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IPAC-RS speakers addressed current key issues and industry’s positions regarding the 2018 US FDA draft guidance for MDIs and DPIs, the European Medical Device Regulations, and pharmacopeial updates.
- 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- IPAC-RS Comments to the Draft Guidance for industry on Metered Dose Inhaler and Dry Powder Inhaler products -Quality Considerations (Gustavo Marco)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)