1. Pink Sheet
  2. >>Geography
  3. >>Europe

Big Data In Medicines Regulation Will Need ‘Considerable Change In Mindset’

 
• By Maureen Kenny

Changing mindsets, technologies outpacing regulatory frameworks, intense international collaboration, and the future of the randomized controlled clinical trial. Big data is forcing us to think big, senior European regulator Thomas Senderovitz tells the Pink Sheet.

PS1808_Big Data_176189567_1200.jpg
Proposals on the use of big data in drug evaluation are under development • Source: Shutterstock

"A considerable change in mindset across the board" will be needed in a new era of drug development where precision medicine, real-world data gathering and the use of big data are the norm. That’s the view of Thomas Senderovitz, Danish Medicines Agency head and until recently chair of the joint Heads of Medicines Agencies/European Medicines Agency Big Data Task Force.

Big data is not the only driver. The fast pace of change and convergence of technologies are also key, says...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Europe

More from Geography

AI In Manufacturing: EU To Revamp GMP Guidance In Light Of Digital Advancements

 
• By Eliza Slawther

Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.

China Unveils Multiple Policies To Support Innovative Drugs Throughout Life Cycle

 
• By Xu Hu

China has announced a raft of new measures to encourage innovative drug development across the product life cycle, including using insurance data to differentiate new therapies and applying commercial insurance to selected novel products.

US FDA Staff Stability Should Be A Congressional Priority, Former Chief Of Staff Says

 
• By Derrick Gingery

Lawmakers should address FDA staff upheaval and help the agency “get back on track,” former agency Chief of Staff Elizabeth Jungman said, while CBER Director Vinay Prasad told staff he is asking ex-colleagues to return to the agency.