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BIOGENERIS (description)

"BIOGENERIS"

Category:Biotechnology
Address:The Harrington Hall Hotel London , , United Kingdom SW7
Phone:44 1483 570099
Event dates:2/22/2006 - 2/22/2006 (This event has already taken place)
Event web site:http://www.management-forum.co.uk/html/con_semin_s
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Management Forum Ltd

Speakers/Presenters:

Topics to be Covered:

  • Speakers at this one day forum will present on the specific aspects for the approach to the development of Similar Biological Medicinal Products in Europe. Presentations will include an update on the implication of the 2004 European Pharmaceutical legislation, the current understanding of the requirements and principles of physiochemical comparability testing, whether there is a requirements for pre-clinical
  • studies with all the classes of SBMPs and if clinical studies are indicated, their nature and scope and the part that statistics play in the design of these studies. In addition, a presentation will focus on the very contentious issue of immunogenicity with the meeting concluding with an update on the progress of the FDA to produce and issue guidelines for follow-on biologics in the USA
Contact:info@management-forum.co.uk
Organizer phone:44 1483 570099
Offering type:Seminar
Specialty:Medical Education
Event frequency:Every Year
First Meeting:
Total events:
Est. attendance:
Target audience:Any
Other target audiences:
Host Sponsor:
Est. # of exhibitors:
Currency:Euro
Language:English
CE Credits:
Organizer URLwww.management-forum.co.uk

Description:

Speakers at this one day forum will present on the specific aspects for the approach to the development of Similar Biological Medicinal Products in Europe. Presentations will include an update on the implication of the 2004 European Pharmaceutical legislation, the current understanding of the requirements and principles of physiochemical comparability testing, whether there is a requirements for pre-clinical; studies with all the classes of SBMPs and if clinical studies are indicated, their nature and scope and the part that statistics play in the design of these studies. In addition, a presentation will focus on the very contentious issue of immunogenicity with the meeting concluding with an update on the progress of the FDA to produce and issue guidelines for follow-on biologics in the USA

Schedule:

Registration Fee Details:

Other items that tuition includes:

Travel and hotel arrangements:

 
 
Contact Person:Barbara McManus / Leigh White
TitleHead of Business Development / Marketing Assistant
Contact Emailinfo@management-forum.co.uk
Organizer Address 148 Woodbridge Road
Organizer Address 2Guildford
Organizer CitySurrey
Organizer State/Province: (Outside US)
Organizer Zip or Postal CodeGU1 4RJ
Organizer CountryUnited Kingdom
Organizer Phone44 1483 570099
Organizer Fax44 1483 536424
Structural makeupOrganization
Event Site/VenueThe Harrington Hall Hotel, London
Event sold out?No
Multiple locations or dates?No
Statistics available for most recent event held in:NA
Average number in event attendance of:
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Number in attendance of:
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Target BoundariesLocal
Is Registration contact information the same as Organizer Contact above?Yes
Web Page
Can one register for your CE on your web site?Yes
E-mail registration:info@management-forum.co.uk
Can registration be made by snail (regular) mail?Yes
Online housing reservations: 
 
Do you have additional written or AV materials for sale?No
If so, are they available for non-attendees as well as those attending?NA
Is full tuition necessary to ensure registration?No
Will there be shuttle service available?NA

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