From Molecule to Medicine - An Introduction to Clinical Trials including ICH-GCP - 29&30 November 2018

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 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

Course Leader

Tamara Schärer, (MSc, ECPM), Managing Director, SRS Schärer Research Services, Basel, Switzerland. Ms Schärer started working in the pharmaceutical industry as a Clinical Research Scientist in the field of CNS for SAndoz in 1996. After the merger to Novartis, she became the Therapeutic Area Coordinator for all Phase IV studies in Oncology. IN 1999 Tamara moved to a small CRO as an International Project Manager and later trained as a GCP Auditor to become Quality Manager Clinical Operations. In 2002, she founded SRS Schärer Research Services.

Learning Methodology

Interactive sessions with a mix of lecture, case studies to illustrate theory, exercises to test the knowledge and Q&A.

Date:

29 & 30 November 2018

Time:

Day 1: 09:00 – 17:00 hrs
Day 2: 09:00 – 17:00 hrs

Venue:

CTC office
Münchensteinerstrasse 41
CH-4052 Basel

Directions:

Tram 15, tram stop «Grosspeterstrasse»

Fee:

Early Bird Fee: CHF 1'305.00 + 7.7% VAT (valid until: 18.10.2018)
Regular Fee: CHF 1'450.00 + 7.7% VAT (valid after: 18.10.2018)
10 % reduction for CTC employees and SwAPP members.
The fee includes course documentation, refreshments, lunch and a course participation certificate

Cancellation Policy:

• Cancellations received more than 14 days before course: 100% refund less bank charges & cancellation fee of CHF 50.00
• Cancellations received 7-14 days before the course: 50% refund
• Cancellations received 7 days before the course: no refund

Document:

Pgm_flyer_M2M.pdf

Training Terms & Conditions