• Application of dossier sections and dossier components
• Product sections and possible pathways to defining products depending on its role in the clinical trial (IMP, AxMP) and marketing authorization status
• IMPD-Q only clinical trial application concept to support a separate sponsor trial application
• Management of responses to RFIs, withdrawal, or resubmission of an application
• Management of substantial and non-substantial modifications in practice

At the conclusion of this activity, participants should be able to:

• Learn best practices for managing applications in the CTIS, helping to avoid withdrawals or lapses in your clinical trials, and saving valuable time and resources.
• Gain a comprehensive understanding of the application functionalities, allowing you to harness the full potential of this system to streamline your processes.
• Discover the intricacies of document submission, including which documents should be submitted and the main rules governing this process. Ensure compliance and efficiency in your trials.
• Experience hands-on live system demonstrations under the guidance of our experienced trainers. Walk away with practical skills that you can implement immediately.
• Understand the application dossier components
• Know the different alternatives to add and define unauthorized and authorized medicinal product(s) in the application dossier
• Use the procedures of responses to RFIs or withdrawal for applications under evaluation
• Describe the principles for subsequent non-substantial modifications and substantial modification applications for relevant business situations