Division Safety of Medicinal Products and Medical Devices
The division is responsible for all pharmacovigilance aspects of medicinal products for human and veterinary use which fall within the competence of the Paul-Ehrlich-Institut (PEI). The division’s work involves the identification, investigation and assessment of risks and the evaluation of the benefit/risk profile of biomedicines. The aim of this monitoring is to identify risks at an early stage in order to initiate proportionate risk minimisation measures –both nationally and EU-wide. In addition to the safety of medicinal products (pharmacovigilance), the division coordinates the approval of clinical trials and is responsible for providing legal advice. Experts from the division represent the PEI on the relevant committees and working parties of the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA), the European Commission (EC).
The unit coordinates and ensures the quality of regulatory and supports the head of the division in her role as a representative on the relevant EMA committees.
It is developing the first physiologically based toxicokinetic model (PBTK model) for the description of aluminium exposure from poorly soluble aluminium adjuvants. PLANS, initiates and conducts surveillance and pharmacoepidemiological studies to monitor the risk profile of a medicinal product even after it has been authorised.
Pharmacovigilance I unit
The unit assesses and records cases of suspected adverse reactions to vaccines, antibody-containing medicinal products and test and therapy allergens. It conducts scientific investigations into the risks of medicinal products, orders risk minimisation measures and coordinates actions to prevent risks. The unit provides information to national and international competent bodies and works closely with the EMA. The unit assesses reports before and after the authorisation and is involved in the assessment of national and centralised marketing authorisation applications. A further duty is to investigate counterfeit medicinal products and to initiate and coordinate the necessary measures.
Pharmacovigilance II unit
The unit assesses the safety of blood products, blood components, tissue and cell preparations, and advanced therapy medicinal products (ATMPs). In addition, the unit investigates reports on the use of high-risk class D in vitro diagnostic devices, such as HIV tests. The unit’s experts review the deficiencies found, order re-evaluation studies and advise the competent state authorities on the measures required. The unit is involved in marketing authorisation or approval of blood products and ATMPs – and conducts scientific investigations into adverse drug reactions.
Pharmacovigilance of Veterinary Immunological Products and Animal Welfare unit
The unit records and assesses suspected adverse reactions to animal vaccines and immunological medicinal products for veterinary use. The aim of this monitoring – which is carried out by means of signal detection and the assessment of periodic safety reports – is to identify medicinal product risks, to investigate them scientifically and to initiate measures to minimise the risks of veterinary medical products. The unit advises the various sections on safety issues relating to veterinary medicinal products and works closely with the EMA.
Legal Affairs unit
The unit advises on legal issues relating to medicinal products, animal health and medical devices. The unit's legal experts are actively involved in the further development of the legal foundations for the regulation of biological and immunological medicinal products by reviewing and authoring opinions on draft laws and European legislation. The unit is involved in the issuing of administrative decisions – in particular with regard to risk and hazard prevention measures and deals with court proceedings.
Clinical Trials unit
The unit coordinates and administers applications for the approval of clinical trials. It assesses the applications in terms of both form and content in collaboration with the authorising sections – and provides advice to applicants (sponsors) during and after the application process. The unit’s experts process the annual reports on the safety and results of clinical trials. The unit is also responsible for the administration of the European Clinical Trials Database (EudraCT), the Voluntary Harmonisation Procedure (VHP).