Fourth industry stakeholder platform on research and development support

This is the fourth in a series of regular meetings between regulators and representatives of industry stakeholder organisations, hosted by the European Medicines Agency (EMA). It addresses all areas of product-development support, from scientific advice, through specifics for paediatric and orphan medicines, to innovation support.

This meeting will focus on the future regulation of integrated drug-device combinations, experience with the qualification of digital technology proposals, current challenges in developments with biomarkers and opportunities for 'post-licensing evidence generation' proposals in scientific advice. It will also provide updates on activities on:

• next generation sequencing;
• Parallel consultation with regulators and health technology assessment bodies;
• orphan designation reviews;
• topics from the paediatric action plan