On February 19, 2015, the ICH M8 electronic Common Technical Implementation Guide (eCTD IG) reached step 2b of the International Conference on Harmonization (ICH) process1. Pursuant to the process a draft technical document was issued. This document provides instructions on Continue reading
The European Medicines Agency’s (EMA) initiative to share Continue reading
The EMA has released a new finalized guideline called Similar Biological Medicinal Products which introduces the main concept of the “possibility for drug product developers to use comparators authorized outside the European Economic Area (EEA)” during clinical development of biosimilars.
The new guidance Continue reading
November 7, 2014. Another client has completed Learn@Regxia’s ICH GCP online training webinar, and we have received more great feedback! Continue reading
As part of Health Canada’s “ongoing efficiency measures and efforts to reduce regulatory burden on industry and transition to an electronic environment, … [Health Canada announced Continue reading
The International Generic Drug Regulators Pilot (IGDRP) was created in 2012 to promote collaboration and convergence in generic drug regulatory programs in order to Continue reading
July 24, 2014. Another client has completed Learn@Regxia’s ICH GCP online training webinar, and we have received more great feedback! “Wow, this Continue reading
The most relevant change in the new Revision of the Declaration relates to the rights of vulnerable people. Differently than in previous versions, specific groups are Continue reading
For the first time ever, the new revision of the Declaration of Helsinki makes explicit mention that Continue reading
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