Feedback Sought On The Tricky Business Of Handling CoIs Under EU HTA Regulation

Representatives and individual experts taking part in joint assessments of new health technologies need to be free from conflicts of interest in relation to the industrial sector in which the health technology developer operates.

rules and regulations marked on rubber stamp
The EU is planning new rules on conflicts of interest • Source: Shutterstock

The European Commission is seeking comments on proposed rules for managing conflicts of interest (CoIs) among the experts and other individuals who will be involved in the EU-level joint clinical assessments (JCAs) that are to take place under the new Health Technology Assessment (HTA) Regulation.

According to the draft rules, launched for public consultation this week, managing CoIs will not be straightforward

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 Europe

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.

EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

More from Geography

Recent and Upcoming FDA Advisory Committee Meetings

 
• By 

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.