Defining characteristics for dose forms, which meet global needs, is a challenge addressed by EDQM and several stakeholders.
This webinar will present the views regarding the “global” aspect of dose form definition: in the regulatory space, in the clinical space, in the domain of adverse event monitoring and what efforts EDQM is deploying to meet these requirements, to be captured in the revision of the relevant ISO standard and the EDQM Standard Terms.
Date: Friday 1st October 2021
Time: 3:00 – 4:30 pm CEST
Presenters: Christopher Jarvis (UNICOM WP 1, EDQM)
Malin Fladvad (UNICOM WP 1, WHO-UMC)
TJ Chen (US FDA)
Joseph Roumier (I~HD)
Panelist: Robert Vander Stichele (UNICOM WP 1, i~HD)
Ron Fitzmartin (US FDA))
Moderators: Christian Hay (UNICOM WP 1, GS1 and ISO TC 215/WG6)
Robert Stegwee (UNICOM WP 1, CEN TC 251)
You can register with the following link: https://us02web.zoom.us/webinar/register/WN_2mpp6dcXRo-z6CNxg1latA