Webinar // The challenges of achieving and maintaining Regulatory CMC Compliance
Wednesday, September 5th
15:00 PM – CEST / 09:00 AM EDT
Key learning objectives:
- The step-wise approach to environmental risk assessment
- Calculation of predicted environmental concentration for standard and orphan indications
- Possibilities to waive environmental studies
You may address your questions at: contact@pharmalex.com
Featured Speaker:
Dr. Angela Vogt-Eisele
Senior Manager Scientific Affairs at PharmaLex
Angela has worked for the pharmaceutical industry for over 10 years supporting non-clinical and clinical development programs for human medicinal products. One of her central areas of expertise lies in the field of environmental risk assessments (Europe, USA and world-wide), including development of overall strategy, communication with authorities, project management and study monitoring as well as compilation of the ERA document.
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