hendeles. Presentations were made sequentially at RDD Europe 2013; these are reproduced here as audio lectures with synchronized powerpoint slides. It is possible to watch all, or only segments of, the presentation as time permits. The duration of the full presentation is approximately 2 hours and has been made possible by the generous support of RDD Online.

A complimentary copy of the advocacy article is available online as published in RDD Europe 2013 Proceedings.

Transatlantic Differences in Clinical Testing Requirements - Is There Room for Compromise?

Leslie Hendeles, Pharm.D.
University of Florida, Gainesville, Florida, USA.

Clinical Requirements for New LABA/ICS Combinations in the USA.

Badrul A. Chowdhury, M.D., Ph.D.
Food and Drug Administration, Silver Spring, Maryland, USA.

What Do You Need to Measure to Establish Efficacy of New LABA/ICS Combinations for Submissions in the EU?

David Wright, Ph.D.
Medicines and Healthcare Products Regulatory Agency (MHRA), London, United Kingdom.

Clinical Demands for New LABA/ICS Combinations in Europe.

David Lyons, M.D.,
Irish Medicines Board, Dublin, Ireland

Clinical Development to Satisfy all Stakeholders. Who Might Give Way and On What?

Sanjeeva Dissanayake, M.D.,
Mundipharma, Cambridge, United Kingdom.

RDD Europe 2013 Panel Discussion

Chairperson and Advocate:

Leslie Hendeles, Pharm.D.,
University of Florida, Gainesville, Florida, USA.

Panel:

  • Badrul Chowdhury
    Food and Drug Administration
  • Sanjeeva Dissanayke
    Mundipharma
  • David Lyons
    Irish Medicines Board
  • David Wright
    Medicines and Healthcare Products Regulatory Agency (MHRA)

During the Panel Discussion at RDD Europe 2013, Peter Byron (VCU), Gunther Hochhaus (University of Florida) and Michal Pirozynski (Orlowski Hospital) agreed to the inclusion of their questions and comments.

The RDD Online editorial team has added slides which summarize the issues discussed during the Q&A session with the audience.