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SMi 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 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.
 

http://bit.ly/2b7KNMy


 

Explore advancements technology for clinical trials and data collection for paediatric drug development
Review and discuss paediatric clinical trial Legislation in the EU and US and changes on the horizon
Debate scenarios where data extrapolation and government incentives might increase access to medicines in paediatric populations
Optimise your approach to clinical success through global collaboration
Evaluate new approaches to recruitment and retention for rare diseases

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 programme

8:30 Registration & Coffee

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

9:10 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

9:50 Paediatric trial design and modeling: Moving into the next decade - industry approach to innovative paediatric trial design

Claudio Fracasso

Claudio Fracasso, Global Pediatric 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
 

10:30 Morning Coffee

11:00 New methodological tools for Paediatric extrapolation

Bernard Sebastien

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

11:40 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
 

12:20 Networking Lunch

13:30 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

14:10 Optimising recruitment by ensuring family friendly information for paediatric

Jane Lamprill

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

Optimising recruitment by ensuring family friendly information for paediatric clinical trials
• 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
 

14:50 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

15:30 Afternoon Tea

16:00 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
 

16:40 Paediatric medicine regulation in the EU: What are the challenges and opportunities 10 years on?

• What effect have PIPs (paediatric investigation plans) had on the quality of the paediatric clinical trials and has this translated into greater efficiency in access to new approved medicines?
• What are future changes/limitations to paediatric research?
• Should extrapolation be the norm?
• How can these challenges be overcome now and in the future?

Sabine Fuerst-Recktenwald

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

Daren Austin

Daren Austin, Senior Fellow and Senior Director, Clinical Pharmacology, GSK

Mark  Turner

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

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

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Philippe  Auby

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

9:10 Preparing for clinical trials in paediatric rare diseases

Meghan Thorne-Miller

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

9:50 Extrapolation in severe eosinophilic asthma: case studies using partial and full extrapolation approaches

• Regulatory background and interactions
 

Caroline Townsend

Caroline Townsend, Global Regulatory Affairs, Respiratory, GSK

Daren Austin

Daren Austin, Senior Fellow and Senior Director, Clinical Pharmacology, GSK

10:30 Morning Coffee

11:00 Development plan and phase 2 data of the bi – specific T cell engager (BiTE) blinatumomab in paediatric B – precursor acute lymphoblastic leukemia (ALL)

Gerhard 	 Zugmaier

Gerhard Zugmaier, Executive Medical Director Global Development, Amgen

• Mechanism of action
• Development program
• Efficacy in paediatric ALL
• Changes in laboratory parameters
• Summary
 

11:40 Advances in paediatric formulation development: Baby steps

Trupti Dixit

Trupti Dixit, Director, Strategy and Operations, Takeda

• What are the “Expectations” versus “Reality”?
• What approaches can be taken to bridge the gap in formulation development
• Conclusions
 

12:20 Networking Lunch

13:30 The UKs Early Access to Medicines Scheme (EAMS) – How can the scheme benefit paediatric patients?

Dominik Karres

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
 

14:10 Paediatric drug development and multiregional regulatory considerations

Solange Rohou

Solange Rohou, Senior Director Regulatory Affairs and Policy , AstraZeneca

• 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
 
 

14:50 Afternoon Tea

15:20 Early phase clinical trials in children: How paediatric pharmacology can help?

Dan Hawcutt

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
 

16:00 Directions in therapeutic vaccination in children

David  McIntosh

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?
 

16:40 Advanced therapy medical products (ATMPs) in Children

Robb Kahn

Robb Kahn, Drug Safety Consultant Clinical Development, Kite Pharma

• The status of development of cell and gene therapies in the EU
• The path to translation outside of the academic realm and into licensed, marketable medicines.
• Discussion of CAR T therapy for children with ALL as a model for ATMPs in paediatrics
 

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

+

FEATURED SPEAKERS

Bernard Sebastien

Bernard Sebastien

Pharmacometrician Clinical Trial Simulation, Sanofi
Caroline Townsend

Caroline Townsend

Global Regulatory Affairs, Respiratory, GSK
Claudio Fracasso

Claudio Fracasso

Global Pediatric Medical Director, Pfizer
Dan Hawcutt

Dan Hawcutt

Senior Lecturer Paediatric Clinical Pharmacology, The Royal Liverpool Children's Hospital trust
Mark  Turner

Mark Turner

Chair, European Network of Paediatric Research at the European Medicines Agency and Senior Lecturer in Neonatal Medicine, University of Liverpool
Meghan Thorne-Miller

Meghan Thorne-Miller

Project Leader and Discovery Scientist, Rare Diseases, Roche
Solange Rohou

Solange Rohou

Senior Director Regulatory Affairs and Policy , AstraZeneca
Trupti Dixit

Trupti Dixit

Director, Strategy and Operations, Takeda

Amy Cheung

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

Bernard Sebastien

Pharmacometrician Clinical Trial Simulation, Sanofi
Bernard Sebastien

Caroline Townsend

Global Regulatory Affairs, Respiratory, GSK
Caroline Townsend

Claudio Fracasso

Global Pediatric Medical Director, Pfizer
Claudio Fracasso

Dan Hawcutt

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

Daren Austin

Senior Fellow and Senior Director, Clinical Pharmacology, GSK
Daren Austin

David McIntosh

Honorary Clinical Senior Lecturer , Imperial College London
David  McIntosh

Dominik Karres

Medical Assessor, Biologicals Unit, LD, MHRA
Dominik Karres

Gerhard Zugmaier

Executive Medical Director Global Development, Amgen
Gerhard 	 Zugmaier

Jane Lamprill

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

Jan-Peer Elshoff

Associate Clinical Program Director, UCB Pharma
Jan-Peer Elshoff

Joana Claverol

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

Klaus Rose

CEO, klausrose Consulting
Klaus Rose

Maria Zambon

Deputy Director National Infection Service, Public Health England
Maria Zambon

Mark Turner

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

Meghan Thorne-Miller

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

Philippe Auby

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

Robb Kahn

Drug Safety Consultant Clinical Development, Kite Pharma
Robb Kahn

Sabine Fuerst-Recktenwald

Senior Medical Director Pediatric Oncology, Roche
Sabine Fuerst-Recktenwald

Solange Rohou

Senior Director Regulatory Affairs and Policy , AstraZeneca
Solange Rohou

Trupti Dixit

Director, Strategy and Operations, Takeda
Trupti Dixit

Workshops

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.

 

HOTEL BOOKING FORM

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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, 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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