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Higher costs headline list of new challenges faced by CROs and sponsors.

Cancer still a primary focus of EMA in light of COVID and vaccine development.


Europe's research ministers are will meet to attempt to reach agreement on European Union research plans for the next seven years, including a cluster devoted to a broad range of health goals that range from general objectives to subjects of more specific interest to the community.

The European Commission has concluded exploratory talks, with Moderna, over the purchase of a fifth potential vaccine against COVID-19.

The European Commission has concluded exploratory talks, with Moderna, over the purchase of a fifth potential vaccine against COVID-19.

Europe is aiming to improve its medium-term planning for citizens' health with an agenda that aims to "enable and leverage research and innovation in regulatory science."

EMA has launched a "communication perception survey" looking for honest views from among the widest audience on how well it is doing.

The search for a coronavirus vaccine is just one of many questions unanswered on European health policy.

Applied Clinical Trials
The balance is being sought in Europe data governance between private protection and public benefit-but has not yet been achieved.

Applied Clinical Trials
Europe’s additional monitoring scheme hasn't been a roaring success, according to a recent report.

Applied Clinical Trials
Peter O'Donnell writes of the European Commission's recently published reports suggesting that some of the gaps were being filled in registries in the field of rare diseases.

Applied Clinical Trials
New money is not going to solve problems when it comes to registries in Europe, Peter O'Donnell writes.

Applied Clinical Trials
Peter O'Donnell writes about Manfred Weber's announcement of what he called "his European Master Plan against Cancer" – with what he termed "a guarantee" for European citizens, taking political lobbying over health to a new level in Europe

Applied Clinical Trials
After taking a long awaited step forward in a rare treatment, the impatience of European patient organizations are understandable given the slow emergence of advanced medicines. Peter O'Donnell writes there is good news for patients - just not quite as good as they may have thought.

Applied Clinical Trials
Discussions on collaborative health technology assessment have been so intense over the last year that it might be thought that Brussels is the hub for HTA action. Peter O'Donnell writes how there is plenty going on elsewhere in Europe.

Regulatory Affairs Professionals Society's Executive Director, Paul Brooks, discusses the looming uncertainty about what will happen after the UK leaves the European Union as many important details remain unclear.

Applied Clinical Trials
Peter O’Donnell gauges the impact of FDA guidance on igniting the adaptive pathways debate in Europe.


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

Applied Clinical Trials
Peter O'Donnell discusses the EU's bid to improve the HTA and weighs in on a report made by Soledad Cabezón's.

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

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

Applied Clinical Trials
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.

Applied Clinical Trials
As concerns grow about the slow progress of advanced therapies, drug developers are pushing for action from European authorities.




