VAXXIUM

REGULATORY AFFAIRS

VAXXIUM provides regulatory affairs expertise through an internal Qualified Person, and constant monitoring/evaluation of the risk/benefit ratio of the product.

01.STUDY SETUP

EMA Scientific advice
Peadiatric strategy - Preparation and submission of Peadiatric investigation plan including waiver or deferral
Risk management plan
For non EU based companies, need to have a Legal representative based in the EEA
EudraCT number and application
Submission of the CTA to competent authorities and Ethics committee
Responses to questions issued during the review process including update of the dossier

02.STUDY CONDUCT

Submission of substantial amendments
Reporting of suspected unexpected serious adverse reactions (SUSAR)
Submission of annual safety report to CA and EC

03.STUDY CLOSE-OUT

End of trial declaration
Submission of final study report within 12 month of the global date of 'end of trial' for clinical
study involving adults and within six months of the 'end of trial' for paediatric trials
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