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Training and education

Work Package 1 - Joint paediatric clinical pharmacology international educational program

 

GRiP Training and education in Paediatric Clinical PharmacologyEducation in paediatric clinical pharmacology is one of the core objectives of GRiP. To achieve this, the GRiP work group dedicated to Training and Education (Work Package 1) aims to establish an internationally recognized educational program in paediatric clinical pharmacology.

Work Package 1 is working to build expert capacity for the development, scientific study and regulatory assessment of paediatric medicines by creating a learning environment in which paediatricians, medical sub-specialists, clinical pharmacists, health care professionals, regulatory authorities, members of the pharmaceutical industry and other relevant organisations can gain expertise in all aspects of paediatric clinical pharmacology and paediatric drug development.

 

LATEST RESULTS 

 

Please see the latest results delivered by the GRiP Network under Work Package 1. Where possible, abstracts of the reports have been provided on this page. To obtain more detailed information, you can download the available materials by clicking on the links (only public documents will be made available).

 

WP1 – Joint Paediatric Clinical Pharmacology International Training Program


Final Report on a Virtual Learning Environment (VLE)

 

Report about Fellowships in Paediatric Clinical Pharmacology

 

Inventory of exchange programs in paediatric clinical pharmacology

 

Detailed core curriculum of specialisation in paediatric clinical pharmacology: GRiP Paediatric Clinical Pharmacology Fellowship curriculum

 

The GRiP Paediatric Clinical Pharmacology Fellowship curriculum has been developed and expanded on the basis of existing training programs in clinical pharmacology in countries such as Australia/New Zealand, Canada, UK, and US. Divided into 17 main subject domains, this curriculum outlines knowledge and skill sets necessary for an independent paediatric clinical pharmacologists, who can work in various settings including academia, industry and regulatory agencies. It also describes training format, program organizational structure and assessment framework. One of the novel aspects of this curriculum is to have the two professional streams for the training entry: physicians and pharmacists. Each of these professions is governed by respective licensing authorities in each jurisdiction for their clinical activity. However, competency in domains of activity such as teaching, research and administration of drug-related issues can be addressed within the same framework in both professions. Even clinical competency in Paediatric Clinical Pharmacology of each profession shares common elements, which can be articulated in this curriculum.


Inventory of existing training programs and courses for inclusion in Training Program Palette

 

The objective of this deliverable is to facilitate awareness and knowledge of existing training programs, modules and courses in paediatric clinical pharmacology in countries in and outside of Europe. The outcome will be a structured database that will facilitate the development of the curriculum for specialisation in paediatric clinical pharmacology, the Masters program in paediatric clinical pharmacology, the training for investigators in paediatric clinical trials, and for paediatric clinical trials staff. The outcome will be that already existing training programs, modules, and courses will be combined with newly developed ones to prevent unnecessary duplication and to assure that available resources will be used as efficient as possible.


First Report on a Virtual Learning Environment (VLE)


Specialisation program in paediatric clinical pharmacology


Master program in paediatric clinical pharmacology: Scope, Organization, Training


Report on the scope, qualifications and training for other qualifications in Paediatric Clinical Pharmacology


Detailed plan describing the critical path to pan-European standardization of qualifications and credentialing in paediatric clinical pharmacology


Introductory Training Program in Peadiatric Clinical Pharmacology (GRiP Roadshow): Scope, Organization, Training


First Report on a Masters program in paediatric clinical pharmacology

 

This document represents the 1st report of the GRiP Master program. In 2010, a consortium of 21 universities and research groups of scientists was awarded a European grant for Global Research in Paediatrics (GRiP, HEALTH-F5-2010-261060). This project aims to stimulate and facilitate the development and safe use of medicines in children. Part of this EC-project is the development of a MSc Programme in Paediatric Medicines Development and Evaluation, aimed at medical professionals with work experience in the field. The Faculty of Medicine at the University of Rome Tor Vergata (Italy) has approved the opening of an International Master of Science programme in Paediatric Medicines Development and Evaluation, with a start date of 19th of November 2014. 

 

Report on the needs assessment of training in Paaediatric Clinical Pharmacology

 

The aim of GRiP WP1Training programs is to build expert capacity for the development, scientific study and regulatory assessment of paediatric medicines. These training programs are intended to be available to all European member states, including new member states not yet included in the network and also to developing countries. The major GRiP Training programs planned are Fellowship program, Master’s Program, Training Program for Investigators and Clinical Trials Support staff, and Introductory Training Program in Paediatric Clinical Pharmacology available worldwide (GRiP Roadshow). In addition, other WPs were to develop training in their specific area of work to disseminate their results and for inclusion in the GRiP Training Program Palette. Best example is the WP5 Meet the Expert Webinars on Paediatric Formulations.

To better understand the various learning needs of members of the European healthcare community in the area of development and testing of medicines for children a Needs assessment was performed. Understanding the educational needs of various members of the system helps GRiP to better tailor its offerings and increase their sustainability after GRiP. This report describes the Needs assessment and its results.

 

Prospectus for a training program for investigators in paediatric clinical trials

 

The «training program for investigators in paediatric clinical trials» aims at informing on practical aspects and responsibilities of investigators participating to clinical trials evaluating drugs and involving paediatric patients ranging from the newborn through adolescence. The final aim is to improve the rational use of medicines both for paediatric patients by generating meaningful data on drug efficacy and safety that will expand the knowledge about a specific medicine and most importantly, enhance its safe use in infants and children.

 

Prospectus of a training program palette 

 

To make training developed by GRiP, and existing external training programs, available for use by other GRiP training programs or as stand-alone continuing professional education for organisers outside of GRiP it was planned to design and implement a sustainable GRiP Training Program Palette (TPP) consisting of modules/courses to fulfil learning needs of the various professional experts involved in development, clinical and biomedical research and regulatory assessment of paediatric medicines. The modules/courses included on the GRiP Training Program Palette have to fulfil the quality criteria for GRiP Education, and have to be tested in practice before inclusion.

 

Final report on a Masters program in Paediatric clinical pharmacology

 

The International Master programme in Paediatric Medicines Development and Evaluation, which started on 19th of November 2014 has come to an end with a Theses-defence-day held at the University of Rome Tor Vergata’s conference site, Villa Mondragone, the 23rd of September 2016. The International Master- programme was a two-year part-time programme with 60 ECTS divided in ten modules comprising of 4 ECTS per module, 19 ECTS dedicated to work placement corresponding to at least 10 weeks’ full time, thesis preparation and defence. The University of Rome Tor Vergata (Unitov), acting as third party to the GRiP beneficiary Children’s Hospital Bambino Gesù (OPBG) in Italy, hosted the programme and enrolled 18 students from the beginning. This programme acted also as a pilot programme for the development of a Joint Degree MSc programme, which is an on-going collaboration among three universities: University of Rome Tor Vergata, Diderot University in Paris, and Erasmus University in Rotterdam.

 

Introductory Training Program in Paediatric Clinical Pharmacology (GRiP Roadshow): Final Report

 

 

GRiP Virtual Learning Environment

 

One of the tasks of GRiP Work Package 1 is to develop a web-based learning environment to facilitate the worldwide participation in GRiP educational programmes. The platform is currently being deveoped but can already be accessed to use GRiP educational tools, browse scientific and educational material, and participate in GRiP events. By accessing the GRiP Virtual Learning Environment you can take part in the series of Meet the Expert Webinars on paediatric formulations - see the Webinars page for more information.

 

Click on the GRiP Virtual Learning Environment page to log on on to the plaftorm and access GRiP educational resources on paediatric clinical pharmacology: 

 

GRiP Virtual Learning Environment

 

 

GRiP Work Package 1 objectives

 

Over the next three years, the GRiP work group dedicated to Training and Education (Work Package 1) plans to acheive the following:

 

• Developing internationally recognized curricula defining the scope, qualifications, and training for the major groups of professional experts necessary for development, clinical, and biomedical research and regulatory assessment of paediatric medicines.

 

• Establishing educational programs including:

  • comprehensive training program leading to certification in paediatric clinical pharmacology, and high scientific competence;
  • an internationally recognized PhD program in paediatric clinical pharmacology;
  • a postgraduate MSc/sub-specialization program integrating all the aspects of the evaluation of medicinal products in children (e.g. ethical, regulatory, methodological and quality assurance);
  • training paediatric clinical investigators;
  • a training course for paediatric clinical trial staff;
  • a training for patient groups to develop their ability to contribute to clinical research.

• Implementing a sustainable educational program consisting of modules to fulfil the learning needs of the various professional experts

 

• Developing a web-based Virtual Learning Environment (VLE)

 

• Organizing an exchange program (fellowship) in paediatric clinical pharmacology in qualified centres

 

• Developing a quality assurance system that will allow accreditation and certification of the programs

 

As the main goal of the GRiP project, the Paediatric Clinical Pharmacology International Training Program intends to harvest a learning environment in which paediatricians, medical sub-specialists, clinical pharmacists, health care professionals, regulatory authorities, members of the pharmaceutical industry and other relevant organizations can gain expertise in all aspects of paediatric clinical pharmacology and paediatric drug development. 

 

GRiP is generally not intended to fund the on-going running of training, rather it will act as a governing body for the educational programmes. WP1 will also develop a long term sustainability plan to ensure the running of the training in the future. A set of guidelines for pilots and demonstrations will also be developed.