EMA

On April 22, 2024, the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) issued a statement on the application of the AI Act in the medicinal product lifecycle. The EFPIA statement highlights that AI applications are likely to play an increasing role in the development and manufacture of medicines.  As drug development is already governed by a longstanding and detailed EU regulatory framework, EFPIA stresses that care should be taken to ensure that any rules on the use of AI are fit-for-purpose, adequately tailored, risk-based, and do not duplicate existing rules.  The statement sets forth five “considerations”:Continue Reading EFPIA Issues Statement on Application of the AI Act in the Medicinal Product Lifecycle

As scientists work around the clock to gain insights into the Corona virus and how to fight it, public and private-sector stakeholders are in discussions to promote the rapid exchange of scientific data. During these discussions, the GDPR acronym inevitably rears its head and casts doubt over what is lawful.
Continue Reading COVID-19, Scientific Research and the GDPR – Some Basic Principles