BrandSure

Author: Gary Lerner

GS1 Connect 2019: Attaining Interoperability and Overcoming the Challenges
June 12, 2019

GS1 Connect 2019: Attaining Interoperability and Overcoming the Challenges

Gary Lerner
Friday 9:00 AM – 9:30 AM – Healthcare Theater Conference Track: Healthcare Type: Industry Track Sessions Speaker: Gary Lerner, Managing Director, BrandSure, LLC Description: This
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Defining DSCSA Trading Partners
August 21, 2017

Defining DSCSA Trading Partners

Gary Lerner
Today FDA issued draft DSCSA compliance guidance on how to identify DSCSA Trading Partners. This draft guidance provides clarity on how to classify trading partner
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Unmarked Product to Become Risky
July 7, 2017

Unmarked Product to Become Risky

Gary Lerner
One Year Enforcement Delay – Not!? Hidden Timetable in DSCSA Product Identifier Requirements With about 100 working days left until the November 27, 2017 deadline
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FDA Proposes 1 Year Enforcement Delay
June 30, 2017

FDA Proposes 1 Year Enforcement Delay

Gary Lerner
Product Identifier Requirements would take effect no later than November 27, 2018 June 30, 2017 FDA issues a draft DSCSA compliance guidance delaying enforcement action
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Interoperability Enables Traceability
November 12, 2015

Interoperability Enables Traceability

Gary Lerner
Understand the Challenges and Opportunities Pharmaceutical traceability is the new regulatory reality. Within the next five years, most markets will mandate pharmaceutical serialization at the
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FDA warns Doctors about Risks of Purchasing Unsafe Medications
June 2, 2015

FDA warns Doctors about Risks of Purchasing Unsafe Medications

Gary Lerner
As of January 1, 2015 the DSCSA mandated that all healthcare practitioners who dispense or administer prescription drugs to patients must purchase their prescription drug
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Know Your Source
June 2, 2015

Know Your Source

Gary Lerner
Doctors, nurses, purchasing agents, pharmacists, office managers and other health care professionals are being warned by the FDA to Know Your Source. The FDA is
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Establishing Supply Network Visibility
May 27, 2015

Establishing Supply Network Visibility

Gary Lerner
Using serialized information to Gain Compliance and Add Business Value All pharmaceutical manufacturers with prescription drugs destined for the United States market must address the
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FDA Announces DSCSA Enforcement Delay
January 6, 2015

FDA Announces DSCSA Enforcement Delay

Gary Lerner
Trading Partners Get Early New Year’s Gift As a result of industry pressure, the FDA has delayed enforcement of Drug Supply Chain Security Act (DSCSA)
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HDMA seeks enforcement leniency for DSCSA non-compliance
December 2, 2014

HDMA seeks enforcement leniency for DSCSA non-compliance

Gary Lerner
HDMA urges FDA to Exercise Enforcement Discretion The Healthcare Distribution Management Association (HDMA) recently wrote the FDA and expressed their concern about the pharmaceutical supply
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Announcements

GS1 Connect Conference 2019

An annual event hosted by GS1 US for the purpose of bringing trading partners together to network and learn about the value of using standards-based business processes and best practices for optimum efficiencies in managing the supply and demand sides of their value chain.

Date: 18-21 June 2019
Location: Denver, CO, United States
Website: http://www.gs1us.org/resources/gs1-connect

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