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Quotes |
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"I am leaving with a wealth of information. Thank you!" K. Antilla, Immune Deficiency Foundation (United States) "An interesting, enjoyable and beneficial event" L. Warren, Alpha One Foundation (Ireland) "As a first time attendee, the meeting was fantastic!" M. Kevani, KOA Eng. (Iran) |
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Day
One –
Tuesday 4
March 2008
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09:00
- 10:15
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Session
1: Keynote Session
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09:00
- 09:25
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Immunoglobulin,
treatment of Alzheimers?
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Dr.
Norman Relkin, Weill Cornell Medical College [download presentation]
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09:25
- 09:45
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09:45
- 10:10
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State
of the Industry
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Mr.
Larry Guiheen, Chairman PPTA Global [download presentation]
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10:10
- 10:45
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BREAK
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10:45
- 12:30
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Session
2: Self-Sufficiency – can we depend on our neighbours?
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10:45
- 11:00
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Welcome
and introduction
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CHAIR:
Ms. Julie Birkofer
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|
11:00
- 11:25
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Challenges
of contract fractionation
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Mr.
Jan Bult, PPTA [download presentation]
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11:25
- 11:50
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11:50
- 12:15
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To
fractionate or not to fractionate: experience from Australia
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Prof.
Albert Farrugia, Therapeutic Goods Agency [download presentation]
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12:15
- 12:30
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Discussion
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12:30
- 14:00
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LUNCH
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14:00
- 16:00
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Session
3: Regulatory – what’s up in Europe?
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14:00
- 14:10
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Welcome
and introduction
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CHAIR: Dr.
Jean-Marc Spieser, EDQM
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14:10
- 14:30
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Variations
– the new European Commission proposal and how it would
relate to plasma products
|
Dr.
Anneliese Hilger, Paul-Ehrlich-Institut [download presentation]
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14:30
- 14:50
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Variations
– is there hope for relief?
|
Dr.
Reiner Laske, CSL Behring [download presentation]
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14:50
– 15:10
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Existing
and emerging pathogens
|
Dr.
Johannes Blümel, Biotech Working Party [download presentation]
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15:10
– 15:30
|
Clinical
evaluation: the Blood Products Working Party
|
Prof.
Rainer Seitz, Paul-Ehrlich-Institut [download presentation]
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15:30
- 16:00
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Discussion
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16:00
- 16:30
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BREAK
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16:30
- 18:00
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Session
4: Quality
in the 21st century
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16:30
- 16:40
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Welcome
and Introduction
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CHAIR:
Dr. Ilka von Hoegen, PPTA
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16:40
– 17:00
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Principles
of the GMP
|
Dr.
Rudolf Bliem, University of Vienna [download presentation]
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17:00
- 17:20
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Regulator’s
perspective on GMP regulation
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Mr.
Francisco Peñaranda, EMEA [download presentation]
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17:20
- 17:50
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Manufacturer’s
perspective & experience on GMP regulation
|
Dr.
Georg Göstl, Baxter BioScience [download presentation]
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17:50
- 18:10
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ICH
– risk and science based approach
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Dr.
Mark Weinstein, FDA [download presentation]
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18:10
- 18:30
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Discussion
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19:00
|
Bus
leaves Sheraton Hotel to Technical University Warsaw
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19:30
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Hilfenhaus
Award and Cocktail Reception, Technical University
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20:00
- 22:30
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Dinner,
Technical University
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22:30
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Bus
leaves Technical University to Sheraton Hotel
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Day
Two – Wednesday 5 March 2008
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|
08:30
-10:00
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Session
5: Availability of plasma for fractionation in the future
|
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08:30
- 08:40
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Welcome
and introduction
|
CHAIR:
Mag. Rudolf Meixner, Humanplasma
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08:40
- 09:00
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Impact
of the new blood transfusion developments and availability of
recovered plasma
|
Mr.
Martin Bezdekovsky, Fenwal [download presentation]
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09:00
- 09:20
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Source Plasma Collection: Overview
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Mr. Josh Penrod, PPTA Source
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09:20
- 09:40
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Epidemiology
|
Dr.
George Schreiber, WESTAT [download presentation]
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09:40
- 10:00
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Discussion
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|
10:00
– 10:30
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BREAK
|
|
10:30
- 12:00
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Session
6: Health Policy – how can the EU make a difference?
|
|
10:30
- 10:40
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Welcome
and introduction
|
CHAIR:
Dr. Peter Pustoslemsek, Biotest
|
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10:40
- 11:00
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Current
European patient access issues
|
Mr.
Brian O’Mahony, Irish Haemophilia Society [download presentation]
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|
11:00
- 11:20
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Report
on communicable diseases in Europe
|
Dr.
Andrew Amato-Gauci, ECDC [download presentation]
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|
11:20
- 11:40
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European
Commission view
|
Dr.
Karl Freese, European Commission [download presentation]
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11:40
- 12:00
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EPPOSI:
a European platform for patients, science and industry
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Mr.
Giovanni Asta, Epposi [download presentation]
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|
12:00
- 12:30
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Discussion
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|
12:30
– 14:00
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LUNCH
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|
14:00
- 16:00
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Session
7: Established products, new indications, great future
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14:00
- 14:10
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Welcome
and introduction
|
CHAIR:
Mr. Ad Veldhuizen, EHC
|
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14:10
- 14:30
|
Living
with haemophilia: the need for access to a choice of factor
concentrates
|
Mrs.
Kerry Fatula, Western Pennsylvania Chapter of the National
Hemophilia Foundation [download presentation]
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14:30
- 14:50
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COPD
|
Dr.
Adam Wanner, Alpha 1 Foundation [download presentation]
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|
14:50
- 15:10
|
Optimal
therapy and early diagnosis including cost benefit
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Dr.
Philip Wood, St. James Hospital, Leeds [download presentation]
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15:10
- 15:30
|
New
developments in the use of albumin
|
Dr.
Nathan Davies, University College London [download presentation]
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15:30
- 16:00
|
Discussion
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16:00
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CLOSURE
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Agenda