IPAC-RS

IPAC-RS RDD 2014 Presentations

Working Group:

Device

GRRO China

Cascade Impaction (CI)

At RDD 2014 in Puerto Rico, Ying Li from Merck gave a presentation “Addressing China’s Growing Needs for Inhaled Drugs: Development Strategies for Marketing, Distribution, and Regulation" on behalf of the IPAC-RS Global Regulatory Review and Outreach (GRRO) Working Group. The talk received a very positive response.

The IPAC-RS GRRO China Subgroup also presented a paper Comparing Regulatory Pathways for Inhaled Product Development and Registration in China, co-authored by Dr. Ying Li and a local Chinese industry association, Inhalation Drug Delivery Association (IDDA). The paper was invited by RDD organizers as a supplement to the presentation by Dr. Li.


Andy Dundon, Chair of the IPAC-RS Device Working Group, gave a presentation titled “Device Design Development & Quality by Design” at RDD 2014. His presentation addressed a QbD approach for defining the Design Space for a drug delivery device and describes design, development, and industrialization of Ellipta to illustrate this approach. Andy will also give a webinar on this topic.

Geoff Daniels and Jolyon Mitchell presented at RDD 2014 a poster on behalf of the IPAC-RS Cascade Impaction Working Group, entitled “Best Practices for Abbreviated Impactor Measurement Testing of Dry Powder Inhalers during Product Development."

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