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Innovation Office

Photo Collage Innovation Office (Source: A. Buck / PEI)

The Innovation Office of the Paul-Ehrlich-Institut (PEI) provides procedural and scientific advice to support the development of new medicines and innovative concepts. A special focus is placed on advanced therapy medicinal products (ATMP) and new innovative products.

Patients and society as a whole benefit from innovation in medicines and therapies. To foster the development of medicinal products with high unmet medical need, the Innovation Office actively supports innovators by offering different advice concepts.

On the following pages of the Innovation Office information regarding advice concepts offered by the PEI, regulatory guidance, details on advanced therapy medicinal products (ATMP), etc. is provided.

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Scientific and procedural advice

The PEI provides procedural and scientific advice for scientists from academia or other research institutions, as well as small and medium-sized enterprises (SMEs).

The Innovation Office is the contact point for procedural and scientific questions in terms of regulatory requirements during the development of biomedicines. The aim is to early support the pharmaceutical development based on a stepwise concept: a process-related advice ranging from drug discovery to first clinical use and subsequent licensing. Scientific aspects related to quality, non-clinic and clinic are discussed in accordance with the corresponding regulatory framework.

Scientific and procedural advice at different stages of product development

Figure: Advice at different stages of development. Figure: Advice at different stages of development.Figure: Advice at different stages of development. Source: PEI

  1. Therapy concept
  2. Manufacturing process
  3. Non-clinical development
  4. Clinical development
  5. National authorisation
  6. With a view to a centralised marketing authorisation

Any Questions? Just call the Innovation Office


* Bettina Ziegele is delegated to the Federal Ministry of Health (BMG)

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