Industry/EMA Discuss Early Concerns Over EU’s Safety Signal Reporting Pilot

Industry representatives have raised some issues around the EU’s pilot program for drug safety signal monitoring and reporting via the revamped EudraVigilance system.

Safety First
The EMA and industry are trialing new safety signal requirements

An early assessment of the EU’s pilot program for monitoring and reporting drug safety information has shown that the initiative has pharmaceutical industry backing but that companies have concerns about how it is operating.

At a meeting with the European Medicines Agency in March, industry representatives said that they supported the proposed metrics for...

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

More from Drug Safety

More from Pink Sheet

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By 

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

UK Looks To Auto-Match NHS Patients With Clinical Trials To Boost Recruitment

 
• By 

The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.

UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.