Initiatives

Global Regulatory Review and Outreach Workstream

Stay abreast of regulatory developments for OINDPs.
Understand requirements for OINDPs in emerging markets.
Engage in outreach to regulatory agencies, pharmacopeias, and other standard-setting bodies worldwide, as appropriate.
Monitor and address, as appropriate, environmental and sustainability priorities.

Grow and evolve membership to ensure IPAC-RS is equipped to address current and future challenges.
Develop and implement visibility and outreach strategies to achieve growth goals.
Advance the science and scientific discourse between IPAC-RS and external stakeholders in areas of common interest.
Collaborate with other trade groups on relevant issues.
Increase public visibility of IPAC-RS advocacy, technical work, and subject matter expertise.

Membership Committee
Roundtables, webinar, and conferences with key stakeholders and thought leaders
Collaborations with other organizations, as appropriate (e.g., ISAM, RDD, DDL, EPAG, AAPS, IPAC, and PQRI)

Monitor, assess, and respond to regulatory developments related to chemisty, manufacturing, and controls (CMC) and product development for small/synthetic molecules as well as large molecules and biologics.
Develop improved approaches, “best practices” and other recommendations for CMC and product development analytical testing, formulation, manufacturing, stability, material selection, product characterization, and other topics.

Develop and share industry practices and monitor regulatory developments related to OINDP devices and device-patient interface, and container-closure systems.
Develop and promulgate device-related recommendations for OINDP industry, device manufacturers, regulators, health-care providers, patients and other potential stakeholders.
Explore and collaboratively address challenges related to nasal delivery systems.
Discuss and publish considerations for materials selection and quality with new propellants.
Examine regulatory requirements related to change management, starting with Europe and thereafter in the US and later ini other world regions. Promote streamlining and harmonization of requirements.