Filing new submissions is a time consuming, laborious task for both industry and Regulators alike. The sheer size of each submission leads to costly time delays at every stage of the process. Using the eCTD has been proven to speed your data through the approval process, saving you valuable resources and time.
Global regulatory agencies are committed to implementing the eCTD as standard. Attend this practical 2-day course and ensure your applications are in the correct electronic format and style from the onset.
Christine Hirt is Director of the Regulatory Competence Center at EXTEDO and is responsible for regulatory business consulting. She has more than 10 years of experience in the field of Regulatory Affairs and worked for several pharmaceutical companies, most recently as Head of Regulatory Affairs, before she joined EXTEDO.
Karl-Heinz Loebel is Head of Regulatory Operations at PharmaLex. Having finished his studies in Chemistry at Heidelberg University, Germany, he joined a Biotech startup company as a Scientific Advisor and a Management Executive for several years. In early 2005 he joined PharmaLex International and was recently promoted to Head of Regulatory Operations.
What will you learn?
- Establish more efficient processes to build, publish and deliver your regulatory submissions
- Meet the challenges of adopting the eCTD on a global scale
- Clarify regulatory requirements and improve your agency communications
- Track and manage multiple agency submissions with effective life cycle management
- Identify the latest challenges presented by the new eCTD validation criteria
Who should attend?
Regulatory Affairs and Operations
- Dossier Management
- Document Management
- Data Management
- Electronic Publishing/ Submissions
- Global Project Management