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For this month’s edition, we knocked on Daniel Capion‘s door. Daniel is a documentation expert with +20 years of experience from biotech, mid-sized and big-pharma industry as well as medical device knowledge. We interviewed him on 4 situations you have probably faced yourself in regulatory operations, and practical tips to overcome them. Enjoy the read! Challenges and

There’s a lot of talk about structured information and how it will solve all our problems with regulatory submissions. If you look at initiatives such as IDMP and EMA’s Digital Application Dataset Integration Project (DADI) or further back, FDA’s Structured Product Labeling, there are good examples of health authorities getting at least some information into

If you work in Regulatory Operations, you are probably knee-deep in transformation. Whether you are upgrading your entire RIM system (or parts of it), or migrating to cloud-based solutions, testing and implementing automation of repetitive and manual tasks, and preparing for IDMP, CTR and data submissions in general, it probably feels like change is everywhere