Webinar on the use of platform technologies in the non-clinical and clinical domains
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The proposal for the EU pharmaceutical legislation introduces the concepts of platform technologies and platform marketing authorisation.
The European Medicines Agency organises a webinar bringing together regulators and medicine developers to discuss the use of platform technologies beyond the quality and manufacturing domains.
We invite interested parties to share insights and case studies on the use of non-clinical and clinical platform technologies and platform marketing authorisation (ITFsecretariat@ema.europa.eu).
The main objectives of the webinar are:
• Clarifying how the current EU legal framework allows for the development and marketing of individualised therapies (n=1) and for the use of prior knowledge in Marketing Authorisation dossiers.
• Presenting case studies on the use of platform technologies in the non-clinical and clinical domains and exploring their possible applications and values.
• Discussing the challenges and identify opportunities related to the use of platform approaches.
• Facilitating the implementation of the NPL provisions on platform technologies and platform marketing authorisation.