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
EFPIA
The Spanish AEPD Publishes Statement on the Interplay Between its Code of Conduct for the Pharmaceutical Industry and the Potential EU Code of Conduct on Clinical Trials
On December 28, 2022, the Spanish Data Protection Authority (“AEPD”) published a statement on the interplay between its recently approved Spanish code of conduct for the pharmaceutical industry and the European Federation of Pharmaceutical Industries and Associations’ (“EFPIA”) proposal for an EU code of conduct on clinical trials and pharmacovigilance. The statement relates specifically to the legal basis for processing personal data in the context of clinical trials.Continue Reading The Spanish AEPD Publishes Statement on the Interplay Between its Code of Conduct for the Pharmaceutical Industry and the Potential EU Code of Conduct on Clinical Trials