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A large number of medicines used in paediactric care have not been tested on children and are therefore used off lable or unlicensed. This absence of suitable authorised medicinal products to treat conditions in children is an issue that has been of concern for some time, and one that is increasingly coming to the fore.

Returning for its ninth year as an industry leading event, SMI are proud to present the 9th annual Paediatric Clinical Trials Conference, 25th - 26th March 2015, 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.


 

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 effectively submit a PIP that meets FDA and EMA regulations and improve skills and understanding of the responsibilities of conducting clinical research in the paediatric population. In addition, consideration of new approaches for clinical trial design to keep costs down whilst navigating the complexities of paediatric research, makes this a must-attend meeting for all individuals based in the world of paediatric trials and care.

 

Key topics include:
• Guidelines on the Paediactric Investigation Plan (PIP) – strategies to overcome any challenges
• Formulating meaningful statistics with a limited patient population
• Site selection and feasibility- identifying appropriate clinical trial sites
• Optimizing patient retention strategies for successful trial development

‘Some great and interesting presentations’ Allergan

This two day networking event will invite in depth discussion of the key drivers impacting Paediatric Clinical Trials. Join us and discover what is going in this burgeoning market to:

• Hear about strategies to covercome PIP challenges
• Meet with industry pioneers to discuss how they see the sector advancing
• Network with major players and see what your competitors are working on
• Determine efficient and effective measures to expand thinking and new approaches to clinical trial

 


Senior Vice Presidents, Vice Presidents, Directors, Heads of Department with responsibility in the following departments:-

Paediatrics
Research and development
Drug Development
Clinical research
Formulation development
Regulatory affairs
Medical writing
Analytical scientist
Medical affairs
clinical pharmacology
clinical research
Parents and patient advocacy organizers

Actelion; Agence Francaise De Securite Sanitaire Des Produits De Sante; Astellas; Austrian Agency for Health and Food Safety; Baye Oy; Bayer Pharma AG; COGSTATE LTD; Consortium for Biological and Pharmacological Evaluations (CVBF); Emerald Lake Ltd ; Empowering Children | Enabling Research ; F. Hoffmann-La Roche; F. Hoffmann-La Roche AG; Ghent University Hospital; GRiP Network of Excellence; HB Clinical; Jenny Walsh Consulting; klausrose Consulting; L2D consulting; Lundbeck; Medicines for Children Research Network (MCRN); Medimmune LLC; Novartis; Novartis Vaccines; Opsona Therapeutics Ltd; Paediatric Research Consultancy; Pharmavision; PPD Inc.; Prince Sultan Military Medical City; Quintiles; Roche Pharmaceuticals; Sanofi Pasteur MSD Ltd; Svabhegy Paediatric Hospital; TAKEDA; UCL, Great Ormond Street Hospital; University of Copenhagen;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Klaus Rose

Klaus Rose, CEO, klausrose Consulting

9:10 From the origin of US and EU pediatric legislation to today’s PIP challenges

Klaus Rose

Klaus Rose, CEO, klausrose Consulting

• The Vision of US and EU pediatric legislation
• Has medical treatment of children improved since 1997?
• Operational challenges in the pediatric discussion with the regulatory authorities
• What  can you do if you think pediatric requirements are exaggerated- tips and pointers
• Processes and procedures to limit the number of PIP modifications required

 

9:50 Paediatric clinical trials in the EU: regulatory perspective

Professor Koenraad  Norga

Professor Koenraad Norga, Head of Clinic Paediatric Oncology,, Universitair Ziekenhuis Antwerpen, Vice Chairman, Paediatric Commitee (PDCO)

• Using the EU Paediatric Regulation to develop better medicines for children

10:30 Morning Coffee

11:00 Revision of the ICH E11 guideline: status and update

Solange Rohou

Solange Rohou, Director Regulatory Affairs/Policy Europe, AstraZeneca

• Reviewing & analysing how an addendum to the current E11 guideline could address new scientific and technical knowledge advances in pediatric drug development
• Discussing how the ICH E11 currently covers many of the relevant issues for consideration in pediatric drug development and reviewing where there are gaps in contemporary guidance on several topics
• Discussing how to best address key specific topics such as the type of studies and methodology including the use of extrapolation of data in pediatric drug development, or modelling and simulation approaches as they might apply to pediatric subpopulations
 

11:40 Infectious diseases – outbreaks and crises – how to include children in clinical trials

David McIntosh

David McIntosh , Head, Global Scientific Affairs, Novartis Vaccines

• Emerging viral infections – risk and transmission in children
• Therapeutics and vaccines – treatment and prevention
• Bacterial meningitis – and end in sight
 

12:20 Networking Lunch

13:20 Pharmaceutical development of medicine for children in the PIP and Marketing Authorisation Dossiers

Diana A.  van Riet - Nales

Diana A. van Riet - Nales, Senior pharmaceutical assessor, Chemical Pharmaceutical Assessments (CFB), Member EMA Quality Working Party, , Medicines Evaluation Board in the Netherlands (MEB)

• Basic principles of the guideline on the pharmaceutical development of medicines for paediatric use
• Selection of the dosage form
• Selection of the excipients in the preparation
• User aspects
• Regulatory science
 

14:00 Optimising the role of the applicant to facilitate a smoother paediatric trial ethics review

Jane Lamprill

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

• Understanding  what the EC/IRB look for in your application and protocol
• Reviewing the aspects of legal and ethical frameworks relevant to paediatric trials
• Addressing key ethical issues e.g. information provision, minimising distress etc.
• Realising the benefits of GEP© (Good Ethical Practice) for successful paediatric trials

 

14:40 Formulating for paediatric clinical trials, pitfalls and opportunities

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)
• The oral route, organoleptics
• Where to find solutions
 

15:20 Afternoon Tea

15:40 Dosage form acceptability assessment & paediatric patient reported outcome instruments

Roy Turner

Roy Turner, Formulation Project Leader, Paediatric & Geriatric Network Leader, Technical Research & Development, Novartis Pharmaceuticals

• Paediatric clinical trials provide an opportunity for formulators to evaluate the acceptability of the dosage form being developed
• The heterogeneous patient population in paediatric clinical trials makes acceptability assessment challenging, since the ability of the patients to provide feedback varies
• Paediatric Patient Reported Outcome Instruments may act as a useful tool to help obtain accurate data
 

16:20 Innovation in paediatrics

Dr Elin Haf Davies

Dr Elin Haf Davies, Director & Founder, Empowering Children | Enabling Research

• Why we need to develop age-appropriate and disease-specific outcome measures
• Defining clinically meaningful involvement – why it’s essential
 

17:00 Optimizing patient retention strategies for successful trial development – how to keep patients on board

• Making sure patients stay on course with all study requirements to ensure the statistical validity of the clinical data analysis
• Listening to study volunteers and developing sustainable relationships throughout the trial
• Knowing what patients want and need in order to maximize retention
• Working with patients to engage them in the study and establishing the most effective methods to reach them
 

Deborah Lee

Deborah Lee, Senior Medical Director, Clinical Affairs, Lundbeck, USA

Philippe Auby

Philippe Auby, Vice President of Global Clinical Research, Paediatric Neuro-Psychiatry, Lundbeck, France

17:40 Chairman’s Closing Remarks and Close of Day One

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Klaus Rose

Klaus Rose, CEO, klausrose Consulting

9:10 Population pharmacokinetic and physiologically based pharmacokinetic modelling in paediatric regulatory submissions

Susan Cole

Susan Cole, Senior Pharmacokinetics Assessor, Statistics and Pharmacokinetics Unit, MHRA

• Determination of posology in paediatric patients usually involves an initial extrapolation from adult data. There is then an iterative process with results from one study informing the design of further studies
• Pharmacokinetic models are important to inform the extrapolation and to collate the data
• Physiologically based models offer an opportunity to mechanistically understand the drug disposition in children and to use this information to optimise clinical study design
• Population pharmacokinetic analysis affords the opportunity for sparse sampling in children and optimal use of the available data
• Pharmacodynamics may also differ in children and should be adequately described in suitable PKPD models
• It is important that size and maturation functions are adequately described in the models
• For Regulatory submissions qualification and verification of these models and the input parameters is very important
 

9:50 Transatlantic collaboration on Paediatric Investigation Plans - recent experience with Type 2 diabetes PIPs

Mette  Due Theilade Thomsen

Mette Due Theilade Thomsen, Principal Scientist, Paediatric Investigation Plan (PIP), Regulatory Affairs , Novo Nordisk A/S, Denmark

• EU Paediatric Investigation Plan vs US Paediatric Study Plan
• What to do with divergent regulatory requirements to paediatric trials
• Challenges with Type 2 Diabetes Mellitus PIPs
 

10:30 Morning Coffee

11:00 The challenges of developing the first drug for a life-threatening disease for which no approved drug exists

Cristina  De Min

Cristina De Min , Chief Medical Officer, NovImmune SA

• Creation of alternative ways to determine dose and dose frequency
• Limitations of conventional study designs in rare diseases
• Challenges in the recruitment of paediatric patients with a rare disease 
• Definition of a regulatory pathway for a disease for which no drug has ever been approved
 

11:40 Strategies for maximizing pediatric studies

Deborah Lee

Deborah Lee, Senior Medical Director, Clinical Affairs, Lundbeck, USA

• Challenges of conducting paediatric trials in orphan indications and part of life cycle management
• Use of PK modelling for establishing paediatric dosing and to support efficacy in orphan populations
• Use of patient advocates in protocol development in paediatric orphan indications
 

12:20 Networking Lunch

13:20 Considerations associated with the use of foods and beverages to assist administration of medicines to children

Terry Ernest

Terry Ernest, Formulation Team Manager, Global Formulation, Product Development , GlaxoSmithKline R&D

• Why are products mixed with food?
• Current practices of mixing with food
• Summary of recent EMA guidance
• Risks associated with mixing products with food
 

14:00 NIHR clinical research network: children support and delivery of clinical research

Sabah Attar

Sabah Attar, Divisional Head of Portfolio Operations, NIHR Clinical Research Network: Children

• Current and emerging Infrastructures 
• Delivery frameworks
• NIHR Children performance to date with key examples
• Challenges and opportunities
 

14:40 Afternoon Tea

15:10 Practical application of physiologically based pharmacokinetic modeling to select starting doses in children

Neil Parrott

Neil Parrott, Modelling & Simulation Scientist, Pharmaceutical Sciences, Roche Innovation Center Basel, Roche Pharmaceutical Research and Early Development

• Advantages and limitations of a physiologically based PK modelling approach
• A strategy for applying PBPK in drug development projects 
• Several case studies from Roche projects will be shared
 

15:50 Learning from paediatric psychopharmacology

Philippe Auby

Philippe Auby, Vice President of Global Clinical Research, Paediatric Neuro-Psychiatry, Lundbeck, France

• Practical guidance for paediatric trials using experience from paediatric psychopharmacology
• Scientific considerations and ethical challenges
• Case studies
 

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

+

FEATURED SPEAKERS

David McIntosh

David McIntosh

Head, Global Scientific Affairs, Novartis Vaccines
Deborah Lee

Deborah Lee

Senior Medical Director, Clinical Affairs, Lundbeck, USA
Klaus Rose

Klaus Rose

CEO, klausrose Consulting
Neil Parrott

Neil Parrott

Modelling & Simulation Scientist, Pharmaceutical Sciences, Roche Innovation Center Basel, Roche Pharmaceutical Research and Early Development

Cristina De Min

Chief Medical Officer, NovImmune SA
Cristina  De Min

Daniel Bar-Shalom

Associate Professor, University of Copenhagen
Daniel Bar-Shalom

David McIntosh

Head, Global Scientific Affairs, Novartis Vaccines
David McIntosh

Deborah Lee

Senior Medical Director, Clinical Affairs, Lundbeck, USA
Deborah Lee

Diana A. van Riet - Nales

Senior pharmaceutical assessor, Chemical Pharmaceutical Assessments (CFB), Member EMA Quality Working Party, , Medicines Evaluation Board in the Netherlands (MEB)
Diana A.  van Riet - Nales

Dr Elin Haf Davies

Director & Founder, Empowering Children | Enabling Research
Dr Elin Haf Davies

Jane Lamprill

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

Klaus Rose

CEO, klausrose Consulting
Klaus Rose

Mette Due Theilade Thomsen

Principal Scientist, Paediatric Investigation Plan (PIP), Regulatory Affairs , Novo Nordisk A/S, Denmark
Mette  Due Theilade Thomsen

Neil Parrott

Modelling & Simulation Scientist, Pharmaceutical Sciences, Roche Innovation Center Basel, Roche Pharmaceutical Research and Early Development
Neil Parrott

Philippe Auby

Vice President of Global Clinical Research, Paediatric Neuro-Psychiatry, Lundbeck, France
Philippe Auby

Professor Koenraad Norga

Head of Clinic Paediatric Oncology,, Universitair Ziekenhuis Antwerpen, Vice Chairman, Paediatric Commitee (PDCO)
Professor Koenraad  Norga

Roy Turner

Formulation Project Leader, Paediatric & Geriatric Network Leader, Technical Research & Development, Novartis Pharmaceuticals
Roy Turner

Sabah Attar

Divisional Head of Portfolio Operations, NIHR Clinical Research Network: Children
Sabah Attar

Solange Rohou

Director Regulatory Affairs/Policy Europe, AstraZeneca
Solange Rohou

Susan Cole

Senior Pharmacokinetics Assessor, Statistics and Pharmacokinetics Unit, MHRA
Susan Cole

Terry Ernest

Formulation Team Manager, Global Formulation, Product Development , GlaxoSmithKline R&D
Terry Ernest

Sponsors and Exhibitors

Official Media Partner

Supporters

Workshops

Pediatric Drug Development – Vision, Challenges, Strategy
Workshop

Pediatric Drug Development – Vision, Challenges, Strategy

Holiday Inn Regents Park
24th March 2015
London, United Kingdom

Interview with Conference Chairman, Klaus Rose, CEO from klausrose Consulting

Download

Q&A with Lundbeck

Download

Attendees at Paediatric Clinical Trials 2015

Download

Sponsors and Exhibitors


Molecular Profiles

Sponsors and Exhibitors
http://www.molprofiles.co.uk/

Molecular Profiles is a contract drug product development and manufacturing organization. We assist clients globally by providing pharmaceutical development services and clinical trial manufacturing, with proven expertise in development of paediatric products. We are also renowned for our expertise in materials characterization to resolve some of the toughest issues during development and in relation to intellectual property litigation.

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Trials

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Open access, peer-reviewed, online journal that encompasses all aspects of the performance and findings of randomized controlled trials in health. The journal publishes articles on general trial methodology as well as protocols, commentaries and traditional results papers - regardless of outcome or significance of findings.


Paediatrics and International Child Health

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http://www.Maneyonline.com/pch

Published by Maney, Paediatrics and International Child Health is an international forum for all aspects of paediatrics and child health in developing and low-income countries. The international, peer-reviewed papers cover a wide range of diseases in childhood and examine the social and cultural settings in which they occur. www.maney.co.uk


Samedan

Official Media Partner
http://www.samedanltd.com/magazine/13.

International Clinical Trials (ICT) is a quarterly magazine edited by Dr Graham Hughes, and written by specialists at the forefront of clinical research. ICT’s coverage of operational developments ranges from adaptive designs in early phase trials through to post marketing research. ICT’s targeted readership consists of key decision makers across the pharmaceutical and biotech industries, along with contract partners and consultants. The magazine is distributed to pharmaceutical professionals in Europe and North America, and is accessed globally online. Read the latest issues, explore the ICT archive and subscribe at www.samedanltd.com/magazine/13.

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SCRIP Intelligence is the leading source of news and strategic analysis for the global pharmaceutical industry. We filter the flood of information on the industry and apply the knowledge of our extensive network of analysts, journalists and key opinion leaders to provide our readers with timely business-critical market and competitor intelligence.


Cutting Edge

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http://www.cuttingedgeinfo.com

Cutting Edge Information provides customized research and benchmarking reports to pharmaceutical, biotechnology and other life science companies. We provide off-the-shelf and customized research for key areas including medical affairs, clinical development, market access, regulatory affairs, marketing management, sales and HCP fair market value.


British Pharmacological Society

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http://www.bps.ac.uk

The British Pharmacological Society (BPS) is the primary UK learned society concerned with research into drugs and the way they work. Our members work in academia, industry, regulatory agencies and the health services, and many are medically qualified. The Society covers the whole spectrum of pharmacology, including laboratory, clinical, and toxicological aspects. Clinical pharmacology is the medical speciality dedicated to promoting safe and effective use of medicines for patient benefit. Clinical pharmacologists work as consultants in the NHS and many hold prominent positions in UK Universities.


KONGPOSH Publications

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http://www.kppub.com

KONGPOSH Publications is one of India’s leading Pharma Publishers. The Pharma Review® is a bi-monthly article based journal covering various fields of pharmacy. Participation and distribution in over 30 Expos & Conferences worldwide each year. It is widely read by decision makers, middle management and the academia. Also available in E-book format. Other publications : Indian Pharma Reference Guide (Annual) – Names and address of Pharmaceuticals, Bulk Drugs, Machinery’s & Instrumentation, AYUSH Manufacturers; and much more; High Performance Thin Layer Chromatography; Elements of Pharmacovigilance; Regulation of Clinical Trials; AYUSH (CD); NDDS/AMD (CD)


Medical News Today

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http://www.medicalnewstoday.com

Medical News Today is the largest independent medical and health news site on the web - with over 10,000,000 monthly unique users it is ranked number one for medical news on all major search engines. Medical News Today is used by pharmaceutical, biotech and health organizations, advertising agencies, PR companies and vertical ad networks to deliver targeted campaigns to HCPs, patients and caregivers. To find out how Medical News Today can help you to reach the right audience contact peter@medicalnewstoday.com or visit www.medicalnewstoday.com.

Holiday Inn Regents Park

Carburton Street
London W1W 5EE
United Kingdom

Holiday Inn Regents Park

Choose the well-connected Holiday Inn London-Regent's Park hotel, with a superb central London location and speedy transport links. Holiday Inn London-Regent's Park is in a leafy and cosmopolitan area of central London, a 10-minute walk from bustling Oxford Street. Leave your car in our NCP managed underground car park, and explore London by Tube. Great Portland Street Tube station is 25 metres from the hotel, from where you can reach the City and Canary Wharf in 30 minutes, and London Heathrow Airport in 45 minutes.

Wireless Internet is available throughout the hotel, and you can invite up to 300 people to events at the Academy Conference Centre, with an IT technician and break-out zones. Holiday Inn London-Regent's Park is a 10-minute walk from Santander's offices and businesses in the BT Tower. Stroll 5 minutes to Regent's Park, where you'll find London Zoo and pretty Primrose Hill. We're a 10-minute walk from Bond Street boutiques and 20 minutes from Buckingham Palace and cruises on the River Thames.

Ask our Concierge to plan your day out and book West End theatre tickets. Room Service is available 24 hours at Holiday Inn London-Regent's Park, or dine in the vibrant Junction Restaurant. Our Junction Bar has a menu of light bites, and a hot breakfast buffet is served daily.

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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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Contact SMi GROUP LTD

UK Office
Opening Hours: 9.00 - 17.30 (local time)
SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
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