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Nov.
2017
GMP for Clinical Trials Manufacture and Supply
Netherlands, Amsterdam
Course Overview :
This highly interactive 4 day training course will teach you all you need to know about international GMP regulations and requirements for the manufacture, control, storage and distribution of medicines to be used in clinical trials. Our tutors, both of whom are former regulatory agency inspectors, will help you to interpret the legislation and guidance into simple pragmatic ways of working that meet the needs of the regulators. They will also help to answer any specific questions you may have regarding your products and studies.
About This Course :
Keeping up with the changing legislation in the area of clinical trials provides challenges for all those working with Investigational Medicinal Products. Our highly interactive 4-day course is taught by ex-MHRA Inspectors; all experts in the field of clinical manufacturing and regulatory requirements. This provides an excellent opportunity for gaining invaluable knowledge about the ever-changing world of clinical supplies.
Practical exercises in this course (such as the “Tic Tac” double dummy packaging exercise) help to reinforce key learning points. Come and join us in Amsterdam to gain a thorough understanding of GMP requirements for clinical supplies, or just to keep up-to-date with what’s changing in this area.
This course is also Royal Society of Chemistry approved as suitable for their members’ Continuing Professional Development.
Key Learning Objectives :
- Understand the legislation and guidance around clinical trials and what is changing
- Understand the interpretation of GMPs suitable for clinical trials
- Understand the phases in clinical trials and how requirements change
- Auditing and control of clinical trial operations
- Clinical batch releases