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Essentials of Clinical Study Management

Nov 27 2013 8:00AM - Nov 29 2013 3:30PM | Mercure Paris la Villette 216 Avenue Jean Jaures 75019 Paris France

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Overview 

    The success of a clinical study is very much dependant on its efficient preparation and effective conduct. Study managers should be knowledgeable about required quality and regulatory standards, roles and responsibilities of team members, and be able to select and oversee internal and external resources. Study managers also should be able to anticipate potential problems, offer creative solutions and develop strategies to mitigate risk.
    This training course provides a comprehensive overview of the essential elements of study management and the clinical study environment in the context of the overall drug development process. After successful completion of the training course, participants will be able to plan, execute and manage a clinical study from protocol to final report.

    What You Will Learn 

      Featured topics include:

      • Drug Development Process
      • Feasibility Assessment
      • Study Planning Tools
      • Regulatory Framework
      • Quality Management System
      • Essentials of Site Management
      • Resource Management
      • Investigational Product Handling
      • Risk Management
      • Safety Reporting
      • Study Evaluation and Reporting

      Who Should Attend 

        This course will particularly benefit those newly appointed to, or interacting with, a clinical study management position, e.g. clinical research professionals with some basic experience in the field of clinical research, who need a broader understanding of the principles of clinical study management. This course will also benefit study managers in an academic research setting who interface with industry.

        Level: Junior/Intermediate Level Clinical Research Professionals.

        Learning Objectives 

          This course will provide proven strategies for preparing, launching and managing a clinical study from protocol to final report.
          At the conclusion of this course participants should be able to:

          • Describe the role of the study manager in reaching the study objectives
          • Explain clinical research phases in drug development and describe basic concepts of study design
          • Explain the regulatory framework in which studies are conducted and how compliance with the applicable regulations is achieved
          • Identify the activities involved in study planning and start-up, including feasibility and budgeting.
          • Qualify, select and oversee vendors and external resources for the study
          • Identify various types of clinical trial communication plans.
          • Describe the data management and statistical evaluation process and be able to manage the final study report preparation
          • Recognise European safety reporting requirements
          • Describe the quality management system
          • Discuss risk management and contingency planning

          Hotel & Travel 

          Contact Information 

          DIA Europe
          Kuechengasse 16, Postfach
          4002 Basel
          Switzerland

          Tel.: +41 61 225 51 51
          Fax: +41 61 225 51 52
          Email: diaeurope@diaeurope.org

          Faculty 

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          Registration Fees 

          Member

          Charitable Nonprofit/Academia Member
          €893.00
          Member Government
          €893.00
          Member Standard
          €1785.00

          Non-Member

          Charitable Nonprofit/Academia Nonmember
          €1008.00
          NonMember Government
          €1008.00
          NonMember Standard
          €1900.00
          Register Online

          CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:

          • Industry (Member/Non-member) = €200.00
          • Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
          • Tutorial cancellation: €50.00

          If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.

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