IDMP/SPOR is just around the corner. The EMA allows submissions via the EU-IRIS portal and more. This 2-day-course by Forum Institut will update you with the latest electronic submission requirements, including Variations Submission, via the PLM portal.

Topics include: :

• EU-IDMP Implementation Guide - Your current to-dos
• Electronic Submission - Using the EMA-IRIS Portal & CTIS
• Electronic Product Information
• Data Elements for the SPOR Database
• Variations Submission via PLM
• eCTD "hands-on" and Outlook on eCTD 4.0

After completing the course, you will be familiar with your to-dos in Regulatory Affairs and Pharmacovigilance, enabling you to professionalize your submission management further. You will know which data you need for IDMP/SPOR and have starting points for optimizing your Regulatory Information Management.

Frank Dickert, Senior Business Consultant RCC, will be one of the speakers. He will give a talk about "eCTD Requirements Outside the EU" and evaluate the critical differences in other ICH and non-ICH regions." He will also contribute to "eCTD "Hands-On" - Common Issues in Dossier Creation and Potential Validation Problems" where - in a practical exercise - validation errors and eCTD import issues are analyzed. Furthermore, EU Module 1 Specifications will be discussed, product dossiers and transitioning to eCTD in the lifecycle, and an overview of eCTD 4.0 in Europe.

Use the following link for your registration and receive a 10% discount on the ticket price: https://www.forum-institut.de/seminar/23112601-esubmission-ihre-to-dos-2023/168/N/0/161850/1c28083

 

Who should participate? This course is intended for all professionals and managers involved in electronically submitting regulatory and vigilance-related documents or those responsible for overseeing regulatory databases.

Specifically, employees from the Medical Affairs, Regulatory Affairs, and Pharmacovigilance departments are encouraged to participate in the knowledge exchange.

 

 

 

 

 

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