To attend, contact Fateja Begum on Tel +44 (0) 20 7827 6184, Fax +44 (0) 20 7827 6185, email fbegum@smi-online.co.ukor visit www.smi-online.co.uk/ts05.asp to register online

SMi MASTERCLASS SERIES 2015

SMi Training Presents an Interactive Two-Part Special Masterclass...

Paediatric DrugDevelopmentHOSTED BY:

Dr. Philippe Auby, Vice President of Global Clinical Research Paediatric Neuro-Psychiatry, H. Lundbeck A/SDr. Vanessa Poustie, Assistant Theme Lead, NIHR CRN Coordinating Centre, University of LiverpoolDr. William van’t Hoff, National Children’s Specialty Lead, University of Liverpool

Overview:Global drug development is changing as paediatric drug development has become an essential partof it, with the need to obtain paediatric information for medicines used in children being a consensusin the EU. Established permanent paediatric regulations requiring early planning and regulatorysubmissions, and a new paradigm is now emerging i.e. protecting children through clinical research.

The Masterclass will focus on how clinical expertise and leadership, alongside the involvement ofchildren and families, can improve the design of, and facilitate the delivery of paediatric medicinesresearch. This will be demonstrated by national and international models of network support, andacross a broad spectrum of paediatric conditions, and will provide an overview of key global initiativesavailable within paediatrics.

Why You Should Attend:This highly successful masterclass will feature two back-to-back dedicative sessions regarding themanagement and research requirements of paediatric clinical trials, as well as an oversight of theinfrastructure for EU-wide and UK research programs.

Delegates will gain an insight into the factors that influence the feasibility of running paediatric studies,and an oversight of the global initiatives, facilities and infrastructure available to support drugdevelopment for children.

MC 443

2015

9th

Central London

DEC

Book by 30th September and save £100Book by 31st October and save £50

@SMIPHARM

To attend, contact Fateja Begum on Tel +44 (0) 20 7827 6184, Fax +44 (0) 20 7827 6185, email fbegum@smi-online.co.uk or visit www.smi-online.co.uk/ts05.asp to register online

Paediatric Drug Development

PART 1

8.30 Registration and Coffee

9.00 Opening remarks and introductions

9.10 Session 1: Clinical research in paediatricpharmacology:

• Planning your paediatric development with astrategic angle: When is paediatrics appropriate?

• Geographic differences of regulatory requirements • Identifying special requirements in planning each

stage of  clinical trials and how to implement them • Case study: Analysis of failures and successes;

Evaluating grey areas and possible solutions invalidation, treatment selection and dose prediction

10.30 Morning Coffee

11.00 Session 2: Designing and managing paediatricclinical trails

• Advancing understanding of drug “paediatric”efficacy and communicating drug safety specific to children and adolescents

• Ethical and scientific challenges • Managing multinational clinical research

programs

11.40 Session 3: Psychiatric development to supportpaediatric research in drug development

• Understanding the consequences of psychiatricpharmacology in providing adequate support for treatment

• Case study: Addressing psychotropic requirements in drug treatment

12.20 Close of session

12.20 Lunch

PART 2

13.30 Session 4: Supporting the development ofpaediatric research

• Opening remarks from the National Children’sSpecialty Lead for England

• Case study outlining how network expertisehelps to develop feasible study design anddelivery

• Involving children and young people in thedesign and delivery of paediatric studies

14.10 Session 5: Delivering paediatric studies • A UK model of network support for paediatric

research • A case study demonstrating the impact of

network support on study delivery

14.50 Afternoon Tea

15.20 Session 6: International initiatives in researchdelivery

• The European network of paediatric researchnetworks

• Emerging global collaborative approaches

16.00 Session 7: Global Research in Paediatrics (GRIP) • Summary of the key projects and outputs of

the GRIP programme

16.40 Closing remarks

Who Should Attend:Chief Executives, Vice Presidents, Heads, Directors and Project Leaders of:

• Clinical Trial ProjectManagement

• Clinical Research• Clinical Trial Design• Paediatrics

• Research and Development Projects

• Regulatory Affairs• Medical Affairs• Toxicology

• Clinical Pharmacology• Medical Advisors• Patient Safety• Medical Writing• Risk Management

FULL DAY PROGRAMME

To attend, contact Fateja Begum on Tel +44 (0) 20 7827 6184, Fax +44 (0) 20 7827 6185, email fbegum@smi-online.co.uk or visit www.smi-online.co.uk/ts05.asp to register online

Paediatric Drug Development

About your masterclass leaders:

Dr. Philippe Auby, MD is an Adult, Child and Adolescent Psychiatrist. He started his residency training

in Psychiatry in 1986 and received his MD from Toulouse University of Medicine, France. In 1989 and

1990, he worked as a psychiatrist in South East Refugee Camps in Thailand.

After his training in adult psychiatry, he completed a board certification in child and adolescent psychiatry and

a post-graduate diploma in psychology.

In 1996, he joined a CRO based in Paris before moving first to Eli Lilly France then to BMS France. In 2001, he moved

to BMS European Headquarter in Belgium prior working for Otsuka America Pharmaceutical, in 2004, working on

paediatric development. Early 2007, Dr Auby moved to Lundbeck to create and lead the paediatric clinical

research department. He is now Vice President of Global Clinical Research Paediatric Neuro-Psychiatry.

Dr William van’t Hoff is a paediatric nephrologist based at Great Ormond Street Hospital in London, and is the

NIHR National Specialty Lead for Children’s Research in England. He was previously the Joint Director of the NIHR

Medicines for Children’s Research Network (MCRN) and led the London and South East MCRN. Dr van’t Hoff is

also the Director of the Clinical Research Facility at Great Ormond Street Hospital.

About the Organisation:

The National Institute for Health Research (NIHR) Clinical Research Network (CRN) provides world-class Health

Service infrastructure to support clinical research in the NHS in England. The University of Liverpool is an Alliance

Partner in the NIHR CRN Coordinating Centre and is the national coordinating centre for the NIHR CRN Children’s

Specialty. This builds on the long-standing role the University of Liverpool has played in the national coordination

of the MCRN from 2005-2015.

If you have NOT received registration confirmation within 48 hours of registering, please call +44 (0) 20 7827 6184

PAEDIATRIC DRUG DEVELOPMENTWednesday 9th December 2015, Central London

4 WAYS TO REGISTER

POST your booking form to: Fateja Begum, SMi Group Ltd, 2nd FloorSouth, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK

ONLINE at www.smi-online.co.uk/ts05.asp

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EARLY BIRDDISCOUNTS

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