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Traceability 2019

Seminars

Traceability | October 21–23 | Washington, D.C.

Coronavirus Information

The evolving COVID-19 pandemic has required us to remain adaptable. To that end, HDA has been closely monitoring updates from the Centers for Disease Control and Prevention (CDC)The Government of the District of Columbia, the specific situation at the Marriott Wardman Park and HDA member travel restrictions. If there is any change in plans for hosting our in-person event, we will provide alerts on hda.org/traceability as well as through attendee emails and our Twitter and LinkedIn channels.

Please contact Brooke Naylor at BNaylor@hda.org for further questions.

Speakers

Justine Freisleben  
Justine M. B. Freisleben, Vice President, Industry Relations, Healthcare Distribution Alliance

Justine Freisleben is Senior Director of Industry Relations at the Healthcare Distribution Alliance (HDA). In this role she is responsible for the development and coordination of strategies, initiatives and projects to help healthcare distributors understand and use standards, emerging technologies and best practices to increase their efficiency and productivity in the movement of information and products throughout the healthcare supply chain. Additionally, she guides development of voluntary industry guidelines for implementing and maintaining technical standards related to product identification and electronic commerce ,and represents HDA on key work groups, particularly related to the development of standards and processes to support implementation of traceability.

Prior to this role she worked for a chemical trade association focusing on international trade advocacy and international regulatory compliance.

Justine holds a BA in government from Franklin and Marshall College and a MA/MBA from American University.

Elizabeth Gallenagh  
Elizabeth A. Gallenagh, Senior Vice President, Government Affairs and General Counsel, Healthcare Distribution Alliance

Elizabeth A. Gallenagh, Esq., is the Senior Vice President, Government Affairs and General Counsel for HDA. She is responsible for overseeing federal and state advocacy on behalf of HDA member companies and is the organization’s chief in-house attorney. Additionally, she serves as HDA’s primary expert on prescription drug traceability, distributor licensure and tax issues.

Since joining HDA in 2003, Ms. Gallenagh led the Alliance's industry-wide efforts to replace a 50-state patchwork of pedigree laws with one national traceability solution, which became a reality through the enactment of Title II of the Drug Quality and Security Act in November 2013. In 2014, she was honored by the industry with the Distribution Management Award for Industry Leadership, which honors an individual who has exhibited the highest standards of honesty and integrity, working to enhance industry relations and knowledge, as well as supply chain efficiency and security.

Gallenagh holds a JD from the George Mason University School of Law and a BA from The George Washington University.

Connie Jung  
Connie Jung, RPh, Senior Advisor for Policy, U.S. Food and Drug Administration

Dr. Jung is currently Acting Associate Director for Policy and Communications in the new Office of Drug Security, Integrity, and Recalls in FDA’s Center for Drug Evaluation and Research, Office of Compliance. Her work focuses on development of policy and regulatory strategies to improve the security and integrity of the U.S. drug supply. Dr. Jung has worked on issues related to stolen, counterfeit and other substandard drugs for several years in her previous position as Senior Advisor for Pharmacy Affairs in the Office of Policy, Office of the Commissioner and will continue these efforts in the new office.

Dr. Jung joined the FDA in 1999 as a researcher in the Center for Food Safety and Applied Nutrition, conducting toxicology research involving skin absorption and metabolism of topically applied compounds, and later served as a Regulatory Reviewer in the Division of Bioequivalence in the Office of Generic Drugs where she analyzed bioequivalence studies of generic products before working on supply chain issues.

She received her BS in Pharmacy from The Ohio State University and her Ph. D. in Pharmaceutical Sciences from the University of Cincinnati.

 
Blair Korman, Sr. Manager, DI&T, Johnson & Johnson Supply Chain

David Mason  
David G. Mason, Supply Chain Compliance and Serialization Lead, Novartis Pharmaceuticals Corporation

Dave Mason is currently the AD North America Serialization – Supply Chain, supporting the implementation of DSCSA for the Novartis group. He is leading the efforts for setting up systems and processes for ESO, supply chain and commercial operations. Dave represents Novartis in trade association, PDSA and FDA public meetings. He communicates to the NTO Global Serialization team with new and existing requirements for other countries, and he assures that the validation approach is consistent within the organization and execution at the sites. Dave also supports the team to develop a global master validation and TPO rollout plan.

Bradley Pine  
Bradley T. Pine, Vice President, Brand Pharma & Regulatory, Smith Drug Company, Div. J M Smith Corporation

Brad Pine is currently Vice President, Brand Pharma & Regulatory for Smith Drug Company; he has over 25 years of experience in the pharmaceutical wholesale industry. Brad's industry experience includes working for national and regional wholesalers; his breadth of knowledge comprises regulatory compliance, branded pharmaceuticals, consumer goods, marketing and overall business operations.

Brad is responsible for oversight of Branded Manufacturer Agreements, regulatory implementation, Distribution Center SOPs, and business strategies. He has been involved in implementing the Drug Supply Chain Security Act (DSCSA) at Smith Drug Company and is an active member on HDA's Traceability Implementation Work Group since its inception in November 2013.

He is an active member on HDA committees, including the Public Policy Council (Chairman), Federal Government Affairs, Regulatory Affairs, and State Government Affairs Committees.

Brad holds a BS degree in Finance from Indiana University.

Matt Sample  
Matt Sample, V.P., Manufacturer Operations, AmerisourceBergen Corporation

Matt Sample is currently the business lead for the serialization efforts at AmerisourceBergen, and also manages the teams responsible for maintaining item and vendor master data, as well as run our manufacturer operations team.. He has over 17 years of experience in the medical device, pharmaceutical and life sciences industry, working both for manufacturers, wholesalers and for a large consulting firm. He has held various roles in the areas of product development, lean six sigma, business system implementation and operational leadership.

His most recent responsibilities have included leading a global medical device serialization effort, device UDI implementation and, until joining AmerisourceBergen, he was the serialization program lead at a mid-size pharmaceutical company.

Peter Sturtevant  
Peter F. Sturtevant, Senior Director, Community Engagement, GS1 US

Peter F. Sturtevant, Senior Director, Industry Engagement – Pharmaceuticals at GS1–US, has more than thirty years of global supply chain management experience. Currently, Mr. Sturtevant is responsible for engaging supply chain business trading partnerships within the pharmaceutical industry and regulatory agencies in support of the implementation of the Drug Supply Chain Security Act (DSCSA). Mr. Sturtevant is a regular speaker and panelist at pharmaceutical conferences in support of GS1–US standards on DSCSA.

Prior to joining GS1–US, Mr. Sturtevant was Director, Global Supply Chain for Haemonetics with responsibilities for global distribution operations, transportation and trade compliance. He also held senior global supply chain positions at Nippon Express and Covidien. Throughout his career, his responsibilities have included the management of functional areas of logistics sales, customer service, vendor management inventory, distribution planning, strategic network design, transportation management, compliance, financial control, system design/implementation, distribution center operations, bar code standards and project management.

Mr. Sturtevant holds a Master's degree in Business Administration from Western New England University in Springfield, MA. He also earned two Bachelor of Science degrees in Business Management from Bentley University in Waltham, MA, and another degree in Transportation and Logistics Management from Northeastern University in Boston.

Gary Tiamsic  
Gary Tiamsic, Manager, Regulatory Affairs, Henry Schein, Inc.

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