European Biosafety Association

Current Consultations

EMEA

Web survey on EudraCT database

Following changes to the European legislation EMEA is now able to make public some of the information in the EudraCT database which contains information on clinical trials in Europe. The set of data that will be made available has been set out in guidelines published by the European Commission.

We are interested in knowing which aspects of this information are of most interest, how people might use this information and how they will want to access it. This research will help us to design a website appropriate for the needs of the public and other interested parties. We would very much appreciate it if you could please complete our very short web survey in order to help us with our research.

This survey is available under the following web page:
http://www.surveymonkey.com/s.aspx?sm=EjMAd5n47EcrXy7leGgSMw_3d_3d

Contact: Iskren Kirilov Todorov
Medical Information Sector
European Medicines Agency (EMEA)
7 Westferry Circus, Canary Wharf
London E14 4HB - United Kingdom
Tel: (44 20) 75 23 7757
Fax: (44 20) 75 23 7129
E-mail:

(posted 09.06.23) 

EMEA

The European Medicines Agency (EMEA) has published a concept paper ‘ON IMMUNOGENICITY ASSESSMENT OF MONOCLONAL ANTIBODIES INTENDED FOR IN VIVO CLINICAL USE' (EMEA/CHMP/BMWP/114720/2009). The document is available here:

http://www.emea.europa.eu/pdfs/human/biosimilar/11472009en.pdf

The aim of this concept paper is to ensure a more rational and systematic approach to unwanted immunogenicity assessment, investigation and prediction for this large class of biologicals by industry, academia and regulators.

Please provide any comments you may have on this concept paper to , by using this template:

http://www.emea.europa.eu/pdfs/human/regaffair/submitcomment.doc

Please note that the deadline for submitting comments is 30th of June 2009 .

(posted 09.04.08)