DANGERS:
Confusing new definitions, including that of ‘Low-intervention’ clinical trials, risk turning European citizens into guinea pigs without asking for prior consent.
Read Message to EU Parlament | Read Debunking
secrecy
myths
which
hinder
transparency


Read Message to EU Parlament | Read Debunking
secrecy
myths
which
hinder
transparency


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Introduction
Directive 2001 versus proposed new Regulation: throwing out the baby with the bathwater?
Dangerous change to the definition of a clinical trial “Low-intervention clinical trials”: caution is needed
Regrettably, the European Medicines Agency (EMA) is being turned into a mere provider of services to the pharmaceutical industry. Other strategies for funding that would help drug regulatory agencies to be more independent do exist. They should be carefully considered.
Submission of comments on 'Quality Review of Documents (QRD) human product information annotated template: revision of the product information - Draft' (EMA/468498/2012)