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SMi are proud to present their 7th annual conference on Paediatric Clinical Trials. This unique event will provide attendees with a complete view of the paediatric market, focusing on regulatory requirements, clinical trial design and formulation development. This informative conference will bring together key opinion leaders provide attendees with an in depth look into current advances in paediatric clinical trials and drug development. Building on the success of our previous events this exciting event conference will also be a focus on ethical issues surrounding the increase in outsourcing clinical investigations to developing countries and provide attendees with a unique opportunity to network with key industry professionals.

This unique conference will bring together distinguished industry leaders, regulatory representatives and leading academics to discuss the key topics in this fast paced field and will be an excellent opportunity to develop PIP strategies and discuss regulatory requirements.

 

 

 

 

 

 

 

 

Key Benefits of Attending Include:

  • Develop strategies for patient recruitment and retention
  • Overcome obstacles in paediatric clinical trial design
  • Evaluate benefits of locating clinical trials in emerging markets
  • Consider new EMA polices and guidelines on Paediatric Investigation Plans (PIP)
  • Discuss the PIP negotiation process with the EMEA/PDCO
  • Understand patient representative perspective
  • Hear the latest in paediatric vaccine development
  • Network with key industry, academic and regulatory representatives

This conference is unmissable for Pharmaceutical and Biotech professionals in positions such as:

Clinical Trial Project Manager
Head of Paediatrics
Director of Clinical Research
Clinical Research Associate
R & D Project Leader
Director of Regulatory Affairs
Director of Medical Affairs

Chief Medical Officer
Toxicologist
Clinical Pharmacologist
Senior Medical Advisor
Formulation Development
Patient Safety & Risk Management
Managing Director

All Russian Institute for Scientific and Technical Information; Baker & Mc Kenzie; Betsson group; Donaghadee Health Centre; E-Control; E-Laad; Elster G Mb H; EMMESSAR BIOTECH & NUTRITION LTD; Iskraeneco D D; Modern Meters Co; Northrop Grumman AGS&BMS; Selboune House; SELEX Systems Integration; Sensus; Shanghai Metering Works Corp; SREEPATHI LAB PVT LTD; swb Bremerhaven GmbH; SWU Stadtwerke Ulm/Neu-Ulm GmbH; T-mobile; ToolClarity; University of Science&Technology; Vodafone Limited; White Hat Rally 2011; Wyeth Research;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Klaus Rose

Klaus Rose, MD, klausrose Consulting

9:10 Paediatric Legislation: Challenges and Impact on Drug Development

Klaus Rose

Klaus Rose, MD, klausrose Consulting

• Background of EU & US paediatric legislation
• Scientific & operational challenges of the Paediatric Investigation Plan (PIP)
• Better medicines for children Vs medicines for adults developed in children
• A tentative assessment of the impact of the EU legislation

9:50 Do I really need a PIP? The importance of understanding the impact of patent/SPC status

Steve Pinder

Steve Pinder, Director, Envestia

• What does the pharmaceutical and SPC legislation say?
• How do I know if my patent qualifies for an SPC?
• What is the impact of the ECJ Neurim judgement?
• Who is responsible for deciding what?
• What are the consequences of getting it wrong?

10:30 Morning Coffee

10:50 Challenges in Paediatric Clinical Development: Planning, Designing and Implementing Clinical Trials

  • Conducting clinical studies in children: study design and technical aspects
  • Paediatric clinical trials environment
  • Feasibility surveys
  • Recruitment-Retention-Motivation
  • Case study
  • Anna La Noce

    Anna La Noce, Executive Medical Director, inVentiv Health Clinical

    11:30 A legal perspective on the activites of the PDCO

    Genevieve Michaux

    Genevieve Michaux, Partner, Covington & Burling

    12:10 Paediatric Vaccine Development

    David McIntosh

    David McIntosh , Medical Director, Novartis Vaccines

  • Licensure based on immunogenicity of efficacy
  • Post-authorisation safety commitments in immunisation
  • Herd protection and the success of conjugate vaccines
  • Viral vaccines eg influenza, rotavirus and human papilloma virus
  • Re-emerging infections and emerging infections: trials
  • Reverse vaccinology
  • 12:50 Networking Lunch

    14:10 Non-clinical safety studies in juvenile animals

    Luc De Schaepdrijver

    Luc De Schaepdrijver, Scientific Director Fellow Toxicology and Pathology, Johnson & Johnson Pharmaceutical Research and Development

    • Non-clinical studies : decision strategies and place in paediatric drug development
    • Juvenile animal toxicity studies (JAS) : why ? when ? how ? 
    • Value of JAS for clinical paediatric trials and for the product label
    • Case examples

    14:50 Designing and implementing paediatric clinical trials: the example of paediatric psychopharmacology

    Philippe Auby

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

    • Understanding ethical and scientific challenges
    • Overcoming practical issues
    • Example of published or ongoing paediatric clinical trials
    • Practical examples

    15:30 Afternoon Tea

    15:50 Focusing your paediatric IRB/ethics committee applications to help avoid study time delays

    Jane Lamprill

    Jane Lamprill, Paediatric Research Consultant Specialist Medical Writer for Children and Member FP7 Ethics Panel, Paediatric Research Consultancy

    • Background and overview of key ethical issues
    • An ethics committee perspective
    • Learning from past experiences and case studies
    • Implementing Good Ethical Practice© to improve success

    16:30 Patient representative perspectives

    Jennifer Newman

    Jennifer Newman, PPI Manager, Medicines for Children Research Network

    • The importance of involving patients and families in the design and delivery of research (explanation of the MCRN model)
    • Examples of involvement – impact of patients and families
    • Disseminating research findings to patients and families to encourage wider participation in trials

    17:10 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Florentine Nieuwmeyer

    Florentine Nieuwmeyer, Associate Scientific Director, Astellas Pharma International BV

    9:10 Developments in Paediatric Blood Sampling

    Lisa Moore-Ramdin

    Lisa Moore-Ramdin, Medical Affairs Manager, Glaxo SmithKline Ltd

  • EU Directives, ICH GCP, and Local Guidelines
  • Minimum blood volumes
  • Lab facilities
  • Staff training in venepuncture and logistics of sampling
  • Consent/Assent
  • 9:50 Improving Recruitment and Retention in Paediatric Clinical Trials: A Rational Path Forward

    Michael Spigarelli

    Michael Spigarelli, Professor of Internal Medicine, Pediatrics and Pharmacy, University of Utah School of Medicine

  • Understand the complexities involved with respect to paediatric trial participation
  • Contrast successful and less than successful strategies
  • Examine the role protocol design factors into improving or worsening the problem
  • Discuss strategies to decrease recruitment time, increase effectiveness and improve satisfaction by parents, care providers and paediatric participants
  • 10:30 Morning Coffee

    11:00 Paediatric Medicine Management

    Steve Tomlin

    Steve Tomlin, Consultant Pharmacist Childrens Services, Evelina Children's Hospital

  • What makes children different? - Is it just size?
  • Quality Assurance of paediatric medicines
  • Ensuring patient compliance
  • Best practice techniques
  • 11:40 Paediatric formulation development

    Hannah Batchelor

    Hannah Batchelor, Paediatric Formulations Research Fellow, University Of Birmingham

  • Designing accurate and safe formulation
  • Specific needs for paediatric medicines – including those related to
  • physiological and anatomical differences
  • Developing age-appropriate formulations
  • 12:20 Formulation development of an acceptable drug product for the

    Florentine Nieuwmeyer

    Florentine Nieuwmeyer, Associate Scientific Director, Astellas Pharma International BV

    13:00 Networking Lunch

    14:20 Tackling the Paediatric Dosage-Form Formulation Issues

    Daniel Bar-Shalom

    Daniel Bar-Shalom, Associate Professor, University of Copenhagen

  • Pairing the right dosage form with the (actual) patient
  • Stability considerations
  • Dose adjustment
  • Choice of excipients (read: dodging trouble)
  • 15:00 Clinical pharmacology considerations in paediatric drug development:

    Bruno Reigner

    Bruno Reigner, Senior Clinical Pharmacologist, Roche Pharmaceuticals

  • The high failure rate in paediatric confirmatory trials, exploring
  • possible reasons
  • A two-step approach to avoid dosing mistakes
  • Extrapolation: current practice and recent developments
  • Modeling and simulation approaches: timing and benefits
  • 15:40 Panel discussion: What lies ahead for the future of peadiatric clinical development?

  • Reducing barriers to international market entry
  • Maintaining relationships with local health authorities
  • Managing local resources directly
  • Improving flexibility
  • Klaus Rose

    Klaus Rose, MD, klausrose Consulting

    Philippe Auby

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

    Florentine Nieuwmeyer

    Florentine Nieuwmeyer, Associate Scientific Director, Astellas Pharma International BV

    Daniel Bar-Shalom

    Daniel Bar-Shalom, Associate Professor, University of Copenhagen

    Bruno Reigner

    Bruno Reigner, Senior Clinical Pharmacologist, Roche Pharmaceuticals

    16:10 Afternoon Tea

    16:40 Chairman’s Closing Remarks and Close of Day Two

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    FEATURED SPEAKERS

    Bruno Reigner

    Bruno Reigner

    Senior Clinical Pharmacologist, Roche Pharmaceuticals
    David McIntosh

    David McIntosh

    Medical Director, Novartis Vaccines
    Lisa Moore-Ramdin

    Lisa Moore-Ramdin

    Medical Affairs Manager, Glaxo SmithKline Ltd
    Luc De Schaepdrijver

    Luc De Schaepdrijver

    Scientific Director Fellow Toxicology and Pathology, Johnson & Johnson Pharmaceutical Research and Development

    Anna La Noce

    Executive Medical Director, inVentiv Health Clinical
    Anna La Noce

    Bruno Reigner

    Senior Clinical Pharmacologist, Roche Pharmaceuticals
    Bruno Reigner

    Daniel Bar-Shalom

    Associate Professor, University of Copenhagen
    Daniel Bar-Shalom

    David McIntosh

    Medical Director, Novartis Vaccines
    David McIntosh

    Florentine Nieuwmeyer

    Associate Scientific Director, Astellas Pharma International BV
    Florentine Nieuwmeyer

    Genevieve Michaux

    Partner, Covington & Burling
    Genevieve Michaux

    Hannah Batchelor

    Paediatric Formulations Research Fellow, University Of Birmingham
    Hannah Batchelor

    Jane Lamprill

    Paediatric Research Consultant Specialist Medical Writer for Children and Member FP7 Ethics Panel, Paediatric Research Consultancy
    Jane Lamprill

    Jennifer Newman

    PPI Manager, Medicines for Children Research Network
    Jennifer Newman

    Klaus Rose

    MD, klausrose Consulting
    Klaus Rose

    Lisa Moore-Ramdin

    Medical Affairs Manager, Glaxo SmithKline Ltd
    Lisa Moore-Ramdin

    Luc De Schaepdrijver

    Scientific Director Fellow Toxicology and Pathology, Johnson & Johnson Pharmaceutical Research and Development
    Luc De Schaepdrijver

    Michael Spigarelli

    Professor of Internal Medicine, Pediatrics and Pharmacy, University of Utah School of Medicine
    Michael Spigarelli

    Philippe Auby

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

    Steve Pinder

    Director, Envestia
    Steve Pinder

    Steve Tomlin

    Consultant Pharmacist Childrens Services, Evelina Children's Hospital
    Steve Tomlin

    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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