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The Safety Aspects of Clinical Trial Reporting in the EU
14 October 2009
The Safety Aspects of Clinical Trial Reporting in the EU

In association with:

European Drug Safety

 

About the workshop:

This workshop would be for those individuals working in the Clinical trials arena such as Project Managers; Safety personnel; Clinical Trial Managers; wanting to know more about the safety aspects of clinical trials including both expedited and periodic reporting ; how to present safety information in the Investigator Brochure; Annual safety reports and issues associated with safety reporting when the product is marketed elsewhere in the world.

There will be plenty of opportunities in the morning to ask questions and understand about best practice for causality assessments; signal detection and benefit-risk calculations too.

 

About the host:

Paul Dolin is the founder and CEO of European Drug Safety. Prior to joining European Drug Safety, he held several senior drug safety positions in the pharmaceutical and CRO industry including:

  • Vice President, i3 Drug Safety
  • Global Head of Drug Safety, Roche.
  • Global Head of Safety Medical Evaluation, Roche
  • Senior Director, World Wide Epidemiology, GlaxoSAE Media GroupthKline

He has extensive drug safety experience at senior leadership level, a long history of drug development and post marketing experience, and is a member of several international committees, including CIOMS VII (DSUR report) and CIOMS VIII (Signal Detection).

Paul holds a Doctorate in Clinical Epidemiology from Oxford University and a Masters in Public Health. He has authored over 30 research articles in peer-review journals and presented at many international conferences.

 

 


 

Workshop agenda

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8:30

Registration & Coffee

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9:00

Welcome & Introductions

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9:10

The Stages of Drug Development

  • When does Safety begin?
  • What is involved in Safety Monitoring?
  • Serious and non-serious events or reactions, expected or unexpected
  • Drug Safety and risk/benefit
  • clock

    9:50

    Writing Safety Information into the Investigator Brochure

  • Regulations concerning Investigators Brochures (IBs) and Safety Data
  • Pre-Clinical Data & Relevance to the IB
  • Writing Safety Information into the IB
  • Presentation of Safety Data in the IB
  • Updating the IB – When and How?
     
  • clock

    10:30

    Coffee Break

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    10:50

    Expedited Reporting in Clinical Trials

  • ICH Regulations for expedited reporting in clinical trials
  • EU Safety reporting in clinical trials
  • Safety reporting when the product is already marketed
  • CIOMS VI and Safety reporting
  • clock

    11:30

    Periodic Safety Reporting in Clinical Trials

  • Periodic reports to Ethics Committees
  • Annual Safety Reports in the EU & USA
  • Developmental Safety Update Reports
  • clock

    12:10

    Questions and Answers Session

    clock

    12:30

    Close of Workshop

    Crowne Plaza Hotel - St James

    Buckingham Gate 45/51
    London SW1E 6AF
    United Kingdom

    Crowne Plaza Hotel - St James

    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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