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“This was a great meeting… it was well handled and I learned a lot”
Paul Wang, Director, Clinical R&D, Pfizer, SMi’s Paediatric Clinical Trials 2007


It takes an average of 15 years and millions of pounds to bring a new medicine to market. Whilst great care is taken to evaluate new treatments on adults, the process for testing medicines for children is much more tightly regulated and all research protocols must be submitted for Ethics Committee / Institutional Review Board (IRB) scrutiny and approval before trials can even start. Furthermore, the ethical and research needs of children are very different from that of adults, and paediatric clinical trials need to be tailored to the patient group as well as the disease and therapeutic area. Approximately 50% of the drugs on the European market have not been specially tested on children and this can lead to adverse effects, many of which can be fatal. With the recent implementation of the European Medicines for Children Regulation, pharmaceutical companies are under immense pressure to ensure they run their paediatric clinical trials effectively and efficiently.

SMi’s 2009 Paediatric Clinical Trials conference offers delegates a unique opportunity to discover the latest developments and regulatory changes in this area:
  • Discussing operational challenges in implementing paediatric plans
  • Evaluating child and adult synergies under the new paediatric guidelines
  • Developing effective patient recruitment and retention strategies
  • Assessing ethical and financial implications of conducting paediatric trials
  • Analysing the differences in clinical trial requirements in the EU, US and the rest of the world
Vice Presidents, Directors and Heads from within the pharmaceutical or biotech industry with responsibilities in the following:

  • Paediatric Clinical Trials
  • Immunology
  • Medical
  • Immunoscience Development
  • Inflammation
  • Clinical Research
  • Clinical Operations
  • Immunopharmacology
  • Arthritis Research
  • Metabolic Diseases
  • Bone Metabolism
  • Health Economics 
  • Regulatory Affairs
  • Respiratory Research


As well as CRO’s and consultants who want to hear about the latest developments in this area.


For Speaking opportunities please contact Michelle Fanus at mfanus@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

Findlay Walker

Findlay Walker, Vice President, EU Administration, Daiichi Sankyo

9:10 KEYNOTE PRESENTATION: OPERATIONAL CHALLENGES IN IMPLEMENTING A PAEDIATRIC PLAN

Francis P. Crawley

Francis P. Crawley, Executive Director, Good Clinical Practice Alliance - Europe

  • The European regulatory and ethical framework for paediatric drug development
  • A roadmap to the Paediatric Investigation Plan (PIP) in the current regulations: sponsor, investigator, and ethical considerations
  • The role of the EMEA Paediatric Committee: objectives, composition, practices
  • European networks of researchers and patients engaged with paediatric drug development
  • Promoting cooperation between Member States and Third World Countries to streamline the development of paediatric drugs
  • 9:50 TRIALS IN PAEDIATRIC POPULATIONS IN DEVELOPING COUNTRIES

    Robert Miller

    Robert Miller, Chief Medical Officer, Fulcrum Pharma

  • Ensuring appropriate trial design for studies in children and infants
  • Obtaining consent/assent in circumstances warranting urgent medical treatment
  • Appropriate endpoints and measures  in paediatric populations
  • Selection of appropriate trial sites in developing countries
  • Developing capacity and competency at trial sites
  • Providing ongoing support and monitoring for trial sites
  • Ensuring real-time medical support and safety reviews
  • 10:30 Morning Coffee

    11:00 PAEDIATRIC CLINICAL TRIALS IN EASTERN EUROPEAN COUNTRIES

    Zorica Zivkovic

    Zorica Zivkovic, Head of Paediatric Pulmonology, Children’s Hospital for Lung Diseases and TB

  • Designing clinical trials in developing countries
  • Relationship between regulations and practice
  • Difficulties in patient recruitment
  • Equipment, logistics and  technical issues in conducting clinical trials
  • Promoting research and clinical investigations in Eastern Europe
  • 11:40 OPTIMISING PAEDIATRIC CLINICAL TRIAL OPERATIONS

    Tricia Fowler

    Tricia Fowler, Ex-Director of Special Projects, Formerly at GlaxoSmithkline

  • Protocol Considerations
  • Site Selection
  • Medicines for Children
  • Resource Requirements
  • 12:20 Networking Lunch

    13:20 AMS-TECHNOLOGY IN PEDIATRIC DRUG RESEARCH AND DEVELOPMENT

    Le Vuong

    Le Vuong, Chief Operating Officer, Vitalea Science

  • The foremost obstacle faced by drug developers for pediatrics is being able to test the drugs in children. 
  • Accelerator Mass Spectrometry (AMS) technology, at attomole (10-18) sensitivity (for drugs labeled with safe and effective 14C isotopes), enables “microdosing” pharmacokinetic studies to be carried out in children, even neonates, using permissible small blood samples (micrograms). 

  • 13:50 DEVELOPING PAEDIATRIC DRUGS

    Philippe  Auby

    Philippe Auby, Director, Lundbeck

  • Designing studies to test existing adult drugs in children
  • Identifying and resolving issues with suitable dosages and drug formulations
  • The role of PK modelling in anticipating dosage / formulation issues
  • The relevance of PK studies in designing efficacy trials
  • Issues with compliance and relation to dosing
  • 14:30 ONCOLOGY DRUG DEVELOPMENT IN PEDIATRICS

    Iman El-Hariry

    Iman El-Hariry, Senior Director, Oncology Medicines Centre, GlaxoSmithKline

  • Features of childhood cancers
  • History of oncology drug development in paediatric population
  • Role of regulatory bodies
  • Design and endpoints challenges
  • Future directions
  • 15:10 Afternoon Tea

    15:40 MULTI-REGIONAL CLINICAL TRIALS

    Heinrich Klech

    Heinrich Klech, Executive Vice President, Vienna School Of Clinical Research

  • Pros and cons
  • Reducing the associated costs
  • Regulations and ensuring quality
  • Overcoming challenges
  • Analysing the collected data
  • Risk management
  • 16:20 FINANCIAL IMPLICATIONS

    John Bolodeoku

    John Bolodeoku, VP, Medical Affairs & Health Economics Europe, Astellas Pharma Europe

  • Minimising costs
  • Cost effective contingency planning and implementation
  • Benefits and limitations of outsourcing and partnerships
  • The hidden costs
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Francis P. Crawley

    Francis P. Crawley, Executive Director, Good Clinical Practice Alliance - Europe

    9:10 ETHICAL ISSUES IN PAEDIATRIC CLINICAL TRIALS

    Findlay Walker

    Findlay Walker, Vice President, EU Administration, Daiichi Sankyo

  • How can information be communicated for “informed” consent
  • “Consent” vs. “assent”
  • Special issues related to very young patients or neonates
  • Confused motives of industry sponsors
  • Provision of ongoing care after the study
  • 9:50 US REGULATORY REQUIREMENTS IN CONTRAST TO THE EU AND THE ADVANTAGE OF A GLOBAL PROGRAM

    Sandra Cottrell

    Sandra Cottrell, Senior Director, Regulatory Affairs, Novo Nordisk Pharmaceuticals

  •  “Children are not little adults” - yet…a reticence to conduct paediatric trials
  • A historical perspective “up to the moment” - US Statutory transformation in regulatory approaches to obtaining paediatric data
  • A regulatory approach to achieving paediatric data is not unique to the US – the European regulatory context
  • Comparing the US and EU paediatric approaches - The case for a global integrated approach for paediatric development
  • 10:30 Morning Coffee

    11:00 FIRST DO NO HARM - PHARMACOVIGILANCE IN CLINICAL TRIALS

    Malcolm Barratt-Johnson

    Malcolm Barratt-Johnson, Managing Partner, The BJ Partnership

  • The evolving regulatory environment
  • What tools are available to us?
  • How can we better serve our patients and volunteers
  • Where to from here?

  • 11:40 CHALLENGES IN CLINICAL TRIALS ON RARE CONGENITAL DISORDERS

    Hartwig Gajek

    Hartwig Gajek, Medical Director, Clinical Operations, Baxter BioPharmaceuticals

  • How rare can rare be?
  • Understanding different angels of the environment
  • Thoughts on clinical development plans
  • 12:20 Networking Lunch

    13:20 ACCELERATING PATIENT RECRUITMENT

    Philippa Smit-Marshall

    Philippa Smit-Marshall, Vice President, Medical Affairs, Pharmanet

  • Global recruitment planning
  • Targeting different geographic regions
  • Tailoring patient information to supplement the informed consent process
  • Taking parents/carers and children through the informed consent and assent process
  • Recruitment and retention plans and techniques
  • Choosing the appropriate metrics to measure recruitment
  • Pros and cons of various media
  • 14:00 CONDUCTING PAEDIATRIC CLINICAL TRIALS IN ONCOLOGY

    Michael Needle

    Michael Needle, Vice President, Pediatric Strategy, Celgene

  • Recruiting and retaining patients with cancer
  • Overcoming the challenges of finding enough participants
  • Designing and conducting clinical trials
  • Study outcomes
  • 14:40 Afternoon Tea

    15:10 KEYNOTE PRESENTATION: PAEDIATRIC AND ADULT SYNERGIES

    David  McIntosh

    David McIntosh, Medical Director, Infectious Diseases, Wyeth

  • Paediatric regulations, PIP, PDCO, PUMA
  • Inventory of needs and waivers
  • Off-patent research
  • Pharmacology, population PK and extrapolation
  • Biomarkers
  • Benefits for adults
  • 15:50 PAEDIATRIC CONSENT

    Tariro Gandiya

    Tariro Gandiya, Medical Student, The University Of Aberdeen

  • Parental/guardian consent
  • Competency of children in decision making
  • Information and trial updates – guardian and child
  • Cultural issues and researcher responsibilities
  • 16:30 Chairman’s Closing Remarks and Close of Conference

    +

    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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