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SMi 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comes at the perfect time to discuss global paediatric legislations which will include a spotlight on the latest draft guidance from the FDA and EU paediatric legislations.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

 

 

 

This unique conference will bring together distinguished industry leaders, regulatory representatives and leading academics to discuss the key topics in this fast paced field and will be an excellent opportunity to develop PIP strategies and discuss regulatory requirements.

  • Discuss the global paediatric legislations and an impact assessmemt of the EU legislation
  • Learn about PIP submissions
  • Discover how the FDA changes the regulatory landscape for paediatric drug development in the US
  • Explore how clinical trials are organised in Hungary
  • Analyse vaccines trials vs. antibiotic trials
  • Evaluate the experience of a paediatrics ethics committee
  • Examine extrapolation in paediatric drug development
  • Consider formulation development and paediatric psychopharmacology
 Clinical Trial Project Manager
Head of Paediatrics
Director of Clinical Research
Clinical Research Associate
R & D Project Leader
Director of Regulatory Affairs
Director of Medical Affairs
 
Chief Medical Officer
Toxicologist
Clinical Pharmacologist
Senior Medical Advisor
Formulation Development
Patient Safety & Risk Management
Managing Director
 

Attendeed at the previous edition included:

Allergan Ltd; Amgen; Astellas; Astellas Pharma International BV; Auxiliis-Pharma; Boehringer-Ingelheim; Celgene; Covington & Burling; Envestia; Evelina Children's Hospital; F Hoffmann -La Roche Inc; F. Hoffmann-La Roche AG; Glaxo SmithKline Ltd ; Guys and St Thomas's NHS Foundation Trust; inVentiv Health Clinical; Johnson & Johnson; Johnson & Johnson Pharmaceutical Research and Development; Johnson And Johnson; klausrose Consulting; Lundbeck; Medicines for Children Research Network; Merck Serono SA; MSD-UK; NDA Group; Novartis Vaccines; Novo Nordisk A / S; Paediatric Research Consultancy; PRA International; Roche Pharmaceuticals; Roche Products Limited; University Of Birmingham; University of Copenhagen; University of Utah School of Medicine; viiv healthcare;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Philippe Auby

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

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?
  • 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
  • 10:30 Morning Coffee

    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
  • 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
  • 12:20 Networking Lunch

    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)
  • 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?

     

  • 14:50 Afternoon Tea

    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
  • 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
  • 16:40 Chairman’s Closing Remarks and Close of Day One

    Philippe Auby

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

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Klaus Rose

    Klaus Rose, CEO, klausrose Consulting

    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
  • 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
  • 10:30 Morning Coffee

    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
     

    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
     
  • 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

    13:00 Networking Lunch

    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

    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
  • 15:30 Afternoon Tea

    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
  • 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)

    17:20 Chairman’s Closing Remarks and Close of Day Two

    Klaus Rose

    Klaus Rose, CEO, klausrose Consulting

    +

    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

    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’

    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.

    CPD AND PROFESSIONAL INSTITUTES

    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.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    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.

    GLOBAL CPD

    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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