It is a challenge to keep up-to-date with the details of the EU Regulatory Telematics environment. Besides electronic Common Technical Document (eCTD), many other eSubmission projects are ongoing, including: electronic Application Form (eAF), Common European Submission Plaform (CESP), the EMA Gateway, eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD), ISO Identification of a Medicinal Product (IDMP), SPOR Master Data Management project and electronic Product Information (ePI).
This course will explain the history, current state and outlook of these Telematics projects and impact on Industry. Moreover, it will provide insight on the latest developments, from direct interactions with EMA and National Competent Authorities (NCAs).With all these developments and ongoing activities, this course becomes a 3x3 hour online class and bring you up-to-date with all you need to know with regards to the roadmap and strategy of eSubmission and what you have to consider from an organizational point of view for your company. If you're responsible for Regulatory Affairs, you might not have the time or resources to be aware of all developments, changes and update on the Telematics roadmap and impact on processes within your organization. To get up-to-date, this course will put the attention on what are the issues to think about for getting ready, including possible Regulatory Information Management (RIM) solutions and company requirements.