Date: 14th November
Days old: 4466
Time: 3PM London/10AM New York
Follow a Case Study Strategy of one central CTS management involving 12 NDA studies
In a typical clinical trial each study team is working independently and is coordinating also the manufacturing, packaging and labelling and distribution of the investigational medicinal products as well as the sourcing and distribution of the required concomitant medication. Forecasting and planning is independent and often shortages are the result of the lack of an overall coordination. In addition parallel activities can lead to simultaneous execution of the same tasks and potential efficacies are not used.
As a consequence an alternative model is presented and concepts for forecasting and planning, manufacturing, labelling and packaging, import and distribution and vendor management will be presented. Impact on the quality and the financial situation will be discussed. The often unattended area of concomitant medication will be highlighted and strategies suggested how to avoid study delays and additional costs.
A case study shows an example of an approach to work with one clinical trial supply in all trials which should lead to an NDA. The various phases of the trials set up are presented and the decision process which end up with a common strategy for all trials including planning, labelling, vendors and a common inventory management for all trials.
Presented by
Dr. Andrea Zobel,
Senior Director Clinical trial Distribution
Dr. Andrea Zobel is Senior Director Clinical Trial Distribution at Marken Ltd.
Before she has worked in a clinical research organization and had built up a clinical trial supply unit offering laboratory services, clinical trial supply and ancillary supply services.
Ms. Zobel has an education as a biochemist with 12 years research in gene technology, pharmacology and preclinical development both in academic research and in biotech companies and holds a PhD in natural sciences.
She is lecturer and trainer for pharmacology and clinical trial logistics at universities and training institutes.
Key Learning Objectives
- Optimization of forecasting and planning
- Labelling and packaging strategies for trials for development of one compound
- Benefits of a central organization for import and distribution
- How to manage vendors in compound programs
Audience
- Supply Chain Professionals
- Clinical Project Managers
- Clinical Supply Managers
- Senior Procurement Managers involved in the global manufacture and distribution of pharmaceutical products.