March 13, 2012: session 1 – session 4 | 9:30 – 17:30 hrs
09:00 – 10:30 hrs | SESSION 1: KEYNOTE SESSION
Industry Update, P. Perreault, PPTA Global Chairman
Evolution of clinical use of plasma protein therapies – 2007-2011, P. Robert, The Marketing Research Bureau
11:00 – 12:30 hrs | SESSION 2: FINANCIAL PRESSURES FACING THE INDUSTRY
How is the pharmaceutical sector? R. Bergström, EFPIA
SWOT for the plasma protein industry in 2012, R. Waeger, Consultant
US State developments, B. Speir, PPTA
14:00 – 15:30 hrs | Session 3: INTERNATIONAL SNAPSHOTS
Latin America, the patients role, R. Anido de Pena, Primary Immunodeficiency Association, Argentina
Fractionation in India and the Sub Continent, K.V. Subramaniam, Reliance Life Sciences
Iran: collecting high quality plasma for fractionation, M. Cheraghali, Iranian Blood Transfusion Organization
16:00 – 17:30 hrs | SESSION 4: Regulatory : EU US REGULATORY DEVELOPMENTS: IS THERE A CHANCE FOR HARMONISATION
EMA: current priorities EMA roadmap, new pharmacovigilance legislation, J.G. Burgos, European Medicines Agency
FDA: recent developments, G. Michaud, FDA/CBER
EU US collaboration and information sharing, G. Silvester, European Medicines Agency
Panel discussion: EU US collaboration – regulators’ objectives and industry aspirations
March 14, 2012: session 5 – session 7 | 9:00 – 16:00 hrs
09:00 – 10:30 hrs | SESSION 5: HEALTH TECHNOLOGY ASSESSMENTS AND RARE DISEASES
HTAs & chronic rare diseases – compatible? K. Tolley, Tolley Health Economics Ltd
Clinical and scientific evidence, A. Farrugia, PPTA
Swedish experience: the story so far, B. O’Mahony, Irish Haemophilia Society
11:00 – 12:30 hrs | SESSION 6: PLASMA – SPOTLIGHT ON…THE DONOR!
Demographic development: the impact of safe blood supply?, M. Greinacher, University of Greifswald
The Czech experience, M. Maly, UNICAplasma
The continuing evolution of a most peculiar medicine – where next for labile blood products? W. Murphy, Irish Blood Transfusion Service
Cholesterol Levels in Plasma Donors, M. Rosa-Bray, Grifols Plasma
14:00 – 16:00 hrs | SESSION 7: ESTABLISHED PRODUCTS, NEW INDICATIONS, GREAT FUTURE
Tolerisation as a route to prophylactic treatment of severe haemophilia, G. Auerswald, Klinikum Bremen-Mitte
Immunomodulation in Neurology, S. Misbah, John Radcliffe Hospital, Oxford
CIDP and other autoimmune neuropathies: The role of IVIg, M. Sturzenegger, University Clinic Bern
Alzheimer Disease: Future of IG use, J. Kerr, Paul-Ehrlich-Institut