Systech is a member and strong supporter of GS1 Healthcare, the global group that promotes standardization in healthcare product and entity identification. On October 17, 2017 in Chicago, GS1 Healthcare held their fall Global Healthcare Conference.
The event always brings together people from all over the world who have ideas and information about improving healthcare through the application of GS1 standards and more. This includes the use of identification standards in both “sides” of healthcare: on medical device and on drugs. This event covered both sides with Day 2 aimed at pharma and Day 3 aimed at devices. Day 1 was aimed at the use of GS1 standards in hospitals to improve patient care and safety.
The industry has made good progress toward meeting the existing Unique Device Identification (UDI) regulation in the United States, but lately the industry has turned its attention toward the new UDI regulation in the European Union and the pending regulation in Turkey. The event included presentations by the device regulators in all three markets.
On the pharma side, Dr. Connie T. Jung, RPh, PhD, Senior Advisor for Policy, Office of Drug Security, Integrity, and Response (ODSIR), Center for Drug Evaluation and Research, Office of Compliance, U.S. Food and Drug Administration spoke about the Drug Supply Chain Security Act (DSCSA). Nothing new was revealed. For a list of DSCSA resources, see Systech’s DSCSA Resources Guide. For a summary of the DSCSA, see Systech’s Regulatory Update for the US and our latest DSCSA webinar recording.
Bianca Zimon, Head of International Affairs with ANVISA, provided an update on the progress of the serialization and tracing pilot in Brazil. ANVISA is determined to learn what works and what does not work from their pilot, and will update the regulations next year to reflect those learnings. For a summary of Brazil’s pilot and draft regulations, see Systech’s Regulatory Update for Brazil and our Brazil webinar recording.
Mike Rose, VP, Supply Chain Visibility with J&J, a leader in the European Federation of Pharmaceutical Industries and Associations (EFPIA) and a Tri-Chair of the GS1 Healthcare Leadership Team, provided an overview of the EU Falsified Medicines Directive (FMD) and explained J&J’s approach to meeting it. For a summary of the FMD, see Systech’s Regulatory Update for the EU and our FMD webinar recording.
A panel of US pharma supply chain veterans representing a drug manufacturer, wholesale distributors and a chain pharmacy discussed DSCSA implementation challenges and successes, and another panel of global supply chain veterans discussed pharmaceutical traceability learnings from around the world.
Ta-Jen (TJ) Chen, Project Management Officer, FDA/CDER/ Office of Strategic Programs, U.S. FDA spoke about Identification of Medicinal Products (IDMP), a set of five ISO standards aimed at international harmonization of the identification of medicinal products. GS1 standards fit within those ISO standards.
The GS1 Global Healthcare Conference is always a great event to find out what is going on with healthcare regulations in markets around the world. This is one source of information Systech uses to keep our Systech Global Serialization Regulatory Update documents up-to-date every quarter.