18th January 2010
T. Hinz (Section Head Therapeutic Vaccines) from the Paul Ehrlich Institute (Langen, Germany) presented at CIMT 2009 news. He has kindly provided us with his presentation ´Regulatory Environment for Therapeutic Vaccines´. You can download it here.17th December 2009
The CI3 Partner CIMT filed an official comment on the FDA draft ´Clinical considerations for Therapeutic Cancer Vaccines´. This FDA guidance document discusses considerations common to early and late phase clinical trials specific for therapeutic cancer vaccines.FDA draft document (FDA-2009-D-0427)
RRG comment
Visit the FDA site for the FDA draft guideline document.
Read all comments on this guideline
5th June 2009
RRG hosted a main session at the annual CIMT Meeting 2009 and will continue to do so in 2010.7th July 2008
RRG filed a comment on the implementation of the ‘Advanced Therapies’ Regulation (EC) No. 1394/2007 during the public consultation period with 198 stakeholders supporting it.Download the RRG comment.
