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2nd Annual Biopharmaceuticals Meeting

What currently matters for Biopharmaceuticals in Europe

Date: 02-03 February 2012

Location: Freiburg, Germany

Following the particularly well received first workshop in 2011 concentrating on the product class of monoclonal antibodies it was a great pleasure to hold the 2nd Annual Biopharmaceuticals Workshop in 2012, with participants from the last year as well as new attendees. We invited colleagues again to meet each other, to exchange ideas, share experiences and listen to talks covering topics of highest current interest and importance. This was the second EUCRAF annual workshop and due to the overwhelmingly positive feedback we got after the first in 2011, we stayed with Freiburg as the location.

Session 1 of the 2012 Workshop was dedicated to the changing regulatory environment. We covered the previous years' news relevant for the European environment; the upcoming European Pharmacovigilance legislation; the status of biosimilars; the increase in manufacturing changes; formulation and dosage forms changes in the EU and U.S.; the current status of adventitious virus risk assessment; the current and future considerations on the clinical trial authorization; clinical trials with ATMPs in the EU and requirements for authorization of biopharmaceuticals in Japan and China.

Session 2 was dedicated to the science and strategy of development of innovative biopharmaceuticals. Here we presented current experience with personalised medicine developments; potential regulatory pathways taking into account the European HTA requirements and news from the ICH S6 guideline revision process.

With this mixture of regulatory and scientific themes we not only wanted to reach specialists from agencies and industry involved in the approval of new biopharmaceuticals but also those who define the relevant strategy and development programme.

Under programme you will see our detailed agenda. The workshop was organized in the Hotel Novotel am Konzerthaus and the social event at the end of the first day, at the famous Old Guild House (Historisches Kaufhaus).