The active dialogue between developers of medicines and the experts responsible for the marketing authorisation of medicines contributes to the steady advancement of the development, marketing authorisation, and testing of medicines and ensures that the individual phases of this advancement interlock in a continued and timely manner. "We are pleased to see that the BAH is now also seeking the dialogue with us"
, said Professor Klaus Chichutek, president of the Paul-Ehrlich-Institut (PEI). The first talk between the BAH and the PEI took place on 9 October 2018 at the PEI.
Eighteen participants from nine companies and one blood donation centre followed the invitation by the PEI to ask questions and discuss matters concerning quite a variety of different subjects. These included practical questions on electronic submissions of marketing authorisation documents, experiences with the voluntary harmonisation procedure for clinical trials in Europe, and collaborations and options for further improvements at a national and international level. Another important subject was the forthcoming Brexit in April 2019: Which effects on the pharmaceutical sector are to be expected, and which preparations are appropriate?
Talks between PEI and BAH
Source: PEI
Innovative adaptive study designs in clinical trials were also in the focus of the talks: Hardly any meetings are currently taking place between industry and the regulators at which this subject is not being discussed. Clinical trials involve the testing of safety and efficacy of medicines in humans. A study design prepared in the preliminary phase exactly defines how the clinical trial should be performed in concrete terms, and which parameters should be recorded. The purpose of these new designs is to render the development process of the innovative therapies more flexible, thus speeding it up – without putting the safety of the patients at risk. An extensive exchange of ideas took place on this subject addressing a great number of important details.
Besides, the magic subject of "big data" was on the agenda: More and more data are captured, also by the patients themselves on mobile devices to an increasing extent. Which role could such data play in future for the marketing authorisation, or else the monitoring of medicines on the market?
The new series of talks with the BAH forms part of an initiative by the PEI to make all pharmaceutical companies in the field of biomedicine familiar with the regulatory requirements of marketing authorisations as early and extensively as possible.
Updated: 11.10.2018
