How To Use The EU’s New Clinical Trial Submission System

Training Offered To Sponsors And National Authorities

From the end of this year, clinical trial sponsors of all shapes and sizes will be able to use the EU’s new centralized trial submissions portal and database. In view of the complexity of the system, practical training sessions as well as online informational materials will be on offer.

Training Courses on Landing Page of Mobile Computer Display
Users will need "skills, capabilities and knowledge" for new clinical trial information system to work well • Source: Shutterstock

The European Medicines Agency is inviting clinical trial sponsors to take part in training programs on how to use the EU’s new centralized clinical trial submission and approval system, which is scheduled to go live at the end of this year.

The clinical trials information system (CTIS) will be a single EU entry point for submitting, assessing, authorizing, supervising and reporting...

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 MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

New Pricing Agreements And Greater Transparency: What A US MFN Policy Could Mean For France

 

A potential MFN drug pricing policy in the US could also lead to a greater push for collaborative action in the EU, such as joint procurement among the member states, says one European industry expert.

EU Pharma Reform Package Clears Big Political Hurdle After Council Adopts Position

 

The Council of the EU has made several key amendments to the legislative reform package, which it will now negotiate with the European Parliament.

MHRA Backs Bacteriophage Innovation To Fight Antimicrobial Resistance

 

The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.

More from Geography

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

New Era Begins In Korea: Policy Predictions For Biopharma

 
• By 

As South Korea's new president immediately gets to work on setting initial policies, essential drug supplies, R&D incentives and AI-driven digital healthcare are among the key topics in focus.

Aurobindo, MSN Fail To Beat US Nuplazid Patent Expiring In August 2038

 
• By 

Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.