Training Course on Essentials of Clinical Study Management

Date(s) And Time(s):
Nov 2 2011 8:00AM - Nov 4 2011 3:30PM

Location:
Marriott Rive Gauche Hotel
17, Blvd Saint-Jacques
75014 Paris
France

Overview:

All you’ve ever wanted to know about Clinical Study Management... and more.

Learn the Ins-and-Outs of Study Management, the Clinical Study Environment, and overall Drug Development.

Featuring an esteemed European training faculty with over 100 years of combined experience in phase I-IV clinical trial management at big pharma, biotechnology firms, CROs and SMEs, as well as academic clinical research centres.

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, the participants will be able to plan, execute and manage a clinical study from protocol to final report.

Key Topics:

Drug Development Process
Study Management
Regulatory Framework
Quality Management System
Essentials of Site Management
Resource Management
Investigational Product Handling
Risk Management & Safety Reporting
Study Evaluation & Reporting

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.

Target Audience:

Junior/Intermediate Level Clinical Research Professionals.

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.

Event Code:
11536

Contact Information:
DIA Europe
ELISABETHENANLAGE 25, POSTFACH
4002 BASEL
SWITZERLAND
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52
E-MAIL: DIAEUROPE@DIAEUROPE.ORG

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