EU: Donate Your Data

Source: http://pharmaviews.eu/donate-your-data/ Today is Organ Donation Day. Millions of European citizens have signed up to allow their organs to be used for transplantation after they die. My friend Miklós Szócska, former health minister of Hungary, suggested we...

EU: eConsent Considerations in Europe (11-Mar-2015)

eConsent Considerations in Europe  Legal Framework for eSignatures The eSignature Directive (Directive 1999/93/EC) establishes the legal framework at European level for electronic signatures and certification services. The aim is to make electronic signatures easier...

EMA: Revision 1 of EMA GVP Module VI (03-Nov-2014)

The long awaited revision of EMA GVP Module VI (Management and reporting of adverse reactions to medicinal products) has been released and became effective on 16-SEP-2014. Revisions include: Revisions in VI.A.2.1.1. (Causality), VI.A.2.4. (Seriousness), VI.B.1.2....

UK: NRES Website Closing Soon (14 Aug 2014)

The website of the National Research Ethics Service (NRES) site will be closing in a few weeks. The only areas that are maintained are the directory of Research Ethics Committees and the Research Summaries. The information previously found on the NRES website can now...