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The EU Commission is soon to implement a new legislative system to drive the development and market release of drugs specifically designed for children. Due to pharmacogemonic and biological development differences, paediatric therapeutics must differ significantly from those given to adults.

To address this, The SMi Group proudly presents our Paediatric Clinical Trials Conference. Falling two months after the new legislation is due to be realized, you will hear from key players in the industry about how they will contend with these changes.

Hear contributions from leading industry experts, including:

Dr Charles Bouchard, Director, European Government Affairs, Merck
Dr Iman El-Hariry, Group Director, Oncology MDC Europe, GlaxoSmithKline
Dr Albert Allen, Medical Director, Neuroscience Global Brand Development, Eli Lilly
Dr Hartwig Gajek, Medical Director, Europe, Baxter BioPharmaceuticals
Dr Francis P Crawley, Executive Director, Good Clinical Practice Alliance - Europe & Member, Ethics Working Group, Confederation of European Specialists in Paediatrics (CESP)
Dr Susan Tansey, Associate Director, Wyeth Vaccines Research Professor
Tim Higenbottam,
Principal Research Physician & Senior Principal Scientist, Respiratory & Inflammation Therapy Area, AstraZeneca
Dr Renate Gilbert, GPRD Clinical Training Manager, Abbott
Kathleen Drennan, Senior Vice President & Managing Director, Iris Global Clinical Trial Solutions

Hear international case studies and expert perspectives on:

REGULATORY AFFAIRS:
Learn how to comply to the new legislation and overcome the pitfalls
PAEDIATRIC RECRUITMENT & RETENTION: Discover strategies and best practices in the recruitment of children into clinical trials and how to reduce drop out rates
PAEDIATRIC DRUG DEVELOPMENT: Learn about the challenges in developing drugs designed for children and how to overcome them
CLINICAL TRIAL DESIGN AND METRICS: Gain an insight into the key drivers and problems facing trial design and analysis and hear practical solutions to overcome them
ETHICS & CONSENT: Listen to the ethical considerations behind paediatric studies and how to gain parental consent, ensuring their full understanding
INDUSTRY EXPERTS: Network with influential experts from leading pharmaceutical companies and learn from their experiences and expertise.

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Keith Wesnes

Keith Wesnes, Chief Executive, Cognitive Drug Research

9:00 THE CHALLENGES OF FORMULATING PAEDIATRIC SPECIFIC MEDICINES

Dr John Bolodeoku

Dr John Bolodeoku, Senior Director, Medical Affairs & Health Economics, Europe, Astellas Pharma EU Ltd

·                Designing studies to test existing adult drugs in children
·                How can you identify the problem areas in drug formulation?
·                Issues with dose testing, efficacy and specificity
·                Strategies to deal with taste, swallowing, dosing regimes and compliance

9:50 THE SUCCESSFUL ENROLMENT OF CHILDREN INTO CLINICAL TRIALS

Elizabeth Moench

Elizabeth Moench, President & Chief Executive Officer, MediciGroup Inc

·                Designing and implementing viable recruitment plans
·                What are the challenges facing the recruitment process?
·                Methods of finding and recruiting patients
·                Enrolment incentives and informed consent on entering a trial
·                What are the common oversights and how can recruitment be improved?

10:30 Morning Coffee

10:50 PATIENT RETENTION IN PAEDIATRIC CLINICAL TRIALS

·                Evaluation of why patients leave before the end of a trial
·                What are the effects on
·          The study
·          The patient
·                How can you prevent a patient from leaving a study before completion and what incentives can they legally be offered
Susan Tansey

Susan Tansey, Associate Director, Wyeth Research

Stephen Lockhart

Stephen Lockhart, Assistant Vice President & Head, Bacterial Clinical Research, Wyeth Vaccines Research

11:30 BEST PRACTICES IN PAEDIATRIC PATIENT RECRUITMENT & CLINICAL TRIAL MANAGEMENT

Kathleen Drennan

Kathleen Drennan, Senior Vice President & Managing Director, Iris Global Clinical Trial Solutions

·                Patient recruitment strategies and tactics
·                The relevance of qualitative research (focus groups) for study strategy
·                Increased study efficiency through measurement – a case study
·                The future of paediatric participation in clinical trials

12:10 CONDUCTING PAEDIATRIC CLINICAL TRIALS FOR RARE DISEASES

Hartwig Gajek

Hartwig Gajek, Medical Director, Europe, Baxter BioPharmaceuticals

·                How do you recruit and retain paediatric patients with a rare disease?
·                Overcoming the challenges of finding enough participants
·                Designing and conducting clinical trials for rare disease
·                Decision making – outsouring and site management
·                Study outcomes and lessons learned

12:50 Networking Lunch

14:20 CONSENT AND ASSENT IN PAEDIATRIC CLINICAL TRIALS

Renate Gilbert

Renate Gilbert, GPRD Clinical Training Manager, Abbott GmbH & Co KG

·                The guideline and regulations for consent
·                Informed consent and ensuring effective, consistent conveyance of accurate and complete information
·                Consent documentation design
·                Implications of the consent process on enrolment of children into a study
·                Evaluating the level of patient and parent understanding

15:00 ETHICAL CHALLENGES AND CONCERNS

Francis Crawley

Francis Crawley, Director General, Good Clinical Practice Alliance

·                An overview of the principles of medical ethics
·                What are the ethical issues that are unique to children?
·                Balancing the risk and the benefits of conducting a paediatric clinical trial
·                Human subject protection
·                What are the common and not so common ethical issues that impact on paediatric clinical trial design and implementation?

15:40 Afternoon Tea

16:00 THE PUBLIC PERCEPTION OF PAEDIATRIC TRIALS

Linda Capsey

Linda Capsey, , Fast4wd Ogilvy

·                Consent vs assent challenges
·                Effective and appropriate visual and written information for recruitment and retention - the teen/child divide
·                Case studies

16:40 THE ASSESSMENT OF COGNITIVE FUNCTION IN PAEDIATRIC CLINICAL TRIALS

Keith Wesnes

Keith Wesnes, Chief Executive, Cognitive Drug Research

·                What cognitive domains should be measured?
·                The validation of tests in children
·                Large trials of cognitive function in school children
·                Year by year changes in performance from 4 to 18 years - the need for closely controlling for age
·                The sensitivity, reliability and utility of automated tests of cognitive function in children
·                Epilepsy and cognitive function in children

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

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Francis Crawley

Francis Crawley, Director General, Good Clinical Practice Alliance

9:10 ASSESSING THE BENEFITS AND DISADVANTAGES OF PAEDIATRIC DRUG DEVELOPMENT

Tim Higenbottam

Tim Higenbottam, Principal Research Physician & Senior Principal Scientist, AstraZeneca R&D

·                The most important considerations in deciding which drugs to develop
·                Developing adult drugs into paediatric drugs vs new paediatric drugs
·                Financial considerations and time constraints
·                Epidemiological factors

9:50 SOME SPECIAL CHALLENGES IN PAEDIATRIC DRUG DEVELOPMENT

Albert Allen

Albert Allen, Medical Director, Eli Lilly

·                The moving target(s) - there isn't just one paediatric age group
·                Child friendly formulations and studies with them
·                Research infrastructure

10:30 Morning Coffee

11:00 KEYNOTE ADDRESS - IMPLICATIONS OF THE NEW EU LEGISLATION

Charles Bouchard

Charles Bouchard, Director, European Government Affairs, Merck

·                How have these new laws affected the pharmaceutical industry?
·                Will they benefit the industry in the long run?
·                The financial impact of putting these laws into action
·                Will these laws protect the patient further?
·                EU vs US legislation

11:40 THE ROLE OF PHARMACOGENOMICS AND DEVELOPMENTAL BIOLOGY IN THE PRODUCTION OF PAEDIATRIC DRUGS

Iman El-Hariry

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

·                How children differ in rates of absorption, distribution, metabolism and excretion, compared to adults
·                Age-associated differences in drug clearance
·                Incorporating this knowledge into the design of the clinical trial
·                Methods of observation to track these differences with the study

12:20 Networking Lunch

13:50 PAEDIATRIC ASSESSMENT AND SPECIALISED TRAINING

- Challenges in the assessment of paediatric patient - Age-dependence of paediatric measures - Choosing appropriate outcomes for paediatric clinical trials - Multidisciplinary approach to paediatric assessment - Training opportunities
Christoph Male

Christoph Male, Associate Professor of Pediatrics, Medical University Of Vienna

14:30 DESIGNING CLINICAL TRIALS IN THE EARLY INFANCY

Zorica Zivkovic

Zorica Zivkovic, Liason Officer, CESP

·                Placebo paediatric trials – the bronchiolitis case study
·                Drug safety and efficacy in formulations that are not prepared for children
·                Drug research in children - new drugs, old drugs, dosages and method of administration
·                Overcoming practical problems in drug therapy – case studies in respiratory diseases; how early, what dose, how long? 
·                Clinical trials in neonates and during pregnancy 

15:10 Afternoon Tea

15:40 CLINICAL TRIAL DESIGN

Sue Richards

Sue Richards, Senior Research Fellow, Oxford University

·                Phase III trials. Deciding what the important questions are - what do we know at present?
·                Systematic reviews - finding them, what do they tell us and how reliable are they?
·                Doing a systematic review
·                Including other types of evidence
·                Paediatric issues

16:20 MEASURING OUTCOME IN CNS PAEDIATRIC CLINICAL TRIALS

Paul Maruff

Paul Maruff, Chief Scientific Officer, Cogstate Ltd

·                Age-associated differences in brain function
·                When to use child-specific vs altered adult measurement tools?
·                Issues with repeated assessment of children
·                How to analyse paediatric outcomes data

17:00 Chairman’s Closing Remarks and Close of Day One

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Workshops

Thinking Strategically About Paediatric Drug Development (PM)
Workshop

Thinking Strategically About Paediatric Drug Development (PM)

Crowne Plaza Hotel - The City
26th January 2007
London, United Kingdom

Crowne Plaza Hotel - The City

19 New Bridge Street
London EC4V 6DB
United Kingdom

Crowne Plaza Hotel - The City

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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