DGRA e.V. - PREISVERLEIHUNG 2007

Today is a first for us. For the first time we have the great pleasure to have our ceremony in the German Haus der Geschichte, the museum of contemporary history of Germany after the second World War. This museum is somewhat different to others as it includes new exhibits whenever they become important for our history and I should say that the definition of the word “important” is not always following the same definition by each and any visitor.

I hope that you all had the opportunity to visit the museum and spend some time with the milestones of our history.

I am sure, you all did enjoy it.

But now back to the German Association for Regulatory Affairs and the award of the Walter Cyran Medal

Today we would like to award the Walter Cyran Medal for the sixths time. As I am chairing the board of the DGRA I have the pleasure to speak to the honour of the new medallist.

The DGRA named this medal after Walter Cyran.
Walter Cyran was born in 1907 in the University City of Tübingen, the same place where he died in 2000. There he studied pharmacy and food chemistry.

After World War II he took over leading positions in the ministry of the interior of Württemberg-Hohenzollern, as it was called then and later on in the country of Baden-Württemberg. You see we have a rather young history as Federal Republic of Germany.
Dr Cyran held a professorship at the universities of Freiburg, Karlsruhe, and Tübingen and was a member of several gremia responsible for the development of a modern drug law. He became well known for his publications on pharmacy and drug legislation issues.

He was the founder and chief editor of the standard commentary on the German drug legislation, the “Kloesel/Cyran”. In a similar fashion he became known and famous for the “Cyran/Rotta”, a similarly important publication for the pharmacy legislation in Germany.
This together with several other important initiatives, work, publications I am not intending to list today led the German Association for Regulatory Affairs to name the medal after Walter Cyran.

This medal is awarded to honour persons for their outstanding merits in drug regulatory affairs.

The board of the German Association for Regulatory Affairs has decided to award this years Walter Cyran Medal to Dr. med. Rolf Bass, Professor for Pharmacology and Toxicology at the Charité in Berlin.

I met Prof Bass for the first time in 1990 as a rooky in regulatory affairs and was impressed by listening to him when he gave a lecture at a symposium on something called international regulatory affairs, at a time when we had a European regulatory system consisting of the national procedure, the multistate procedure and the concertation procedure, things, which were the predecessors of the current registration systems. Guidance documents like those derived from ICH did not yet exist and, actually only a few believed that international guidance or even something called global might ever exist. In addition, the EU was pretty small compared to now.

Rolf Bass is a German citizen. He was born in Berlin. He is married and has three children. Rolf Bass qualified as a physician in 1967. He holds a medical degree from the Free University of Berlin. Following postdoctoral work for three years at The Johns Hopkins University, with Prof. Albert L. Lehninger, whom most of us “know” because of his textbook on Biochemistry he did research in pharmacology, toxicology and clinical pharmacology at the Dept. of Toxicology and Prenatal Pharmacology of the Free University Berlin with Prof. Diether Neubert, where he was appointed Adjunct Professor in 1984. In 1998 Rolf Bass was awarded an honorary degree (FFPM hon) from the Faculty of Pharmaceutical Medicine of the three Royal Colleges of Medicine (Edinburgh, Glasgow and London) of the UK.

Rolf Bass joined the German Health Authority (BGA) as Head of the Pre-Clinical Department at its Drug Institute in 1979.
He became Chairman of CPMP´s Safety Working Party in 1984 where he was in charge of the pre-clinical ICH programme;
He created the tripartite ICH guideline on „Testing for Reproductive Toxicity“,
Furthermore, he was responsible for the development and implementation of European toxicological guidelines.
From 1995 to 2000 he was Head of the Human Medicines Evaluation Unit at the EMEA in London. In this function he was responsible for the development and the day to day business on medicines for human use. His tasks comprised of pre-approval aspects like scientific advice, and ICH-liaison, post-marketing issues like pharmacovigilance, variations or renewals, external contacts with the press, trade associations, health professionals and patient associations. In addition, he took an active role in the support of designated Central and Eastern European Countries Drug Regulatory Authorities (CADREAC) to prepare the accession of their respective countries to the European Union.
Following his term at the EMEA he returned to Germany in 2000.
Rolf Bass was given the task of managing the „Nachzulassung“ (re-registration).

In August 2000 he was appointed member to the CPMP, and set up the new Department for European and International Business of the Federal Institute for Drugs and Medical Devices (BfArM), first in Berlin and then in Bonn.
He officially retired from his position at the BfArM in mid-2006.

Rolf Bass has been chosen by the Polish Government to lead two EU-“Twinning projects” as Resident Twinning Advisor, whereby the Polish drug regulatory authorities received support and training to achieve and maintain EU-Standards.

There would be much more to say about the achievements of Rolf Bass, but I thought I should stop here.

The German Association for Regulatory Affairs today awards at the Haus der Geschichte in Bonn this years Walter Cyran Medal to Professor Dr Rolf Bass for his outstanding merits in Regulatory Affairs and, in particular, his international activities and achievements.