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Newsletters "UptoDate" of BASG/AGES MEA are published monthly and contain the latest articles from the last month (link to subscription page).
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reporting obligation regarding serious adverse events according to the AMG must be submitted to the BASG in advance. Forms Form: SUSAR Waiver (F_I437) | 62 KB Request for waiver for direct reporting of SUSARs [...] Update Report (DSUR)". For further details, please refer to Section 8 of the CT-3 Guideline and the BASG FAQ on this subject.
on of receipt will be sent from the BASG system PHAROS to the applicant. Confirmations of receipt from the e-mail system do not apply here. From this date the BASG will confirm that the notification is [...] Clinical investigations with medical devices Electronic Submission Form of the BASG General requirements for applications (technical validation) Clinical investigations according to Regulation (EU) 2017/745 [...] studies according to Directives 90/385/EEC, 93/42/EEC and 98/79/EC Electronic Submission Form of the BASG The electronic registration form is mandatory for a valid initial application a clinical investigation
ongoing procedures please contact for RMS applications rms@basg.gv.at for CMS applications basg-cms@basg.gv.at for purely national applications nat@basg.gv.at [...] to cesp@basg.gv.at, but not the accessible PDF/UA documents. These must be uploaded by the applicant in the eService after creation of the respective procedure(s) by the BASG. 3. Does the BASG check the [...] documents providing for accessibility were prepared by the BASG and can be found here on the website of the BASG. 8. Is it allowed to deviate from the BASG Templates and use a different font? You are free to
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