PHARMA REGULATORY EXPERT DIRK RODGERS TO SPEAK AT UNIQUITY INDIA CONFERENCE

Focus on Global Regulations, Timeframe and Necessary Steps for Compliance

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Author, global regulatory expert, and blogger Dirk Rodgers will be a speaker at UNIQUITY India 2016, where he will discuss the global serialization and tracing regulations impacting India’s pharmaceutical manufacturers. Rogers is a senior regulatory strategist with Systech International, a global leader in brand protection technologies, which will host the event.


The event will be hosted by Systech International, the global leader in serialization, track-and-trace, and regulatory compliance. Systech’s one-day conference will provide customers, industry leaders, and equipment manufacturers with a firm understanding of the many complex regulatory mandates that are quickly unfolding in India and around the world, as well as effective technologies to meet those demands. The event will take place October 6, 2016 at the ITC Maratha Hotel in Mumbai.


The United States is the largest market for healthcare products in the world, and India is one of the largest sources of drugs and active pharmaceutical ingredients for the US market. Within this ecosystem, drug manufacturers, contract manufacturers and third-party logistics providers based in India need to carefully follow the applicable sections of the US Drug Supply Chain Security Act (DSCSA). Indian companies that manufacture finished pharmaceuticals for the US market must make some very specific changes to their packaging and business processes by November 2017 or they will be in violation of the DSCSA law.


Mr. Rodgers’ talk is titled: Global Serialization and Traceability Regulations — What Indian Exporters Need to Know, and Do! With expertise in pharma and medical device supply chain collaboration technologies, Mr. Rodgers will explain the specific changes that drug manufacturers must make to stay in compliance with the DSCSA, focusing particularly on the new serialization and labeling requirements that take effect about one year from now. He will discuss the various global mandates, review stakeholder positions on the specific requirements (with focus on DSCSA), address potential non-compliance scenarios and possible penalties, debate the costs of compliance, examine possible models for a domestic anti-counterfeiting program in India, and take up specific questions from the attendees.


Many in the pharmaceutical industry are familiar with Rodgers as a result of his book titled The Drug Supply Chain Security Act Explained, as well as his essays posted on RxTrace. Rodgers also participates on key industry work groups in GS1, GS1 US, HDMA and the Open-SCS organizations.

Register for UNIQUITY India at http://systechone.com/uniquity2016in/.

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