EMA’s initiative to enhance cooperation on generics is expanded to include regulators from outside the EU

The European Medicines Agency’s (EMA) initiative to share agency assessments reports, aims to facilitate the timely authorization and availability of safe, effective and high quality generic medicines in support of the International Generic Drug Regulators Pilot (IGDRP), and has now expanded to include regulatory agencies worldwide.

The IGDRP was created in 2012 to Continue reading

The Informed Consent Process and the changes introduced to the Declaration of Helsinki in 2013. Part 3 of 5

Declaration of HelsinkiPart 3: Vulnerable Persons and Consent

Another distinctive modification in this new revision is the expansion of considerations on vulnerable populations and their needs of specifically considered protection according to the case.

With respect to the Informed Consent Process, the Declaration preserves the essential principle that Continue reading