Key updates from the regulatory authorities and industry

Regulatory and analytical developments present transformational opportunities and change to the way drugs and medical devices are developed. Stay on top of key developments across the life sciences industry with PharmaLex ’s October newsletter.

Europe’s comprehensive AI Act puts industry on notice

In a world-first, the European Artificial Intelligence Act (AI Act) establishes far-reaching requirements that aim to ensure the development of safe, responsible AI. The Act has important implications for the life sciences, including around risk management, data governance, transparency and human oversight. Learn more about the AI Act and its impact on industry.

Regulatory divergence presents barriers to EU combined studies

The European Commission’s COMBINE project seeks to address the lack of regulatory alignment with combined studies involving a medicinal product and in vitro diagnostic and/or medical device. PharmaLex’s Piritta Maunu will present on the topic of CDx Clinical Performance Studies at a key RAPS conference to be held in Barcelona in October. Her blog and presentation delve into this important topic. ?

Exploring the evolution of outsourcing in pharma

Pharmaceutical outsourcing has accelerated over the past 15 years, driven by factors ranging from drug and technology advances to the need for greater flexibility, as well as cost and personnel pressures. In a Pharmaceutical Executive article, Kirsten Jacobs, PhD , Chief Strategy Officer at PharmaLex, explores the next phase of outsourcing.

Leveraging transcriptomic data analysis for precision medicine studies

Transcriptomics data analysis can help to harness the potential of precision medicine, offering insights into disease mechanisms, biomarker discovery and treatment strategies. The first step will be to address the challenges and questions introduced by personalized medicine. Learn more about transcriptomics and its potential in precision medicine.

Unlocking the requirements and challenges in the transition to CTR

The transition to the Clinical Trial Regulation (CTR) has raised regulatory questions and challenges for companies around minimum requirements, managing tight timelines and the potential ramifications of not transitioning an ongoing clinical trial before 30 January 2025, among other key issues. PharmaLex’s Xandra Neuberger ?shares her insights with Applied Clinical Trials.

The information provided in this newsletter does not constitute legal advice. PharmaLex and its parent Cencora , Inc., strongly encourage readers to review available information related to the topics discussed herein and to rely on their own experience and expertise in making decisions related thereto.