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The conference listed on this page was held in February 2010. For information on the 2011 conference go to www.paediatric-trials.co.uk

 

Paediatric Clinical Trials Conference 2011

  

 

  • Hear about the regulatory framework for paediatric trials in the US and EU
  • Learn about the latest drug delivery forms and devices
  • Explore therapeutic area specific issues
  • Discuss ethical issues and the consent process
  • Network with industry associates and discuss experiences

 

Vice Presidents, Directors and Heads from within the pharmaceutical or biotech industry with responsibilities in the following areas:

  • Paediatrics
  • Research and Development
  • Clinical Operations
  • Regulatory Affairs
  • Medical Affairs
  • Quality Assurance
  • Patient Monitoring
  • Compliance

As well as CRO’s and consultants who want to hear about the latest developments in paediatric research

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Ulrich Granzer

Ulrich Granzer, Managing Director, Granzer Regulatory Consulting & Services

9:10 DRUGS FOR CHILDREN – HOW ARE THEY DELIVERED?

Ulrich Granzer

Ulrich Granzer, Managing Director, Granzer Regulatory Consulting & Services

  • Drug administration issues
  • Special delivery devices
  • Special delivery forms
  • Examples and issues with their registration
  • 9:50 PRACTICALITIES OF PREPARING, SUBMITTING AND NEGOTIATING PIPs WITH EMEA

    Steve Pinder

    Steve Pinder, Managing Director, Envestia

  • Requirements for the structure, content, format and timing of PIP submissions
  • What happens after PIP submission?
  • How to respond to questions
  • Thoughts on practical experience from 15 PIP submissions
  • 10:30 Morning Coffee

    11:00 FUNTIONAL AND QUALITY OF LIFE EVALUATION IN PAEDIATRIC TRIALS

    Rodrigo Escobar

    Rodrigo Escobar, Medical Advisor, European Team Physician, Eli Lilly

  • Rating and validation of scales
  • A proxy evaluation - opportunities and challenges
  • Differences and overlapping of measures
  • Study designs and electronic tools
  • 11:40 NEW STANDARDS FOR RESEARCH WITH CHILDREN

    Martin Offringa

    Martin Offringa, Chairman, StaR Child Health

  • Empirical evidence of poor quality of trials in children
  • New standards for the design, conduct and reporting
  • Lessons learned at the 1st StaR Child Health Summit
  • PIP development and Standards for Research with Children
  • 12:20 Networking Lunch

    13:50 ETHICAL ASPECTS AND PHARMACOVIGILANCE IN PAEDIATRIC CLINICAL TRIALS

    Mercedes Martinez

    Mercedes Martinez, Senior Auditor, Medical Quality Assurance-Auditing, Eli Lilly

  • Informed consent/assent administration in paediatric clinical trials
  • Pharmacovigilance in paediatric clinical trials
  • Paediatric pharmacovigilance studies
  • Data Safety Monitoring Boards
  • 14:30 PAEDIATRIC TRIAL ETHICS

    E. David Mcintosh

    E. David Mcintosh, Honorary Clinical Senior Lecturer, Imperial College London

  • At what stage of drug development should paediatric trials start?
  • Ethical considerations in performing PK studies
  • What are the ethics of performing "compassionate use" studies in children?
  • When is it no longer ethical to conduct trials in children?
  • At what age should the child be given a choice?
  • 15:10 Afternoon Tea

    15:40 DEVELOPMENT OF OFF-PATENT PEDIATRIC MEDICINE: O4CP EXPERIENCE

    Vincent Grek

    Vincent Grek, President, Only For Children Pharmaceuticals

  • Priority list and current needs
  • Regulatory environment and incentives
  • Process for the development of off-patent medicine
  • Case study
  • 16:20 LIPOSOMES FOR PULMONARY DELIVERY OF ANTIASTHMA DRUGS

    Abdelbary Elhissi

    Abdelbary Elhissi, Senior Lecturer, School of Pharmacy and Pharmaceutical Sciences, University Of Central Lancashire

  • Advantages of the respiratory route compared with other routes of administration
  • Liposomes as drug carriers in pulmonary drug delivery
  • Device technology in inhalation therapy for children
  • Suitability of inhaled liposome formulations in paediatrics
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's opening remarks

    Klaus Rose

    Klaus Rose, Former Head of Paediatrics, Roche Pharmaceuticals

    9:10 IMPACT OF US AND EU PAEDIATRIC LEGISLATION ON DRUG DEVELOPMENT

    Klaus Rose

    Klaus Rose, Former Head of Paediatrics, Roche Pharmaceuticals

  • PIP (Paediatric Investigation Plan) as condition for Marketing Authorisation Application in Europe
  • Increasing collaboration of FDA and EMEA in paediatric drug development
  • PIP working stages: strategy and execution
  • The PIP puzzle: potential barriers
  • Workload of PIP’s for pharmaceutical companies
  • Key role of external academic paediatric advice in negotiating PIP’s with EMEA & PDCO
  • 9:50 CHALLENGES OF STUDY DESIGN IN PAEDIATRIC PSYCHOPHARMACOLOGY

    Philippe  Auby

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

  • The importance of pharmacokinetics
  • Criteria for evaluation in clinical studies
  • Therapeutic area specific issues
  • Moving forwards
  • 10:30 Morning Coffee

    11:00 CONTINUED CLINICAL DEVELOPMENT AND RISK MANAGEMENT IN THE POST-APPROVAL PHASE

    Hartwig Gajek

    Hartwig Gajek, Director, Global Clinical and Medical Affairs, Baxter Innovations

  • From PIP to real life
  • Epidemiological research – an undervalued opportunity
  • Pharmacovigilance and risk management – a lifeline for the product cycle
  • 11:40 IMPROVING RECRUITMENT AND COMPLIANCE IN PAEDIATRIC CLINICAL TRIALS

    Jane Lamprill

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

  • In-house issues that may lead to final, unworkable protocols
  • Recruitment challenges and ethical issues
  • Quick Interactive session on writing information for children
  • Think global,  act local for a win/win between pharma and family
  • 12:20 Networking Lunch

    13:50 A FRAMEWORK FOR PAEDIATRIC EARLY PHASE CLINICAL TRIALS IN EUROPE

    Pamela Kearns

    Pamela Kearns, Consultant Senior Lecturer in Paediatric Oncology, Institute for Cancer Studies

  • The European consortium for early phase clinical trials: ITCC
  • The unique challenges of drug development in children relating to trial
  • design, toxicology, pharmacokinetics and pharmacodynamic markers
  • Successes and on-going challenges in paediatric drug development
  • Development of PIP from a paediatric oncologist point of view
  • 14:30 EVALUATING THE DOSAGE REQUIREMENTS OF MEDICINES IN CHILDREN USING A POPULATION PK APPROACH

    James C. McElnay

    James C. McElnay, Chair of the Clinical and Practice Research Group, School of Pharmacy, Queen's University Of Belfast

  • Unlicensed and off-label medicines
  • Sparse data analysis
  • Analysis of drugs in low volume paediatric samples
  • A network approach to improve patient recruitment
  • 16:00 Afternoon Tea and Close of Conference

    +

    Workshops

    Preparing a Paediatric Investigation Plan
    Workshop

    Preparing a Paediatric Investigation Plan

    Crowne Plaza Hotel - St James
    27th January 2010
    London, United Kingdom

    Crowne Plaza Hotel - St James

    Buckingham Gate 45/51
    London SW1E 6AF
    United Kingdom

    Crowne Plaza Hotel - St James

    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.

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    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.

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    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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