Transcription of Guideline Immunogenicity Assessment Therapeutic Proteins ...
{{id}} {{{paragraph}}}
Example: dental hygienist
Guideline Immunogenicity Assessment Therapeutic Proteins ...
30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 18 May 2017 EMEA/CHMP/BMWP/14327/2006 Rev 1 Committee for Medicinal Products for Human Use (CHMP) Guideline on Immunogenicity Assessment of Therapeutic Proteins Draft revision agreed by Biosimilar Medicinal Products Working Party (BMWP) August 2015 Adopted by CHMP for release for consultation 24 September 2015 Start of public consultation 01 October 2015 End of consultation (deadline for comments) 31 January 2016 Agreed by Biosimilar Medicinal Products Working Party (BMWP) November 2016 Adopted by CHMP 18 May 2017 Date of coming into effect 01 December 2017 This Guideline replaces Guideline on Immunogenicity Assessment of biotechnology-derived Therapeutic Proteins ( EMEA/CHMP/BMWP/14327/2006).
Guideline on Immunogenicity assessment of therapeutic proteins . Draft revision agreed by Biosimilar Medicinal Products Working Party (BMWP) ... selection of tools and effectiveness indicators (Rev 2) (EMA/204715/2012 Rev 2* ) (EU-GVP Module XVI) ... If the product is indicated for the pediatric population, clinical studies are usually expected ...
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: