Update on Regulations Surrounding CNS in Europe: BfArM session on Optimising Clinical Development for CNS
Dr. Karl Broich, Vice President, BfArM, will discuss the new regulatory landscape as well as projected amendments to the current guidance documents on CNS clinical trials at Optimising Clinical Development for CNS conference, 15th-16th February 2011 in London.
Despite being the second largest therapeutic segment on the planet and having the fastest growth rate, the global central nervous system (CNS) market faces several challenges. According to URCH Publishing, the market value was forecast to expand to US$63.9 billion (£40 billion) by the end of 2010, but researchers and organisations are experiencing difficulties when it comes to conducting clinical trials, specifically when complying with new suicidality regulation imposed by the US Food and Drug Administration (FDA).
Dr. Karl Broich will discuss the current regulations (e.g. developing benefit-risk management plans), explain the current guidance document updates and proposals, and explain what are acceptable biomarkers from a regulator’s point of view and highlighting the data that is needed to support a biomarker.
Other key conference speakers include:
- Karl Broich, Department Head, BfArM
- Joakim Tedroff, Head of Clinical Science, NeuroSearch
- Babak Boroojerdi, Head of Therapeutics Area,Neurology, Global Projects and Developments, UCB
- Johannes Streffer, Director, Experimental Medicine Europe, Janssen Research & Development
- Jeppe Klint Buchbjerg, Clinical Pharmacology Scientist, Lundbeck
- Dr. Gvido Cebers, Principal Scientist, Global Safety Assessment, AstraZeneca
- Yves Auberson, Head of Chemistry, Neuroscience and PET Imaging, Novartis
- Dr. Wolfgang Eglmeier, Head Clinical Operations Germany, Grünenthal GmbH
Optimising Clinical Development in CNS is co-located with Optimising Clinical Development in Oncology as a part of Clinical Trials Summit. To see the final speaker line-up, please visit www.clinicalcns.com or www.oncologysummit.co.uk