International Pharmaceutical Aerosol Consortium on Regulation & Science

IPAC-RS seeks to advance the science of orally inhaled and nasal drug products (OINDP) by collecting and analyzing data, and conducting joint research and development projects.

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News & Updates

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.

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IPAC-RS Board Meets in Sweden

The IPAC-RS Board of Directors held its summer meeting at AstraZeneca in Mölndal, Sweden on June 17-18. The Board heard updates on GRRO, the Device Working Group, IPAC-RS/ISAM Workshop plans, and the response to FDA’s recent action regarding combination products. Participants also discussed opportunities for increasing the impact of IPAC-RS through proactive communication of its work, a topic which the Planning Committee will take up later this year.

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Upcoming Events

  • IPAC-RS Board of Directors Meeting

    IPAC-RS Board of Directors Meeting

    This meeting is open to the IPAC-RS Board of Directors and invited guests.

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  • ISAM/IPAC-RS Workshop on Device Design

    ISAM/IPAC-RS Workshop on Device Design

    This workshop will address device design in relation to patient use and the evolving regulatory framework.  Topics that may be covered include patient handling studies, instructions for use, electronic device features and mobile applications, the global regulatory context, and quality by design, among others. The workshop will be of interest to individuals involved in device development and testing, as well as clinicians with an interest in device design and its impact on patient errors and adherence.

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