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INITIATIVES
![iStock_000074468145_XXXLarge.jpg](https://static.wixstatic.com/media/932589_77ccfe8d1b3543848cd381c56e7741df~mv2_d_6000_4000_s_4_2.jpg/v1/crop/x_1000,y_0,w_4000,h_4000/fill/w_140,h_140,al_c,q_80,usm_0.66_1.00_0.01,enc_auto/iStock_000074468145_XXXLarge.jpg)
Global Regulatory Review and Outreach Workstream
Workstream Objectives
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Stay abreast of regulatory developments for OINDPs in countries with well-established regulatory systems.
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Understand requirements for OINDPs in emerging markets, such as China and Brazil.
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Initiate outreach to regulatory agencies, pharmacopeias and other standard-setting bodies worldwide as appropriate.
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Collaborate with other trade groups on issues relevant for OINDPs.
Working Groups
![GettyImages-868959004 [Converted].jpg](https://static.wixstatic.com/media/932589_a314c583e4514ef089b56aae8b5c1442~mv2_d_2084_2084_s_2.jpg/v1/fill/w_140,h_142,al_c,q_80,usm_0.66_1.00_0.01,enc_auto/GettyImages-868959004%20%5BConverted%5D.jpg)
Bioavailability (BA), Bioequivalence (BE), In-Vitro/In-Vivo Correlations (IVIVC) Workstream
Workstream Objectives
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Monitor, evaluate and, as appropriate, engage in discussions related to research and regulatory recommendations for BA, BE, IVIVC clinical inputs for Quality-by-Design (QbD) and similar topics.
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Stay abreast of research, and as appropriate collaborate with other organizations pursuing clinical topics for OINDPs.
Working Groups
![initiative_cmc.png](https://static.wixstatic.com/media/932589_0ddf06556e074d128a8625990948512c~mv2.png/v1/fill/w_140,h_140,al_c,q_85,usm_0.66_1.00_0.01,blur_3,enc_auto/initiative_cmc.png)
Chemistry, Manufacturing and Controls (CMC) & Product Development Test Workstream
Workstream Objectives
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Monitor regulatory developments related to CMC and product development requirements.
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Assess and respond to regulatory developments as appropriate.
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Develop improved approaches, “best industry practices” and other recommendations for CMC and product development tests, such as delivered dose uniformity, aerodynamic particle sizing, material characterization and others.
Working Groups
![gettyimages-103583201-2048x2048.jpg](https://static.wixstatic.com/media/932589_b143fce6357c44988a19ef28c3a1195e~mv2_d_2048_1361_s_2.jpg/v1/crop/x_344,y_0,w_1361,h_1361/fill/w_140,h_140,al_c,q_80,usm_0.66_1.00_0.01,blur_3,enc_auto/gettyimages-103583201-2048x2048.jpg)
Delivery Systems Workstream
Workstream Objectives
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Study industry practices and regulatory developments related to OINDP devices and device-patient interface.
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Develop and promulgate recommendations for OINDP industry, device manufacturers, regulators, health-care providers, patients and other potential stakeholders.
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Coordinate with other IPAC-RS activities and seek potential synergies in areas of mutual interest.
Working Groups
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Materials and Propellants Quality Considerations
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Change Management
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Nasal