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The new EMEA regulation has opened a new chapter in paediatric drug research and development.
With requirements for submitting a Paediatric Investigation Plan, along with the benefits of enhanced patent protection, paediatric clinical trials have become a key challenge for pharmaceutical companies this year.
   
The 2008 Paediatric Clinical Trials Conference offers delegates a unique opportunity to benefit from a wealth of knowledge presented by leading industry experts:
  • Devising globalised integration of paediatric development plans
  • Performing cost analysis under the new paediatric guidelines
  • Applying patient retention strategies for paediatric population
  • Overcoming practical challenges in paediatric trials

      

Confirmed speakers include:
  • Dr Jerome Zeldis, Chief Medical Officer and Vice President, Medical Affairs, Celgene
  • Dr John Bolodeoku, Vice President, Medical Affairs and Health Economics, Europe, Astellas Pharmaceuticals
  • Dr Albert J Allen, Medical Director, Neuroscience Platform Team, Eli Lilly
  • Dr Paul Wang, Director, Clinical Research and Development, Pfizer
  • Dr François Bompart, Medical Director, Access to Medication, Sanofi-Aventis
  • Dr Brahm Goldstein, Director, Clinical Research, Biopharmaceuticals, Novo Nordisk
  • Dr Vijay Tammara, Director, Regulatory Affairs, Merck
  • Dr Carlos Camozzi, Medical Director, Orphan Europe France
  • Dr Sabine Fürst-Recktenwald, Paediatric Specialist and Director, Clinical Research, Sanofi-Aventis
  • Jane Lamprill, Director, Paediatric Research Consultancy
  • David Gauden, Head of Imaging Technology Operations, GE Healthcare
  • Dr David McIntosh, Medical Director, Infectious Diseases, EMEA, Wyeth
   
Who should attend SMi’s Paediatric Clinical Trials Conference?
  • Medical Directors
  • Directors of Regulatory Affairs
  • Directors, Health Economics
  • Director of Clinical Operations
  • Directors of Clinical Research
  • Senior Clinical Project Managers

                                                                                                                    

For Speaking opportunities please contact Venus Simbulan at vsimbulan@smi-online.co.uk
For Sponsorship opportunities please contact Alia Malick at amalick@smi-online.co.uk

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Philippa Smit-Marshall

Philippa Smit-Marshall, Head of the European and Asia Pacific Medical Department, PharmaNet

9:10 A CLOSER LOOK AT THE PAEDIATRIC EUROPEAN REGULATORY REQUIREMENTS

Dr David  McIntosh

Dr David McIntosh, Medical Director, Infectious Diseases, EMEA, Wyeth

  • The Paediatric Investigation Plan (PIP) requirements
  • Paediatric committee overview – membership and activities
  • Criteria for waivers and deferrals and associated implications for the PIP
  • 9:50 PAEDIATRIC CLINICAL TRIALS – YESTERDAY, TODAY AND TOMORROW

    Dr John Bolodeoku

    Dr John Bolodeoku, Vice President, Medical Affairs and Health Economics, Europe, Astellas Pharma EU Ltd

  • Case studies - paediatric development plans prior and post the new European regulation
  • Health economics of paediatric studies
  • Phase III and post marketing surveillance trials
  • 10:30 Morning Coffee

    10:50 RESOLVING LIABILITY CLAIMS IN THE US AND UK: A COMPARATIVE VIEW

  • Reviewing the informed consent document in the tort context 
  • Disclosure and the Sponsor's interests in the clinical trial outcome
  • Adverse events in clinical trials - resisting the conspiracy theory
  • US:UK parallels and distinctions 
  • Theodore Voorhees Jr

    Theodore Voorhees Jr, Partner and Chair of the Product Liability Practice Group, Covington & Burling

    Anne Ware

    Anne Ware, Partner, Covington & Burling

    11:40 DEVELOPMENTAL ISSUES TO KEEP IN MIND FOR PAEDIATRIC DRUG RESEARCH

    Dr Sabine  Fürst-Recktenwald

    Dr Sabine Fürst-Recktenwald, Paediatric Specialist and Director, Clinical Research , Sanofi-Aventis

  • Distinguishing children and adults by anatomy, physiology, pathophysiology, pharmacolgy, psychiology  
  • Physiological changes affecting pharmacokinetics and pharmacodynamics in the paediatric population
  • Assessment and tailoring of formulation solutions
  • Drug toxicity and long term safety
  • 12:20 Networking Lunch

    13:50 PEDIATRIC DRUG DEVELOPMENT STRATEGY FROM A GLOBAL PERSPECTIVE

    Dr Albert J Allen

    Dr Albert J Allen, Medical Director, Neuroscience Platform Team, Eli Lilly

  • Getting to the right mindset
  • ICH, US, and EU guidelines, initiatives and legislation
  • Other special considerations with paediatrics
  • Developing a single global plan that is compliant with regulations across markets
  • It doesn't end with completion of development plan -- risk management
  • 14:30 PAEDIATRIC PATIENT RECRUITMENT AND RETENTION: IT'S FAR FROM CHILD'S PLAY

    Elizabeth Moench

    Elizabeth Moench, President and CEO, MediciGroup

  • Issues related to applying recruitment and retention solutions strategies across multiple therapeutic conditions, multiple child-developmental stages and multiple countries
  • How to incorporate parent and child perspectives into retention program development and implementation
  • Considerations for recruitment and retention across different languages and cultures
  • 15:10 Afternoon Tea

    15:40 DEVELOPING MEDICINES FOR CHILDREN

    Rob Harris

    Rob Harris, Head of Formulation Development, Penn Pharmaceuticals

  • Paediatric applications in the development programme for all new medicines
  • Implications of the new EU legislation on product development strategy
  • Product attributes that need to be considered when developming medicines for children
  • How the new EU legislation governs the development and authorisation of medicines for use in children
  • 16:20 INTEGRATING PAEDIATRIC STUDIES INTO DRUG RESEARCH AND DEVELOPMENT

    Dr Richard Tiner

    Dr Richard Tiner, Medical Director, Association of the British Pharmaceutical Industry (ABPI)

  • Legal requirements
  • Timing of research in children
  • How and where to do the required research
  • 17:00 PAEDIATRIC IMLEMENTATION PLANS – IS IT NOW OR NEVER?

    Dr Robert Miller

    Dr Robert Miller, Chief Medical Officer, Fulcrum Pharma Developments Ltd

  • As the requirements for Paediatric Investigation Plans (PIP) are put into force, companies who hope to register new agents or apply for a variation to an existing license will need to not only have an accepted PIP at the time of submission, but also a means by which these can be implemented to avoid a delay to licencing or for existing products penalties or even a request to withdraw the product from the market
  • The extent of paediatric work already performed, the nature of any additional work and the age groups which need to be addressed or for whom a waiver can reasonably be granted needs to be an integral part of these plans
  • Depending on the stage of development the urgency with which these plans have to be in place will vary
  • Paediatric indication investment and return on investment
  • This presentation will explore these aspects and put them into perspective for companies developing medicines for human administration
  • 17:40 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Philippa Smit-Marshall

    Philippa Smit-Marshall, Head of the European and Asia Pacific Medical Department, PharmaNet

    9:10 OPERATIONAL CHALLENGES IN IMPLEMENTING A PAEDIATRIC PLAN

    Philippa Smit-Marshall

    Philippa Smit-Marshall, Head of the European and Asia Pacific Medical Department, PharmaNet

  • The legal and regulatory context of the Paediatric Investigation Plan (PIP)
  • Establishing a discussion with the Paediatric Committee at the EMEA
  • Ethical considerations in the PIP
  • The PIP in comparison with the current US regulatory framework
  • 9:50 CHILDREN ARE NOT LITTLE ADULTS: PRACTICAL CHALLENGES IN PAEDIATRIC TRIALS

    Dr Paul Wang

    Dr Paul Wang, Associate Director, Clinical Research and Development, Pfizer

  • consent and assent
  • Assessment of growth and development as study endpoints
  • Reliability of self-reports by children
  • Qualification and training of paediatric investigators
  • 10:30 Morning Coffee

    10:50 PAEDIATRIC PHARMACEUTICALS: AN INDUSTRY’S PERSPECTIVE

    Angus Grant

    Angus Grant, Vice President , Celgene Corporation

  • Why it is important for industry to develop drugs for the under 18 year old crowd
  • Clinical trials in paediatric population before substantial adult use – the implications on drug development
  • Barriers to conducting paediatric clinical trials
  • The implications on the adult formulation developments and a modest solution
  • 11:30 COMPOSING A PAEDIATRIC INVESTIGATION PLAN: A CHALLENGING EXCERCISE

    Hans van Bronswijk

    Hans van Bronswijk, Vice President, PAREXEL Consulting

  • Timing and Timelines
  • Scientific advice
  • Risk Management Plan aspects
  • Compliance
  • 12:10 Networking Lunch

    13:10 SPECIFICITIES OF PAEDIATRIC CLINICAL INVESTIGATIONS IN DEVELOPING COUNTRIES

    Dr Francois  Bompart

    Dr Francois Bompart, Medical Director, Access to Medicines, Sanofi-Aventis

  • Pre-clinical, clinical and pharmaceutical development plans to include children needs right from the start
  • Issues specific to paediatric clinical development: dose selection, dosing convenience, route of administration, safety monitoring
  • Issues with clinical trials in developing countries: ethical review, informed consent, standard of care, post-trial commitments
  • 13:50 OUTLOOK ON THE EVOLVEMENT OF PUBLIC AND INDUSTRY PAEDIATRIC DRUG RESEARCH

    Dr Rosalind Smyth

    Dr Rosalind Smyth, Director, Medicines for Children Research Network (MCRN)

  • Supportive attributes of the UK market: secure government funding and a unified heath system
  • The UK Medicines for Children Research Network; organisation, workstreams    
  • Scope of network studies: population, disease areas, resource allocation
  • Partnerships with the pharmaceutical industry
  • 14:30 THE “EDUCATION GAP” IN PEDIATRIC CLINICAL TRIALS

    Dr Brahm  Goldstein

    Dr Brahm Goldstein, Director, Medical Research, Novo Nordisk

  • Misperceptions of current pediatric medications
  • Understanding clinical trials and the drug approval process
  • Are children at increased risk in clinical trials?
  • Informed consent versus assent
  • 15:10 Afternoon Tea

    15:40 A FAMILY CENTRED APPROACH FOR SUCCESSFUL PAEDIATRIC TRIALS

    Jane Lamprill

    Jane Lamprill, Paediatric Research Consultant, Paediatric Research Consultancy

  • How to avoid wasting time and money
  • Assessing needs: protocol, PIP, parent, patient
  • Practical and ethical considerations
  • Writing paediatric information sheets
  • Handling the recruitment challenge
  • 16:20 DESIGN CHALLENGES IN PAEDIATRIC CLINICAL TRIALS

    Dr Carlos  Camozzi

    Dr Carlos Camozzi, Medical Director, Orphan Europe

  • Tailoring solutions to phase of growth  
  • Analysis of pre-clinical information
  • Tracking pharmacokinetics, pharmacodynamics and toxicity changes
  • Creative statistical methods
  • Case studies
  • 17:00 BIOPHARMACEUTICAL DEVELOPMENT FOR ORPHAN-DRUG INDICATIONS: THE PAEDIATRIC PERSPECTIVE

    Henk Schuring

    Henk Schuring, Director, European Regulatory Affairs, Genzyme

  • The established European framework for orphan-drug designation – benefits in extended lifecycles  
  • The strong correlation between paediatric indications and orphan drugs
  • The Us experience: paediatric population constituting a "medically plausible" subset of patient population
  • Implementing the two regulatory guidelines into the paediatric investigation plan
  • 17:40 Chairman’s Closing Remarks and Close of Day One

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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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