IPAC-RS

ISAM/IPAC-RS Workshop on Device Design

ISAM/IPAC-RS Workshop on Device Design

Working Group:

Device

Type of Event:

Workshops

Venue:

Munich, Germany

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Both spontaneous feedback during the workshop and follow-up interactions indicate that the May 30 IPAC-RS/ISAM Device Design Workshop in Munich, Germany was very successful. Industry, academic, and regulatory speakers presented their perspectives on the design of inhalation devices, current challenges, and future directions. The topics of human factors and appropriate patient information/user instructions resonated with the audience, especially with regulators. Interested speakers and Organizing Committee members will be preparing a publication reflecting the workshop’s discussions.  Thanks to the entire Organizing Committee and to all who attended.

This full‐day workshop conducted as part of the ISAM 2015 Congress focused on the challenges and opportunities associated with changes in inhalation device design and their regulatory implications. Inhalation device changes may occur during clinical development by an Innovator company, as well as post approval, and the implications can have a
profound impact on invested resources, time, approval and regulatory commitments. The Generics industry is also facing challenging regulatory requirements related to the development of generic/secondentry inhalation products meant to replace the original products. This workshop will consider these topics through the perspectives of global inhalation experts representing academia, industry, regulators and health care providers. Two panel discussions will allow for audience participation and engagement with the speakers.

Morning Session: Patient Focus Moderated by Andy Dundon (GSK)

Afternoon Session: Regulatory/Standards Focus Moderated by Róisín Wallace (Mylan)

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