<연사 소개>
Marieke van Dalen is the Global Regulatory Specialist of Aspen Oss B.V., an API producing company. Next to this she is a Board member of APIC, the organisation for European API manufacturers. She often represents APIC in meetings with Health Authorities and often makes presentations on their behalf. She also is a speaker at various trainings and seminars organized by the European Compliance Academy (ECA).
<강연 소개>
1. CEP 2.0: the CEP of the future
The CEP system in Europe exists since 1992. It is a system that is globally accepted by both Industry and Health Authorities. EDQM has adopted the system to be future proof and this called the CEP 2.0. In this presentation an overview will be given of this renewed system, including tips and tricks on how and where to use the CEP.
2. Sustainable API production
The world is calling for sustainability and this also has an effect on the API Industry. API producers are expected to produce in a more sustainable matter. The presentation will provide a case study and show you the complications that may arise when applying greener technologies.