Opening Plenary Question & Panel Debate
Facilitator: Martin Ince, Science Journalist
Panel members: to be confirmed
The Heart of Cardiology
Chair - Prof Avijit Lahiri, Wellington Hospital, London
The MIST trial Migraines/ Devices
Dr Mike Mullen, Royal Brompton Hospital, London
Reliable evaluation of treatments
Dr Marcus Flather, Royal Brompton Hospital, London
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Basics of clinical trials
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How to design a trial
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Examples of recent trials that have influenced practice
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Future perspectives – are trials becoming too complicated?
Continued at 11.45 - click here to read on
Off-Shoring in Clinical Research?
Paul Wathall, HCA International Limited, Harley Street Clinic
David Jefferys, Eisai Europe Limited
Off-shoring has been around for sometime particularly in the banking and IT industries. The cost savings are well documented but what are the other driving factors?
Topics include:
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Arguments for and against offshoring
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The market and bioethical concerns
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The impact of socioeconomic conditions
An effective offshoring strategy requires….
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Full integration of systems and processes
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Provision of support and training
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Performance indicators and monitoring
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Effective workload distribution
Evidence for Good Quality: The Hidden Costs of Inspections
Two speakers with extensive experience of running and regulating clinical trials review the increasing regulatory elements of clinical trial research and discuss whether these actually improve quality or by adding to the burden for researchers, divert limited resources and risk compromising quality.
Professor Richard Gray, Birmingham Clinical Trials Unit
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How to improve the quality of clinical trials
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Some examples of good and bad practice
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The potential impact of recent increases in regulations/ inspections on CTU resources and trial costs
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A review of the MHRA inspection process
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Can the regulatory framework be improved?
Joan Perou, Freelance Consultant
Leadership Workshop
Ian Robson, Perception Dynamics
This session will show delegates how to:
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Develop High Performance, Cross Functional and Virtual Teams
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Eliminate Silo Mentality and Resistance to Change
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Ensure that everyone is focused on the Common Goal
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Create a collective and aligned view of the big picture
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Build a genuine commitment to the success of the organisation
Refreshments, Exhibition and Posters
Parallel Sessions
The Heart of Cardiology (Continued)
Evolving role of cardiac CT and assessment of coronary atherosclerosis
Prof Avijit Lahiri, Wellington Hospital, London
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Advances in dual source cardiac CT angiography
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Dual energy cardiac CT imaging
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Coronary artery plaque morphology
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CT coronary angiography compared to myocardial perfusion imaging
Fundamentals of Paediatric Investigation Plans (PIPs)
Before & Beyond the Nuts & Bolts of PIPs
Klaus Rose, F. Hoffmann-La Roche Ltd
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Off-label use of drugs in children; history of paediatric legislation in USA, EU; key elements of the US legislation; the WHO paediatric campaign 'make medicines child size'
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What a team and a company have to do before they can even start writing a PIP - paediatric homework: epidemiology of the targeted disease(s) in adults and children, assessment of therapeutic alternatives, identify key opinion leaders, identify appropriate paediatric networks, consider paediatric development strategies in the US and try to avoid duplications US / EU
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How would we like the EU paediatric legislation modified in the two review rounds in 2013 and 2017?
Paediatric Investigation Plans (PIPs)
Dr Ian Dews, Envestia Ltd
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Overview of the PIP process
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The letter of intent
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Relevant guidelines for completing the PIP
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Basic shape of the PIP documentation
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Mandatory headings for PIP sections
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Publishing the paper & electronic versions
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Details that can bring you down!
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Validation
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The PDCO summary report
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Responding to requests for modification
Inspectors: Why do they do it?
Mark Poulton, Medicines and Healthcare products Regulatory Agency (MHRA)
The presentation will overview the GCP inspection process for the various types of inspection that are performed and will be a high level introduction into the MHRA inspection process.
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Why are GCP Inspections performed?
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Who performs the GCP Inspections?
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Where are the Inspections carried out?
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What is Inspected at an Inspection?
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How is an Inspection carried out?
NHS Clinical Research Facility GCP Inspection
Theresa Ledger, Royal Hallamshire Hospital, Sheffield
The presentation will focus on experiencing a GCP Inspection of a CRF dedicated to the conduct of research within an NHS setting and the integration of both clinical and research governance systems which are pivotal to a successful outcome.
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What is a Clinical Research Facility (CRF)
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Why Inspect a CRF
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How the CRF Prepared
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The Inspection visit in the CRF
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Managing a positive outcome
GCP Question Time
Chair - David Talbot, LEO Pharmaceuticals, Chair of ICR's GCP Forum and member of the steering group
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The interpretation of GCP issues is often difficult. This session will take the issues and by means of discussion and consensus look to resolve and give suggestions on possible solutions
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The session will be interactive with a number of questions being presented and making full use of the voting pad system to ensure everyone has a voice in the session
Lunch, Exhibition and Posters
Closing Keynote Plenary Lecture & Panel Debate
Pharma 2020: Virtual R&D - Which path will you take?
Kate Moss, PricewaterhouseCoopers LLP
This lecture will provide a visionary perspective on how companies can work to shorten their R&D process and increase productivity. It will explore:
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Dynamics, Environment & Key Challenges for Pharma in 2020
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Innovation Essentials
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Getting to know ourselves
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Expediting Development
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Collaborating to bring treatments to the market
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Imperatives for change
