FDA CDER to host webinar on DSCSA- Oct 5th 1pm Eastern
FDA CDER announces a planned webinar "Enhanced Drug Distribution Security in 2023 Under the DSCSA"
We encourage any US Rx stakeholders to join to hear the latest on FDA's plans for the important DSCSA 2023 that is just 26 months away!
Based on the recent significant number of comments on the FDA related draft guidance on enhanced DSCSA and the variety of opinions on the progress and direction towards interoperability, there is a clear need for more stakeholders to understand, engage and participate in the road to November 27, 2023.
As was pointed out in many of the comments, DSCSA requires a significant level of collaboration to understand the requirements of each sector and ensure solutions and processes align. With transaction data sharing with the product identifier (including serial number) at the saleable unit level, hang ups in data will lead to risks in product moving in a compliant manner. We are honored to be helping clients across the supply chain from manufacturers to "dispensers" understand, form perspectives, join industry alignments and begin the ramp up to DSCSA 2023 and do our best to share any information that is relevant for our clients, peers and stakeholders.
DSCSA is an important law that was passed to protect patients from counterfeit and any potentially dangerous products. The industry has seen some continued cases in the US along with significant growth in counterfeits around the world so active participation by all stakeholders is needed as the most important part of the law is implemented.
We welcome any questions or suggestions for information worth sharing with the industry around DSCSA and can be reached at info@tencountconsulting.com
Further Info on the FDA Webinar
When: Oct 5th 1-2pm Eastern
Where: More info and signup through the link below.
Intended Audience:
- Trading partners (Manufacturers, Repackagers, Wholesale Distributors, Dispensers (primarily Pharmacies), and Third-party Logistics Providers (3PLs))
- Regulatory affairs professionals working on compliance with DSCSA requirements
- Solution providers or consultants working on DSCSA requirements
- Other Federal or State regulators
