Module 6

04 October 2024

Early Dialogue – Business Pipeline meeting (1)

• Platform for an overarching dialogue regarding medicine pipelines • Initiated by large pharmaceutical companies • Guidance on the optimal approach to develop and submit their product portfolio • Topics: multiple comparable products, regulatory pathways, regulatory/legal issues, PIPs, regulatory aspects, non-SA topics • Enable EMA to make informed decisions about its activities and work plan

5-year analysis of Oncology BPM

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An Agency perspective: the success and failure of a medicinal product in the EU

Classified as public by the European Medicines Agency

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Early Dialogue – Business Pipeline meeting (2)

• Targeted therapy, • Companion Diagnostics • Institutional collaboration • Trial design • Regulatory pathways • Guidelines In Oncology Most commonlydiscussedtopics in Oncology:

Moleculardevelopmentis the common denominator

19 An Agency perspective: the success and failure of a medicinal product in the EU

Classified as public by the European Medicines Agency

19

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