New York, NY, March 04, 2014 --(PR.com)-- Systech teams up with The Knowledge Group for KC’s upcoming webcast entitled “Exploring Drug Quality and Security Act: (HR 3204) and its Impact to Drug Manufacturers, Pharmacies, and Healthcare.” This two-hour event will be held on Friday, March 28, 2014 at 12:00 PM - 2:00 PM ET.
For further details about this event, please visit:
http://theknowledgegroup.org/event_name/the-drug-quality-and-security-act-hr-3204-implications-for-drug-manufacturerspharmacies-and-healthcare-live-webcast/
Systech International is the global leader in brand protection technologies, with solutions that address the needs of Enterprise Serialization, Authentication, and Track and Trace, serving a wide variety of industries ranging from pharmaceutical, biotechnology and medical devices to food and beverage and healthcare.
As global supply chains become more complicated and counterfeiting threats continue to grow, Systech will continue to be at the forefront of brand protection innovation.
KC Event Synopsis
On November 2013, President Obama signed into law The Drug Quality and Security Act (HR 3204) that authorizes the Food and Drug Administration (FDA) to develop a track-and-trace system to protect the public from counterfeit, stolen, and harmful drugs. The law replaces State level ePedigree regulations.
The bill clarifies Food and Drug Administration (FDA) over-sight of drug compounding under Section 503A of the Food, Drug and Cosmetic Act (FD&C) and creates a new section, 503B, that provides over-sight of a new class of manufacturers - large compounding entities called ‘outsourcing facilities.’ These entities will be subject to FDA registration, regulation, and reporting requirements (list of products compounded, active ingredients, and adverse effects).
This law comes in response to a meningitis outbreak attributed to tainted steroid injections that caused 64 deaths and sickened hundreds in 2012.
The electronic tracking system is designed to prevent counterfeited or stolen compounded prescription drugs from entering the U.S. Within four years, drug manufacturers will have to include serial numbers on all drug packages and, within 10 years, to add electronic codes to track medicines from factories to pharmacies. Pharmaceutical serialization, transaction verification, lot and unit-level tracing, and other requirements come into effect as early as Jan 1, 2015.
New and existing companies face some regulatory confusion and legal risks. Hence, enforcing the new act may be delayed. This gives companies the opportunity to prepare early for the impending regulations by attending this webinar.
This webinar will address some important issues regarding the new law:
• H.R. 3204 Regulatory Overview
• The Manufacturer and H.R 3204
• Wholesale Distributor and H.R 3204
• Dispenser Focus and H.R 3204
• Re-packager / 3PL and H.R 3204
Specific Issues:
• Regulatory and business implementation issues
• Key definitions for product and transaction requirements
• Serialization requirements for packages
• Product tracing (lot and unit level) of transaction history, statements, and information
• Requests for information on transaction histories
• Verification of product identity and transaction requirements
• Data retention, returns, drop shipments, grandfathering
• Network compliance timelines for supply chain participants
About The Knowledge Group, LLC/The Knowledge Congress Live Webcast Series
The Knowledge Congress is a series of live webcasts produced by The Knowledge Group, LLC, which examine trends, regulatory, and technology changes across a variety of industries. For further details, please visit: www.knowledgecongress.org.
For further details about this event, please visit:
http://theknowledgegroup.org/event_name/the-drug-quality-and-security-act-hr-3204-implications-for-drug-manufacturerspharmacies-and-healthcare-live-webcast/
Systech International is the global leader in brand protection technologies, with solutions that address the needs of Enterprise Serialization, Authentication, and Track and Trace, serving a wide variety of industries ranging from pharmaceutical, biotechnology and medical devices to food and beverage and healthcare.
As global supply chains become more complicated and counterfeiting threats continue to grow, Systech will continue to be at the forefront of brand protection innovation.
KC Event Synopsis
On November 2013, President Obama signed into law The Drug Quality and Security Act (HR 3204) that authorizes the Food and Drug Administration (FDA) to develop a track-and-trace system to protect the public from counterfeit, stolen, and harmful drugs. The law replaces State level ePedigree regulations.
The bill clarifies Food and Drug Administration (FDA) over-sight of drug compounding under Section 503A of the Food, Drug and Cosmetic Act (FD&C) and creates a new section, 503B, that provides over-sight of a new class of manufacturers - large compounding entities called ‘outsourcing facilities.’ These entities will be subject to FDA registration, regulation, and reporting requirements (list of products compounded, active ingredients, and adverse effects).
This law comes in response to a meningitis outbreak attributed to tainted steroid injections that caused 64 deaths and sickened hundreds in 2012.
The electronic tracking system is designed to prevent counterfeited or stolen compounded prescription drugs from entering the U.S. Within four years, drug manufacturers will have to include serial numbers on all drug packages and, within 10 years, to add electronic codes to track medicines from factories to pharmacies. Pharmaceutical serialization, transaction verification, lot and unit-level tracing, and other requirements come into effect as early as Jan 1, 2015.
New and existing companies face some regulatory confusion and legal risks. Hence, enforcing the new act may be delayed. This gives companies the opportunity to prepare early for the impending regulations by attending this webinar.
This webinar will address some important issues regarding the new law:
• H.R. 3204 Regulatory Overview
• The Manufacturer and H.R 3204
• Wholesale Distributor and H.R 3204
• Dispenser Focus and H.R 3204
• Re-packager / 3PL and H.R 3204
Specific Issues:
• Regulatory and business implementation issues
• Key definitions for product and transaction requirements
• Serialization requirements for packages
• Product tracing (lot and unit level) of transaction history, statements, and information
• Requests for information on transaction histories
• Verification of product identity and transaction requirements
• Data retention, returns, drop shipments, grandfathering
• Network compliance timelines for supply chain participants
About The Knowledge Group, LLC/The Knowledge Congress Live Webcast Series
The Knowledge Congress is a series of live webcasts produced by The Knowledge Group, LLC, which examine trends, regulatory, and technology changes across a variety of industries. For further details, please visit: www.knowledgecongress.org.
| Contact Information |
| The Knowledge Congress Thomas LaPointe, Jr., Executive Director 1.800.578.4370 Contact www.knowledgecongress.org Therese Lumbao, Director Account Management & Member Services tlumbao@knowledgecongress.org |
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