Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticleseCTDGemma RobinsonHow-To & ExplainersPharmaceuticalSubmissions
How Do You Translate Your Non-EU Dossier For The EU Market?
The issues faced when translating a non-EU dossier for the EU market is covered in this blog by the CMC team at Acorn Regulatory.
Regulatory Affairs Masters Students Meet Acorn Regulatory Consultants
Students taking the Regulatory Affairs Masters degree in IT Carlow met with consultants from Acorn Regulatory at our offices recently. Last week the students welcomed two of our consultants as guest lecturers to the IT Carlow campus.
Most Read Pharmaceutical News Stories on AcornRegulatory.com in 2016
The team at Acorn Regulatory has been busy all year working with our global client base. Nevertheless, they have taken time to share their expertise on issues such as risk minimisation, the EU regulatory framework, the Periodic Safety Update Single Assessment...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticleseCTDFeatured NewsGemma RobinsonPharmacovigilance
Periodic Safety Update Single Assessment Updates
In December 2015, we published a pharmacovigilance article “Periodic Safety Update Single Assessment (PSUSA) – An Overview” which outlined the process the European Medicines Agency(EMA) take to monitor the safety of medicines in Europe. Periodic safety update reports (PSURs) are pharmacovigilance documents submitted...
DCP Applications To Be Accepted Only in eCTD format from July 1st 2015
Looking back on how far we have progressed from the standard paper submission one thing is clear – the age of the electronic common technical document is upon us. For instance, according to the eSubmission roadmap published, as of the 1st...