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Author Archives: Peter ODonnell
EU Questions Electromagnetic Radiation Limits
It is fashionable in many healthcare circles to denigrate the European Union for adopting a high-handed and inflexible approach to many of the complex issues that health policy is fated to cover. It is still more fashionable—indeed almost mandatory—to castigate the European Parliament, the EU’s self-styled representative of the people, for adopting an unrealistically cautious [...]
Posted in Regulatory Tagged electromagnetic radiation, European Parliament, European Union, MRI, Peter Liese, Peter O'Donnell Leave a comment
Happier New Year? Busier, Anyway
For those who—understandably—have better things to do with their time than study the inner workings of regulatory authorities, it may perhaps be helpful as another year opens to see at least a snapshot of what two of the principal authorities in the world consider as important upcoming business.
Posted in Regulatory Tagged EMA, european commission, London, New Year, Peter O'Donnell Leave a comment
Patients Lose Patience
One of Europe’s most energetic patient organizations, Eurordis, is leaving no-one in doubt about how tolerant it is of the continuing discussions on revising the clinical trials directive. Not very tolerant at all.
Its European Public Affairs Officer, Flaminia Macchia, offered a spirited view of these lengthy debates at a recent meeting in the European Parliament.
Posted in Regulatory Tagged EU, Eurordis, Flaminia Macchia, patients, Peter O'Donnell, Regulatory Leave a comment
What to Do With So Much Money?
It is, on the face of it, paradoxical that as Europe suffers its worst economic and financial crisis for generations, almost every week brings announcements of further public money available for research–and particularly for health research.
Early in November, European Health Commissioner John Dalli unveiled proposals for a seven-year health program for the European Union, explicitly [...]
Posted in Regulatory Tagged budget, EU, financial crisis, healthcare, Innovative Medicines Initiative, JOhn Dalli, money, Peter O'Donnell Leave a comment
Europe’s CT-Drain Gathers Pace
It is not just at the level of macro-economics that the European Union is having a hard time these days. New evidence continues to emerge of a decline in the relative strength of Europe as a pharmaceutical power, too. The Belgian pharmaceutical industry has just emitted a wail of anguish at the fall-off in clinical [...]
Posted in Regulatory Tagged Belgian, CT, developing countries, Eastern Europe, EU, Europe, Peter O'Donnell, pharma.be, Poland Leave a comment
A Manifesto from Rasi
Papam habemus. After nearly a year’s delay, the European Medicines Agency at last has an executive director. Guido Rasi has been installed, and Europe—and the world—waits to see what he is going to do.
But it is already possible to make more than an inspired guess. He set out his ambitions in a little-studied document earlier [...]
Posted in Regulatory Tagged EMA, EU, European Medicines Agency, Guido Rasi, Manifesto, Peter O'Donnell, Regulatory Leave a comment
Advertising Industry’s European Woes
October will see the relaunch of a longstanding European battle—over what sort of information patients should get about prescription medicines. Like many European battles, this one has a long history, pitting companies’ championing of their products against campaigners fears of unbridled direct-to-consumer advertising. The explosive cocktail of debate has been made all the more volatile [...]
Posted in Regulatory Tagged EPHA, EU, Europe, European Medicines Agency, European Public Health Alliance, JOhn Dalli, Peter O'Donnell, Regulatory Leave a comment
Spin-offs from Spin-offs
The Protean capacity of the pharmaceutical industrial and academic complex to adapt and reinvent itself is one of the defining characteristics of the last 20 years. From mergers to spin-offs, from acquisitions to new partnerships, the constantly shifting kaleidoscope of pharma intelligence is a monument to unfailing initiative and energy.
Alongside industry and academia, a whole [...]
Posted in Regulatory Tagged biotech, EU, HIV/AIDS, partnerships, patients, Peter O'Donnell, pharma, Protean capacity, R&D, Regulatory, spin-offs, subjects 1 Comment
How Much Transparency is too much Transparency?
Europe’s bid to become-whiter-than-white in terms of disclosure of pharmaceutical data to the world outside is running into snags. It’s a long story—driven over the years by strong demands from health activist lobbies, academics, patient associations, and even just ordinary relatives of ordinary patients in cases where medication appears to have done more harm than [...]
Lessons for World CTs from European Medical Device Failings