IPAC-RS

Device

The objective of the Device Working Group is to understand and promote best practices for OINDP device design. The Working Group was formed to prepare and conduct a Device Design session at the IPAC-RS 2008 Conference, and has since published on the same topic, developed and conducted a survey on testing needed to support device changes, and presented at the IPAC-RS 2011 conference on the topics of "Regulatory Expectations for User Testing" and "Human Factors and the Design of Inhalation Devices." 

The Device Working Group is active in the areas of device change management, knowledge space and design space and human factors. The group has completed a white paper proposing a risk-based approach to management of device changes, and is developing voluntary guidelines for approaching knowledge space and design space. Group members are also considering opportunities to improve instructions for use, an integral part of the user interface for devices.

News

Device Working Group Comments to FDA

The Device Working Group has submitted comments on the FDA Draft Guidance, Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.

Device Working Group September 2015 Update

An ISO Working Group developing a standard for Device Change Management held their 4th meeting in Washington, DC on August 31 – September 1, 2015. Highlights will be discussed within the IPAC-RS Device WG and at the upcoming IPAC-RS Board of Directors Meeting.

Device Working Group Update

The Device Working Group met in Cambridge, UK on June 16, 2015. The Working Group agreed to develop a Global Device Development Roadmap and standard materials for interfacing with external stakeholders. As part of an effort to engage with regulatory authorities as stakeholders, the Device Working Group will engage with the Global Regulatory Review and Outreach team focused on the EU as appropriate. The Working Group is also considering liaising with other industry organizations and planning participation at external conferences.

ISO TC 84 Committee Agrees to Move Forward with Device Change Initiative

At the ISO TC 84 Committee meeting in Como, Italy earlier this month, the Committee agreed to create an ad-hoc group that will outline the structure for a guidance document related to device change management, a topic initially proposed to ISO by the Device Working Group. Andy Dundon, Frederik Mannerstrale, and Roisin Wallace from the Device Working Group will participate in this group. It is expected that a preliminary outline will be available this fall.

IPAC-RS RDD 2014 Presentations

At RDD 2014 in Puerto Rico, four IPAC-RS members representing GRRO China, the Device Working Group, and the Cascade Impaction Working Group gave very well-received presentations.

Device Design Space Update

An update from the IPAC-RS Device Working Group workstream focused on describing the steps in establishing the device design space.

Past Events

ISAM/IPAC-RS Workshop on Device Design

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.

Publications

An IPAC-RS Update: Delivery Systems, L&E and GRRO

By Working Group: Global Regulatory Review Outreach (GRRO). By Working Group: Leachables and Extractables (L&E) Development Paradigm Knowledge Network. By Working Group: Device. Ilse Peterson, Svetlana Lyapustina, and Lee Nagao Article, Inhalation (published)

Equivalence Considerations for Orally Inhaled Products for Local Action

is available at: IPAC-RS. By Working Group: Cascade Impaction (CI). By Working Group: Device. Carole Evans, David Cipolla, Tim Chesworth, Eva Agurell, Richard Ahrens, Dale Conner, Sanjeeva Dissanayake, Myrna Dolovich, William Doub, Anders Fuglsang, Afredo García Arieta, Michael Golden, Robert Hermann, Günther Hochhaus, Susan Holmes, Paul Lafferty, Svetlana Lyapustina, Parameswaran Nair, Dennis O'Connor, David Parkins, Ilse Peterson, Colin Reisner, Dennis Sandell, Gur Jai Pal Singh, Marjolein Weda, and Patricia Watson Journal of Aerosol Medicine and Pulmonary Drug Delivery, Vol. 25, No. 3: 117-139 (published)

Presentations

Comments on Guidances

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