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SMi is proud to present the 10th Paediatric Clinical Trials Conference, 16th – 17th March 2016, London. This event will look at the paediatric therapeutic developments, directives and procedures which have been put in place to protect children taking part in clinical trials.

Many treatments of today are the result of past clinical trials. The need for improving strategies in conducting paediatric clinical trials has never been greater. Even if the costs linked trials are not always affordable, pharmaceutical industries continue to expand their research.

A series of interactive conference sessions, roundtables and panel discussion facilitated by leading industry experts will provide executives with useful tools and best practices to develop analgesics in paediatric population, implement a strategy regulatory partnership through collaboration, explore innovations in drug formulation, monitor and audit issues specific to paediatric research and utilize clinical pharmacology to model adult data to paediatrics.
 

• Discuss the framework of US and EU Paediatric Legislation
• Evaluate approaches for recruitment and retention
• Review the challenges in paediatric drug development developing new oncology drugs for children
• Learn about safety considerations of paediatric clinical trial
• Explore recent development in paediatric trials in the US
• Study the role of analgesics in paediatric population
• Analyse why paediatric formulation does really matter
 

Directors, Chiefs, VPs, Heads, Managers, Principals of:

  • Clinical Trials/ Paediatric
  • Clinical Research
  • Regulatory Affairs
  • Clinical Operations
  • (Paediatric) Drug Development
  • Drug Formulation
     

Appletree CI Group AG; AstraZeneca; Boehringer-Ingelheim; Bracket; Celgene International; Empowering Children | Enabling Research ; F. Hoffmann-La Roche AG; GlaxoSmithKline R&D; GSK; INC Research; Janssen Pharmaceutica NV; Janssen pharmaceutical companies; KAIMRC; klausrose Consulting; Lundbeck; Medicines for Children Research Network (MCRN); MHRA; Molecular Profiles; Novartis Pharmaceuticals; Novartis Vaccines; NovImmune SA; Novo Nordisk A/s; Novo Nordisk A/S, Global developement; Novo Nordisk A/S, Global Development; Paediatric Research Consultancy; PharmaLex; ROCHE DIAGNOSTICS GMBH; Roche Holding A G; Roche pharma ltd; Sequani Limited; TAKEDA; The Evelina London Children Hospital; The Medicines Evaluation Board ; UCB BioSciences; UCB Biosciences GmbH; Universita Di Pavia; Universitair Ziekenhuis Antwerpen; University of Copenhagen; Voisin Consulting Life Sciences; Ziarco Pharma;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Klaus Rose

Klaus Rose, CEO, klausrose Consulting

9:10 Update of the frameworks of US and EU paediatric legislation

Klaus Rose

Klaus Rose, CEO, klausrose Consulting

  • Paediatric legislation US and UE
  • Challenges in paediatric negotiations with FDA and UE 
  • Scientific and operational challenges of the UE PIPs
  • 9:50 Challenges in paediatric drug development - developing new oncology drugs for children

    Sabine Fuerst-Recktenwald

    Sabine Fuerst-Recktenwald, Senior Medical Director Paediatric Oncology, Roche Pharma Schweiz AG

  • The 'optimal' timing
  • A more sustainable and more actionable based drug development model
  • Historical adult centric vs. integrated paediatric development at Roche
  • Long-term safety considerations
  • 10:30 Morning Coffee

    11:00 Panel Discussion: Paediatric microdosing

  • Microtracer technology in early clinical development, of added value in PIP
  • Alternative pharmacokinetic phenotyping in children
  •  Monitoring Phase II drug metabolism
  • Esther Van Duijn

    Esther Van Duijn, Scientist, TNO

    Daniel Bar-Shalom

    Daniel Bar-Shalom, Associate Professor, University of Copenhagen

    Klaus Rose

    Klaus Rose, CEO, klausrose Consulting

    11:40 Towards a better understanding of bioethics and paediatric drug development and clinical trials

    Albert Allen

    Albert Allen, Medical Director, Eli Lilly And Company

  • How bioethics is a fundamental justification for the need for paediatric drug development efforts
  • Differences between bioethics in paediatric vs. adult research, differences in the US vs. EU approaches
  • Bioethics and the design and implementation of a well-conceived paediatric drug development plan
  • Bioethics and the design and implementation of individual paediatric clinical trials at different phases of development
  • 12:20 Networking Lunch

    14:00 Prelicensing strategies to support paediatric development

    Karl-Heinz Huemer

    Karl-Heinz Huemer, Scientific Office, Austrian Agency for Health and Food Safety

  • Paediatric Investigation Plans (PIP)
  • Scientific advice, orphan Drugs, advanced therapies
  • Global development
  • 14:40 Safety considerations of paediatric clinical trial

    Robert Kahn

    Robert Kahn, Senior Safety Science Leader, Genentech

  • Current safety challenges and opportunities in paediatric drug development
  • Understanding unique paediatric safety concerns
  • Novel methods to address short and long-term safety issues in children
  • 15:20 Afternoon Tea

    15:50 Children on the move: Travel, trials and tests

    David McIntosh

    David McIntosh , Honorary Clinical Senior Lecturer - Imperial College London, Imperial College

     

    ·         Diseases affecting children who travel and migrate
    ·         Treatment or prevention? Trials in children on the move
    ·         Lab tests, sample transport, data-bases: keeping trak

    16:30 Chairman’s Closing Remarks and Close of Day One

    Klaus Rose

    Klaus Rose, CEO, klausrose Consulting

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Philippe Auby

    Philippe Auby, Vice President of Clinical Development – Paediatrics, Lundbeck

    9:10 Paediatric drug development, a bottom up approach with the SAFEPEDRUg-project

    Johan Vande Walle

    Johan Vande Walle, Professor in Paediatric Nephrology, University Hospital Ghent

  • Understanding the patient, age, disease specific problems
  • Alternative paediatric drug research
  • Need for studies in critical ill children and neonates
    ·                          
  • 9:50 Development of bosentan in paediatric PAH patients with modeling support

    Martine Gehin

    Martine Gehin, Clinical Pharmacologist, Actelion

  • PBPK modeling and paediatric dose finding
  • PopPK modeling
  • Interactions with health authorities
  • 10:30 Morning Coffee

    11:00 Formulation challenges in paediatric drug development

    Daniel Bar-Shalom

    Daniel Bar-Shalom, Associate Professor, University of Copenhagen

  • Understanding the patient, age specific problems
  • Excipients, do and do not (mostly do nots)
  • Organoleptic in the oral route
  • Where to find solutions and inspiration
  • 11:40 Why paediatric development does really matter? Psychopharmacology as a paradigm

    Philippe Auby

    Philippe Auby, Vice President of Clinical Development – Paediatrics, Lundbeck

  • Considerations for dosing frequency, stability and storage requirements
  • Impact on the progress and success of clinical trials
  • Improving formulation on the safety profile and efficacy of medicines for children
  • Decreasing the risks of adverse drug reactions
  • 12:20 Networking Lunch

    13:30 Challenges of drug development in rare diseases - inhalation anthrax

    Sangeeta Sedani

    Sangeeta Sedani, Clinical Investigation Lead, GlaxoSmithKline R&D

  • Background to raxibacumab as a recently developed drug for treatment of inhalation anthrax
  • Regulatory challenges for developing a PIP
  • Study design of field studies
  • Logistical challenges of implementing clinical studies during a public health emergency
  • 14:10 Networking in paediatric oncology

    Ellen Bolotin

    Ellen Bolotin, Global Clinical Leader in Paediatrics , Bayer Corporation

     

    • Improving drug formulation

    • Facilitating paediatric formulation development through existing data

    • Using innovative technologies in adults that can be used to develop new paediatric formulations

    14:50 Afternoon Tea

    15:20 How to write clinical trial information for parent and children ?

    Jane Lamprill

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

     

     

     

     

     

  • Introduction to consent and dissent
  • Brief overview ethical and regulatory requirements
  • Information needs for different age children and their parents
  • Tips to ensure clear communication
  • Information and respect for cultural differences
  • 16:00 Challenges in paediatric drug development, example with Down syndrome

    Xavier Liogier

    Xavier Liogier, Clinical Scientist, Hoffmann La Roche Ltd

  • Global development strategy
  • Operational aspects
  • Selection of endpoints
  • 16:40 Chairman’s Closing Remarks and Close of Day Two

    Philippe Auby

    Philippe Auby, Vice President of Clinical Development – Paediatrics, Lundbeck

    +

    FEATURED SPEAKERS

    Daniel Bar-Shalom

    Daniel Bar-Shalom

    Associate Professor, University of Copenhagen
    Philippe Auby

    Philippe Auby

    Vice President of Clinical Development – Paediatrics, Lundbeck

    Albert Allen

    Medical Director, Eli Lilly And Company
    Albert Allen

    Daniel Bar-Shalom

    Associate Professor, University of Copenhagen
    Daniel Bar-Shalom

    David McIntosh

    Head, Global Scientific Affairs, Novartis Vaccines
    David McIntosh

    David McIntosh

    Honorary Clinical Senior Lecturer - Imperial College London, Imperial College
    David McIntosh

    Ellen Bolotin

    Global Clinical Leader in Paediatrics , Bayer Corporation
    Ellen Bolotin

    Esther Van Duijn

    Scientist, TNO
    Esther Van Duijn

    Jane Lamprill

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

    Johan Vande Walle

    Professor in Paediatric Nephrology, University Hospital Ghent
    Johan Vande Walle

    Karl-Heinz Huemer

    Scientific Office, Austrian Agency for Health and Food Safety
    Karl-Heinz Huemer

    Klaus Rose

    CEO, klausrose Consulting
    Klaus Rose

    Martine Gehin

    Clinical Pharmacologist, Actelion
    Martine Gehin

    Philippe Auby

    Vice President of Clinical Development – Paediatrics, Lundbeck
    Philippe Auby

    Robert Kahn

    Senior Safety Science Leader, Genentech
    Robert Kahn

    Ronald Rosenburg

    Head Global Clinical Development Strategy, Grunenthal GmbH
    Ronald Rosenburg

    Sabine Fuerst-Recktenwald

    Senior Medical Director Paediatric Oncology, Roche Pharma Schweiz AG
    Sabine Fuerst-Recktenwald

    Sangeeta Sedani

    Clinical Investigation Lead, GlaxoSmithKline R&D
    Sangeeta Sedani

    Xavier Liogier

    Clinical Scientist, Hoffmann La Roche Ltd
    Xavier Liogier

    Supporting Media Partners

    Supporters

    Workshops

    Drug Development in the Paediatric Population
    Workshop

    Drug Development in the Paediatric Population

    Holiday Inn Kensington Forum
    15th March 2016
    London, United Kingdom

    VENUE

    Holiday Inn Kensington Forum

    97 Cromwell Road , London, United Kingdom

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

    HOTEL BOOKING FORM

    Preliminary list of 2016 attendees

    Download

    Speaker interview - Deborah Lee, VP of Clinical Development, INSYS Therapeutics, Inc.

    Download

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    Paediatrics and International Child Health

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    Holiday Inn Kensington Forum

    97 Cromwell Road
    London SW7 4DN
    United Kingdom

    Holiday Inn Kensington Forum

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

    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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