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About the conference:

Many drugs which are prescribed to children have not been adequately studied in the paediatric population. The lack of specific drugs is now a long-standing international problem. This has resulted in changes in legislation and updated regulatory guidance ensuring that medicines for use in children are of high quality, ethically researched and authorised appropriately. Pharmaceutical companies are now required to produce medicines specifically aimed at 0-17 year olds which has resulted in an increase in paediatric clinical trials.
 

SMi’s 6th annual conference on Paediatric Clinical Trials explores a range of key issues relating to the involvement of children in pharmaceutical development. There will be a strong focus on operational considerations when designing studies and an update on international regulations governing their conduct. There will also be a focus on ethical issues surrounding the increase in outsourcing clinical investigations to developing countries. Attendees will have access to presentations from a variety of senior professionals working in industry and renowned academic experts.
 

Our expert speaker line-up includes:

Klaus Rose, Paediatric Drug Development Consultant, Klausrose Consulting

Jane Lamprill, Paediatric Research Advisor & Trainer, Paediatric Research Consultancy

Philippe Auby, Director, International Clinical Research, Paediatric Neuropsychiatry, Lundbeck

Lisa Moore-Ramdin, Senior Medical Advisor, Paediatric Vaccines, GlaxoSmithKline

Sabine Desset-Brethes, Project Leader, Pharmaceutical & Analytical Development, Novartis

Georg Schmitt, Head of Toxicology & NCS Paediatrics, F. Hoffman-La Roche

David McIntosh, Global Scientific Affairs Senior Expert, Novartis 

Stephen Heaton, Head of Safety Risk Management Planning & Coordination, Bayer Healthcare

Thomas Hassall, Senior Director, Regulatory Policy & Intelligence, Abbott Laboratories

Michael Bolger, Chief Scientist, Simulations Plus, Inc.

Philippa Smit-Marshall, Vice President and General Manager Paediatrics and Medical Sciences, PharmaNet

Steve Pinder, Managing Director, Envestia

Thorsten Ruppert, Senior Manager, Research Development Innovation, VFA

Joseph Standing, Paediatric Clinical Lecturer, School of Pharmacy, University College London

Dirk Matthys, Head of Paediatrics, Ghent University Hospital

Michael Beresford,  Professor in Child Health, University of Liverpool

The design of paediatric clinical trials must be customized for children which brings about many regulatory, ethical and scientific challenges. Through explanatory presentations and panel discussion, delegates will leave the conference with a knowledge that will allow them to conduct safe and ethical studies with patients from this vulnerable population.

 

How will you benefit?


• Hear about the current issuessurrounding paediatric clinical research


• Discuss the practical considerations associated with drug discovery in the juvenile population


• Explore the ways to optimise benefit and minimise risks when conducting paediatric trials


• Learn from a range of case studies demonstrating real life experiences


• Network with key opinion leaders and industry associates to share knowledge

 

Sponsored by

 

 

Heads of Department, Directors, Managers, Team Leaders Researchers and Scientists from:


• Research & Development
• Clinical Research
• Pharmacology
• Toxicology
• Formulation Development
• Clinical Trial Design
• Safety & Risk Management
• Regulatory Affairs
• Medical Writing
• Paediatrics

 

 Previous attendees and participants have come from organisations including:

Accovion
Astellas
AstraZeneca
Bayer Schering
BioMS Medical
Boehringer Ingelheim
Celgene
Covance
Debiopharm SA
Eli Lilly
Fulcrum Pharma
GE Healthcare

GlaxoSmithKline
Grunenthal
ICON Development Solutions
Johnson & Johnson
Laboratorious Almirall
LEO Pharmaceuticals
Lundbeck
Merck Serono
Norgine Ltd.
Novartis
Novo Nordisk
Nycomed
Omnicom Healthcare
Only For Children Pharmaceuticals
Orion Clinical Services
Paraxel
Pharmanet
Protopharma
QRxPharma, Inc.
SCM Pharma
Shire Allergan
Swedish Orphan Biovitrum
Vitalea
Voisin Consulting
Xceleron

 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Klaus Rose

Klaus Rose, Managing Director, Klaus Rose Consulting

9:10 Medicines for children: regulatory aspects

Klaus Rose

Klaus Rose, Managing Director, Klaus Rose Consulting

  • Regulatory initiatives worldwide
  • EMA, PDCO, PIP
  • EnprEMA
  • ICH E 11
  • Pharmacodynamics, disease and conditions
  • Pediatric Scientific Advice
  • 9:50 An update on the United States paediatric clinical research legislation

    Thomas Hassall

    Thomas Hassall, Senior Director, Regulatory Policy & Intelligence, Abbott Laboratories

  • Improving children's health through advancements in research
  • The protection of children through ethical clinical research
  • Cooperation between the FDA and EMA
  • 10:30 Morning Coffee Sponsored by PREMIER RESEARCH

    11:00 Supporting development and delivery of paediatric clinical trials in paediatric rheumatology: Experience of the UK's Paediatric Rheumatology Clinical Studies Group

    Michael Beresford

    Michael Beresford, Professor in Child Health, University of Liverpool

  • workflow for optimal development of a PIP
  • integrating knowledge from different areas of expertise
  • defining a paediatric clinical developmental plan
  • applications of M&S in paediatric drug development
  • 11:40 Mechanistic absorption and physiologically-based PK/PD simulations of paediatric data

    Michael Bolger

    Michael Bolger , Chief Scientist, Simulations Plus Inc

  • Assumptions for scaling paediatric gastrointestinal physiology
  • Estimating paediatric population distribution and clearance parameters
  • Virtual stochastic clinical trials
  • Linking unbound tissue  concentrations to pharmacodynamic effects

     

  • 12:20 Networking Lunch

    13:50 Implementing Paediatric trials based on your approved PIP

    Eeva-Kaarina  Koskelo

    Eeva-Kaarina Koskelo, Executive Director, Pediatrics Europe, Premier Research Group Ltd

  • Checking the feasibility of the study as approved in the PIP
  • Feasibility results; implications on timelines and regulatory actions (PIP modification)
  • Working with paediatric networks and choosing the appropriate countries  

         

     

  • 14:30 Technical approaches and experiences in developing therapies for children

    Sabine Desset-Brethes

    Sabine Desset-Brethes, Project Leader and Paediatric Network Leader, Novartis Pharma AG

  • Key challenges with paediatric dosage form development
  • Age appropriate formulations, integrating child adherence and API properties
  • Industry perspective on palatability testing in children
  • 15:10 Afternoon Tea Sponsored by PREMIER RESEARCH

    15:40 Pharmacokinetic/Pharmacodynamic modelling of paediatric data

    Joseph Standing

    Joseph Standing, Paediatric Clinical Lecturer, The School of Pharmacy University of London

  • Population approach to PK/PD studies in children
  • Physiological factors affecting pharmacokinetic differences between adults and children
  • Similarities between adults and children, including appropriate scaling methods
  • Examples of recent PK/PD modelling studies/applications
  • 16:20 Management of PIP and incentives for industry

    Steve Pinder

    Steve Pinder, Director, Envestia

  • Compliance check process and how to manage the PIP to maximise the chances of success at compliance check
  • What the incentives are and what they really mean to sponsors
  • Trends in the quantity of paediatric research as a result of the paediatric legislation
  • 17:00 Non-clinical testing to assess potential for toxicity

    Georg Schmitt

    Georg Schmitt, Head of Toxicology, Roche Pharmaceuticals

  • Guidelines and regulatory expectation
  • Challenges when working with juvenile models
  • Pharmacology, Kinetics & Metabolism, Safety Pharmacology, Toxicology (focus)
  • Toxicology studies – why, when, what
  • 17:40 Chairman’s Closing Remarks and Close of Day One

    Klaus Rose

    Klaus Rose, Managing Director, Klaus Rose Consulting

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Jane Lamprill

    Jane Lamprill, Paediatric Research Advisor & Trainer, Paediatric Research Consultancy

    9:10 Safety management teams (SMT): Evaluating the safety specification from a paediatric perspective

    Stephen Heaton

    Stephen Heaton, Head of Safety Risk Management Planning and Coordination, Bayer Schering Pharma

  • Safety management teams: Responsibilities and expertise required for paediatrics
  • EU-RMP template: paediatric relevant sections
  • Methodology for risk characterisation
  • Risk minimisation tools adaptable for paediatrics
  • 9:50 Paediatric drug development: Challenges in trial design and operational efficiency

    Philippa Smit-Marshall

    Philippa Smit-Marshall, Vice President, Pharmanet

  • Assessing the feasibility of paediatric clinical trials
  • The logistics of patient recruitment and retention
  • Considerations for the conduct of paediatric studies
  • Recruitment and retention aspects in paediatric studies
  • 10:30 Morning Coffee Sponsored by PREMIER RESEARCH

    11:00 Strategies to optimise ethics review of paediatric study protocol

    Jane Lamprill

    Jane Lamprill, Paediatric Research Advisor & Trainer, Paediatric Research Consultancy

  • Overview of key practical and ethical issues
  • Linking paediatric investigation plans to ethical requirements
  • Common causes of study rejection by ethics committee/IRBs
  • Implementing Good Ethical Practice © to improve timelines
  • 11:40 Blood sampling in paediatrics: Laboratory Point of View

    Hermann Schulz

    Hermann Schulz, CEO, INTERLAB central lab services – worldwide

  • kids are no “small adults”
  • organ maturity and PK/PD considerations
  • impact on blood volume
  • what is “minimal blood volume”
  • innovative collection techniques
  • impact on lab technology
  • 12:10 Blood sampling in paediatrics: Sponsor point of view

    Lisa Moore-Ramdin

    Lisa Moore-Ramdin, Medical Affairs Manager, GlaxoSmithKline

  • Directives/Regulations/Guidelines
  • Assessment of potential costs to the sponsor
  • Study sites and lab facilities
  • Staff training and logistics of blood sampling
  • Assessment of risk to study subjects and team
  • Consent/Assent
  • Dealing with anxious parents and screaming children
  • 12:40 Networking Lunch

    13:50 Practical aspects of assent and consent - German templates

    Thorsten Ruppert

    Thorsten Ruppert, Senior Manager, Research Development Innovation, VFA

  • Introduction of the elements of the two standard assent templates for two age groups: 7 to 11 years and 12 to 16 years
  • Templates are the result of an open and trustful discussion between German ethics committees and industrial sponsors
  • Set up of the assent process with children/adolescents
  • What is a child-specific/age-adjusted language?
  • Practical hints and tips for doctors/investigators
  • 14:30 Paediatric vaccine development

    David Mcintosh

    David Mcintosh, Senior Expert, Global Scientific Affairs, Novartis

  • Immunogenicity versus efficacy - what is a correlate and what end-points are used?
  • Safety and post-licensure studies - monitoring the long-term effects of vaccines
  • Developing a vaccine for universal use versus a vaccine for targeted use
  • Some key clinical trials - their design, execution and ethics.
  • Maternal immunisation - complementary to paediatric immunisation
  • New vaccines - reverse vaccinology
  • 15:10 Afternoon Tea Sponsored by PREMIER RESEARCH

    15:40 Conducting effective studies across networks

    Dirk Matthys

    Dirk Matthys, Head of Paediatrics, Children's cardiology, Ghent University Hospital

  • Clinical trials in adults cannot be transposed into children 
  • Methodology and endpoints are different in children: long term follow up, growth, maturation, cognitive functions 
  • Networking is essential as the number of patients is restricted
  • To obtain high quality results it is mandatory to centralise clinical studies in a few specialised units with expertise in paediatric clinical research 
  • 16:20 Practical guidance for phase III and IV paediatric trials

    Philippe Auby

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

  • Strategies for working with the PDCO
  • Overcoming the challenges of designing paediatric Phase III and IV trials
  • Timing of PIP initiation
  • Practical issues in implementing paediatric trials
  • 17:00 Chairman’s Closing Remarks and Close of Day Two

    Jane Lamprill

    Jane Lamprill, Paediatric Research Advisor & Trainer, Paediatric Research Consultancy

    +

    Workshops

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    HOTEL BOOKING FORM

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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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