Speakers
Dr Stephan Kiessig
Dr Birgit Reipert
Dr Manuela Leitner
Dr Dorothea Stahl
Target Group
This workshop is designed for persons from
Research and Development
Manufacturing
Marketing Authorisation
Authorities
dealing with recombinant factors.
Programme
Pre-conference Workshop on Recombinant Factors, 18 April 2016
Immunology of F.VIII
Overview on Factor VIII deficiencies
How factor VIII is seen by the immune system
Epitope recognition by antibodies
Epitope, neotope, cryptotope
Dr Stephan Kiessig
From bench to bedside - monitoring evolving FVIII inhibitors
Neutralizing antibodies against FVIII as the major complication in the replacement therapy of haemophilia A patients with FVIII products
Current understanding of the root cause for the development of FVIII inhibitors
Novel approaches to monitor evolving FVIII inhibitors in patients
Dr Birgit Reipert
Regulatory experiences with recombinant coagulation factors – Quality issues
Different types of coagulation factors – full-length, domain-deleted, fused
Testing issues
Adventitious agents
Dr Manuela Leitner
Assessing, managing and evolving safety and efficacy of coagulation factors
Aspects of Regulatory Science
Aspects of Clinical Medicine
Aspects of Health Services Research
Dr Dorothea Stahl
Panel Discussion
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This course is part of the GMP Certification Programme "ECA Certified Regulatory Affairs Manager"
Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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