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EU Regulatory Network 'Competing With Google' For Tech & AI Experts

EMA Needs More Staff To Meet Its Goals

 
• By Ian Schofield

The European medicines network needs to quickly build up its capabilities in the area of data analysis and digital transformation, but finding the necessary staff is difficult in the face of stiff competition from both the pharmaceutical industry and the likes of Google and Facebook, according to the head of the Danish regulator. 

Finger pressing an interface with the text digital transformation. Concept of digitization of business processes. Composite between a photography and a 3D background
The EU regulatory network needs to boost its digital footprint • Source: Shutterstock

The European medicines regulatory network needs to up its game in the area of data analysis and digital health so that it can keep up with new developments in technology and “get at least on a par with the pharmaceutical industry, if not ahead,” says Thomas Senderovitz, director general of the Danish medicines agency.

“Regulators can’t be a bottleneck. This is not acceptable when it comes to new technology, because this will have a negative impact on patients if we can’t… evaluate new medicines...

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Scientists Work With AI To Uncover ‘Unexpected’ Drug Combos For Breast Cancer

 
• By Natasha Barrow

A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.

EMA Official Clarifies Benefits And Limitations Of Innovation Pathways

 
• By Eliza Slawther

A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

EU Emergency Response Authority Needs Bigger Budget To Address Health Threats, Says Industry

 
• By Eliza Slawther

The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

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China NMPA Lays Out Regulatory Priorities At DIA

 
• By Xu Hu

At this year’s DIA China meeting, the national regulator updated its policy focus areas for this year, including clinical trial data protection and pilot projects to shorten IND approval times.

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
• By Sarah Karlin-Smith

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.