2nd Annual EUCRAF Workshop

What currently matters for Biophamaceuticals in Europe

Date: 02-03 February 2012

Location: Freiburg i. Breisgau

Following the particularly well received first workshop in 2011 concentrating on the product class of monoclonal antibodies it is a great pleasure to announce the programme of the second annual EUCRAF workshop. We would like to invite you to Freiburg again to meet colleagues to exchange ideas, share experiences and listen to talks covering topics of highest current interest and importance. This will be the second EUCRAF annual workshop and due to the overwhelmingly positive feedback we got after the first in 2011, we thought we stay with Freiburg as the location. Sounds as an invitation to the Freiburg biopharma summit to be scheduled regularly into your coming years' agenda!

Session 1 of the 2012 Workshop is dedicated to the changing regulatory environment. We cover the last 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 is dedicated to the science and strategy of development of innovative biopharmaceuticals. Here we present 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 want 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.

Agenda

Thursday, 2 February 2012

09.00 - 10.00 Registration and welcome coffee

10.00 - 10.15 Welcome of the Workshop Chair

Session 1: Changing Regulatory Environment

10.15 - 11.15: Ilona Reischl, AGES: Clinical trials for biopharmaceuticals in the EU - experience with the VHP, numbers, challenges and changes and overview on the review of the legislation

11.15 - 12.00: Edward Geissler, Regensburg University Medical Centre: The ONE study as an example for daily practice in ATMP research - clinical research on a new somatic cell concept in renal organ transplantation

12.00 - 12.45: Christian Schneider, Danish Medicines Agency: Follow-up on activities related to the guideline on biosimilar monoclonal antibodies

13.45 - 14.45: Monika Pietrek, Pietrek Associates: Impact of the new Pharmacovigilance Legislation on Biopharmaceuticals - procedures, processes, impact

14.45 - 15.45: Johannes Löwer, President IABS: Don't forget them! Risks associated with virus contaminations

16.15 - 17.00: Steffen Gross, PEI: Introducing changes in the manufacture - nowadays common but also easy? The current practice for an assessor

17.00 - 17.45: Lois Hinman, Novartis: Experience with the regulatory landscape in the EU and U.S. for the introduction of new formulations and new dosage forms

17.45 - 18.15: Q&A on CMC variations

19.00 Networking Dinner

Friday, 3 February 2012

08.15 - 09.00 Welcome to Day 2 with breakfast

Session 1: Changing Regulatory Environment

09.00 - 10.00: Gopalan Narayanan, MHRA: A regular day-to-day schedule in the life of a European regulator - news, typical practical issues and concerns to deal with and wish list to industry

10.30 - 11.30: Tetsuya Tanimoto, Cancer Institute Jaopan, Japanese Foundation for Cancer Research, Japan: Recent trends in the regulatory practice of authorizing biopharmaceuticals in Japan

11.30 - 12.30: Martina Schwinger, Novartis: Requirements of authorization of biopharmaceuticals in China

Session 2: Science and Strategy of Development

13.30 - 14.15: Jennifer Sims, Novartis: Current scientific considerations in the preclinical development of biopharmaceuticals in 2012 following the news from the ICH S6 guideline revision process

14.15 - 15.15: Anja Langeneckert, F. Hoffmann-La Roche: Personalised medicine to deliver innovations of the future - what is the focus in development and what are the scientific and regulatory challenges?

15.30 - 16.30:Jan Müller-Berghaus, PEI: Potential future regulatory pathways taking into account the European HTA requirements

16.30 - 16.45: Johannes Löwer, President IABS & Gabriele Dallmann, EUCRAF: Wrap-up and concluding remarks

Interested to receive more information? Send your email to anita.dioszegi@eucraf.eu
Phone: +49 (0)761 13734424