Dialogue goes into a second round: German Medicines Manufacturers´ Association (BAH) meets PEI

Last year, members of the German Medicines Manufacturers´ Association (BAH) met PEI experts for the first time at the PEI in Langen, Hesse. The PEI has now established a successful discussion format for a goal-oriented exchange with the various interest groups: in preparation of the event, the guests submit questions which are answered at the meeting in the form of a presentation followed by a discussion. "We are very pleased that with the German Medicines Manufacturers´ Association, another important player in the development of biomedicines is interested in an exchange with us. It is our concern to address important aspects of regulation at all stages of drug development so that the development of urgently needed innovative therapies can progress rapidly," said Professor Stefan Vieths, Vice President of the Paul-Ehrlich-Institut, explaining the motivation of the PEI.

The development of biomedicines is booming – while the number of applications for clinical trials for drugs with chemically defined active substances (small molecules) is decreasing, the number of applications for clinical trials for biomedicines continues to increase. The interest in advice on this group of medicines is correspondingly high. The PEI provides consultation on quality, non-clinical study concepts and clinical trials in humans from the development of the active substance to national scientific advice.

Topics addressed at the meeting were the management of medicines safety monitoring for active substances which are subject to additional monitoring (signal management in the EudraVigilance data system), reporting requirements and the establishment of medicine supply in the context of shortages. One subject of the meeting was the supply of flu vaccines. Questions on certain groups of medicines were also discussed, including the question of the substitutability of immunoglobulins.