EMEA sets out priorities for 2009 with a focus on transparency
This article was originally published in SRA
Plans are under way to reorganise the European Medicines Agency in an effort to increase efficiency and ensure greater accountability of personnel associated with various processes concerning medicines for human use1.
You may also be interested in...
The International Pharmaceutical Regulators Programme has documented various approaches currently being used for the clinical comparability of biosimilar monoclonal antibodies in different jurisdictions.
Remote inspections are here to stay, and global regulators are aligning efforts to develop consensus on how these should be conducted.
Device companies operating in Canada are being advised to review their internal procedures in anticipation of new postmarket requirements that come into force this year.