IDMP is a life sciences hot topic - Frits Stulp, Managing Director at Iperion Life Sciences Consultancy explores how organizations can use data smarter and more effectivelyRead more
Following his recent retirement from life sciences regulatory consultancy, former consultant Andrew Marr reflects on 30+ years in the industry
A few months ago I hung up my hat after more than 30 years advising on processes around regulatory document management, submissions and data in life sciences, giving me cause to reflect on some milestone changes I have witnessed over that time.Read more
Life sciences firms are used to an on-going stream regulatory hurdles, and the upcoming ISO IDMP compliance is another to add to the list. But ISO IDMP is also a little different, and promotes the kind of structure and discipline needed if organisations want to really break new ground and take their businesses forward.
How can organisations use ISO IDMP to change the way they operate, and to transform their master data management?Read more
The ISO IDMP Task Force met in April to compile recommended changes to the content of the information model. A revised draft version was scheduled for vote in the meeting on May 12. A revised timeline was also on schedule to be discussed. We will publish an update in the next blog.Read more
Regulatory compliance has always been a double-edged sword for life sciences. It is an essential and central focus for investment because public safety, consumer confidence and sales depend on it. Yet this preoccupation with rules and risk can also be a barrier to innovation, because any deviation from the status quo increases the chance of non-compliance.Read more
Every business, and often every department, has its own way of doing things. In the life sciences industry this is true of the way companies and individual business functions record and manage information about drugs, making it difficult to gain a clear line of sight across a product’s lifecycle and its performance in the market. This has implications for the business as well as public safety.Read more