INITIATIVES

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Global Regulatory Review and Outreach Workstream

Workstream Objectives

  • Stay abreast of regulatory developments for OINDPs in countries with well-established regulatory systems.

  • Understand requirements for OINDPs in emerging markets, such as China and Brazil.

  • Initiate outreach to regulatory agencies, pharmacopeias and other standard-setting bodies worldwide as appropriate.

  • Collaborate with other trade groups on issues relevant for OINDPs.

Working Groups

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Bioavailability (BA), Bioequivalence (BE), In-Vitro/In-Vivo Correlations (IVIVC) Workstream

Workstream Objectives

  • 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.

  • Stay abreast of research, and as appropriate collaborate with other organizations pursuing clinical topics for OINDPs.

Working Groups

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Chemistry, Manufacturing and Controls (CMC) & Product Development Test Workstream

Workstream Objectives

  • Monitor regulatory developments related to CMC and product development requirements.

  • Assess and respond to regulatory developments as appropriate.

  • 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

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Delivery Systems Workstream

Workstream Objectives

  • Study industry practices and regulatory developments related to OINDP devices and device-patient interface.

  • Develop and promulgate recommendations for OINDP industry, device manufacturers, regulators, health-care providers, patients and other potential stakeholders.

  • Coordinate with other IPAC-RS activities and seek potential synergies in areas of mutual interest.

Working Groups