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SAE Media Group is pleased to present the return of their 12th annual Paediatric Clinical Trials Conference taking place on 19th – 20th March 2018, London, UK.


Clinical trials in paediatric populations still pose several challenges and often many studies remain un- published*. 10 years on from the introduction of EU Paediatric Investigation Plans (PIPs) there are still many lessons to be learned about the planning and execution of trials which should be tailored around the needs of children.
Recent advancements in immuno- oncology research has led to an increase in clinical trials to treat cancer in children and adolescents. Greater emphasis has also been placed on pain-free administration of drugs in the bid to increase vaccination uptake and access to medicines.


Join us as we discuss current clinical trials and the innovative digital technology being used to improve clinical recruitment and retention as well as improve the quality of data being collected. leading industry experts will be looking at how to work within regulations and foster the involvement of young people in their care. We will also be looking at the planning and executing of a paediatric clinical trial and the ways this can vary according to region. We will be exploring the complexities of paediatric drug formulation and helping you determine clinical endpoints. 
 

VIP Treatment:
To all the SAE Media Group delegates choosing to stay at the Copthorne Tara Hotel in February and March, we will offer an upgrade to a superior room and welcome drink voucher
 

http://bit.ly/2b7KNMy


 

  • Regulatory keynote from the MHRA on The UK's Early Access to Medicines Scheme (EAMS) and how this scheme benefits paediatric patients
  • Hear from Amgen and Roche as they give exclusive case studies on new approaches to recruitment, retention, and clinical trial design for rare diseases
  • Pfizer and Barcelona Children’s Hospital will be exploring how advancements in technology are facilitating improved clinical trials and data collection for paediatric drug development
  • AstraZeneca will be reviewing and discussing paediatric clinical trial Legislation in the EU and US.
  • There will be an exciting panel with the likes of GSK, Roche and regulatory bodies debating challenges and opportunities 10 years on from paediatric regulation in the EU and potential changes on the horizon
  • There will be multiple pharmaceutical companies (UCB, Sanofi and GSK) debating scenarios where data extrapolation and government incentives might increase access to medicines in paediatric populations
  • Discover how to optimise your approach to clinical success through global collaboration being discussed by Takeda

 

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

- Clinical Trials/ Paediatric
- Clinical Research
- Medical Officer
- Regulatory Affairs
- Clinical Operations
- (Paediatric) Drug Development
- Drug Formulation
- Medical devices
 

Alexion Pharmaceuticals; Apeiron Biologics AG; Astrazeneca; Austrian Agency for Health and Food Safety; Baxter BioPharmaceuticals; Birmingham Children's Hospital; EURODIS; Genencor International; GSK; Hoffmann-La Roche Limited; Insys Therapeutics, Inc.; Johnson & Johnson; Kiadis Pharma; KinderPharm; klausrose Consulting; mayer brown llp; MHRA; Novo Nordisk; Novo Nordisk AS; Orchard Therapeutics; Otsuka Europe Development and Commercialisation Ltd; Paediatric Research Consultancy; PHARMALEX GmbH; Proveca; Roche Products Ltd; tesa Labtec GmbH; The Doctors Laboratory Limited; The Royal Children's Hospital Melbourne; UCB Biosciences GmbH; University Hospital Ghent; Zeincro Hellas S.A.;

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Mark  Turner

Mark Turner, Chair, European Network of Paediatric Research at the European Medicines Agency and Senior Lecturer in Neonatal Medicine, University of Liverpool

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9:10

Paediatric trial design and modeling: Moving into the next decade - industry approach to innovative paediatric trial design

Claudio Fracasso, Global Paediatric Medical Director, Pfizer

• What is industry doing to improve paediatric clinical trial innovation (infrastructure, patient engagement, collaboration)
• Innovative study design and solutions
• Call for actions
 

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9:50

New methodological tools for Paediatric extrapolation

Bernard Sebastien, Pharmacometrician Clinical Trial Simulation, Sanofi

• Various levels of Paediatric extrapolation
• Bayesian approach for Paediatric extrapolation
• Paediatric extrapolation of adult Exposure-response relationships
• Paediatric extrapolation of adult efficacy data

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10:30

Morning Coffee

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11:00

Model informed Drug discovery and development (MID3) and extrapolation in Paediatric trials

Amy  Cheung

Amy Cheung, Senior Clinical Pharmacometrician, Project Manager, Paediatric Working Group, AstraZeneca

• Overview of MID3: What are the benefits?
• Regulatory expectations
• Case examples using MID3 framework
 

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11:40

Extrapolation in paediatric development: A case in partial onset seizures

Jan-Peer Elshoff

Jan-Peer Elshoff, Associate Clinical Program Director, UCB Pharma

• PBPK to estimate dosing in first paediatric study
• Population PK to adapt dose recommendations and predict IV dosing
• Support of dose selection by PK-PD using adult data and data from a second compound

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12:20

Optimising recruitment by ensuring family friendly information for paediatric clinical trials

Jane Lamprill, Paediatric Research Consultant & Specialist Medical Writer for Children and Adults, Member H2020 Ethics Panel, European Commission. Owner and Director, Paediatric Research Consultancy and Please Read Carefully Lay Language Communications


• The challenges of paediatric study information provision
• Brief overview legal and ethical framework
• Top tips to avoid ethics committee pitfalls
• Brief overview of consent assent and dissent
• Information considerations for parents
• Information considerations for different age children
 

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13:00

Networking Lunch

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14:00

Patient involvement in paediatric research and medicines development

Joana Claverol

Joana Claverol, Clinical Research Unit Manager, Barcelona Children’s Hospital

• The voice of children in research: The European YPAG (Young Persons’ Advisory Group) network
• Collaborative research with the involvement of parents of children with rare disease
• Rare commons and Share4Rare platform

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14:40

Preparing for clinical trials in paediatric rare diseases

Meghan Thorne-Miller, Project Leader and Discovery Scientist, Rare Diseases, Roche

• Understanding the disease and patient population
• Adopting a patient centric approach. Importance of the patient/caregiver perspective
• Selecting relevant outcome measures
• Early engagement with regulatory authorities

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15:20

European collaboration on paediatric research and regulation

Mark  Turner

Mark Turner, Chair, European Network of Paediatric Research at the European Medicines Agency and Senior Lecturer in Neonatal Medicine, University of Liverpool

• Patient recruitment across borders and the current state of European Networks
• How might Brexit impact the development and approval of new medicines will be regulated in the UK and are PIPs still likely to apply?
• What are the funding options for paediatric clinical research in the UK and the rest of Europe?
• Ensuring children have access to new medicines
 

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16:00

Afternoon Tea

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16:30

Paediatric medicine regulation in the EU: What are the challenges and opportunities 10 years on?

Sabine Fuerst-Recktenwald

Sabine Fuerst-Recktenwald, Senior Medical Director Paediatric Oncology, Roche

Mark  Turner

Mark Turner, Chair, European Network of Paediatric Research at the European Medicines Agency and Senior Lecturer in Neonatal Medicine, University of Liverpool

clock

17:10

Paediatric drug development and multiregional regulatory considerations

Martine Dehlinger-Kremer, Vice President, Global Scientific and Medical Affairs , Synteract

• Global paediatric collaboration and how paediatric drug development differs according to countries
• Paediatric research initiatives and networks: Exploring how these can improve drug development
• Developing a common scientific approach to enable effective patient access to approved medicines
 
 

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17:50

Chairman’s Closing Remarks and Close of Day One

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Philippe Auby, CEO & President, OEDC, Otsuka Europe Development and Commercialisation Ltd

clock

9:10

Extrapolation in severe eosinophilic asthma: case studies using partial and full extrapolation approaches

• Regulatory background and interactions
 

Caroline Townsend, Global Regulatory Affairs, Respiratory, GSK

• Regulatory background and interactions
 

Isabelle Pouliquen, Clinical pharmacology Modelling and Simulation, GSK

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9:50

The UKs Early Access to Medicines Scheme (EAMS) – How can the scheme benefit paediatric patients?

Dominik Karres, Medical Assessor, Biologicals Unit, LD, MHRA

• The Promising Innovate Medicines (PIM) designation and the scientific opinion – what is the procedure and how does it work?
• How to weigh the risks and the benefits in cases of small numbers
• Real life examples
 

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10:30

Morning Coffee

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11:00

Live attenuated influenza vaccination in children

Maria Zambon

Maria Zambon, Deputy Director National Infection Service, Public Health England

• Experience of live attenuated influenza vaccine (LAIV) introduction in the UK
• Challenges and successes
• Improving strain selection
• Discussion of unanswered scientific questions

clock

11:40

Early phase clinical trials in children: How paediatric pharmacology can help?

Dan Hawcutt, Senior Lecturer Paediatric Clinical Pharmacology, The Royal Liverpool Children's Hospital trust

• Developing a deliverable protocol
• Adapting risks and benefits to needs of children and parents
• Delivering the study safely, and to time and target
• Capacity building within the specialty: developments in paediatric pharmacology training in the UK including the addition of early phase clinical trial experience and Faculty of Pharmaceutical medicine collaboration
 

clock

12:20

Directions in therapeutic vaccination in children

David McIntosh, Honorary Clinical Senior Lecturer , Imperial College London

• How can successes in adult therapeutic vaccination be translated to children?
• What therapeutic areas in children may benefit from this approach?
• The immune systems of adults and children: similarities and differences
• What are the sorts of clinical trials that need to be performed in children?
 

clock

13:00

Chairman’s Closing Remarks and Close of Day Two

clock

13:30

Networking Lunch


Senior Clinical Pharmacometrician, Project Manager, Paediatric Working Group
AstraZeneca
Pharmacometrician Clinical Trial Simulation
Sanofi
Global Regulatory Affairs, Respiratory
GSK
Global Paediatric Medical Director
Pfizer
Senior Lecturer Paediatric Clinical Pharmacology
The Royal Liverpool Children's Hospital trust
Senior Fellow and Senior Director, Clinical Pharmacology
GSK
Honorary Clinical Senior Lecturer
Imperial College London
Medical Assessor, Biologicals Unit, LD
MHRA
Member of the Brussels and Paris Bar, Partner
mayer brown llp
Clinical pharmacology Modelling and Simulation
GSK
Paediatric Research Consultant & Specialist Medical Writer for Children and Adults, Member H2020 Ethics Panel, European Commission. Owner and Director
Paediatric Research Consultancy and Please Read Carefully Lay Language Communications
Associate Clinical Program Director
UCB Pharma
Clinical Research Unit Manager
Barcelona Children’s Hospital
Deputy Director National Infection Service
Public Health England
Chair, European Network of Paediatric Research at the European Medicines Agency and Senior Lecturer in Neonatal Medicine
University of Liverpool
Vice President, Global Scientific and Medical Affairs
Synteract
Project Leader and Discovery Scientist, Rare Diseases
Roche
CEO & President, OEDC
Otsuka Europe Development and Commercialisation Ltd
Senior Medical Director Paediatric Oncology
Roche

Official Publication

Supporters

Workshops

Paediatric regulation: From PIP to rewards
Workshop

Paediatric regulation: From PIP to rewards

Copthorne Tara Hotel
21 March 2018
London, United Kingdom

VENUE

Copthorne Tara Hotel

Scarsdale Place, Kensington, London, United Kingdom

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.

 

A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
HOTEL BOOKING FORM

Amy Cheung, AstraZeneca - Interview

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Paediatric Clinical Trials - Sample Delegate List from 2017

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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, SAE Media 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@saemediagroup.com

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Contact SAE Media Group

UK Office
Opening Hours: 9.00 - 17.30 (local time)
SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
Website: http://www.smgconferences.com Email: events@saemediagroup.com
Registered in England - SMi Group Ltd trading as SAE Media Group




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Full details of our privacy policy can be found here https://www.smgconferences.com/privacy-legals/privacy-policy/.
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