Joan Boren works in Oncology Regulatory Science Strategy and Excellence, AstraZeneca, Cambridge, UK. He provides regulatory strategy and advice on global product development and marketing strategies, being involved in interactions with regulatory authorities worldwide to agree on a successful pathway. His area of focus is on oncology products, with expertise in ATMP and biologics. He holds a PhD in biochemistry and molecular biology.
This has led to differences in interpretation between IVD manufacturers, investigational drug sponsors, ethics committees and regulators across Europe, resulting in delays to initiation of clinical trials. A coordinated consultation process is urgently needed, alongside clear guidance on the interface between the Clinical Trial Regulation (CTR) and IVDR, to address ...
As medicinal innovation evolves and becomes more complex, there is a need for agencies to support this innovation by establishing additional expedited pathway routes to improve drug development and its evaluation