Master of Science in Paediatric Medicines Development and Evaluation

-Fresher’s meetingPreliminary agendaDate:19-21 of November 2014

Conference site:Villa Mondragone - Via Frascati 51, 00040 - Monte Porzio Catone (Rome), Italy

The Architectural history of Villa Mondragone starts in 1567 when the young cardinal Marco Sittico Altemps beloved nephew of Pope Pius IV, buys the Villa, which previously had been the property of Cardinal Ricci of Montepulciano. In 1866, the Jesuit Order bought the Villa, which became the international headquarter of the Ghisleri College and later on a boarding school. Since 1981, the Villa belongs to the University of Rome Tor Vergata.The restructured section of the Villa includes conference rooms, library, gallery of exhibits etc.The structure is currently the seat of many conferences. The estate consists of an 18-hectare lot with a magnificent view towards Rome.

Hotels:There are several hotels in the area, Hotel Villa Vecchia is the closest hotel situated on the hill below Villa Mondragone. For booking your room, please send an email to info@villavecchia.it referring to “GRiP/Univ Tor Vergata Master in Paediatric Medicines Development and Evaluation” so that you will be able to receive a reduced prize for your room.

Information on “how to reach the hotel” please link to:http://www.villavecchia.it/index.php?option=com_gmapfp&view=gmapfp&Itemid=280&lang=en .

Wednesday 19th of November 2014

1

Time

Topic Faculty

13.00-14.00

Welcome and Introduction to the Master course

Paolo Rossi, Univ Tor Vergata and Children’s Hospital Bambino Gesù

14.00-15.00

Virtual Learning Environment (VLE) introduction and explanation- “how do I do on the VLE?”

Christian Komonen, Fronter

15.00-16.30

Module 7:Post-licensure Paediatric drug evaluation: Pharmacovigilance & Pharmacoepidemiologypresentation of topics and learning objectives ,questions and answers

Miriam Sturkenboom,Erasmus University, Rotterdam

16.30-18.00

Module 10:Paediatric vaccinesPresentation of topics and learning objectives, questions and answers

Jan BonhoefferUniversity Children's Hospital Basel,

18.00

End of the day

20.00

Social programme:Dinner somewhere in the Frascati wine district, place to be confirmed

Thursday, 20th of November 2014

Time Topic Faculty09.00-10.30

Module 1:Introduction to Paediatric Medicinespresentation of topics and learning objectives, questions and answers

Paolo Rossi, Viviana MoscheseUniv Tor Vergata,Agnes Saint-Raymond, European Medicines Agency (EMA), LondonGregory L. Kearns,University of Kansas School of Medicine, USA

10.30-12.00

Module 2:Developmental Pharmacology – Pharmacokineticspresentation of topics and learning objectivesquestions and answers

Evelyne Jacq-Aigrain, INSERM/ Univ Diderot, Paris

12.00-13.30

Module 4:Experimental Drug evaluation in Paediatricspresentation of topics and learning objectives questions and answers

Adriana Ceci, Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF), PaviaGerard Pons, University Paris Descartes PRES Sorbonne Paris Cité

2

13.30-14.00

Lunch

14.00-15.00

Guided tour in the Villa

15.00-16.30

Module 8:Pharmacology in pregnancy and in neonatesPresentation of topics and learning objectives questions and answers

Evelyne Jacq-Aigrain, INSERM/ Univ Diderot, Paris

16.30-18.00

Module 5:Paediatric drug formulationspresentation of topics and learning objectives questions and answers

Catherine Tuleu, University College LondonTony Nunn, University of Liverpool (via TC)

18.00

End of the day

20.00

Dinner, place to be confirmed

Friday 21st of November 2014

Time Topic Faculty09.00-10.30

Module 3:Regulatory and ethical issues regarding Paediatric medicines researchpresentation of topics and learning objectives questions and answers

Agnes Saint-Raymond, European Medicines Agency (EMA), London

10.30-12.00

Module 9:Biomarkers and Innovative tools in paediatric clinical pharmacologyPresentation of topics and learning objectives questions and answers

Oscar Della Pasqua ,UCL School of Pharmacy, London,Paola Baiardi, Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF), Pavia

12.00-12.30

Light lunch

12.30-14.00

Module 6:Paediatric Clinical Trial ManagementPresentation of topics and learning objectives questions and answers

Mark Turner, University of Liverpool andJohn van der Anker, University Children's Hospital Basel

14.00-15.00

Sum-up, assessment and study-time-schedule

Paolo Rossi, Univ Tor Vergata

15.00

End of the Fresher’s meeting

3

4