SMART Open workshop - Paediatric Foresight Training Course

"Current status and future changes in the European paediatric biomedical research"


Day 1, Thursday, 29.11.2018

08.30 - 9.00          Registration and welcome coffee

09.00-09.15          Opening remarks

Adriana Ceci , Marek Migdal, officials

09.15 -11.00         Session 1.

Paediatric biomedical research - novelties in the regulatory, academic  and ethical framework

09:20-09.30           Course presentation

Viviana Giannuzzi

09.30-09.40           Aim of SMART

Marek Migdal

09.40-10.00          Overview of EU current legal framework relevant for drug development

Anna Cieslik

       10.00-10.20          Impact and revision of the Paediatric Regulation

Dirk Mentzer

       10.20-10.40           GDPR & secondary use of data from paediatric CT

Annagrazia Altavilla

10.40-11.00          Discussion

11.00-11.30          Coffee break

11.30-13.30          Session 2

Paediatric Formulations

       11.35-11.55          Why we need age appropriate formulations - regulatory point of view

Dirk Menzer

      11.55-12.15           Industry perspective on age appropriate formulations

Serena Tongiani

      12.15-12.35           Quality issues for paediatric formulations & new opportunities

Nunzio Denora

      12.35-12.55           An example of a new paediatric formulation development

Aleksandra  Sobczyk, Piotr Salwa, Katarzyna Witulska, Cosimo  Altomare

12.55-13.15           Role of hospital local pharmacy in preparation of paediatric formulations - example of the IPCZD

Ryszard Sot

13.15-13.30          Discussion

13.30-14.30          Lunch break

14.30-17.00          Session 3

How to prepare and run paediatric clinical trials  

14.35-14.55          Clinical trials preparedness

Angeliki Siapkara

14.55-15.15           Patient's advocacy and involvement of young people

Doriana Filannino & YP representative - KIDS Bari

15.15-15.35           CTs in small populations

Bożenna Dembowska-Bagińska

15.35-15.55           Ethical and regulatory requirements in paediatric clinical trials

Annagrazia Altavilla & Jacek Kołodziejczyk

15.55-16.15           Paediatric Pharmacovigilance

Mariagrazia Felisi & Katarzyna Żyluk

16.15-16.35           Role of research nurse in paediatric CTs  

Sean Oosterholt & Aleksander Wi¶niewski

16.35-17.00          Discussion

17.00-18.00          Get together


Day 2, Friday, 30.11.2018

09.00- 11.00         Session 4

The paediatric initiatives around Europe: how are we using innovations in paediatric  research dedicated  to drugs development?  

       09.05-09.25          From TEDDY to c4c

Adriana Ceci

       09.25-09.45          EnprEMA

Angeliki Siapkara

       09.45-10.05          EPTRI

Donato Bonifazi

      10.05-10.25           Role of ERNs in empowering paediatric research

Katarzyna Kotulska

      10.25-10.45           POLPEDNET - a Polish network

Piotr Socha

10.45-11.00          Discussion

11.00-11.15          Coffee break

11.15-13.15          Session 5

Paediatric research innovative methods 

11.20-11.40           Role of modelling and extrapolation in paediatric drug development

                              Oscar Della Pasqua

11.40-12.00           Creation of pharmacological models for IPCZD

Oscar Della Pasqua, Sean Oosterholt & Agnieszka Czajkowska

12.00-12.20           Kidney transplantation: PKPD model and drug dosing 

Oscar Della Pasqua, Sean Oosterholt & Jacek Rubik

12.20-12.40           PK-PD data M&S modelling on pain relievers simulation in neonates  

Oscar Della Pasqua, Sean Oosterholt & Eliza Michalska

12.40-13.00           PK-PD data M&S modelling on pain relievers simulation in children 

Oscar Della Pasqua, Sean Oosterholt & Mariya Tsupruk

13.00-13.15          Discussion

13.15-13.30          Wrap up and closing remarks

Adriana Ceci, Marek Migdal

13.30-14.00          Lunch