REGULATORY AFFAIRS

—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

—Submission of substantial amendments

—Reporting of suspected unexpected serious adverse reactions (SUSAR)

—Submission of annual safety report to CA and EC

—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