Collaborative IPAC-RS Initiatives to Advance Device Development

Andy Dundon, Roisin Wallace & Fredrik MannerstrĂ¥le

The purpose of this DDL presentation is to exemplify the work conducted by the International Pharmaceutical Aerosol Consortium on Regulations and Science (IPAC-RS, in the area of devices for orally inhaled and nasal drug products (OINDPs) so as to seek broader engagement from interested companies and individuals who wish to inform the regulatory framework within which companies must operate. The Device Working Group is just one of a number of strategic workstreams within IPAC-RS:

  1. General (e.g., communications, global regulatory review outreach).
  2. Bioavailability, bioequivalence, in vitro in vivo correlations (e.g., population bioequivalence testing).
  3. CMC & Product Development (e.g., cascade impaction, delivered dose uniformity, leachables and extractables development paradigm).
  4. Delivery Systems (e.g., materials for OINDPs, devices, patient concordance).

This presentation reports on the several initiatives spearheaded by the Device Group, such as streamlining and harmonizing quality requirements for devices, device change management, interpretation of the ICH Q8-9-10 risk management and quality-by-design (QbD) guidelines, patient’s instruction for use, and similar issues.

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