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Qdossier presenting at TOPRA Autumn Introductory Course 2021
2 November 2021 - 5 November 2021
This is an excellent course taught by experts with real-life practical knowledge and experience in regulatory affairs. This course will strengthen your knowledge of EU regulatory procedures and regulatory requirements for marketing approvals.
We will be covering the following topics* in this course:
Common Technical Document Module 1:
Administrative Information & Prescribing Information
• Introduction to CTD
• Overview of Module 1
• Type of application (including abridged applications)
• Summary of Product Characteristics (SmPC)
• Application form including appendices
• PIL user testing
• EU regional requirements
Speaker: Marloes van der Geer
• Regulatory guidance leading to eCTD
• Prerequisites for proper eCTD usage
• Other e-submission initiatives including PIM
• EVMPD and IDMP
Speaker: Hans van Bruggen
*Please note that these are pre-recorded sessions.
For more information, click here.