In June 2017 ISDB Committee members and other bulletins interested, participated in a workshop on clinical study reports (CSRs). This two day workshop was organized by the Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care, IQWIG) in Cologne, Germany. Beate Wieseler and her colleagues lectured about the framework of these CSRs and we could also practice what we had learned. The participants were very enthusiastic about this experience and the Committee discussed how we could further develop our knowledge. Interestingly, the Cochrane Collaboration was also working on this topic and the Committee and interested members gave input to their proposal on the guidance for including CSR’s in their reviews. On the Cochrane Collaboration’s website the following information was shared (http://community.cochrane.org/ news/request-comments-draftinterim-guidance-how-decidewhether-incorporate-clinical-studyreports-and-other-regulatorydocuments-cochrane-reviews).
Nuria Homedes We have been working hard. Two years ago, we divided Bulletin Farmacos in four bulletins. Due to the large amount of information that is emerging and the interests of our Spanish readership, one of the bulletins has been dedicated to Ethics and Clinical trials. The other bulletins are devoted to Pharmacovigilance and Appropriate use, Access and Economics, Regulatory Agencies and Policies. Consequently, we have increased the number of translations into Spanish from English and French sources.
Paris, 28 November 2017
Prescrire, along with around 20 civil society organisations, has signed a joint declaration drawing attention to potential problems posed by the provision of confidential scientific advice by the European Medicines Agency to pharmaceutical companies, especially a decline in regulatory standards, a risk of institutional capture, and a total lack of transparency surrounding the activity of European regulatory authorities.
Brussels, 8 September 2017
33 civil society organisations, including Prescrire, acting together in the name of responsible pharmaceutial research and affordable medicines, called for the European Commission to abolish the mechanism of supplementary protection certificates (SPCs).