This will be a detailed oriented session on the regulatory requirements of impurities in medicines. It will include an investigation into the origins of impurities (API, manufacturing and degradation), specification requirements and supporting data required for submission and GMP purposes. Speakers will discuss relevant guidelines in the context of case studies to show practical implementation in real-life circumstances. This session is of equal relevance to prescription & OTC medicines.
Chairperson: Deb Cooper, ARCS Australia
- Regulatory Affairs
- Date:May 7, 2015
- Time:11:15 am