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The Masterclass will focus on how clinical expertise and leadership, alongside the involvement of children and families, can improve the design of, and facilitate the delivery of paediatric medicines research. This will be demonstrated by national and international models of network support, and across a broad spectrum of paediatric conditions, and will provide an overview of key global initiatives available within paediatrics.

Global drug development is changing as paediatric drug development has become an essential part of it, the need to obtain paediatric information for medicines used in children being a consensus in EU and EU with established permanent paediatric regulations requiring early planning and regulatory submissions, and a new paradigm is now emerging i.e. protecting children through clinical research.

Whatever your role in drug development, a solid background knowledge is required to understand the specific challenges and opportunities of paediatric drug development. You might be directly involved in PIPs and PSPs, you might be asked for advice, or you might work in a management, regulatory affairs, technical or clinical development position; without background understanding you might overlook regulatory, scientific, ethical or operational issues and take wrong decisions.


Delegates will gain an insight into the factors that influence the feasibility of running paediatric studies, and an oversight of the global initiatives, facilities and infrastructure available to support drug development for children.

Masterclass LEADER


Daniel Bar-Shalom

Associate Professor , University of Copenhagen

Associate Professor at the Institute of Pharmacy, University of Copenhagen, and at Bioneer, a non-for-profit organization servicing the Biotech and Pharmaceutical industries. Studied pharmacy and biology. Had a compounding pharmacy where he gained insight into the problems compliance. Started Egalet, a drug-delivery company where he worked for more than 20 years. The technologies being Egalet, (erosion controlled release dosage form) and Parvulet, a paediatric formulation. Consults the pharmaceutical, medical-device and cosmetic industries, many of his inventions maturing into marketed products. He is involved in initiatives to improve the medication of pediatric and geriatric therapies and formulations. His “leitmotif” is patient-centric products. He is the inventor of numerous patents, authored papers, reviews, book chapters and assiduously presents his - often unconventional - views in meetings, symposia and interest groups. He is the co-editor of the AAPS/Springer book “Pediatric Formulations: A roadmap” (2014).

University of Copenhagen

H. Lundbeck A/S (commonly known simply as Lundbeck) is a Danish international pharmaceutical company engaged in the research and development, production, marketing, and sale of drugs for the treatment of disorders in the central nervous system (CNS), including depression, schizophrenia, Alzheimer's disease, Parkinson's disease, Huntington's disease, epilepsy and insomnia.

The University of Cophenagen provides a unique vehicle to work closely with the pharmaceutical and biotech industries as well as clinical hospital departments, seeking to boost  cross-disciplinary collaborations with research institutions and industry, both nationally and internationally.

Innovation strategies aimed at generating novel therapeutics or diagnostics are integrated into research projects and have led to several licenses and spin-out activities.

Masterclass programme

8:30 Registration & Coffee

9:00 Opening remarks and introductions

Philippe Auby

Philippe Auby, Director, International Clinical Research, Paediatric Neuro-Psychiatry, Lundbeck

9:10 Session 1: Clinical research in paediatric pharmacology

Philippe Auby

Philippe Auby, Director, International Clinical Research, Paediatric Neuro-Psychiatry, Lundbeck

  • Planning your paediatric development with a strategic angle: When is paediatrics appropriate?
  • Geographic differences of regulatory requirements 
  • Identifying special requirements in planning each stage of  clinical trials and how to implement them
  • Case study: Analysis of failures and successes; Evaluating grey areas and possible solutions in validation, treatment selection and dose prediction


  • 10:30 Morning Coffee

    11:00 Session 2: Designing and managing paediatric clinical trails

    Philippe Auby

    Philippe Auby, Director, International Clinical Research, Paediatric Neuro-Psychiatry, Lundbeck

    ·         Advancing understanding of drug “paediatric” efficacy and communicating drug safety specific to children and adolescents

    ·         Ethical and scientific challenges

    ·         Managing multinational clinical research programs


    11:40 Session 3: Psychiatric development to support paediatric research in drug development

    Philippe Auby

    Philippe Auby, Director, International Clinical Research, Paediatric Neuro-Psychiatry, Lundbeck

    ·         Understanding the consequences of psychiatric pharmacology in providing adequate support for treatment

    ·         Case study: Addressing psychotropic requirements in drug treatment


    12:20 Networking Lunch

    13:20 Session 5: Supporting the development of paediatric research

    Daniel Bar-Shalom

    Daniel Bar-Shalom, Associate Professor , University of Copenhagen
    View Bio


    ·         Opening remarks from the National Children’s Specialty Lead for England.

    ·         Case study outlining how network expertise helps to develop feasible study design and delivery.

    ·         Involving children and young people in the design and delivery of paediatric studies.



    14:10 Session 6: Delivering paediatric studies

    Daniel Bar-Shalom

    Daniel Bar-Shalom, Associate Professor , University of Copenhagen
    View Bio

    ·         A UK model of network support for paediatric research.

    ·         A case study demonstrating the impact of network support on study delivery.


    14:50 Afternoon Tea

    15:20 Session 7: International initiatives in research delivery

    Daniel Bar-Shalom

    Daniel Bar-Shalom, Associate Professor , University of Copenhagen
    View Bio

    ·         The European network of paediatric research networks.

    ·         Emerging global collaborative approaches.


    16:20 Session 8: Global Research in Paediatrics (GRIP)

    Daniel Bar-Shalom

    Daniel Bar-Shalom, Associate Professor , University of Copenhagen
    View Bio

    ·         Summary of the key projects and outputs of the GRIP programme.

    16:40 Closing Remarks and Close of Day


    Holiday Inn Kensington Forum

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    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.


    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.


    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.


    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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