Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2579252 | Thérapie | 2010 | 8 Pages |
Abstract
The recommended changes could be made within the scope of a European Regulation, avoiding the need to transpose it at a later date into each country's regulations, which is a source of possible lack of harmonisation. More specifically, for trials with institutional sponsors and/or investigator driven trials such as “drug therapy strategy trials”, modulating restrictions according to the “risk added by the research” would enable the trial's organisation to be simplified regarding monitoring, adverse reactions reporting and study drugs labelling.
Related Topics
Health Sciences
Pharmacology, Toxicology and Pharmaceutical Science
Pharmacology, Toxicology and Pharmaceutics (General)
Authors
Pascal Bilbault, Chantal Belorgey, Faiez Zannad, Danielle Golinelli, Yannick Pletan,