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Programme

Thursday, 2 February 2012

09.00 - 10.00:

Registration and welcome coffee

10.00 - 10.15:

Welcome of the Meeting 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, 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 remark