2023 Traceability Webinar Series | Healthcare Distribution Alliance | HDA

Speakers

Riya Cao

CEO

LSPedia
- DSCSA Solutions Panel: Innovative Systems for Solving Compliance Requirements
  Thursday, August 17, 2023 | 1:00—2:15 PM
Riya Cao

CEO

LSPedia
- DSCSA Solutions Panel: Innovative Systems for Solving Compliance Requirements
  Thursday, August 17, 2023 | 1:00—2:15 PM
Dwight De Vera

Vice President, Product Strategy

Inmar Intelligence
- DSCSA Solutions Panel: Innovative Systems for Solving Compliance Requirements
  Thursday, August 17, 2023 | 1:00—2:15 PM
Dwight De Vera

Vice President, Product Strategy

Inmar Intelligence
- DSCSA Solutions Panel: Innovative Systems for Solving Compliance Requirements
  Thursday, August 17, 2023 | 1:00—2:15 PM
Elizabeth A. Gallenagh

General Counsel and Senior Vice President, Supply Chain Integrity

Healthcare Distribution Alliance
- DSCSA Implementation: A Phased Approach and Other Industry Recommendations
  Thursday, July 27, 2023 | 1:00—2:00 PM
Elizabeth A. Gallenagh

General Counsel and Senior Vice President, Supply Chain Integrity

Healthcare Distribution Alliance
- DSCSA Implementation: A Phased Approach and Other Industry Recommendations
  Thursday, July 27, 2023 | 1:00—2:00 PM
Elizabeth A. Gallenagh is the General Counsel and Senior Vice President, Supply Chain Integrity at the Healthcare Distribution Alliance (HDA). She is the organization’s chief legal officer, overseeing all legal matters for HDA. Gallenagh also serves as HDA’s primary expert on prescription drug traceability, supply chain safety and integrity, distributor licensure and tax issues.

Since joining HDA, 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 the Drug Supply Chain Security Act (DSCSA) in November 2014. 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 is a graduate of the George Mason University School of Law and The George Washington University.
Scott A. Mooney

Vice President Distribution Operations, Traceability

McKesson Corporation
- DSCSA Implementation: A Phased Approach and Other Industry Recommendations
  Thursday, July 27, 2023 | 1:00—2:00 PM
Scott A. Mooney

Vice President Distribution Operations, Traceability

McKesson Corporation
- DSCSA Implementation: A Phased Approach and Other Industry Recommendations
  Thursday, July 27, 2023 | 1:00—2:00 PM
Scott Mooney is Vice President of Distribution Operations at McKesson Corporation. His primary responsibilities are assuring product integrity through regulatory compliance and traceability. Scott leads McKesson’s Traceability Team working on implementation across McKesson’s various business units.

Scott joined McKesson in 1987 and had previous roles in Finance, Distribution Center Management and as a Regional Vice President of Distribution Operations. Scott has participated in McKesson’s integration of acquisitions over the last 16 years.

Scott has been active in HDA’s Traceability Workgroup, the HDA Industry Relations Council and participates in several committees including the FGAC, RAC and SGAC. He is tri-chair of GS1 Global Healthcare Leadership Team and is a member of the GS1 US Healthcare Executive Leadership Committee.

Scott has a BA in Accountancy and a MBA from the University of Wisconsin – La Crosse.
Tracy Nasarenko

Vice President of Community Engagement, Healthcare

GS1 US
- GS1 GLN Management and DataHub Overview: How to Acquire and Maintain GLN Data
  Thursday, July 6, 2023 | 1:00—2:00 PM
Tracy Nasarenko

Vice President of Community Engagement, Healthcare

GS1 US
- GS1 GLN Management and DataHub Overview: How to Acquire and Maintain GLN Data
  Thursday, July 6, 2023 | 1:00—2:00 PM
Tracy Nasarenko, vice president of Community Engagement at GS1 US for Healthcare, is an accomplished leader with more than 20 years of experience in healthcare and pharmaceutical supply chain, finance, product management, marketing, and operations.

In her current role, Ms. Nasarenko leads a collaborative healthcare industry group focused on addressing supply chain challenges and meeting the requirements of regulations like the Drug Supply Chain Security Act (DSCSA). Using GS1 Standards, the most widely used supply chain standards in the world, Ms. Nasarenko guides the implementation of these standards to help the pharmaceutical industry deliver safe products to patients.

Prior to joining GS1 US, Ms. Nasarenko held several leadership positions with SPI Pharma Inc. Most recently, she served as a site general manager, overseeing end-to-end operations and performance of the entire team, where she built a culture of engagement, innovation, and collaboration.

Ms. Nasarenko earned her bachelor’s degree from Villanova University and received her Master of Business Administration from West Chester University.
Maryann Nelson

Regulatory Manager

Cardinal Health, Inc.
- DSCSA Implementation: A Phased Approach and Other Industry Recommendations
  Thursday, July 27, 2023 | 1:00—2:00 PM
Maryann Nelson

Regulatory Manager

Cardinal Health, Inc.
- DSCSA Implementation: A Phased Approach and Other Industry Recommendations
  Thursday, July 27, 2023 | 1:00—2:00 PM
Maryann Nelson is a Regulatory Manager with Cardinal Health, Inc. responsible for developing strategies to insure supply chain integrity, preventing prescription drug diversion and complying with state and federal legislative requirements. She has over 30 years of experience in Pharmaceutical Distribution. She is actively involved with industry organizations, including HDA and GS1, focused on implementing the Track and Trace requirements of the Drug Supply Chain Security Act (DSCSA).

Ms. Nelson is a graduate of The Pennsylvania State University where she received a BS degree in Business Logistics.
Tish E. Pahl

Principal

Olsson Frank Weeda Terman Matz PC
- DSCSA Implementation: A Phased Approach and Other Industry Recommendations
  Thursday, July 27, 2023 | 1:00—2:00 PM
Tish E. Pahl

Principal

Olsson Frank Weeda Terman Matz PC
- DSCSA Implementation: A Phased Approach and Other Industry Recommendations
  Thursday, July 27, 2023 | 1:00—2:00 PM
Tish Eggleston Pahl is a principal at Olsson Frank Weeda Terman Matz PC. She is regulatory counsel to drug, cosmetic, dietary supplement and food clients with concerns before the Food and Drug Administration, the Federal Trade Commission, and other federal agencies. Her work has encompassed representation of companies making and marketing human and animal prescription and over-the-counter (OTC) drugs, dietary supplements, and cosmetics. She has particular expertise in the areas of health care communications, advertising and labeling of FDA-regulated products. Further, she advises trade association clients on a range of antitrust and trade regulation issues.

Since November 2013, Tish has been heavily involved with implementation of the Drug Quality and Security Act (DQSA). She has advised pharmacy compounders and outsourcing facilities on their new FDA responsibilities under Title I of the DQSA. She has worked closely with pharmaceutical supply chain stakeholders, including manufacturers, repackagers, and wholesale distributors, on implementation of Title II of the DQSA, the Drug Supply Chain Security Act (DSCSA).

Tish is a regular participant in HDA activities, providing FDA regulatory and antitrust counsel to the Public Policy Council, the Traceability Implementation Work Group, the Regulatory Affairs Committee, the Returns Task Force, and other committees.

Tish graduated from Northwestern University and earned her Juris Doctor from Northwestern University (cum laude).
Jaidalyn Rand

Director, Industry Relations

Healthcare Distribution Alliance
- DSCSA Solutions Panel: Innovative Systems for Solving Compliance Requirements
  Thursday, August 17, 2023 | 1:00—2:15 PM
Jaidalyn Rand

Director, Industry Relations

Healthcare Distribution Alliance
- DSCSA Solutions Panel: Innovative Systems for Solving Compliance Requirements
  Thursday, August 17, 2023 | 1:00—2:15 PM
Tim Stearns

Senior Director, Industry Relations

Healthcare Distribution Alliance
- GS1 GLN Management and DataHub Overview: How to Acquire and Maintain GLN Data
  Thursday, July 6, 2023 | 1:00—2:00 PM
Tim Stearns

Senior Director, Industry Relations

Healthcare Distribution Alliance
- GS1 GLN Management and DataHub Overview: How to Acquire and Maintain GLN Data
  Thursday, July 6, 2023 | 1:00—2:00 PM
Tim Stearns is a Senior E-Commerce Analyst with Baxter HealthCare, focusing primarily on the distributor customer base. With over 22 years of experience in information systems, he has integrated back–end systems and implemented numerous EDI transaction sets focused on contract/chargeback administration, customer credit and invoicing, returns processing, order management and shipping notices, track–and–trace /pedigree systems design, customer–to–HIN alignment with HIBCC and distributor Fee for Service/inventory management agreements. Tim has served twice as co–chair of the HDMA Business Technology Committee, member of the HDMA eCommerce Task Force, member of the CSOS Working Group and the Health Industry Business Communications Council E-Business Council.
Brian P. Waldman

Partner

ArentFox Schiff LLP
- DSCSA Implementation: A Phased Approach and Other Industry Recommendations
  Thursday, July 27, 2023 | 1:00—2:00 PM
Brian P. Waldman

Partner

ArentFox Schiff LLP
- DSCSA Implementation: A Phased Approach and Other Industry Recommendations
  Thursday, July 27, 2023 | 1:00—2:00 PM
Brian Waldman concentrates his practice in the area of food and drug law and advertising law, counseling clients primarily on pharmaceutical, medical device, food, dietary supplement and cosmetic issues, with particular emphasis on developing effective strategies for introducing and distributing new products. Brian advises clients on a broad range of legal and regulatory issues in all phases of a product’s life cycle, including (i) developing appropriate strategies for the introduction of new ingredients and finished products, (ii) coordinating pre-market safety, efficacy, and claims evaluations, (iii) preparing FDA-related applications and notifications, (iv) designing compliant and effective labeling, advertising, and promotional materials, as well as educational materials, (v) ensuring post-marketing regulatory compliance, including compliance with adverse event reporting requirements and limitations on off-label promotion, and (vi) responding to threatened enforcement action. Brian has been advising clients including HDA on drug distribution issues since 1995.
Herbert Wong

SVP Product & Strategy

Antares Vision Group
- DSCSA Solutions Panel: Innovative Systems for Solving Compliance Requirements
  Thursday, August 17, 2023 | 1:00—2:15 PM
Herbert Wong

SVP Product & Strategy

Antares Vision Group
- DSCSA Solutions Panel: Innovative Systems for Solving Compliance Requirements
  Thursday, August 17, 2023 | 1:00—2:15 PM