Regulated Phases of Drug Development
Online Training Course for Self-Paced Learning.
The development of new medicinal products is a step-wise approach. The regulated phases are generally divided into the three phases pre-clinical, clinical and pharmaceutical development.
The learning objective of the course is to gain understanding for the regulatory requirements that need to be considered during the various stages of drug product development within the European Union. Particular focus is put on the revision of the EU clinical trial provisions and related changes in the EU legal framework.
Tools and Learning Techniques
If you are interested to register for the workshop, please contact us at email@example.com.
Please indicate whether you are interested to register for an individual use or for a team.
Single web-based interactive training course for self-paced learning.
Dr. Barbara Jentges, Phact GmbH
The development of a new medicine is a step-wise approach. After identifying a promising lead-substance in the (non-regulated) research phase, the substance undergoes various regulated development phases. Each of these phases is regulated by good practices (GxP): The non-clinical safety testing in vitro and in animals has to be conducted according to Good Laboratory Practice (GLP); clinical testing for safety and efficacy in human subjects has to comply with Good Clinical Practice (GCP), the manufacturing of drug substances and drug products has to comply with the Good Manufacturing Practice.
While the developmental phases for a new medicine are in principle the same all over the world the legislative provisions to regulate these phases differ between regions. At the same time the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has released various guidance documents to achieve greater harmonisation worldwide.
The learning contents are structured into four units, whereas each unit can be trained independent of each other:
- GxP in Development of a New Medicine
- Non-Clinical Safety Studies: GLP
- Clinical Trials: GCP
- Quality of Medicinal Product: GMP.
At the end of the course the knowledge can be tested in an interactive quiz. During the usage period, the lecture can be interrupted, continued and repeated at will.