CONFERENCE AGENDA
Hotel Aquincum1036 Budapest, Árpád fejedelem útja 94.
November 13-15. 201708:45 am – 21:00pm
17 CONFIRMED SPEAKERS1 workshop, 2 conference days
13th Nov. Workshop (Monday)
14th Nov. (Tuesday)
15th Nov. (Wednesday)
13:30 PM
REGISTRATION
The workshop is delivered by Klaus Rose, Managing Director Klausrose Consulting, formerly Head of Paediatric at Roche
by Klaus Rose
14:00 PM
Pediatric drug development and pediatric legislation
15:00 PM
Physiology of different child age groups, pediatric studies
15:30 PM
Coffee Break
16:00 PM
The EU Pediatric Investigation Plan (PIP), European Medicines Agency (EMA) website, other websites
16:30PM
Summary and interactive Q&A
18:00 PM
Wrap up, closing and thank you
08:45 AM
Opening
by Csilla Pozsgay
Director of the National Institute of Pharmacy and Nutrition, Budapest
09:00 AM
Incentives and their impact on Pediatric indications development
by Tamás Szolyák
Deputy Director of the National Institute of Pharmacy and Nutrition, Budapest
09:30 AM
Pediatric Drug Development: Bench to Bedside
by Philip Walson
Professor Clinical Pharmacology; University Medical Center Gottingen
10:00 AM
Global Clinical Trial Networks for Paediatrics
by Mark Turner
MCRN UK, Enpr – EMA/to be confirmed/
10:30 AM
COFFEE BREAK
11:00 AM
The new Clinical Trials Regulation in the context of Paediatric Research
by Martine Dehlinger-Kremer
Chair Pediatric Working Group, EUCROF and Global Vice President Medical and Regulatory Affairs, SynteractHCR
11:30 AM
Drug Development Framework to Deliver Better Pediatric Therapies Tomorrow
by Christina Bucci-Rechtweg
Head, Pediatric & Maternal Health Policy, Novartis
12:00 PM
Roundtable Discussion – Current and Future Challenges
Day One speakers/panellists
13:00 PM
LUNCH BREAK
14:00PM
The changing landscape of paediatric drug development
by Wouter Wijker
Managing Director of Auxiliis Pharma, Head of Biometrics Unit
14:30 PM
Global paediatric drug development
by Mette Theilade Thomsen
Managing Director, “PIP Adviser”
15:00 PM
Pediatric drug registration and market access in the challenging Canadian market
by Benoît Hébert Vice President, Business Development & Licensing, Pediapharm Inc.
15:30 PM
COFFEE BREAK
16:00 PM
How new genomic-based technologies support the diagnosis and clinical research of rare paediatric diseases
by Judit Mária Molnár
Director of the Institute of Genomic Medicine and Rare Diseases, Semmelweis University, Budapest
16:30 PM
Multi-particulate Formulation Approach for Paediatrics
by Sarah Barthold
Project Manager, Pharmaceutical Development, GLATT Pharmaceutical Services
17:00 PM
Drug Re-purposing for rare paediatric diseases
by Cesare Spadoni
Director Business Development, Auxiliis B.V.
17:30 PM
CLOSING DAY ONE
19:00 – 21:00 PM
"BUDAPEST BY NIGHT"
Social event including dinner
09:00 AM
EU Pediatric Investigation Plans (PIPs): Intellectual Foundations, Lessons Learned, The Way Forward
by Klaus Rose
Managing Director, Klausrose Consulting Ltd
09:30 AM
Regulatory pathway and challenges for EU approval
by Evie Mengou
Regulatory Consultant. EV Consulting
10:00 AM
Pediatric drug development – Path to FDA approval
by Eva Kohegyi
Senior Director, Global Clinical Development, Neurospychiatry, Otsuka
10:30 AM
COFFE BREAK
11:00 AM
Novel approaches to paediatric drug development
by Martin Graham
CEO; KinderPharm
11:30 AM
Current limitations and opportunities for precision paediatric oncology
by Jaroslav Sterba
Brno Paediatric Hospital, EMA PDCO Member
12:00 PM
Roundtable Discussion – Practical experiences and lesson learnt
Day Two speakers/panellists
13:00 PM
Wrap up, closing and thank you
CONTACT US
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Early Bird Deadline: August 31