The Safety of Biomedicines and Diagnostics Division is responsible for all safety aspects of vaccines and other biomedicines for human use. The division's tasks include scientific and regulatory activities related to the detection, analysis, evaluation, understanding, and prevention of adverse effects or other aspects of biomedicines related to safety. Other tasks involve monitoring vaccines and biomedicines throughout the life cycle via inspections related to clinical trials, pharmacovigilance, and the plasma master file certification scheme. In the field of in vitro diagnostic medical devices (IVDs), the product safety of high-risk Class D IVDs is monitored for the safety of blood preparations such as screening tests for human immunodeficiency virus (HIV). The Legal Affairs Section advises on legal issues relating to medicines safety and also provides cross-institutional advice on questions of pharmaceutical, animal health and medical device law. The Data Science and Methods Section supports all divisions of the Paul-Ehrlich-Institut (PEI) with mathematical, statistical and pharmacometric expertise.
In order to play an active role both nationally and in the EU network of regulatory authorities, the division's experts are represented on relevant committees and working groups of the committees at the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA), the European Commission (EC), the European Directorate for the Quality of Medicines & HealthCare (EDQM), the World Health Organization (WHO), and a large number of national expert committees.
This section evaluates and registers suspected adverse drug reactions to vaccines, medicinal products containing antibodies, and test and therapy allergens. Its experts analyse medicinal product risks and orders and coordinates measures for risk aversion and prevention. The Pharmacovigilance Section designs and initiates scientific studies in order to gather further information for the understanding of potential pharmacotoxicological risks or to analyse the pharmacoepidemiological backgrounds and relationships of safety signals and drug therapy or vaccination. The section provides information to both national and international competent authorities and works closely with EMA committees. The experts evaluate reports on safety in clinical trials prior to authorisation and are involved in the evaluation and processing of risk management plans within authorisation applications. Post-authorisation monitoring of vaccine and biomedicine safety is carried out via evaluations of periodic safety reports and the updated risk management plans. Another section task is identifying counterfeit medicines and initiating and coordinating necessary measures to ensure the safety of authorised vaccines and therapeutics.
This section evaluates and monitors the safety of blood products, blood components, tissue preparations, and cell preparations (blood, tissue, and cells, BTC) as well as advanced therapy medicinal products (ATMPs) in Germany and Europe. In addition, it examines and monitors reports on the use of high-risk class D in vitro diagnostic medical devices (IVDs), such as HIV tests. The experts review IVD defects and advise federal authorities on any necessary measures. The section is also responsible for evaluating the safety of blood products and ATMPs in the context of European authorisation or approval procedures, and it analyses adverse drug reactions using scientific methods.
This section is responsible for carrying out and coordinating all inspections in the Paul-Ehrlich-Institut's remit. Inspectors lead and accompany Good Clinical Practice (GCP) inspections in the context of national and European authorisation procedures, inspections of pharmacovigilance systems, and inspections within the European plasma master file certification procedure. To ensure compliance with national and European standards, the Paul-Ehrlich-Institut inspects facilities worldwide (e.g. investigators’ facilities, clinics, sponsors, pharmaceutical companies, blood and plasma donation facilities, laboratories).
The section also coordinates all inspections in which the Paul-Ehrlich-Institut participates, including the participation of Paul-Ehrlich-Institut colleagues as experts in inspections conducted prior to federal state authorities granting manufacturing permits.
This section provides cross-divisional advice on all questions related to pharmaceutical, animal health and medical device law. The lawyers in the Legal Affairs Section actively participate in the continued development of the legal basis for the regulation of biomedicines for human use and immunological veterinary medicinal products by examining and drafting opinions on draft laws of national and European legislation. This section participates in the issuance of administrative acts, in particular those involving risk prevention and security measures, and is involved in appeal and court proceedings.
This section supports all divisions of the Paul-Ehrlich-Institut with mathematical, statistical, and pharmacometric expertise. The section's work includes predominantly regulatory tasks, such as providing scientific and regulatory advice to drug developers, and the statistical and pharmacometric evaluation of clinical trial applications (CTIS) and dossiers for paediatric investigation plans, marketing authorisations as well as variations or amendments. Evaluations are primarily focussed on examining the study designs and evaluation methods for clinical data, including pharmacological and pharmacodynamic aspects. The section also supports the evaluation of quality aspects, assists in the statistical evaluation of validation studies in batch testing, and advises on research questions. Experts from this section also represent the Paul-Ehrlich-Institut in working groups of EMA committees, – in particular the Scientific Advice Working Party (SAWP) and the Methodology Working Party (MWP), as well as in working groups of the EDQM.
The Data Science and Methods Section is involved in a number of regulatory and methodological research projects. These projects concern areas such as novel clinical study designs (including platform studies), improved study designs for vaccines and monoclonal antibodies to combat antibiotic-resistant germs, the application of artificial intelligence (AI) in regulation, and modelling and simulation approaches to the risk assessment of active substances and excipients (e.g. physiologically-based toxicokinetic modelling for adjuvants containing aluminium).
Updated: 05.12.2023
