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National Advice

National Advice at the Paul-Ehrlich-Institut (PEI)

Based on the requirements for medicinal products with regard to quality, efficacy, safety, and environmental risk assessment, early interaction with regulatory bodies fosters the translation of research findings into products and product development. Therefore the PEI provides early scientific advice and regulatory guidance to promote efficient translation of basic research findings into new treatment approaches.

Since August 2018 the Innovation Office at the Paul-Ehrlich-Institut organizes and coordinates the national advice meetings for all products within the scope of the institute.

Scientific and procedural advice

The aim of an advice at PEI is to support the pharmaceutical development as early as possible. For this reason we provide tailor-made scientific and procedural advice meetings which are specific for the developmental phase of the respective product - ranging from drug discovery to the non-clinical stage, and finally first clinical use and subsequent licensing. Scientific aspects related to quality, non-clinic and clinic are discussed with regard to the corresponding regulatory framework. The advice meetings can focus on either one area or a combination of areas depending on the need of the applicant.

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

Advice Concept

Any questions? Just call the Innovation Office:

Innovation Office

Phone: +49 6103 77 2772


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