Conect4children (c4c) invites you to apply for membership of a Methodology Expert Group in your area of paediatric drug research.
c4c is an EU funded pan-European consortium with a general aim of facilitating the development and availability of new medicines for babies, children and young people through the creation of a large collaborative paediatric network. One task of the consortium is to deliver the advice needed to improve child health and paediatric medicine development.
Groups of experts (methodological, clinical, and parents/patients) will be set up to provide Strategic Feasibility advice to individual requests from pharmaceutical industry and academic consortia in conducting feasible,
innovative and scientifically sound paediatric clinical trials. Therefore, we are now seeking experts interested to be part of Methodology Expert Groups and provide advice. This call is for methodology experts. For clinical experts, in paediatric subspecialties, a separate call is being launched.
Who should apply?
Criteria for experts (not all criteria have to be met):
  • Has relevant expertise in a specific (paediatric) drug development research field of > 5 years and is currently active in the field of expertise.
  • Has knowledge in and experience with methodology advisement and is familiar with regulatory requirements within drug development research.
  • Has capacity to provide a minimum of 2 expert advices yearly. 
  • Is enthusiastic to contribute to building an international expert group in his/her field.
We aim for diversity, including representatives from different career levels, genders, European regions and from a wide range of clinical subspecialties. If you are a clinician specialized in a very specific patient population, but with
less experience in research, we still invite you to apply.
We are looking for approximately 8-20 experts per group with diverse background; we may have to do a selection out of the applications. This does not mean we will not need you in the future, as requests maybe very
specific. Hence by applying you agree that we keep your contact details in our database so we will be able to approach you at a later stage.

What I am expected to do?
  1. Be available to provide advice on methodology aspects of paediatric clinical trials for at least two projects per year in the ad hoc ‘’strategic feasibility advice groups”. When requests for expertise come to c4c, the WP4 leadership together with the relevant Methodology Expert Group leads will form these ad hoc ‘’strategic feasibility advice groups”. These groups may also contain clinical experts and patient/parents. 
  2. Contribute to the development of a standing expert group in your area. We have already nominated expert group leads for most groups whose task is to organise and develop each expert group. 
  3. Support the expert lead with the creation of guideliness and contribute to white papers. 
  4. Be available for 3 years as expert member, with the possibility to prolong for another term of 3 years if both parties agree.
How will I benefit?
  1. Involvement in the design of pediatric trials resulting in financial (industry requests) and/or academic recognition.
  2. Opportunity to work with your expert group on White Papers on innovative methodology.
  3. Expand your network and visibility
Which groups can I apply for:
Pharmacovigilance                 Ian Wong
Formulations                    Catherine Tuleu
Study design & Clinical Trial Methodology     Armin Koch / Kit Roes
Development Pharmacology           lead to be nominated
Pharmacometrics                Jean Marc Treluyer
Health Technology Assessment                            Francesco Moretti
Ethics                                                                         Dirk Lanzerath
Pharmacogenomics and
other OMICS technologies                                    Matthias Schwab

How to apply?
You should fill in the online application form , including motivation and a short CV, highlighting your expertise.

How is this work reimbursed?
The time that you spend on giving expert advice to pharmaceutical companies will be reimbursed. In addition, expert group leads have been allocated funds to develop the expert groups, e.g. for organizing meetings, travel costs, some secretarial support.

What are the timelines?
Deadline for applications is 26.03.2019
Notification of acceptance 26.04.2019

Additional information
WP4 secretariat-
Prof. Saskia de Wildt - Lead Methodology Expert Groups & WP4 Academic Lead -
Prof. Irja Lutsar - Lead Clinical Expert Groups-

We are looking forward to your application.
C4c WP4 Leadership team