Date: Tuesday April 26, 2022

Time: 11:00am - 11:45am CEST

Duration: 45 mins

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.

Join us to learn more about how you can transition to a risk-based logistics methodology and the roles and responsibilities of the teams involved. Throughout the presentation, we will explore the regulatory environment for creating a lane risk assessment and will provide you with examples of GxP-compliant transportation processes.

A live Q&A will follow this session with the speakers, and all attendees will receive a copy of the recording.

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

This session will be followed by a live Q&A with the speakers and all attendees will receive a copy of the recording to listen on-demand.