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Paediatric Clinical Trials

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


 

FEATURED SPEAKERS

Bernard Sebastien

Bernard Sebastien

Pharmacometrician Clinical Trial Simulation, Sanofi
Claudio Fracasso

Claudio Fracasso

Global Paediatric Medical Director, Pfizer
Dan Hawcutt

Dan Hawcutt

Senior Lecturer Paediatric Clinical Pharmacology, The Royal Liverpool Children's Hospital trust
David  McIntosh

David McIntosh

Honorary Clinical Senior Lecturer , Imperial College London
Dominik Karres

Dominik Karres

Medical Assessor, Biologicals Unit, LD, MHRA
Mark  Turner

Mark Turner

Chair, European Network of Paediatric Research at the European Medicines Agency and Senior Lecturer in Neonatal Medicine, University of Liverpool
Martine Dehlinger-Kremer

Martine Dehlinger-Kremer

Vice President, Global Scientific and Medical Affairs , Synteract
Meghan Thorne-Miller

Meghan Thorne-Miller

Project Leader and Discovery Scientist, Rare Diseases, Roche

Amy Cheung

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

Bernard Sebastien

Pharmacometrician Clinical Trial Simulation, Sanofi
Bernard Sebastien

After a PhD in statistics Bernard Sebastien worked in phase 2/phase 3 drug development, as project statistician, at Synthelabo, and then Sanofi. In 2006, he worked in early development/clinical pharmacology Biostatistics still in Sanofi. Since 2010 Bernard has been fully dedicated to Modelling and Simulation activities in Sanofi.

Caroline Townsend

Global Regulatory Affairs, Respiratory, GSK
Caroline Townsend

Caroline Townsend began her career in pharmacovigilance before moving to Global Regulatory Affairs at GlaxoSmithKline. Since then she has provided regulatory support to a broad range of products in various therapeutic areas. Currently she is working in the Respiratory area at GSK providing regulatory support to a product with multiple indications and associated paediatric investigation plans.

Claudio Fracasso

Global Paediatric Medical Director, Pfizer
Claudio Fracasso

Claudio Fracasso graduated as a Medical Doctor at the University of Bari, Apulia, Italy, where he also completed his specialization in Infectious Diseases, and got the certification for medical practice. Since early ‘90s he has been involved in basic and clinical research, with focus on clinical management and therapy of HIV-infected subjects, at the Clinic of Infectious Diseases of Bari, and then for a few years at the Microbiology and Tumorbiology Center of the Karolinska Institute in Stockholm, Sweden.
In 1997 he was appointed Senior Researcher at the Superior Institute of Health in Rome, Italy, the research body of the Ministry of Health, for the setup of the preclinical evaluation of a candidate anti-HIV vaccine, currently in clinical evaluation.
In 1999 he joined Wyeth in the CR&D department being responsible for the medical oversight of clinical trials conducted in several Mediterranean countries, with close attention to those involving vulnerable populations. In this role he followed several phase 1 to 3 pediatric trials in different therapeutic areas, developing new tools specific for children.
In 2010, Claudio joined Pfizer as Regional Clinical Development Director, being responsible of the scientific integrity and medical oversight of clinical trials, and he was almost fully dedicated to children’s clinical studies, working very closely with the most important children’s hospitals in South Western Europe, becoming a reference point in Europe for the Pfizer Pediatric Center of Excellence, that he joined in 2016 as Global Pediatric Medical Director.
He is collaborating with several organizations outside Pfizer, including the Children’s Working Party at the European Forum for Good Clinical Practice, the Children Research Industry Group in UK, the IMI-2 Call 10 Sponsor Consortium, and he is making available his experience in the creation and growth of children’s advocacy groups in Italy and Europe. Claudio is lecturer at the Master on Clinical Research at the Catholic University of Rome. 
 

Dan Hawcutt

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

Dan Hawcutt is a paediatric pharmacologist working at the University of Liverpool and Alder Hey Children’s hospital. He graduated from the University of Liverpool, before working in Nottingham and Oxford, and returning to Liverpool. He has research interests in pharmacogenomics (precision dosing, and genomic risk factors for adverse drug reactions in children), early phase clinical trials (antimicrobials, cystic fibrosis), and pharmacovigilance (including hard to access paediatric populations). He is clinical lead for the NIHR Alder Hey clinical trials unit, a specialist paediatric early phase trials unit based within Alder Hey, and is chair of the Alder Hey drugs and therapeutics committee, and a member of the Royal College of Paediatrics and Child Health Medicines Committee. He also supervises the clinical and academic training of junior doctors in Paediatric Clinical Pharmacology and Therapeutics.

Daren Austin

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

David McIntosh

Honorary Clinical Senior Lecturer , Imperial College London
David  McIntosh

Dr E. David G. McIntosh AM is an Australian paediatrician (with dual Australian and British nationality), vaccinologist and infectious disease specialist. David joined Takeda Vaccines as Senior Director Policy and Scientific Affairs (Vaccines) on 1st September 2015, and became Regional Medical Affairs Lead, Latin America, on 7th December 2015.

Previously, David was Head, Global Scientific Affairs at Novartis Vaccines from 29th April 2014, and Global Scientific Affairs Senior Expert there, from 1st December 2009. Prior to this, David was Medical Director Vaccines and Infectious Diseases Europe/Middle East/Africa at Wyeth Pharmaceuticals. He worked on pneumococcal conjugate vaccines, the intra-nasal cold-adapted influenza vaccine, the antibiotics tigecycline and piperacillin-tazobactam, and the anti-parasitic agent moxidectin, for the treatment of River Blindness (onchocerciasis) in Africa.

He originally trained as a medical doctor in Sydney, Australia, and specialised in paediatric infectious diseases and public health. His early work was in Papua New Guinea, the Northern Territory of Australia, Peru, Argentina, New Zealand and the UK.

His early research was on early-onset Group B streptococcal in Sydney. His MPH treatise involved the study of chronic suppurative otitis media in Australian Aborigines. His PhD thesis described the molecular epidemiology of hepatitis B virus in recent immigrant families to Australia. He co-authored the landmark 50-year follow-up of the original congenital rubella syndrome patients. His post-doctoral work was on gene therapy for hepatitis, in the Department of Medicine at Imperial College, a university in London, UK.

David completed a four-year Higher Medical Training period in Pharmaceutical Medicine at the Royal College of Physicians, London, and is on the Specialist Register of the UK as a Pharmaceutical Physician and as a Paediatrician. He has written chapters on hepatitis A and hepatitis B vaccination, pneumococcal vaccination, paediatric clinical pharmacology, paediatric clinical trials, post-infectious sequelae and long-term consequences of infectious diseases, efflux pumps, respiratory infections and meningococcal vaccination. In May 2012 he obtained another post-graduate degree, a Master’s degree in Medical Law and Ethics (LLM), the dissertation for which was on the subject of maternal immunisation.

David is the founder and Artistic Director of the Glebe Music Festival in Sydney, Australia, founded in 1990: www.glebemusicfestival.com

David is an Honorary Clinical Senior Lecturer at Imperial College, London, and Honorary Professor at the Scientific Center for Children’s Health, Moscow, Russia. He is an ECDC Expert. On 13th June 2011 in the Queen’s Birthday Honours List he was appointed as a Member in the General Division of the Order of Australia, within the Australian Honours System. He holds the following qualifications: MBBS, MPH, LLM, PhD, FAFPHM, FRACP, FRCP&CH, FFPM, DRCOG, DCH, Dip Pharm Med.
 

Dominik Karres

Medical Assessor, Biologicals Unit, LD, MHRA
Dominik Karres

Dominik’s clinical background is in Paediatrics with special interest in paediatric oncology. He worked in Germany and the UK, last as a clinical research fellow in paediatric oncology drug development at the Royal Marsden Hospital. He as an MD in paediatric drug development and published several book chapters and articles in Peer-reviewed journals on the topics of therapeutic drug monitoring and drug development in children. Since beginning of 2014 he works as a medical assessor at the MHRA, now in the Biologicals Unit of the Licensing Division.

Genevieve Michaux

Member of the Brussels and Paris Bar, Partner, mayer brown llp
Genevieve Michaux

Geneviève Michaux is a partner in the Government & International Trade group of Mayer Brown's Brussels office. She is a Belgian- and French-qualified lawyer who focuses on European and national (French and Belgian) food and drug law, with particular emphasis on issues surrounding the regulation of drugs, biologics, medical devices, cosmetics and food both at the Union and national levels.


Her work covers a wide range of issues, including regulatory status of borderline products, life cycle management, clinical trials and investigations, labeling and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. Geneviève provides assistance to companies on important new legislative projects and policy developments in the EU. She regularly instructs and supervises local counsels for pan-European or worldwide projects. She also has broad litigation experience in life science matters, including product liability, advertising and promotional activities, and generic approvals.


Geneviève is recognized as one of the "Most Highly Regarded Individuals" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an "unsurpassed knowledge of legal areas," as well as being "extremely dedicated to the case and the client." She has published a number of articles on food and drug law and regularly speaks at legal and regulatory conferences on pharmaceuticals and medical devices.
 

Isabelle Pouliquen

Clinical pharmacology Modelling and Simulation, GSK
Isabelle Pouliquen

Dr Isabelle Pouliquen Pharm D is a Clinical Pharmacologist with more than 20 years of experience in drug development in the pharmaceutical industry. She has been involved in the development of both small and large molecules across multiple therapeutic areas, from early phase of development to submissions. During the past five years, she has been extensively involved in the design and implementation of extrapolation strategies for paediatric drug development in common and rare diseases.

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
Jane Lamprill

Paediatric Research ConsultancyTM (PRC) based near London was founded in 2004 by Jane Lamprill RN RSCN FICR. Jane trained as a sick children’s nurse at Great Ormond Street Hospital for Children. She was Senior Research Sister/SSC for 17 years organising and performing industry and academic paediatric trials & was Paediatric Research Advisor for Origin Pharmaceutical Services. Since 2008 Jane has been an ethics expert for the European Commission, reviewing research grant applications with e.g. European Research Council. Her advice and family friendly information & artwork have helped clients significantly improve recruitment and compliance. She provides protocol feasibility reports for practical, ethical and operational issues which have helped smooth ethics committee/IRB reviews. Jane has just launched another PRC called Please Read CarefullyTM. This will focus on lay language communications for EMA Layperson clinical trial summaries. www.janelamp.co.uk and www.laylanguage.com

Jan-Peer Elshoff

Associate Clinical Program Director, UCB Pharma
Jan-Peer Elshoff

Joana Claverol

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

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

Martine Dehlinger-Kremer

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

Dr. Martine Dehlinger-Kremer is Vice President, Global Scientific and Medical Affairs at Synteract, a CRO with headquarters in California.
She is the President of EUCROF, the European CRO Federation and a Board member of EFGCP, the European Forum for GCP.

Dr. Dehlinger-Kremer has over 30 years of experience in the clinical research industry, including 28 years of progressively higher levels of Regulatory and Medical Affairs leadership responsibility.

Dr. Dehlinger-Kremer has contributed to the global development of numerous products, including orphan drugs and biosimilars. She has participated in more than 100 New Drug Applications (NDAs) and Marketing Authorization Applications (MAAs) globally and in numerous clinical studies across all phases.

Dr. Dehlinger-Kremer has served as Chair of the Paediatric Working Group of EUCROF since 2008 and is chair of the EFGCP Children Medicines Working Party. She is also Member of two Working Parties of Enpr-EMA, the European Network of Paediatric Research at the European Medicines Agency.
Dr. Dehlinger-Kremer has influenced the standards, protocols and number of trials conducted for drugs being administered to children.

Dr Dehlinger-Kremer was Named One of PharmaVOICE 100’s Most Inspiring People in Life Sciences (Industry leader recognized for impact, experience and advocacy in clinical research) in August 2015.


Dr. Dehlinger-Kremer holds a doctorate in sciences from the University of J.W. Goethe in Frankfurt, a general academic studies degree in neurophysiology from the Louis Pasteur University in Strasbourg, France, and a Master of Science from the University Moulin de la House in Reims, France.
 

Meghan Thorne-Miller

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

Meghan is a Discovery Project Leader in the Rare Diseases group at Roche in Basel, Switzerland. Bridging the interface between pre-clinical development and clinical translation, her work focuses on bringing the science and patient perspective to clinical trial design.
Meghan earned her PhD in Biomedical Sciences from the department of Pharmacology at the University of California, San Diego in 2010. Joining Roche in 2012, she first worked as a postdoc in the Neuroscience department before joining the Rare Diseases group in 2015.
 

Philippe Auby

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

Philippe Auby is an Adult, Child and Adolescent Psychiatrist. He 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 board certification in adult psychiatry, he completed a board certification in child and adolescent psychiatry.
In 1996, he joined a CRO in Paris before moving to Eli Lilly and BMS. In 2001, he moved to BMS European Headquarter in Belgium prior working for Otsuka America working on paediatric development. Early 2007, he moved to Lundbeck to lead paediatric clinical development until 2016 and was Vice President of Clinical Development, Paediatrics. He is currently CEO & President of Otsuka Europe Development and Commercialisation.

 

Sabine Fuerst-Recktenwald

Senior Medical Director Paediatric Oncology, Roche
Sabine Fuerst-Recktenwald

Conference agenda

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8:30

Registration & Coffee

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9:00

Chair's Opening Remarks

Genevieve Michaux

Genevieve Michaux, Member of the Brussels and Paris Bar, Partner, Mayer Brown LLP

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9:10

SESSION 1 – Do I need a PIP?

Genevieve Michaux

Genevieve Michaux, Member of the Brussels and Paris Bar, Partner, Mayer Brown LLP

  • Exemptions
  • New active substances
  • 'Old' (authorised) active substances
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    9:50

    SESSION 2 – What should the PIP cover?

    Genevieve Michaux

    Genevieve Michaux, Member of the Brussels and Paris Bar, Partner, Mayer Brown LLP

  • EMA Policy on the Content of the PIP
  • Waiver
  • Deferral
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    10:30

    Morning Coffee

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    11:00

    SESSION 3 – Procedures

    Genevieve Michaux

    Genevieve Michaux, Member of the Brussels and Paris Bar, Partner, Mayer Brown LLP

  • Paediatric Procedure: PIP and PIP modification
  • Interactions with the Marketing Authorisation Procedure: from compliance check to authorisation of a paediatric indication
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    11:40

    SESSION 4 – Rewards

    Genevieve Michaux

    Genevieve Michaux, Member of the Brussels and Paris Bar, Partner, Mayer Brown LLP

  • Extension of supplementary protection certificate (SPC) protection
  • Orphan products: extension of market exclusivity protection
  • PUMA
  • How to maximise the chances of obtaining a reward
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    12:20

    Closing Remarks

    Genevieve Michaux

    Genevieve Michaux, Member of the Brussels and Paris Bar, Partner, Mayer Brown LLP

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    13:50

    End of workshop

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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

    clock

    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

    clock

    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
     

    clock

    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

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    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
     

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    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

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    Paediatric regulation: From PIP to rewards

    Paediatric regulation: From PIP to rewards

    Copthorne Tara Hotel
    21 March 2018
    London, United Kingdom

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    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.
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    Amy Cheung, AstraZeneca - Interview

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    Paediatric Clinical Trials - Sample Delegate List from 2017

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    Inderscience is a dynamic, leading, independent journal publisher. The company disseminates the latest research across the broad fields of science, engineering and technology; management, public and business administration; environment, ecological economics and sustainable development; computing, ICT and internet/web services, and related areas. Inderscience offers over 35 years' experience in publishing and has succeeded in building a substantial collection approaching 400 high-quality peer-reviewed international research journals in both online and print formats. We offer a variety of ways to keep up-to-date with the latest published leading-edge research while our online collection represents a fully-searchable digital archive of around 60,000 articles.


    Copybook - Pharmaceutical

    Supporters
    http://www.copybook.com/pharmaceutical

    Copybook is a global business network with many pharmaceutical events, exhibitions and seminars. We encourage business-to-business transactions and work tirelessly to gain our customers new business contracts worldwide. You can add events, companies and associations for free. When you are a member, you can add your company to the events listed in order to encourage other visitors to arrange meetings and appointments at those events to facilitate new business contracts. Want to see how we can increase your business network and transactions? SIGN UP FOR FREE today! Copybook – Your Global Business Network


    Labsave

    Supporters
    http://www.labsave.com

    Labsave is the leading savings website for Laboratory Equipment and Lab Supplies. We work closely with the top suppliers in the world to bring you the best products at the most competitive prices. We are constantly striving to secure the biggest and most exclusive offers that you won’t find anywhere else! http://www.labsave.com/


    Medical News Today

    Supporters
    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.


    CanBiotech

    Supporters
    http://www.canbiotech.com

    CanBiotech - A Portal and B2B Outsourcing Marketplace for the Biotech and Pharmaceutical Industry. The Marketplace features the Outsourcing Services Showcase; the Portal features our biopharmaceutical and venture capital directories and databases. Publications include the BioMedical Outsourcing Report and the Bio Outsourcing Asia© Publication.


    Gate2Biotech

    Supporters
    http://www.gate2biotech.com

    Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


    European Biotechnology Network

    Supporters
    http://european-biotechnology.net/

    The European Biotechnology Network is dedicated to facilitating co-operation between professionals in biotechnology and the life sciences all over Europe. The non-profit organisation brings research groups, universities, SMEs, large companies and indeed all actors in biotechnology together to build and deliver partnerships.


    SciDoc Publishers

    Supporters
    http://www.scidoc.org

    SciDoc Publishers is a major source provider of e-journals in the field of Science, Technology and Medicine (STM). The nature of journals - Open Access and Peer-reviewed. We are aimed with a sole motive in making a mark in the field of Open Access, by propagating the knowledge to the scientific community. Our prime concern involves, the knowledge to reach millions of readers and give them access to scientific publications - online.


    Select Science

    Supporters
    http://www.selectscience.net/

    SelectScience is an independent, online information resource for the worldwide scientific community, and the home of trusted information for laboratory scientists. Discover impartial, expert opinion and trusted reviews about latest laboratory equipment and techniques; plus videos, application notes and science news from around the world. Become a member for free today.


    Samedan

    Supporters
    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.


    Swiss Biotech Association

    Supporters
    http://www.swissbiotech.org/

    The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.


    Journal for Clinical Studies – Your Resource for Multisite Studies & Emerging Markets

    Supporters
    http://www.JforCS.com

    Published bi-monthly.JCS is a unique journal, dedicated to providing information to the global pharmaceutical, biotechnology, medical devices and contract research organisations. JCS details practical and theoretical operational procedures, challenges, validatory and regulatory guidelines when conducting trials on a multisite basis and particularly within the emerging markets, naïve patient population, and remote access areas. JCS provides country by country objectives and uniquely brings you experiences in therapeutic areas of Liver diseases, kidney diseases, insect borne diseases, malnutrition and under nutrition. JCS is led by a strong editorial advisory board sourced out for their experiences; you will get the most practical insight for your global studies. JCS invites you to join us, write for us, feature your experiences with us, advertise your capabilities with us, and ask our advisory board for suggestions and guidelines. Let us make health care available to all.


    Absave

    Supporters
    http://www.absave.com

    Absave.com is the leading savings website for Antibodies and Immunological Products. Search our extensive database of Antibodies, Kits, Proteins & Peptides, Reagents, etc. to find the best savings!


    Drug Development Technology

    Supporters
    http://www.drugdevelopment-technology.com

    Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval. Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.


    Pharmavision

    Supporters
    http://www.pharmavision.co.uk

    PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.


    Pharmalicensing

    Supporters
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


    Mednous

    Supporters
    http://www.MedNous.com

    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


    Contract Biotechnology

    Supporters
    http://www.contract-biotechnology.com

    Contract-Biotechnology.com is a web-based platform for laboratory outsourcing solutions. It is an online R&D matching tool that connects Scientifics and service and product providers worldwide. The platform Contract-Biotechnology.com would help you in the process of finding the right partner saving time and money, because with one single and secure application you would be able to receive multiple quotes quickly, keeping your contact information confidential. Contract-Biotechnology.com is the new Collaboration Network Model for Discovery Research and Development. Contract-Biotechnology.com team has extensive experience working for pharmaceuticals, biotechs, universities and academic research institutes and can help you addressing your key gaps.


    Bentham Science

    Supporters
    http://www.benthamscience.com/

    Bentham Science Publishers is a major STM journal publisher of 130 plus print and online journal. Out of these, 40 journals have already registered good IMPACT FACTORS as per Journal Citation Reports® 2017. These titles have extensive readership mostly in Europe and North America. For a detailed profile please visit our website at http://www.benthamscience.com. Besides, Bentham Science publishes eBooks in all areas of Science, Technology and Medicine. Our eBooks provide professionals, academicians, corporate researchers, graduates and undergraduates worldwide with the most current information in their subject areas of interest. Our eBooks are also available in the ePub and Kindle formats besides the PDF edition here http://ebooks.benthamscience.com/. Bentham is offering attendees of this conference discounts on its publication. For more information click here


    Biosave

    Supporters
    http://www.Biosave.com

    Biosave.com brings together the best Life Science promotions, product releases, featured products, publications, videos and events from 100’s of leading Life Science suppliers. Updated 24 hours a day, Biosave is constantly uploading special promotions and exciting product news that you won’t find anywhere else. Our goal is to provide our users with the most exclusive product information to help reach that all important purchasing decision.


    Pharmaceutical-Review

    Supporters
    http://www.pharmaceutical-review.com

    Pharmaceutical-review.com is part of Integrated IQ technologies Private Limited(IIQ). A Leading platform for all the Pharma manufacturing companies and buyers across the world.Having a subscriber database of more than 120,000 globally helping the clients to reach their target buyers through our exclusive listing, branding(banner advertisement), e-news letters, e-mail marketing, product reviews, product launch promotions, event marketing, search engine marketing and social media marketing services.


    ASD MEDIA

    Supporters
    http://www.asd-network.com

    Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
    • Be informed on the latest market developments; www.asd-network.com
    • Find the latest business news; www.asd-network.com
    • Find the upcoming events; www.asd-network.com
    • Find companies and organizations; www.asdsource.com
    • Distribute news globally. www.asdwire.com
    The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

    For more detailed information please contact with: ASD MEDIA
    Stefan.koopman@asdmedia.nl


    PharmaVOICE

    Supporters
    http://www.pharmavoice.com

    PharmaVOICE magazine, and its supporting VIEW publications, provide commentary about the challenges and trends impacting the life-sciences industry, covering a range of issues from molecule through market. PharmaVOICE's more than 41,000 U.S.-based subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers.

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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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