CRED ERP 25

Case Study 2

TOPRA CRED EU Procedures

A phase 3 clinical trial of Inductomor is being considered. A decision on the data package required to support a successful application has yet to be made.

Strategy development

Outline the regulatory strategy and practical considerations for this product in Europe including (but not limited to):

• • •

Product profile planning Procedure to be used Any meetings to be held

• Potential data gaps which need to be considered/addressed before filing • Legal basis for the application with consequence for potential data exclusivity • Data required for each of the Modules 1 to 5 • Safety considerations • Implications of the Paediatric regulation (EU Regulation 1901/2006, as amended) • HTA requirements

Practical considerations

Outline the practical considerations for the submission of Inductomor in Europe, including (but not limited to):

• •

Planning for any meetings

Identification of key stakeholders

• Document preparation for procedure chosen • Any assistance that might be available to TOPRAPharm • Timings for preparation of data for each of the Modules 1 to 5 • Dossier preparation • eCTD preparation • Consider procedure timings taking account of clock-stops, arbitration if applicable, answering questions, anticipation of potential questions/objections

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