Uitgebreide uitnodiging incl. programma

NIA Symposium
Orphan drugs for kids
Practical experiences of development,
regulatory and market access of paediatric
drugs for rare diseases
To register please follow the instructions on the included
registration form
Visit our website www.industrieapothekers.com for
more information, for directions to the conference
location and for updates on exact programming and
speakers.
27 March 2014
West Indisch Huis
Herenmarkt 99, Amsterdam
Programme:
Expert speaker panel:
9.30 – 10.00
Welcome and coffee/tea
10.00
Symposium – part I
Edwin Spaans, PharmD, Clinical Pharmacologist, Director Clinical
Development at Kinesis Pharma BV, The Netherlands; Clinical
Pharmacologist at ErasmusMC Sophia Childrens’ Hospital, The
Netherlands
12.00 – 13.30
Lunch
Meet & Greet with the regulators:
o Henk van den Berg, MEB/CBG
o Diana van Riet, MEB/CBG, Chemisch
Farmaceutische Beoordelingen (to be
confirmed)
13.30
Symposium – Part II
15.15 – 16.00
Coffee and tea
Translations for Children
***
Dr. Henk van den Berg, Paediatrician-haematologist/oncologist;
Clinical Pharmacologist, Emma Kinderziekenhuis AMC, Amsterdam,
the Netherlands; Dutch Medicines Evaluation Board
Regulatory issues in relation to PIP’s and orphan designations
***
Dr. Michel Zwaan, MD, PhD, Assoc. Prof. of Paediatric Oncology,
Erasmus MC, Rotterdam, the Netherlands
Paediatric drug development: the paediatric oncology perspective
Meet & Greet with the regulators:
o Henk van den Berg, CBG
o Diana van Riet, Chemisch
Farmaceutische Beoordelingen, CBG (to
be confirmed)
***
Dr. Mark Turner, PhD, MRCPCH, Senior Lecturer / Consultant in
Neonatology, University of Liverpool / Liverpool Women's NHS
Foundation Trust, UK
Paediatric Drug Development: the views of investigators and the
value of networks
16.00 – 16.45
Symposium – Part III
16.45 – 17.00
Closure
Dr. Ingrid van der Eijk, PhD, Market Access Manager, Takeda
Nederland bv, the Netherlands
17.00 – 18.00
Drinks
Financing of orphan drugs and off-label use
***
***
Dr. Cor Oosterwijk, Director VSOP (Vereniging Samenwerkende
Ouder- en Patiëntenorganisaties – voor zeldzame en genetische
aandoeningen), the Netherlands
The Dutch policy regarding rare diseases, the role of centres of
expertise and their importance for paediatric diseases

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