Master internazionale di II livello A.A. 2017/2018
Paediatric Medicines Development and Evaluation
ChiusoPaediatric Medicines Development and Evaluation
- Chair Paolo Rossi
It is widely known that pharmacological treatment of children poses unique efficacy and safety challenges for children and health professionals in all countries worldwide.
The use of off-label drugs is a public health problem. Indeed, in Europe over 50% of children admitted to hospitals or in primary care will receive an unlicensed or off-label medicine.
Such drug use is associated with increased risk of reduced efficacy as well as medications errors. According to the National Patient Safety Institute, at least 60,000 children suffer from medical errors every year in the US.
The largest category of mistakes, involving about 10,000 children and babies, is referred to medication.
The heart of the problem remains the absence of clinical trials that examine optimal dosage in children and the absence of formulations adapted to young patients.
One strategy to address this is to adequately educate current and future generations of health professionals to be able to conduct robust paediatric clinical trials aimed to ensure Marketing Authorization with specific Paediatric therapeutic Indications.
In 2010, a consortium of 21 universities and research groups of scientists was awarded a European grant to implement the network of excellence GRiP-Global Research in Paediatrics (www.grip-network.org).
GRiP aims to stimulate and facilitate the development and safe use of medicines in children. Part of this EC-project is the development of a Master of Science (MSc) Programme in “Paediatric Medicines Development and Evaluation”, targeting health professionals with work experience in the field.
Programma
The curriculum of the MSc on Paediatric Medicines Development and Evaluation has two important aims:
1. To educate the next generation of researchers, paediatricians, physicians and health professionals in paediatric pharmacology and trial design in order to conduct robust clinical drug trials in the paediatric ages.
2. To stimulate continuing professional development of practicing physician and pharmacists to acquire additional competences in all the specific aspects of paediatric pharmacology, drug evaluation, trial design and conduct, as well as the regulatory requirements for the in-label use of medicines.
The MSc programme on Paediatric Medicines Development and Evaluation is a two-year programme with 60 ECTS, awarded by the University of Rome Tor Vergata.
The Programme is based on ten modules to be taken in a sequenced manner (see table below).
Almost all theoretical education is offered online through the GRiP Virtual Learning Environment https://fronter.com/grip/
Students are required to attend face-to-face lessons during the Fresher’s and Re-Fresher’s meetings and during their work placement and/or training stages.
The start of the Programme is 19th of November 2014 with a face-to-face meeting named “Fresher’s Meeting” to be held at Villa Mondragone, the conference site belonging to the University of Rome Tor Vergata, Italy.
Fresher’s meeting is a three days obligatory get-together with the aim to give an overview of the course, organization, methodology, learners objectives and to demonstrate how to use the virtual learning environment.
Module NR and Abbreviation: Module
Module title: Start of the Master: Fresher's meeting (19-21 Nov 2014)
Responsible GRiP Partner/Faculty Member: PAOLO ROSSI
Affiliation:University of Rome Tor Vergata. Conference site: Villa Mondragone
ECTS: 1
Module NR and Abbreviation: Module 1 MED
Module title: Introduction to Paediatric Medicines
Responsible GRiP Partner/Faculty Member: PAOLO ROSSI, VIVIANA MOSCHESE
Affiliation:University of Rome Tor Vergata
ECTS: 4
Module NR and Abbreviation: Module 2 DEV
Module title: Developmental Pharmacology - Pharmacokinetics
Responsible GRiP Partner/Faculty Member: EVELYNE JACQ AIGRAIN, JOHN VAN DEN ANKER
Affiliation:INSERM/Université Paris DIDEROT-Paris 7
University Children's Hospital BaselECTS: 4
Module NR and Abbreviation: Module 3 RET
Module title: Regulatory and Ethical Issues Regarding Paediatric Medicines Research
Responsible GRiP Partner/Faculty Member: AGNES SAINT RAYMOND
Affiliation:European Medicines Agency (EMA)-London
ECTS: 4
Module NR and Abbreviation: Module 4 EXP
Module title: Experimental Drug Evaluation in Paediatrics
Responsible GRiP Partner/Faculty Member: ADRIANA CECI, PAOLA BAIARDI, GERARD PONS
Affiliation:Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF)-Pavia
University Paris Descartes PRES Sorbonne Paris CitéECTS: 4
Module NR and Abbreviation: Module 5 FOR
Module title: Paediatric Drug Formulations
Responsible GRiP Partner/Faculty Member: TONY NUNN, CATHERINE TULEU
Affiliation:University of Liverpool
University College London (UCL) School of Pharmacy-LondonECTS: 4
Module NR and Abbreviation: Module 6 TRI
Module title: Paediatric Clinical Trial Management
Responsible GRiP Partner/Faculty Member: MARK TURNER, JOHN VAN DEN ANKER
Affiliation:University of Liverpool
University Children's Hospital BaselECTS: 4
Module NR and Abbreviation: Module 7 PPP
Module title: Post-Licensure Paediatric Drug Evaluation: Pharmacovigilance & Pharmacoepidemiology
Responsible GRiP Partner/Faculty Member: MIRIAM STURKENBOOM, KATIA VERHAMME, SABINE STRAUS, AGNES SAINT RAYMOND
Affiliation:Erasmus University-Rotterdam
European Medicines Agency (EMA)ECTS: 4
Module NR and Abbreviation: Module 8 PREG
Module title: Pharmacology in Pregnancy and Neonates
Responsible GRiP Partner/Faculty Member: EVELYNE JACQ-AIGRAIN
Affiliation:INSERM/ Université Paris Diderot-Paris 7
ECTS: 4
Module NR and Abbreviation: Module 9 BIO
Module title: Biomarkers and Innovative Tools in Paediatric Clinical Pharmacology
Responsible GRiP Partner/Faculty Member: OSCAR DELLA PASQUA, ADRIANA CECI, PAOLA BAIARDI
Affiliation:University College London (UCL) School of Pharmacy-London
Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF)ECTS: 4
Module NR and Abbreviation: Module 10 VAC
Module title: Paediatric Vaccines
Responsible GRiP Partner/Faculty Member: JAN BONHOEFFER, JOHN VAN DEN ANKER, MIRIAM STURKENBOOM
Affiliation:University Children's Hospital Basel
Erasmus University, RotterdamECTS: 4
Costi
Registration Fee
EU student’s admission fee is 4.000 €, non EU-students fee is 8.000 €. The fee can be paid in two instalments (50% per instalment) with deadlines for academic year 1:
I7 th of November 2014 and 31st of January 2015
Deadline for academic year 2:
16th of January 2015 and 31st of January 2016
If you choose to take separate module(s) only, the registration fee is 600 €/module.
If the student is unable to fulfil his/her program the fee cannot be repaid.
The registration fee include the following services:
- enrolment in the teaching units and modules delivered by the Univ. of Rome Tor Vergata;
- free access to library, document centres and related services at the University of Rome Tor Vergata provided that the local rules are respected;
- examination, diploma and/or certificate.
The fees do not include costs relating to accommodation, food, international travel or travel onsite. Additional costs other than the tuition fee may be requested for re-examination, or late registration.
Requisiti
All individuals are selected and treated based on their relative merits and abilities.
Requirements to enter the International Master are:
Degree in:
- Medicine and Surgery
- Biology and Biotechnology
- Pharmacy
- Chemistry
- Nursing
- Bachelors’ degree (180 ECTS credits) or equivalent of relevant professional experience to be validated by the Master Selection Committee
- English proficiency corresponding to a minimum IELTS 6.5
The Master Selection Committee will select the students on the basis of their:
- relevant academic background;
- convincing letter of motivation;
- work experience and professional qualifications (if applicable);
- results of any interviews (if applicable)