Evaluation form Regulatory Affairs workshop 17 October 2024

This was the first edition of the workshop. We aimed to cover the starting principles and introduce the topic of regulatory affairs, and to give a few starting points to help you pave a path towards market approval. We would like to know how we did. We can only improve if you give us feedback!




1. Content of the Regulatory Affairs workshop




Knowledge level BEFORE the workshop:

1. Regulatory affairs in general
Scale 1 = no knowledge at all, 3 = some knowledge (knew about the existence of the topic, but nothing about use or implementation) and 5 = complete understanding of topic.
2. Target Product Profile
Scale 1 = no knowledge at all, 3 = some knowledge (knew about the existence of the topic, but nothing about use or implementation) and 5 = complete understanding of topic.
3. Quality Target Product Profile
Scale 1 = no knowledge at all, 3 = some knowledge (knew about the existence of the topic, but nothing about use or implementation) and 5 = complete understanding of topic.
4. Pediatric Investigation Plan
Scale 1 = no knowledge at all, 3 = some knowledge (knew about the existence of the topic, but nothing about use or implementation) and 5 = complete understanding of topic.
5. Platform Technologies
Scale 1 = no knowledge at all, 3 = some knowledge (knew about the existence of the topic, but nothing about use or implementation) and 5 = complete understanding of topic.

Knowledge level AFTER the workshop:

1. Regulatory affairs in general
Scale 1 = no knowledge at all, 3 = some knowledge (knew about the existence of the topic, but nothing about use or implementation) and 5 = complete understanding of topic.
2. Target Product Profile
Scale 1 = no knowledge at all, 3 = some knowledge (knew about the existence of the topic, but nothing about use or implementation) and 5 = complete understanding of topic.
3. Quality Target Product Profile
Scale 1 = no knowledge at all, 3 = some knowledge (knew about the existence of the topic, but nothing about use or implementation) and 5 = complete understanding of topic.
4. Pediatric Investigation Plan
Scale 1 = no knowledge at all, 3 = some knowledge (knew about the existence of the topic, but nothing about use or implementation) and 5 = complete understanding of topic.
5. Platform Technologies
Scale 1 = no knowledge at all, 3 = some knowledge (knew about the existence of the topic, but nothing about use or implementation) and 5 = complete understanding of topic.

2. What topic(s) did you find most interesting or useful to hear about?


3. What topics were you missing in this first edition?


4. What topics would you like to see covered in a next edition?


5. Did the workshop impact your clinical development in any way?

Examples can be: implementing a TPP and/or QTPP, altered timeline for PIP submission or altered plan, different outlook on how to streamline your development / assembling a team covering diverse topics, etc:

6. If you attended online, was the sound and video quality sufficient?


7. Any other remarks about the content or the organization of the workshop?

Contact

For questions or comments related to DARE-NL or oncological ATMPs, to become a partner or connect for information

contact us at info@dare-nl.nl.

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