BASIC COURSE FOR ASSISTANTS TO THE CLINICAL RESEARCH TEAM
Who should attend?
Clinical Research Assistants and persons with related functions, with little or no experience or who would like to get an overview of responsibilities and tasks within clinical research. Administrative assistants and others with an interest in learning more and gaining an insight in clinical research and the involved tasks.
Course Objectives
The course offers a general overview of the drug development process and most relevant tasks and responsibilities within the clinical research setting, focusing on practical aspects and mainly addressing the needs of assistants and support personnel. With this course you will:
- Understand how drugs are developed and who the key players are in the process
- Become knowledgeable about the terminology used in the clinical research environment
- Find out what rules, guidelines and laws are essential
- Learn how a clinical study is set up and performed
- Become familiar with and understand how to handle the documentation required in clinical research
- Be aware of how an assistant integrates into the clinical research team
Course Leader
Dr. Christa J. Silberbauer has a PhD in Natural Sciences from the Swiss Federal Institute of Technology (ETH) in Zurich and has worked in the pharmaceutical industry since 1997. She has experience as a project leader for international clinical research projects, and as a writer of standard operating procedures (SOPs) and SOP
manager. She has been involved in GCP and Clinical Research training for over six years.
Topics
- Developing a drug in the pharmaceutical industry – from the idea to the product you buy in the pharmacy – and the contributions of clinical research
- What is a clinical study – the four phases of clinical development
- Who are the key players and what are their roles in the process
- The language and abbreviations the clinical research team are using every day
- What are the rules, guidelines and laws that need to be followed and why are they so important
- How is a clinical study performed – from preparation over conduct to termination of a study
- A key to a successful study: the master study file. What documents are essential and how are they handled, filed and archived?
- What is the job description and what is the role of a clinical research assistant?
| Date | 15 October 2010 |
| Time | 08.30 – 17.00 hrs |
| Venue | BIOP Trainings Centre Centralbahnstrasse 9, 4051 Basel |
| Directions | Tram No. 1/2/8/10/11 at tram stop SBB |
| Fee | CHF 950.00 + 7.6 % VAT 10 % reduction for SwAPP (Swiss Association of Pharmaceutical Professionals) members. The fee includes course documentation, refreshments, lunch and a course participation certificate |
| Cancellation Policy | 7 to 14 days prior to the course: 50% of the fee. Less than 7 days or no notification received: FULL course fee is required. |
