Date
- Monday, 25 July 2011, All day
Location
- European Medicines Agency, Amsterdam, the Netherlands
A transatlantic two-day workshop co-chaired with the United States Food and Drug Administration (FDA) on drug-related progressive multifocal leukoencephalopathy (PML).
Documents
Workshop proceedings - Transatlantic workshop on drug-related progressive multifocal leukoencephalopathy (PML)
English (EN) (177.1 KB - PDF)
Programme - Transatlantic workshop: Drug-related progressive multifocal leukoencephalopathy (PML)
English (EN) (111.71 KB - PDF)
Invitation for expressions of interest - Transatlantic workshop: drug-related progressive multifocal leukoencephalopathy (PML)
English (EN) (38.32 KB - PDF)
List of participants - Transatlantic workshop: Drug-related Progressive Multifocal Leukoencephalopathy (PML)
English (EN) (143.57 KB - PDF)
Presentation - Welcome, PML - Balancing risks and benefits - the patients' view, Christoph Thalheim
English (EN) (2.06 MB - PDF)
Presentation - The possible mechanisms of the disease, Eugene Major
English (EN) (584.15 KB - PDF)
Presentation - The outcomes of drug-induced PML, Joseph Berger
English (EN) (730.43 KB - PDF)
Presentation - Natalizumab (Tysabri) and PML - the current figures, Brigitte Keller-Stanislawski
English (EN) (302.71 KB - PDF)
Presentation - The relationship between PML-rituximab and other immunobiologicals: an overview, Renaud Du Pasquier
English (EN) (471.83 KB - PDF)
Presentation - The risk in transplanted patients, Marco Tuccori
English (EN) (286.38 KB - PDF)
Presentation - Activities in USA, the experience of FDA Neurology Division, Russel Katz
English (EN) (85.71 KB - PDF)
Presentation - PML: Risk communication in the EU, Rafe Suvarna
English (EN) (401.22 KB - PDF)
Presentation - Changes in the incidence of PML in Tysabri-treated patiens, Alice Hughes
English (EN) (128.35 KB - PDF)
Presentation - A common case definition for PML, Dirk Mentzer
English (EN) (192.64 KB - PDF)
Presentation - The Italian natalizumab registry, G. Tedeschi
English (EN) (434.47 KB - PDF)
Presentation - The TYSEDMUS Study, Christian Confavreux
English (EN) (751.35 KB - PDF)
Presentation - Industry Experience with PML, Carmen Bozic
English (EN) (193.7 KB - PDF)
Presentation - Development of models for testing possible treatments, Igor Koralnik
English (EN) (1.87 MB - PDF)
Presentation - Discovery and development of PML treatments, Teresa Compton
English (EN) (516.37 KB - PDF)
Presentation - Evidence about plasma exchange in natalizumab related PML, Ralf Gold
English (EN) (2.46 MB - PDF)
Presentation - Immune Reconstitution Inflammatory Syndrome, Joseph Berger
English (EN) (1.22 MB - PDF)
Presentation - PML development, Heinz Wiendl
English (EN) (1019.16 KB - PDF)
Presentation - Diagnosing PML, Joseph Berger
English (EN) (1.63 MB - PDF)
Presentation - Viral subtypes and the development of the disease: what is the evidence, Igor Koralnik
English (EN) (3.75 MB - PDF)
Presentation - The research in the field: Where to progress?, Eugene Major
English (EN) (295.37 KB - PDF)
Presentation - Regulators initiative, research agenda, Ana Hidalgo
English (EN) (299.34 KB - PDF)
Presentation - Research Agendas, Eugene Major
English (EN) (270.76 KB - PDF)
Presentation - The Interface of Academia and Clinical Practice, Joseph Berger
English (EN) (288.89 KB - PDF)
Presentation - PML consortium - industry, Susan Goelz
English (EN) (229.23 KB - PDF)
Presentation - Challenges and opportunities from public private partnerships, Richard Bergstrà¶m
English (EN) (442.6 KB - PDF)
Presentation - The importance of clarity in relationships and transparency, Henry FItt
English (EN) (256.69 KB - PDF)
Presentation - Drug Safety Surveillance Initiatives, Gerald Dal Pan
English (EN) (188.64 KB - PDF)
Presentation - How to facilitate the communicationsdata exchange, Janice Soreth
English (EN) (1.1 MB - PDF)
Presentation - Public funding of research - EU perspective, Stefanie Prilla
English (EN) (141.04 KB - PDF)
Presentation - Public funding of research - US, Eugene Major
English (EN) (591.5 KB - PDF)
Presentation - The role of the pharmaceutical industry, Sophie Banzet
English (EN) (45.68 KB - PDF)
Presentation - Public Private Partnerships as funders, Hugh Laverty
English (EN) (739.34 KB - PDF)
Presentation - EU Regulators perspective, Peter Arlett
English (EN) (14.4 KB - PDF)
Presentation - US Regulators perspective, Russell Katz
English (EN) (23.58 KB - PDF)
Presentation - Industry PML consortium view, Sophie Banzet
English (EN) (23.08 KB - PDF)
Presentation - PML London Clinical Researchers perspective, Igor Koralnik
English (EN) (86.12 KB - PDF)
Presentation - Benefits of Public Health, Eugene Major
English (EN) (33.23 KB - PDF)
Presentation - Discussion 'progress for the benefit of public health', Ralf Gold
English (EN) (51.94 KB - PDF)
Presentation - What patients and caregivers want to happen now - priorities for action, Christoph Thalheim
English (EN) (451.47 KB - PDF)
Presentation - PML Final Conclusions, Peter Arlett
English (EN) (25.79 KB - PDF)