FROM MOLECULE TO MEDICINE
Who should attend?
Newcomers to the industry, clinical research personnel with up to 2 years experience, those returning to “the sharp edge” of Clinical Operations, scientists working in related areas.
Course Objectives
This highly interactive course with a balance of information, workshops, exercises and quizzes offers a general overview of the drug development process. With this course you will:
- Understand how drugs are developed and learn in brief about the history and business side of drug development
- Find out what rules, guidelines and laws are essential, who the key players and what their
responsibilities are - Learn the top ethical principle and responsibility behind clinical research – protecting the patient
- Become knowledgeable about the safety aspects and how they are handled in clinical research
- Learn about clinical trial methodologies used and the key documents involved
- Know in detail about the activities necessary before the study can start
- Become familiar with the activities performed during and after the conduct of the clinical study
Course Leaders
Sigrid Burkhalter, SRN, has worked for the pharmaceutical Industry since 1989, she has been a project leader for many globally conducted clinical studies in various therapeutic indications. Sigrid is a former founder of CTC and works as a freelance trainer and consultant to the pharmaceutical industry for more than eight years.
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.
Course Topics
- The Drug Development Process
- Good Clinical Practice / ICH Guidelines / Directives
- “Who’s Who” in Clinical Research – Roles and Responsibilities
- Conducting Clinical Trials: pre-, during and post study activities
- Clinical Trial Methodology and Design
- Understanding and Handling of Adverse Events
- Monitoring Clinical Studies
| Date | 4 & 5 November 2010 |
| Time | Day 1: 09.00 – 17.00 hrs Day 2: 08.30 – 16.30 hrs |
| Venue | UBS Training Centre, Viaduktstrasse 33 CH – 4051 Basel |
| Directions | Tram no. 8 at tram stop ‘Markthalle’ |
| Fee | CHF 1’450.00 + 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. |
