Dear Dr. Granzer, dear members of the DGRA management  board, ladies and gentlemen, dear friends!

When in February this year Mrs Friederike Sträter informed me that the board of the DGRA had decided to award the Walter Cyran Medal to me I didn’t know what to say at first, and so I asked for a moment’s time to think it over. After all  I was well aware of the fact that up to now this medal has been awarded to public personalities who have rendered outstanding services, both nationally and internationally, to the rules governing medicinal products, like Prof. Alexandre, Dr. Feiden, Dr. Ernst and Dr. Lumpkin. Would I be in a position to take my place in this phalanx of distinguished colleagues?

I eventually agreed because my activities in the regulatory sector of biologicals have for the past 20 years been inseparably connected to the Paul-Ehrlich-Institut, that is, to the close  and absolutely essential cooperation with my colleagues and the strong support I had from my superiors. In a word, I’m looking at my  distinction in this wider context of cooperation and mutual support, which  requires me to also emphasize the excellent coordination with my colleagues at the European Medicines Agency, in particular its Biologicals Unit, and the European Network of Official Medicines Control Laboratories.

To be precise, my involvement with the European Union drug regulatory institutions began in 1986, when the safety concerns of biologicals derived from blood suddenly exploded, when the first monoclonal antibodies appeared on the licensing agenda and when it became indispensable to develop harmonized guidelines for the successful outcome of community marketing authorisation procedures for biologicals.  Thus, 20 years ago, Prof. Löwer and myself started our European activities in the Biotechnology/Pharmacy Working Party of the former CPMP. Only recently, in February this year, we enjoyed the opportunity to celebrate the 20th anniversary of this extremely efficient working party and to look back on the success we managed to achieve with our guidelines, e.g. for the production and quality control of a variety of biotech products, human plasma derived products as well as for virus safety and TSE. As to my professional career Dr. Granzer kindly gave you some further details.

Finally, I would not want to forget to mention the enormous freedom of manoeuvre that I have been granted by Prof. Kurth and Prof. Löwer since 1995 on behalf of the Paul-Ehrlich-Institut and its role in London with the European Medicines Agency. There is ample reason to believe that eventually it has been possible to meet their expectations in the form of about 50 rapporteurships for a surprising and rapidly increasing number of biologicals, the chairing membership of various working groups and before all the respected reputation of our institute  in the EU as a Centre of Excellence.

Let me close by repeating my personal gratitude for the award. I am also expressing my best wishes to the DGRA for any conceivable success in its various sectors of activity.

Preisträger Cyran-Medaille Dr. Manfred Haase