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Thursday, November 21 • 1:55pm - 2:15pm
The Common Threads Across All Sample Types. Challenges of Sample Management Quality and Compliance- Controlled Substance Compliance in Drug Discovery and Clinical Supply

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Controlled substances are highly regulated around the world and the regulations are becoming increasingly complex as legislators try to combat threats posed to communities by illicit drugs and protect the public health. Pharmaceutical and Life Science companies, in our endeavor to find cures for unmet medical needs, manage an even more complex supply chain from compound acquisition and discovery to clinical supply, encompassing storing and transporting chemical inventories, compound libraries and clinical materials internally and externally across a multiplicity of geographies. Adhering to the controlled substance regulations of each country or jurisdiction, both at the federal and state levels, is becoming more challenging. It might often be overlooked or an afterthought. This presentation describes fundamental elements to consider in establishing an adequate system, control, and structure to meet the rapidly changing environment. The presentation also provides practical checklist a scientist or management can consult when handling controlled substances in the context of drug discovery and clinical supply.

Speakers
avatar for Jessie Bin Song, BS

Jessie Bin Song, BS

Director of Controlled Substance Compliance, Merck & Co., Inc.
Ms. Song currently holds the position of Director of Controlled Substance Compliance at Merck Co. Inc. With over 20 years’ experience in pharmaceutical industry, she has broad experience in manufacturing, packaging, Quality Assurance, technology transfer, business compliance and... Read More →

Chairs

Thursday November 21, 2019 1:55pm - 2:15pm
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA