The European Commission and Heads of Medicines Agency have agreed with the phased wise implementation of ISO IDMP.
Would you like to know what they agreed?
Our Regulatory Information Director, Remco Munnik, attended the IWG group meeting on ISO IDMP at EMA.
With more than 20 years of experience in the European regulatory environment, our speakers will present the important steps for setting the strategy for successful European submissions.
Starting this autumn, the EMA will ask CPs Applicants to send clinical information from your registration dossier eCTD format. These new requirements are part of the Transparency Policy (Policy/0070).
Last July EMA started a pilot phase to provide MAH’s a new service of medical literature searches (mandatory task for authorized products, according to pharmacovigilance legislation).
EUCRAF provides the opportunity of a specialized education in the area of biopharmaceutical-related regulatory affairs
The complete course presents the regulatory environment for the pharmaceutical industry along with numerous directives, regulations and guidelines.
EMA offers Gateway user organisations the possibility to test the receipt of the 3rd acknowledgment in the External Compliance Testing environment as of 1 July 2015
ASPHALION has been working for 10 years in biotech projects and has become one of the leading regulatory services companies for Biologicals and Advanced Therapy Medicinal Products.
The alliance allows to effectively manage submission content, mitigate compliance risk and bring products to market faster.
As from 16 February 2015, the use of the web application for electronic entry of the Summary of Product Characteristics and Patient Information Leaflet is mandatory.