May 23 2012 8:00AM - May 25 2012 3:30PM
Courtyard Munich City Centre Schwanthalerstrasse 37 80336 Munich Germany
This training course is a comprehensive overview of the essential elements of study management and the clinical study environment in the context of the overall drug development process. Participants will be able to plan, execute and manage a clinical study from protocol to final report.
The course will be taught by experts in phase I-IV clinical trial management at big pharma and biotechnology firms, as well as academic clinical research centres.
Participants will be taught the roles and responsibilities of team members and how to select and oversee internal and external resources. Study managers will learn how to anticipate potential problems and offer creative solutions and develop strategies to mitigate risk.
Who Should Attend
Junior-level and intermediate-level clinical research professionals
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
Study managers in an academic research setting who interface with industry
Participants who complete this course 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.
Kuechengasse 16, Postfach
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52