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SMi’s 5th annual conference on Paediatric Clinical Trials will explore a range of key issues relating to the involvement of children in pharmaceutical development. There will be a strong focus on preparing paediatric investigation plans (PIPs) and complying with legislation laid out by the European Medical Agency's paediatric committee (PDCO). Attendees will have access to presentations from a variety of senior industry professionals and renowned academic experts.

Following the conference there will be a specialised half-day workshop on Preparing a Paediatric Investigation Plan which will examine the different stages of PIP preparation. Topics covered will include negotiation with the European Medicines Agency and the PDCO, the challenges of PIP execution and reporting results. It will give practical tuition on how to scan the FDA and EMEA websites.

 


 View the conference programme

 Register for the event

 Download the brochure

 


 

"An excellent opportunity to share experiences and discuss key issues" Paediatric Clinical Trials 2010 attendee 

 

All clinical trials present a multitude of logistical challenges but when products are tested on children study design must conform to a whole different set of regulations and standards. In 2007, the European Medicines Agency Paediatric Committee (PDCO) introduced new clinical trial requirements to protect children who take part in clinical trials and pharmaceutical companies are still dealing with the repercussions.

Key topics at this year's Paediatric Clinical Trials conference:

  • Paediatric Investigation Plan regulatory compliance strategy
  • Identification of adverse drug reactions in children
  • Practical guidance for Phase III and IV paediatric trials
  • Formulation, pharmacokinetics and pharmacogenomics research priorities in paediatric trials
  • Non-invasive biomarkers for drug safety in paediatrics
 

Pharmaceutical and biotech industry professionals with responsibilities in the following areas:

  • Paediatric Research 
  • Clinical Logistics
  • Regulatory Affairs
  • Medical Affairs
  • Quality Assurance
  • Patient Recruitment
  • Drug Monitoring
  • Compliance
  • Pharmacovigilance

 


Previous attendees have included representatives from the following organisations:

  • Allergy Therapeutics
  • Astellas Pharma Europe
  • Astrazeneca
  • Bayer Schering Pharma
  • Boehringer Ingelheim
  • Celgene
  • Covance
  • Eli Lilly
  • Fulcrum Pharma
  • GE heatlhcare
  • GlaxoSmithKline
  • Grunenthal
  • Ipsen
  • Johnson & Johnson
  • King's College London
  • Laboratorios Almirall
  • Medical Products Agency
  • Merck Serono
  • Nestlé
  • Norgine
  • Novartis
  • Novo Nordisk
  • Nycomed
  • Orion Clinical Services
  • Parexel
  • Pfizer
  • Roche Products
  • Sanofi Pasteur MSD
  • Shire Pharmaceuticals
  • Takeda

 

Conference programme

8:30 Registration and coffee

9:00 Chairman's opening remarks

Stephen Heaton

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

9:10 Paediatric clinical development plans: A clinical pharmacology perspective

Bruno Reigner

Bruno Reigner, Senior Clinical Pharmacologist, Roche Pharmaceuticals

  • A two-step model, with an exploratory dose finding and a confirmatory efficacy/safety trial
  • Adding the paediatric bridging elements to the two-step model
  • Paediatric bridging and regulatory guidance
  • Challenges in paediatric drug development: The high failure rate in paediatric confirmatory trials, exploring possible reasons
  • Future directions in paediatric drug development, including Trials Simulations to design the confirmatory study
  • 9:50 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
  • Extrapolating data from adults to children
  • Overcoming the challenges currently faced in PIPs
  • 10:30 Morning coffee

    11:00 PIP CASE STUDY

    Marcelo Marotti

    Marcelo Marotti, Global Research and Development Physician, AstraZeneca

  • Addressing unmet needs in paediatric oncology and aligning with the regulations
  • Designing a feasible study that allows for interpretable efficacy and safety data
  • Alignment of academia, pharma and regulators to reach a meaningful common ground
  • 11:40 Identification of adverse drug reactions in children: Challenges and opportunities

    Peter Helms

    Peter Helms, Professor of Child Health, University of Aberdeen

  • What does routinely acquired health service data contain?
  • Methods for linking datasets
  • Key ethical, confidentiality and data protection issues
  • Methods for generating pharmacovigilance signals
  • 12:20 Networking lunch

    13:50 Paediatric safety risk management in clinical trials

    Stephen Heaton

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

  • Impact of child development and adverse events in paediatric trials
  • Risk minimisation tools appropriate for the paediatric setting
  • Establishing paediatric safety management teams
  • Evaluating safety sections of paediatric clinical trials
  • Study protocols
  • 14:30 Clinical trial design tailored for children

    Paola Baiardi

    Paola Baiardi, Executive Board Member, Task-force in Europe for Drug Development for the Young (TEDDY)

  • TEDDY NoE five year experience
  • How to face the issues of small samples.
  • Compliance to guidelines and innovative approaches
  • Regulatory framework
  • 15:10 Afternoon tea

    15:40 Using a national network for paediatric clinical trials

    William van't Hoff

    William van't Hoff, Co-Director, National Institute for Health Research Medicines for Children Research Network (MCRN), England

  • Integrating trial design and delivery
  • Improving efficiency of study performance
  • Enhancing children and families input to paediatric trials
  • Supporting pharmaceutical industry in paediatric trials
  • 16:20 Paediatric clinical research in dermatology

    Diep Tran

    Diep Tran, Principal Medical Advisor, LEO Pharma

  • Dermatology (equals use of topical medicine) in children, ARDs & percutaneous toxicities
  • Differences between dermatologic and systemic treatment
  • Examples of registered drugs/PIPs. What could be improved?
  • Conclusions
  • The way forward
  • 17:00 Chairman’s closing remarks and close of day one

    8:30 Registration and coffee

    9:00 Chairman's opening remarks

    Klaus Rose

    Klaus Rose, Prinicipal Consultant, Granzer Regulatory Consulting & Services

    9:10 Lessons learnt from interaction with EMA /PDCO

    Klaus Rose

    Klaus Rose, Prinicipal Consultant, Granzer Regulatory Consulting & Services

  • The complex process of early planning for paediatric development
  • Timeframe for PIP submission in EU, paediatric discussion with FDA and potential conciliation of requirements
  • Strategic decision making in negotiation with EMA and FDA
  • The EMA negotiation process
  • Resources absorbed for paediatric drug development in pharmaceutical industry
  • The societal impact of EU and US paediatric legislation
  • 9:50 KEYNOTE ADDRESS

    Himanshu  Upadhyaya

    Himanshu Upadhyaya, Senior Medical Advisor, ADAP Team, Neuroscience Platform, Eli Lilly

  • Ethical concerns
  • Research infrastructure
  • Logistical issues
  • Data quality related issues
  • 10:30 Morning coffee

    11:00 Ethical considerations for clinical trials performed in children: European Commission Ethics Committee

    E. David Mcintosh

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

  • Paediatric healthy volunteer studies
  • Issues to be taken into consideration when planning a paediatric study
  • General Medical Council: Ethical considerations in paediatric consent
  • Compassionate and innovative treatments in children: A proposal for an ethical framework
  • 11:40 Are member states ready to pay for new upcoming paediatric medicines?

    Vincent Grek

    Vincent Grek, President, Only For Children Pharmaceuticals

  • Regulation: What says the new European paediatric regulation with regard to pricing?
  • Is Paediatric-Use Marketing Authorisation (PUMA) a real incentive?
  • Review of pricing policy in Europe and presentation of the French model
  • New model for pricing: Can government, pharma companies and patient associations invent new cooperative models for financing paediatric medicines?
  • 12:20 Networking lunch

    14:00 Tips for successful recruitment and participation in paediatric clinical trials

    Sylvie Jouve

    Sylvie Jouve, Associate Director, Vaccines and Infectious Diseases Department, Pfizer

  • Improving child selection e.g. diagnosis
  • Revisiting parents’ consent and child’s assent content and process
  • Facilitating parents’ and child’s compliance to study requirements and procedures
  • 14:40 Non-invasive biomarkers for drug safety in paediatrics

    Heike Rabe

    Heike Rabe, Consultant Neonatologist and Lead for Research, Trevor Mann Baby Unit, Brighton and Sussex University Hospitals NHS Trust

  • Applications
  • Monitoring drug effects
  • Reduction of risk in PIP
  • Short and long term outcome measures
  • 15:20 Company decision options when faced with PDCO requests

    Klaus Rose

    Klaus Rose, Prinicipal Consultant, Granzer Regulatory Consulting & Services

    Bruno Reigner

    Bruno Reigner, Senior Clinical Pharmacologist, Roche Pharmaceuticals

    E. David Mcintosh

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

    Philippe Auby

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

    Vincent Grek

    Vincent Grek, President, Only For Children Pharmaceuticals

    16:00 Chairman’s closing remarks and close of conference

    +

    Workshops

    Preparing a Paediatric Investigation Plan
    Workshop

    Preparing a Paediatric Investigation Plan

    The Rubens at the Palace
    26th January 2011
    London, United Kingdom

    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.

     

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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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