Participants: People from pharmaceutical companies, who will work in the fields of marketing authorization, production, marketing or logistics of drugs and active pharmaceutical ingredients and who have no formal education in this field.

Dates: Monday 18:00 – 20:00
three evenings, two lessons each
 Next Dates: 9., 16. and 23. August 2010

Place:  IPS AG, Falknerstrasse 11, 4001 Basel

Themes: - Swiss and European Medical Laws
- Medical Ethics
- National and international requirements for marketing authorization
- Authorizations for production and distribution
- Guidelines for the manufacture of drugs:
Good Manufacturing Practice GMP
- Guidelines for clinical tests:
Good Clinical Practice GCP
- Guidelines for toxicological tests:
Good Laboratory Practice GLP

Lecturer:  Dr. Hans Ulrich Gally, GxP GmbH, lecturer FHNW Life Sciences

Fee:  500.-
 Students: 250.-
exclusive MWST  
 
Inscription: Until  30. July 2010
 E-Mail:              hans-ulrich.gallyanti spam bot@gxpanti spam bot.ch
or by mail 
Participants: not less than 5

Name :
Company :
Street, No
PLZ, Place : E-Mail:
Date :
Signature :
Mail to: Dr. H.U. Gally, GxP GmbH, Business Parc, Christoph Merian-Ring 11, 4153 Reinach

Contents
Lesson 1
• Fundamentals of drugs for humane use
• Medical ethics
• National and international authorities and laws
Lesson 2
• Marketing authorization, GMP, GDP, GLP, GCP – an overview
• Laws and Guidelines applicable for drugs
• International organisations/authorities EMA, FDA, WHO
Lesson 3
• Marketing authorization in Switzerland and in the world
• The process of marketing authorization
• Documentation – the Common Technical Document CTD
Lesson 4
• GMP – Good Manufacturing Practice
• GMP for active pharmaceutical ingredients
• GMP for drug products / finished dosage forms
Lesson 5
• Pharmacopoeias: European Pharmacopoeia, Ph. Helv and the USP
• Important regulations in the Pharmacopoeias
• Good Laboratory Practice - GLP
Lesson 6
• Good Clinical Practice - GCP
• Practice of clinical testing, ethics- committees, handling of results
• Final considerations concerning requirements for drugs

Dr. Hans Ulrich Gally, GxP GmbH, Tel 061 713 21 72, hans-ulrich.gallyanti spam bot@gxpanti spam bot.ch