Asphalion is happy to announce that it has been certified by Health Canada to perform electronic submission by the Gateway.
The first results with the first vaccinated patients are quite optimistic and the discussion on the phase II clinical trial was productive, setting the foundations for this second part of the project.
As part of the European Medicines Agency strategy to reinforce regulatory support and improve timely access to medicines, a new scheme will be launched in Q1 2016 to further support development of new medicines addressing major public health needs.
If you have a project that falls under the eligibility criteria for Horizon 2020 Programme, Asphalion is available to provide you with our regulatory expertise.
We are very pleased to have participated in this charity project where the main objective has been to help recover Nepal after the earthquake in April 2015.
The phased wise implementation of ISO IDMP will probably mean first submission of data end 2017 or 2018.
However, this is depending on the finalisation of the ISO standards
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.