Webinar on-demand: Mitigating the risks in clinical trial supply chains
By World Courier
Speakers:
- Dr. Wanda Scherner, Director Quality CSS, World Courier
- Sharon Schnieder, Regional Quality Manager EMEA, World Courier
Overview:
The pharmaceutical logistics industry faces unprecedented change as greater expectations are placed upon providers to deliver enhanced services while ensuring transparency, security, and flexibility against a backdrop of global disruption.
By complying with a highly regulated environment, the right logistics partner can help design a quality risk management approach. Regulations that must be adhered to include everything from the International Conference on Harmonisation (ICH) Q9 Quality risk management principles to the revised version of Annex 15 of the EU Guidelines for Good Manufacturing Practice (GMP) for Medicinal Products for Human and Veterinary use. A well-thought-out design will anticipate the complexity of supply chains, leading to fewer corrective and preventive actions, a higher level of understanding and adherence from all parties, and reduced costs.
In April 2022, World Courier organized a webinar to explore how you can transition to a risk-based logistics methodology and the roles and responsibilities of the teams involved. Throughout the presentation, we explored the regulatory environment for creating a lane risk assessment and provided examples of GxP-compliant transportation processes.
The session was followed by a live Q&A with the speakers.
Key learnings:
- Examining the current regulatory environment
- Setting the right approach to assess risks in the clinical trials supply chain
- Mitigating those risks with real examples of GxP-compliant transportation processes
