Columns | View from Brussels

Peter O’Donnell explores the convergence of policy and science in new vaccine R&D pursuits in Europe.

Relocating the European Medicines Agency was always going to be hard-but no-one ever expected it to degenerate into farce.

Peter O’Donnell weighs the varying views in Europe on the risks of going the adaptive pathways route for drug approval.

Peter O’Donnell looks at efforts in Europe to improve R&D communication and trust with investors and the public.

With the literal toss of a coin officially sending the EMA to Amsterdam post-Brexit, it's worth reflecting on what might have been if the decision went differently.

Collaboration focuses on the use of a digital toolset in medication management and patient engagement during studies.

New safety review of epilespy treatment puts spotlight on issues such as communication between regulators and prescribers.

The European Health Data Network (EHDN) initiative kicks off-a challenging and resource-intensive effort designed to harmonize data analysis and conversion amid the push toward outcomes-focused healthcare in Europe.

Several projects in works illustrate the importance of those unsung heroes in Europe's R&D engine room.

Is the much anticipated Europe action plan on personalized medicines, unveiled recently by an EU-sponsored international consortium, worth paying a close eye on?

Europe is issuing a significant update to its ethical guidelines governing health-related research involving humans.

Q&A explores the evolution and challenges of new technology implementation in clinical trials.

With bidding starting to intensify among member states, several factors will determine the EMA’s next home.

New actions underway seek to find a consensus on the role of HTAs in the decision-making chain, including with clinical trials.

The discussion on the main characteristics and implementation of the new Clinical Trials Regulation is heating up in Europe.

A look at the EMA’s proposed guidance revisions for first-in-human studies.

Janssen releases key findings from its pilot study evaluating the use of electronic informed consent technology in clinical trials.

Renewed attention on ways to tackle this age-old scourge is building in Europe and beyond.

European forum tackles the problem of limited elderly patients involved in clinical trials.

New policy hopes to calm the fervor around clinical trial data disclosure and confidentiality issues.

Incoherencies in Europe’s drug-access arrangements raise questions, debate.

Despite orphan-drug R&D and approval being all the rage, issues such as patient access could leave these treatments out in the rain.

Several initiatives are focused on integrating biomarkers and personalized medicine techniques into studies.

Officials tackle such areas as early diagnosis and treatment, patient access, and personalized medicine

The tone of agency’s annual report contrasts its recent candid stance on regulatory vision for Europe

Patients in Europe have been increasingly vocal in their demands for engagement in drug development and regulatory processes-and they have been increasingly effective.

Novel Approach May Help to Prevent False Positive Cardiac Safety Findings in New Drug Development

Technology-Amplified dCRO Model Accelerating Personalized Approach to Targeted Therapies, Including Greater Collaboration, Higher Data Quality, and Reduced Development Costs

Camargo Pharmaceutical Services is adding expertise to its projects and helping postdoctoral researchers gain real-world experience through a unique internship program.