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Paediatric Clinical Trials
31 March - 1 April 2014
Paediatric Clinical Trials

SAE Media Group are proud to present their 8th annual conference on Paediatric Clinical Trials. This unique event will provide attendees with a complete view of the paediatric market, focusing on regulatory requirements, challenges in clinical trials designs, formulation development, extrapolation form the adult population and so forth. This informative conference will bring together key opinion leaders provide attendees with an in depth look into current advances in paediatric clinical trials and drug development.

Building on the success of our previous events this exciting conference comes at the perfect time to discuss global paediatric legislations which will include a spotlight on the latest draft guidance from the FDA and EU paediatric legislations. This event will provide attendees with a unique opportunity to network with key industry professionals.


 

Key areas to be discussed in this year's conference are:

  • Global paediatric legislations and impact assessment of the EU legislation
  • An update on the US legislation
  • PIP submissions: reguirements and strategic considerations
  • The activities of the PDCO
  • Vaccines trials verus antibiotic trials 
  • The role of the ethics commmittee in paediatric clinical trials
  • Extrapolation in paediatric drug development 
  • Dosing, modelling and simulation strategies
  • Formulation development
  • Operational challenges and how to overcome them
  • Paediatric clinical research to cardiology
  • Stimulating discovery and development of safer medicines for children 

The conference will be made up of a number of presentations and case studies from key opinion leaders and updates on their latest paediatric clinical trials that they have undertaken and real life success stories for all attendees to learn from.

 

"Good presentations and important topics" - Abbott

 "I very much enjoyed this conference, thanks to the organisers" - UCB

"Very good meeting" - Boehringer Ingelheim

 

 

 

FEATURED SPEAKERS

Bruno Reigner

Bruno Reigner

Senior Clinical Pharmacologist, Roche Pharmaceuticals
Christina Bucci-Rechtweg

Christina Bucci-Rechtweg

Head, Maternal & Paediatric Regulatory Policy, Novartis
Daniel Bar-Shalom

Daniel Bar-Shalom

Associate Professor, University of Copenhagen
David McIntosh

David McIntosh

Global Scientific Affairs Senior Expert, Novartis Vaccines
Elin Haf Davies

Elin Haf Davies

Director & Founder, Empowering Children | Enabling Research
Karl-Heinz Huemer

Karl-Heinz Huemer

Scientific Office, Austrian Agency for Health and Food Safety
Klaus Rose

Klaus Rose

CEO, klausrose Consulting
Mark Sorrentino

Mark Sorrentino

Executive Medical Director, PPD Inc.
Philippe Auby

Philippe Auby

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

Bruno Reigner

Senior Clinical Pharmacologist, Roche Pharmaceuticals
Bruno Reigner

Christina Bucci-Rechtweg

Head, Maternal & Paediatric Regulatory Policy, Novartis
Christina Bucci-Rechtweg

Daniel Bar-Shalom

Associate Professor, University of Copenhagen
Daniel Bar-Shalom

Daniel De Wolf

Director - Department of Paediatric Cardiology, Ghent University Hospital
Daniel De Wolf

David McIntosh

Global Scientific Affairs Senior Expert, Novartis Vaccines
David McIntosh

Elin Haf Davies

Director & Founder, Empowering Children | Enabling Research
Elin Haf Davies

Fedele Duccio Bonifazi

Project Manager, GRiP Network of Excellence
Fedele Duccio Bonifazi

Frank Verheggen

Clinical Program Management Director, Astellas
Frank Verheggen

Jane Lamprill

Paediatric Research Consultant Specialist Medical Writer for Children , Paediatric Research Consultancy
Jane Lamprill

Jenny Walsh

Director, Jenny Walsh Consulting
Jenny Walsh

Karl-Heinz Huemer

Scientific Office, Austrian Agency for Health and Food Safety
Karl-Heinz Huemer

Klaus Rose

CEO, klausrose Consulting
Klaus Rose

Mark Sorrentino

Executive Medical Director, PPD Inc.
Mark Sorrentino

Otto Skoran

CEO, Svabhegy Paediatric Hospital
Otto Skoran

Paola Baiardi

Director, Consortium for Biological and Pharmacological Evaluations (CVBF)
Paola Baiardi

Philippe Auby

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

Sabah Attar

Network Lead, Medicines for Children Research Network (MCRN)
Sabah Attar

Sylvie Benchetrit

French PDCO Delagate, Referent of Paediatric Medicines, Agence Nationale de Sécurité du Médicament et des produits de santé (French Medicines Agency)
Sylvie Benchetrit

For speaking opportunities, please email Roochita Imrit on rimrit@smi-online.co.uk

Conference agenda

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8:30

Registration & Coffee

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9:00

Opening Remarks

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9:10

Background: Off-label use of medicines in children and paediatric regulatory requirement since 1997

  • Off-label use of drugs in children
  • key elements of EU & US paediatric legislation
  • EU paediatric coordinator, rapporteur, co-rapporteur, EU forms
  • Request for a PIP vs. request for a Waiver
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    9:50

    Physiology and drug treatment in children

  • Absorption, distribution, metabolisation & excretion in children
  • Consequenses for drug treatment
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    10:30

    Coffee Break

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    11:00

    EMA/PDCO PIP decisions

  • The 2013 EU Commission report on paediatric legislation and the EMA 2013 report to the Commission
  • Going together through the EMA paediatric website
  • Discuss the case samples on the decision page
  • Identify key elements of EMA/PDCO paediatric decisions
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    11:40

    Interactiveproblem solving session: EU & US paediatric Research Networks, CROs, Consultancies

  • European national paediatric research networks
  • European disease-specific paediatric research networks
  • US networks, CROs, consultancies
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    12:20

    Closing remarks and wrap-up

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    13:15

    End of Workshop

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Philippe Auby

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

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    9:10

    Global paediatric legislations and an impact assessment of the EU legislation

    Klaus Rose

    Klaus Rose, CEO, klausrose Consulting

  • Paediatric clinical research and drug development in the USA, EU, Japan: a worldwide update
  • The EMA Report on Paediatric Legislation April 2013, the EU Commission report June 2013 and industry experience
  • How much do EU PIPs contribute to better child health?
  • The planned revision of the EU paediatric legislation 2018
  • The way forward: how should the EU paediatric legislation change? How has it changed?
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    9:50

    PIP submission: requirements and strategic considerations

    Karl-Heinz Huemer

    Karl-Heinz Huemer, Scientific Office, Austrian Agency for Health and Food Safety

  • The impact of PIP requirements on companies
  • How to plan the submission with regards to content and strategy
  • Tips for interacting with EMA and delegates
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    10:30

    Morning Coffee

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    11:00

    How does FDASIA change the regulatory landscape for paediatric drug development in the US

    Christina Bucci-Rechtweg

    Christina Bucci-Rechtweg, Head, Maternal & Paediatric Regulatory Policy, Novartis

  • The Paediatric Study Plan (PSP) as a tool to encourage paediatric research earlier during product development
  • A new approach toward considerations for an overarching paediatric program development plan
  • Non-compliance in the post-FDASIA environment
  • An opportunity for global harmonisation
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    11:40

    Innovative Ideas for rare diseases

    Elin Haf Davies

    Elin Haf Davies, Director & Founder, Empowering Children | Enabling Research

  • Innovative deisgns to meet demand
  • Regulator buy-in
  • Patient involvement
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    12:20

    Networking Lunch

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    13:30

    Paediatric clinical trials in Hungary

    Otto Skoran

    Otto Skoran, CEO, Svabhegy Paediatric Hospital

  • How are paediatric clinical trials organised in Hungary
  • Clinical trials sites, role of the national network (MCRN Hungary)
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    14:10

    Vaccines trials versus antibiotic trials

    David McIntosh

    David McIntosh , Global Scientific Affairs Senior Expert, Novartis Vaccines

  • Prevention versus cure
  • Role of vaccines in decreasing antibiotic resistance
  • Key examples of large randomised controlled vaccine trials
  • Antibiotic trials – the risk of failure
  • Severe life-threatening infections – what is the best approach?

     

  • clock

    14:50

    Afternoon Tea

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    15:20

    NIHR Clinical Research Network: Delivering studies for Children

    Sabah Attar

    Sabah Attar, Network Lead, Medicines for Children Research Network (MCRN)

  • Infrastructure
  • Delivery
  • MCRN performance to date with key examples
  • Challenges and opportunities
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    16:00

    The activities of the PDCO: assessment of the PIPs

    Sylvie Benchetrit

    Sylvie Benchetrit, French PDCO Delagate, Referent of Paediatric Medicines, Agence Nationale de Sécurité du Médicament et des produits de santé (French Medicines Agency)

  • Assessing applications for waivers and deferrals
  • The key issues of the paediatric development plans
  • Innovative methodology and extrapolation issues
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    16:40

    Chairman’s Closing Remarks and Close of Day One

    Philippe Auby

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

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Klaus Rose

    Klaus Rose, CEO, klausrose Consulting

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    9:10

    Extrapolation in pediatric drug development: Perspectives from industry

    Bruno Reigner

    Bruno Reigner, Senior Clinical Pharmacologist, Roche Pharmaceuticals

  • The regulatory framework (US, EMA) about extrapolation
  • Different types of extrapolation and the need to communicate with clarity
  • Full and Partial extrapolation of efficacy
  • Extrapolation of dosing to get approval for dosing selection in a pediatric clinical trial
  • The way forward: Extrapolation to increase probability of success
  • clock

    9:50

    Paediatric formulations for new products

    Daniel Bar-Shalom

    Daniel Bar-Shalom, Associate Professor, University of Copenhagen

  • Summary of topics to be presented in bullet points
  • Understanding why “adult-” and “traditional-paediatric” formulations are not good enough for children in 2014
  • Reviewing the parameters that make the children different from adults when developing paediatric formulations
  • Exploring “one formulation fits all approaches"
  • Examining novel paediatric formulations
  • clock

    10:30

    Morning Coffee

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    11:00

    Lessons learned through strategic feasibility in paediatric trials: Case studies in utilising global strategic feasibility to identify key factors that influence study design and optimise operational execution of paediatric clinical trials

    Mark Sorrentino

    Mark Sorrentino, Executive Medical Director, PPD Inc.

    •             Differences in medical practices
    •             Acceptability of trial design and study procedures
    •             Consent/ assent differences
    •             Parental perception
    •             Disease prevalence variation
     

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    11:40

    Formulation development for the paediatric population

    Jenny Walsh

    Jenny Walsh, Director, Jenny Walsh Consulting

  • Quality aspects of the EU PIP
  • Selection and development of age-appropriate products
  • Excipient considerations
  • Acceptability of paediatric medicines
     
  • clock

    12:20

    Operational challenges in executing a pediatric clinical trial program

  • Alignment EMA and FDA requirements
  • Co-operation with CAs and IECs
  • Clinical execution points of interest
  • Frank Verheggen

    Frank Verheggen, Clinical Program Management Director, Astellas

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    13:00

    Networking Lunch

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    14:10

    Identifying barriers and building bridges in early phase paediatric trials

    Jane Lamprill

    Jane Lamprill, Paediatric Research Consultant Specialist Medical Writer for Children , Paediatric Research Consultancy

    • Paediatric Committee – discussions at clock stop
    • Ethics Committees/IRBs – identifying key issues to help prevent approval delay
    • Study sites – practical solutions to facilitate smoother study management
    • Parents and children – effective communications to optimise recruitment

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    14:50

    What can we learn from paediatric psychopharmacology?

    Philippe Auby

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

  • Practical guidance for Phase III and phase IV paediatric trials using experience from paediatric psychopharmacology
  • Addressing different psychotropic medical needs in the paediatric population
  • Scientific considerations and ethical challenges
  • Case studies and examples
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    15:30

    Afternoon Tea

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    16:00

    Paediatric clinical reserach in cardiology

    Daniel De Wolf

    Daniel De Wolf, Director - Department of Paediatric Cardiology, Ghent University Hospital

  • Latest advances in cardiology drugs development in children
  • Clinical features and treatment of different types of heart problems
  • Proper involvement of infants, children and their parents in the clinical trials
  • Latest clinical trials and research in cardiology
  • clock

    16:40

    Stimulating discovery and development of safer medicines for children

  • The GRiP Network, aims and contribution
  • New methods for clinical studies in paediatrics
  • Ovewview on paediatric clinical trials
  • Case studies in GRiP
  • Fedele Duccio Bonifazi

    Fedele Duccio Bonifazi, Project Manager, GRiP Network of Excellence

    Paola Baiardi

    Paola Baiardi, Director, Consortium for Biological and Pharmacological Evaluations (CVBF)

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    17:20

    Chairman’s Closing Remarks and Close of Day Two

    Klaus Rose

    Klaus Rose, CEO, klausrose Consulting


    Senior Clinical Pharmacologist
    Roche Pharmaceuticals
    Head, Maternal & Paediatric Regulatory Policy
    Novartis
    Associate Professor
    University of Copenhagen
    Director - Department of Paediatric Cardiology
    Ghent University Hospital
    Global Scientific Affairs Senior Expert
    Novartis Vaccines
    Director & Founder
    Empowering Children | Enabling Research
    Project Manager
    GRiP Network of Excellence
    Clinical Program Management Director
    Astellas
    Paediatric Research Consultant Specialist Medical Writer for Children
    Paediatric Research Consultancy
    Director
    Jenny Walsh Consulting
    Scientific Office
    Austrian Agency for Health and Food Safety
    CEO
    klausrose Consulting
    Executive Medical Director
    PPD Inc.
    CEO
    Svabhegy Paediatric Hospital
    Director
    Consortium for Biological and Pharmacological Evaluations (CVBF)
    Director, International Clinical Research, Paediatric Neuro-Psychiatry
    Lundbeck
    Network Lead
    Medicines for Children Research Network (MCRN)
    French PDCO Delagate, Referent of Paediatric Medicines
    Agence Nationale de Sécurité du Médicament et des produits de santé (French Medicines Agency)

    Exclusive Interview with Elin Haf Davies, Empowering Children, Enabling Research

    Download

    Paediatric Interview with Jane Lamprill

    Download

    Paediatric Interview Christina Bucci Rechtweg

    Download

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    WHAT IS CPD?

    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’

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    GLOBAL CPD

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