Forum Update: Supporting Community-Led Discussion
The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.
Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:
- Correct any misunderstandings
- Provide guidance when questions remain unanswered after a few days
- Support discussions where official clarification is needed
Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.
Thank you for being part of the conversation.
Submission requirement for translation
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Hi. The company medical/regulatory staff needs to review the material prior to submission to PAAB. When the material was already approved in English (internally and by PAAB), is it mandatory for medical/regulatory staff to review the translation too? The translations are done and reviewed by certified translators.
Thank you -
Hi. The company medical/regulatory staff needs to review the material prior to submission to PAAB. When the material was already approved in English (internally and by PAAB), is it mandatory for medical/regulatory staff to review the translation too? The translations are done and reviewed by certified translators.
Thank youHi @Sil
No, it is not required that medical/regulatory staff review the translation. As a reminder, Code s.1.4G states “The sponsoring company shall be responsible for accuracy of translation of APS".
