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Paediatric Clinical Trials
25 March - 26 March 2015
Paediatric Clinical Trials

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, SAE Media Group 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

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

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Klaus Rose

Klaus Rose, CEO, klausrose Consulting

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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

 

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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

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10:30

Morning Coffee

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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
 

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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
 

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12:20

Networking Lunch

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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
 

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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

 

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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
 

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15:20

Afternoon Tea

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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
 

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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
 

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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

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17:40

Chairman’s Closing Remarks and Close of Day One

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Klaus Rose

Klaus Rose, CEO, klausrose Consulting

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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
 

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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
 

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10:30

Morning Coffee

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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
 

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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
 

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12:20

Networking Lunch

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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
 

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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
 

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14:40

Afternoon Tea

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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
 

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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
 

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16:30

Chairman’s Closing Remarks and Close of Day Two


Chief Medical Officer
NovImmune SA
Associate Professor
University of Copenhagen
Head, Global Scientific Affairs
Novartis Vaccines
Senior Medical Director, Clinical Affairs
Lundbeck, USA
Senior pharmaceutical assessor, Chemical Pharmaceutical Assessments (CFB), Member EMA Quality Working Party,
Medicines Evaluation Board in the Netherlands (MEB)
Director & Founder
Empowering Children | Enabling Research
Paediatric Research Consultant Specialist Medical Writer for Children and Member FP7 Ethics Panel
Paediatric Research Consultancy
CEO
klausrose Consulting
Principal Scientist, Paediatric Investigation Plan (PIP), Regulatory Affairs
Novo Nordisk A/S, Denmark
Modelling & Simulation Scientist, Pharmaceutical Sciences, Roche Innovation Center Basel
Roche Pharmaceutical Research and Early Development
Vice President of Global Clinical Research, Paediatric Neuro-Psychiatry
Lundbeck, France
Head of Clinic Paediatric Oncology,
Universitair Ziekenhuis Antwerpen, Vice Chairman, Paediatric Commitee (PDCO)
Formulation Project Leader, Paediatric & Geriatric Network Leader, Technical Research & Development
Novartis Pharmaceuticals
Divisional Head of Portfolio Operations
NIHR Clinical Research Network: Children
Director Regulatory Affairs/Policy Europe
AstraZeneca
Senior Pharmacokinetics Assessor, Statistics and Pharmacokinetics Unit
MHRA
Formulation Team Manager, Global Formulation, Product Development
GlaxoSmithKline R&D

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
24 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.

Media Partners


Trials

Official Media Partner
http://www.trialsjournal.com

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

Official Media Partner
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.

Media Partners


Drug Discovery Today

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Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


Swiss Biotech Association

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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.


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.


Labsave

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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/


SelectScience

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SelectScience is an independent, online information resource for the worldwide scientific community, and the home of trusted information for laboratory scientists. Discover the latest drug discovery and development technologies, products and techniques with product reviews, videos, application notes and news articles. Become a member for free today.


Drug Development Technology

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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.


CanBiotech

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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.


Technology Networks

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Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


Pharmavision

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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.


Bentham Science

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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


Pharmiweb

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http://www.pharmiweb.com

Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.


Absave

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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!


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

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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.


Gate2Biotech

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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.


Pharmaceutical Technology

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Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


Lab Bulletin

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Lab Bulletin is a free online resource for scientists and laboratory professionals where you can catch up on the latest news for laboratory products and services. You will find an extensive directory of laboratory suppliers and manufacturers enabling you to contact companies quickly and easily to request further information. Lab Bulletin also publishes four free monthly E-Newsletters keeping you up-to-date with all of the latest laboratory products and industry news directly to your inbox. We have dedicated E-Newsletters for Chromatography and Spectroscopy, Microscopy and Image Analysis, weekly Industry News updates and our monthly Lab Bulletin E-Newsletter sent out to over 29,000 readers worldwide. To request your free copy click here


Medical News Today

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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.


Mednous

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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


Pharma Technology Focus

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Pharma Technology Focus Magazine is a dynamic bi-monthly online publication available on iPad and online. It offers in-depth coverage of the most important issues and the latest developments in the pharmaceutical industry, in an innovative digital format. Brought to you by an experienced editorial and design team, Pharma Technology Focus is the essential magazine for decision-makers wanting up-to-date pharmaceutical industry news and analysis, with articles and features covering technology, discovery and development, packaging and labelling, supply chains, manufacturing and ingredients, trials and successes and much more.


pharmaphorum

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pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


Pharmacircle

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PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….


Labhoo

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LabRoots

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LabRoots is a free, social networking site that enables scientists, engineers, and other technical professionals to connect, collaborate with, and learn from each other. LabRoots fosters world-wide scientific communication and incorporates the newest social networking technologies. LabRoots allows scientists to connect with each other as they describe their research interests on a myriad of unique features and tools, discovering meaningful collaborations across geographic boundaries and fields of expertise.


Contract Biotechnology

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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.


Cutting Edge

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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.


Maney Publishing

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Maney Publishing delivers personalised service to authors, societies, readers and libraries for the publishing and international dissemination of high quality, peer-reviewed scholarship and research. Specialising in print and electronic journal publishing, Maney is committed to technical and editorial innovation combined with traditional values of quality and collaboration.


Bioportfolio Limited

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http://www.bioportfolio.com

BioPortfolio.com is a leading news, information and knowledge resource covering the global life science industries impacted by biotechnology. The site aims to provide the lay person, the researcher and the management executive with a single location to source core information on specific bio-related topics, to collate relevant data associated with each topic and to point the user to relevant knowledge resources


International Pharmaceutical Industry

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http://www.ipimediaworld.com

IPI gives you an insight into all areas of Biopharm, Medical, Pharmaceutical and Healthcare. IPI provides a proven supportive means of communication to the Pharmaceutical, Bio Pharmaceutical, Nutraceutical and Medical Devices industry, incorporating the latest in research and technology innovations, regulatory guidelines, marketing and communication strategies.


PharmaVOICE

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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.


One Nucleus

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Established in May 2010, One Nucleus is the result of the merger of ERBI and London Biotechnology Network. One Nucleus is a not-for-profit membership organisation for international life science and healthcare companies and the largest of its kind in Europe. The company is based in Cambridge UK and London, at the heart of Europe's largest cluster. The 470 members include pharmaceutical, biotech, medical device and diagnostic companies and associated technical and commercial Service Providers.


Journal of Negative Results in Biomedicine

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http://www.jnrbm.com

Open access, peer-reviewed, online journal that provides a platform for the publication and discussion of unexpected, controversial, provocative and/or negative results in the context of current tenets. The journal strongly promotes and invites the publication of clinical trials that fall short of demonstrating an improvement over current treatments. The aim of the journal is to provide scientists and physicians with responsible and balanced information in order to improve experimental designs and clinical decisions.


Scrip Intelligence

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http://www.scripintelligence.com

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.


PMR

Supporters
http://www.pmrcorporate.com

PMR (www.pmrcorporate.com) is a British-American company providing market information, advice and services to international businesses interested in Central and Eastern European countries as well as other emerging markets. PMR's key areas of operation include business publications (through PMR Publications), consultancy (through PMR Consulting) and market research (through PMR Research ). Being present on the market since 1995, offering high international standards in projects and publications, as well as providing one of the most frequently visited and top-ranked websites, PMR is one of the largest companies of its type in the region.


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.


PharmCast

Supporters
http://www.PharmCast.com

www.PharmCast.com is the world leading website designed specifically for pharmaceutical, clinical and biotechnology professionals. www.PharmCast.com brings up-to-date information on pharmaceutical patents, FDA, news, jobs and Buyer's Guide to our visitors. It was created and is maintained by pharmaceutical and biotechnology professionals. Visit www.PharmCast.com and discover for yourself why it is so popular among professionals.


Antibodies Online

Supporters
http://www.antibodies-online.com

antibodies-online.com facilitates researchers to find the appropriate antibodies for their respective research project. As an independent and multi-vendor marketplace for research antibodies and thanks to the cooperation with more than 130 different manufacturers, a large selection of Antibodies (over 700,000), ELISA Kits (over 130,000), Secondary Antibodies (17,000), Proteins (130,000), Peptides and Isotype Controls is available. By supporting the Independent Validation Initiative and the Resource Identification Initiative, antibodies-online.com also addresses the important topics of transparent product quality and scientific reproducibility. In addition scientists receive news and detailed information about the individual antibodies from databases such as the PubMed and others.


KONGPOSH Publications

Supporters
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)

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, 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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