PAUL-EHRLICH-INSTITUT (PEI) BUNDESINSTITUT FÜR IMPFSTOFFE UND BIOMEDIZINISCHE ARZNEIMITTEL
The Paul-Ehrlich-Institut (PEI) is a National Competent Authority. Its duties include the approval of clinical trials and the licensing of marketing authorizations of medicinal products, provision of scientific advice and research in the area of drug development, quality and efficacy of medicines and innovative clinical trial designs.
The Section Biostatistics as the main contributor to EU-PEARL is involved in all mentioned activities at the PEI with quantitative aspects and supports and conducts itself regulatory and methodological research.
Further personnel at PEI will provide input to other specific regulatory questions. Due to the varied nature of questions to be addressed (ranging from legal and regulatory over quality to clinical questions), this will be handled via centralized requests to Dr Hofner who will, in close collaboration with the Innovation Office at PEI, distribute the requests to relevant individuals or groups at the PEI.