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Seminar M4 – Design for safety in drug development

Room:

Hall B

Facilitator:

Hoppe-Tichy, Torsten*

Speakers:

Abstract:

 

ACPE UAN: 0475-0000-15-014-L04-P. A knowledge based activity.

Abstract
 
Design has a big impact on safety. Other industries know this for a long time. One example: Banks designed cash machines with almost no chance to leave ones credit card in the machine.
 
The Pharmaceutical Industry is spending huge resources on the design of the chemical or biological active ingredient, the appropriate formulation and dosage form and the packaging of the medicinal product. Other pillars of drug safety are e.g. the product information and the monitoring of the product post authorisation. Every approval of a medicinal product comes with a risk management plan containing detailed measures to secure the safe use of the medicine, and pharmacovigilance is becoming more and more important.
 
Also hospital pharmacists have learned that design for safety in the hospital production or even reconstitution of drugs is of importance and that even the design of a simple label can have a crucial impact on drug safety.
 
Teaching Goals
 
• To explain the term design for safety by showing examples;
• To explain how errors can be avoided by having a design step in the development process.
 
Learning Objectives
 
After the presentation the participant should be able:
 
• to explain the different approaches to get a safe drug and a safe drug package;
• to evaluate the drugs produced by the own hospital pharmacy regarding the design for safety process.
 
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