Program Perspectives in Cell- and Gene-Based Medicines - DGTI
Program Perspectives in Cell- and Gene-Based Medicines - DGTI
Program Perspectives in Cell- and Gene-Based Medicines - DGTI
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Friday, March 16<br />
The Regulation of Advanced <strong>Cell</strong>ular Therapies<br />
3rd workshop: March 16, 2012, HZ 3<br />
Workshop “Regulatory aspects related to Advanced <strong>Cell</strong>ular Therapies” chaired by<br />
Ulrike Köhl (Frankfurt), Andrea Hauser (Regensburg) <strong>and</strong> Mart<strong>in</strong> Hildebr<strong>and</strong>t (München),<br />
<strong>in</strong>clud<strong>in</strong>g round table discussions with colleagues from European <strong>and</strong> national authorities,<br />
legal advisors <strong>and</strong> stakeholders from academic <strong>and</strong> <strong>in</strong>dustrial GMP facilities <strong>in</strong> the context<br />
of the EU-FP7 research project: “ACADEMIC GMP”.<br />
8:30 Registration<br />
Session 1: Introduction<br />
8:40 Welcome & <strong>in</strong>troduction to the project M. Hildebr<strong>and</strong>t, U. Köhl<br />
Session 2: Impact of regulations on advanced cellular therapies<br />
8:50 Regulatory l<strong>and</strong>scape <strong>in</strong> ATMPs S. Sethe (Newcastle, UK)<br />
9:10 Safety aspects O. Wildner (Langen, D)<br />
9:30 ATMPs – view of the local authorities I. Astner (Braunschweig, D)<br />
9:50 ATMPs – view of the national authorities R. Sanzenbacher (Langen, D)<br />
10:10 ATMPs – <strong>in</strong>ternational view P. Salmikangas (Hels<strong>in</strong>ki, SF)<br />
10:30 COFFEE BREAK<br />
11:00 Introduction participants round table discussion U. Köhl, M. Hildebr<strong>and</strong>t<br />
11:15 Round table discussion (S. Sethe, I.Astner, P. Salmikangas,<br />
R. Sanzenbacher, A. Hauser, A. Dick<strong>in</strong>son, O. Wildner)<br />
13:15 LUNCH + POSTER<br />
Session 3: Impact of rules on advanced cellular therapies<br />
14:00 Incentive for quality controls <strong>in</strong> cell-based therapies J. Oostendorp (Leiden, NL)<br />
14:10 New concepts <strong>in</strong> cl<strong>in</strong>ical trials M. Lowdell (London, UK)<br />
14:30 Ethics <strong>and</strong> regulation J. Namorado (Brussels, B)<br />
14:50 Application of regulation T. Tonn (Dresden, D)<br />
15:10 Introduction participants round table discussion A. Hauser, S. Sethe<br />
15:20 Round table discussion<br />
(M. Lowdell, J. Namorado, T. Tonn, S. Sched<strong>in</strong>g,<br />
M. Hildebr<strong>and</strong>t, P. Salmikangas, K. Pearce, J. Oostendorp, U. Köhl)<br />
16:00 Conclud<strong>in</strong>g remarks M. Hildebr<strong>and</strong>t, U. Köhl, A. Hauser<br />
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