Understanding restrictions on Synthetic Polymer Microparticles (SPM): a practical Guide for pharmaceutical excipients
The European Commission's new restrictions on synthetic polymer microparticles (SPM) are now in effect, with significant implications for pharmaceutical excipient manufacturers and drug product producers. Are you prepared? Join the webinar and discover the IPEC Best Practices guide to help you handle the requisites.
Date and time: Wednesday 18 March - 10:00-11:00 CET / 9:00-10:00 GMT
What you need to know
EU Regulation 2023/2055, which amended Annex XVII of REACH, entered into force on 17 October 2023. This regulation restricts the use of synthetic polymer microparticles across industries—including pharmaceutical excipients.
To help the industry navigate these requirements, IPEC Federation has developed a comprehensive guide. This guide provides best practices for preparing and sharing microparticle data to justify applicable derogations, offering a streamlined compliance process for polymer manufacturers, suppliers, and downstream users.
This webinar presents a practical, methodical approach to interpreting key regulatory clauses, developed through collaboration between excipient and medicinal product manufacturers.
What you will learn
Who should attend
This webinar is essential for personnel in regulatory affairs, quality, R&D, formulation, purchasing, manufacturing, and supply chain roles at excipient manufacturing, distribution, and user companies.
Presenter
Kevin Hughes, Director Innovation Development and Solutions Support, Colorcon
