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IPAC-RS speakers addressed current key issues and industry’s positions regarding the 2018 US FDA draft guidance for MDIs and DPIs, the European Medical Device Regulations, and pharmacopeial updates.
Slide presentations from the event are now available!
- Global Regulatory Topics in Orally-Inhaled and Nasal Drug Product DevelopmentDDL/IPAC-RS workshop (Jeremy Clarke, GSK)
- EU Medical Device Regulation and it’s impact on Combination Products (Tim Chesworth, AstraZeneca)
- Human Factors (Róisín Wallace, Mylan)
- IPAC-RS Comments to the Draft Guidance for industry on Metered Dose Inhaler and Dry Powder Inhaler products -Quality Considerations (Gustavo Marco)
- IPAC-RS Delivery Systems Workstream –Activity UpdateInstructions for Use (IFU) Subgroup (Julian Dixon)
- Cascade Impaction Testing and Data Analysis: Regulatory and Pharmaceutical Developments (Adrian Goodey and Jolyon P. Mitchell)