Award for Merits in Pharmaceutical Quality, Safety, and Marketing Authorisations of Medicinal Product in Europe

Dr. Manfred Haase (right hand side) Source: DGRA

On Tuesday, 9 May 2006, Dr. Manfred Haase received the Walter Cyran Medal for his long and successful activities in the field of quality, safety, and marketing authorisations of medicinal products in Europe. Dr. Haase is the head of the Division of Bacteriology of the Paul-Ehrlich-Institut in Langen. He has been working in international bodies for the Paul-Ehrlich-Institut since 1986. The award was granted during the 2006 Annual Conference of the Deutsche Gesellschaft für Regulatory Affairs (German Association for Regulatory Affairs, DGRA). The DGRA has awarded this medal together with a certificate since 2002 for special merits in “Regulatory Affairs”.

In his laudatory speech, Dr. Ulrich Granzer, chairperson of the management board praised Dr. Haase as one of the key figures in regulatory affairs in biotechnology worldwide.

The President of the Paul-Ehrlich-Institut, Prof. Johannes Löwer explained: “I am very pleased that Manfred Haase has been given an award for his commitment to safety and quality of biological medicinal products throughout the decades, and as one of the first in regulatory affairs in Germany who showed his commitment at a European level”.

In 1986, Dr. Haase assumed his responsibilities as national representative for Germany in the working group known as Biotechnology Working Party (BWP) of the CPMP (Committee for Proprietary Medicinal Products) which, at that time, was still a body of the EU Commission. It was not until 1995 that the European Medicines Agency (EMEA) was founded of which the CPMP was part from then on. In February 2001, Dr. Haase was elected vice-chairman of the Biotechnology Working Party.

In his laudatory speech, Dr. Granzer explicitly indicated that Dr. Manfred Haase made important contributions to the development of major EU Guidelines, e.g. relating to the development and control of vaccines and monoclonal antibodies from blood. In addition, as Dr. Granzer emphasised, Dr. Haase was appointed rapporteur for a great number of new guidelines relating to the quality and safety of biological medicinal products both at the EMEA and at the WHO. Finally, he was a member of the “ICH Expert Working Group on Quality of Biotechnological Products” and EU rapporteur in the field of stability testing of biotechnological/biological medicinal products.

In May 1998, Dr. Haase was appointed chairman of the CPMP Working Group on Blood Products (BPWG). He is also chairman of the Paul-Ehrlich-Institut’s own EU committee. Last but not least, Dr. Haase is one of altogether five co-opted members of the CHMP (Committee for Human Medicinal Products), and is thus the Paul-Ehrlich-Institut’s representative of this important European body.

Information on previous award winners and on the medal can be found on the DGRA website.

Walter Cyran, after whom the medal was named, was born in Düsseldorf in 1907 and died in Tübingen in 2000. Together with Arno Kloesel, he was the founder and chief editor of the standard commentary on the German medicinal products legislation which is known as “Kloesel/Cyran”. This commentary also became known by a number of publications in the field of pharmacy and pharmaceutical law. Naming the honour’s award of the DGRA after Walter Cyran serves as recognition for his well remembered merits in pharmaceutical law.

A photo of the award ceremony can be obtained from the Press Office of the Paul-Ehrlich-Institut.

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