Webinar - European Regulatory Framework

An IPEC Europe webinar

European Regulatory Framework

WEBINAR

20 September 2022 - 15:30-16:15 CEST

This webinar aims to provide a short introduction into the regulatory requirements of excipients in Marketing Authorization Applications in Europe. References to excipients in the guidelines for the dossier for application for marketing authorization of a medicinal product and examples are discussed. A further attention is turned on the supplier approval process to fulfill the requirements according to a formalized risk assessment for ascertaining the appropriate GMP practice for excipients.
GUIDELINES

IPEC Europe develops and publishes guidelines to promote the best use of excipients in medicines as a means of improving patient safety.

BECOME A MEMBER

Since 1992, IPEC Europe brings together producers, distributors and users of pharmaceutical excipients to exchange good practices and develop harmonised standards.

EXCiPACT

Member of EXCiPACT

EXCiPACT is a non-profit organisation that owns and manages oversight of the independent, high quality, third-party Certification Scheme available to pharmaceutical excipient manufacturers and distributors worldwide.

IPEC Federation

Member of IPEC Federation

Together with its sister associations (Americas, Japan, China, India), IPEC Europe is a member of IPEC Federation, who promotes quality in pharmaceutical excipients worldwide.