BE: Update of the national eSubmission Guideline and corresponding NeeS checker

The Belgian Federal Agency for Medicines and Health Products (FAGG) has released an updated version 2.11 of the national eSubmission Guideline applicable for electronic...[mehr]

CMDh releases updated Best Practice Guide for the use of eCTD in MRP/DCP

The Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has released an updated revision 3 of the "Best Practice Guide on the Use of the...[mehr]

Updated national eSubmission guidance for Spain released

The Spanish Medicines Agency AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) has releases and updated version 2.1 of their national eSubmission guidance...[mehr]

2nd Intern. Workshop 'Regulatory Requirements and Current Scientific Aspects on the Preclinical and Clinical Investigation of DDIs'

The 2nd International Workshop on Regulatory Requirements and Current Scientific Aspects on the Preclinical and Clinical Investigation of Drug-Drug Interactions (DDIs) is taking...[mehr]