Master of Science in Paediatric Medicines Development and Evaluation
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International masters_\

Master of Science in Paediatric Medicines Development and Evaluation

  • Chief_ Paolo Rossi

Introduction and Background


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.

Master Organization



Fresher’s meeting

Is one of the few face-to-face occasions in this master course since almost all the education is made on-line. The Fresher’s meeting is an obligatory event and will serve to get to know the teachers, the students and how the course is organized. The face-to-face-meeting will take place at Villa Mondragone, which is one of the Tuscolana villas in the Frascati area in the suburb of Rome http://www.villamondragone.it

The training sessions

Training activities are composed of one or several of the following:

  • The teaching sessions consist of lectures, tutorials or dedicated seminars, all using English as the main language.
  • A tutorial is a session of exercises guidance and discussion/ correction with a teacher. Tutoring is provided through interactive sessions e-learning platform tools.
  • The home exercise sessions consist of home exercises such as scientific publication review and appraisal, case studies, case based-learning, study proposals, quizzes.
  • Module validation session assessment consists of the evaluation of the trainee’s progress by different type of tests according to the Bloom‘s level of the topic. (multiple choice test, open questions test, case study evaluation etc.).
  • Work-placement or Training stages sessions

A 19 ECTS work-placement or training stages are required.  The thesis can be prepared at the premises of one of the GRiP partners or at another third party location.

The student who wishes to write their thesis at a third party location has to get approval of their thesis location from the Joint Quality Committee.

Virtual Learning Environment (VLE)

The educational activities are mostly made on-line with the help of Fronter learning platform. For each student, a tutor will be appointed within the Partecipating Partners, whom the Student may consult for advice or assistance during the Course.
An IT expert will be available to assist students in their activity on the VLE platform if needed.

Thesis

A thesis is part of the Master degree. The student has to write the thesis with the overview of a tutor.

Program



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 Basel

    ECTS: 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 Cité

    ECTS: 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-London

    ECTS: 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 Basel

    ECTS: 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, Rotterdam

    ECTS: 4

Costs, durations and requirements



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.

Syllabus
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)

Registration

The enrolment is available on-line via the following link: 
https://delphi.uniroma2.it/totem/jsp/index.jsp?language=EN

Student Section, in Section A select: Postgraduate courses

1: Specialization Courses - Master
2: Enrollment to the Admission Test for the Master/Specialization Courses
3: Start application procedures
4: Faculty of Medicine and Surgery
5: Paediatric Medicines Development and Evaluation-PNG

Deadline for registration is: 3/11/2014

Students will be enrolled at the University of Tor Vergata when:

  • they have paid the first instalment of the annual Master degree fee;
  • students can also register to study one or more modules only; in that case only a certificate of completion or participation will be awarded for each module. 

Faculty




Ceci Adriana

Saint Raymond Agnes

Tuleu Catherine

Jacq-Aigrain Evelyne

Pons Gerard

Bonhoeffer Jan

Van Den Anker John

Verhamme Katia

Turner Mark

Sturkenboom Miriam

Della Pasqua Oscar

Baiardi Paola

Rossi Paolo

Straus Sabine

Nunn Tony

Moschese Viviana

Ceci Adriana

Saint Raymond Agnes

Tuleu Catherine

Jacq-Aigrain Evelyne

Pons Gerard

Bonhoeffer Jan

Van Den Anker John

Verhamme Katia

Turner Mark

Sturkenboom Miriam

Della Pasqua Oscar

Baiardi Paola

Rossi Paolo

Straus Sabine

Nunn Tony

Moschese Viviana