As we enter a transitional period within the pandemic, some uncertainties remain. The need to continually improve supply chain resiliency remains certain, as demonstrated by the challenges with Single Use Systems. Health Authorities (HA) globally demonstrate continued interest in adopting measures targeted towards drug shortage prevention activities, particularly in regard to risk assessment and business continuity planning. In parallel over this past year, the ISPE Drug Shortages Initiative has modernized the drug shortages prevention plan and prepared an example of how to apply risk management concepts to drug availability. Experts from the front line will present experiences.
As a result of this session participants will gain:
Experience and learnings from the COVID 19 pandemic supply chain pressures particularly as applicable to Single Use Systems (SUS).
Learnings relevant to Single Use Systems shortages and strains in the supply chain during and after the COVID 19 pandemic.
An overview of initiatives which aim to achieve further transparency across the supply chain.
Example approach of Quality Risk Management to address Product Availability Risks, as discussed in the draft ICH Q9(R1).
An understanding of HA perspectives (e.g., FDA, ANVISA, ANSM, etc.)
Opportunities to interact with FDA and industry in a Q&A session and informally at the conference.
Associate Director-US & Global Regulatory Affairs,
Merck & Co Inc