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Supply Chain Integrity (USP)

Agenda
USP-APEC RHSC Center of Excellence (CoE) for Product
Quality & Supply Chain
Pilot Program: Securing Medical Product Quality Through the Supply Chain

US Pharmacopeial Convention (USP) - Rockville March 28-31, 2017 USA
APEC RHSC - USP Center of Excellence (CoE) for Product Quality & Supply Chain Pilot Program: “Securing Medical Product Quality Through the Supply Chain”
Day 0; Monday, March 27th, 2017: Rockville Hilton Hotel
6.00 pm- 8.00 pm Optional Pre- Program Reception and Dinner (participants, speakers, invited guests)
Welcome Remarks
      • APEC HARMOINZATION CENTER REPRESENTATIAVE (5 mins)
      • USP Leaders (5-10 mins)
Day 1; Tuesday, March 28th, 2017: Spaulding Auditorium, USP
8.30 am - 9.00 am Arrival/Sign-In
Plenary Session Open
9.00 am - 9.15 am
Welcome and Opening Remarks
      • Yeowon Sohn Ph.D., (Director, APEC Harmonization Center) (Via video)
      • Jesse Goodman, M.D. M.P.H. (President, USP Board of Trustees and Professor of Medicine, Georgetown University)
      • Donald Ashley J.D., (Director, Office of Compliance, Center for Drug Evaluation Research, US FDA)
9.15 am - 9.30 am Context and Goals for the Pilot CoE Program
Katherine Bond Sc.D (Vice President, International Public Policy and Regulatory Affairs, USP)
Key Notes
9.30 am - 09.45 am
09.45 am - 10.05 am
Overview of APEC Road Map to Promote Global Medical Product Quality and Supply Chain Security
Ilisa Bernstein Pharm.D., J.D. (Deputy Director, Office of Compliance, US Food and Drug Administration)
Promoting a Quality Culture in the Supply Chain
Ronald T. Piervincenzi, Ph.D. (CEO, USP)
10.05 am - 10.40 am Photos & Break
10.40 am - 11.20 am The Current Global State of Substandard/Falsified Medicines
Michael Deats (Group Lead, Vigilance, Substandard, Spurious, Falsely Labelled, Falsified And Counterfeit Medical Products, Essential Medicines and Health Products, WHO)
Questions and Answers
Panel Session 1
11.20 am - 12.20 am
Global Perspectives on Medicine Quality in the Supply Chain
    • Presentations from invited panelists and participants of observations about Pharmaceutical quality issues in APEC regions, and on public private partnerships
      • Christine Malati, Pharm. D., (Pharmaceutical Advisor, Global Health Bureau - Office of HIV/AIDS - Division of Supply Chain for Health (SCH), USAID)
      • Jude I. Nwokike, Pharm.D. (Director, Promoting the Quality of Medicines (PQM), USP)
      • Mark Paxton, M.S., J.D. (CEO, Rx360)

Moderator:Emily Kaine M.D. (Senior Vice President, Global Public Health, USP) Discussion (Questions & Answers)
12.20 pm - 1.10 pm Lunch
1.10 pm - 1.50 pm Public Quality Standards: Foundations for Securing Quality in the Global Supply Chain
Jaap Venema, Ph.D., (Chief Science Officer, USP)
Discussion (Questions & Answers)
1.50 pm - 2.00 pm
PLENARY CLOSE
Closing Remarks
Tony Lakavage J.D. (Senior Vice President, Global External Affairs, USP)

*The Program proceedings are thus closed to the Press
2.00 pm -2.15 pm Break
Focus Area 1: Good Manufacturing Practices (GMP)
2.15 pm - 5.00 pm
Good Manufacturing Practices: Essentials for Quality
    • John Giannone (Senior Director, SMPO-Excipients, USP), Karen Takahashi (US FDA), Kang Ong Teng (HSA, Singapore), Francis Godwin (US FDA), Rick Friedman Ph.D. (US FDA)
      • APEC RHSC Gap Analysis and Tool Development
      • Session Introduction and Brief Overview: Panama Glycerin Case
      • Glycerin: Ingredient production
      • Glycerin: Supply Chain
      • Mini Break
      • Glycerin: Incoming ID Verification
      • Glycerin: Final Release
      • Other tools and considerations
5.00 pm -5.10 pm Announcement & Close
Day 2; Wednesday, March 29th 2017: Bache-Wood, USP
8.30 am - 9.00 am Arrival
Panel Session 2
9.00 am - 9.30 am
GMP and Quality : Areas of Concern for APEC Economies
Panelists: P. Phungnil (Thai FDA, Ministry of Public Health), M. Martinez (Food and Drug Administration, Philippines), T. Oviedo Latorre (DIGEMID, Peru)

Moderator: John Giannone (Senior Director, SMPO-Excipients, USP)
GMP Breakout Session
9.30 am - 10.00 am
Case Study: Exploring GMP from a product quality perspective
John Giannone (Senior Director, SMPO-Excipients, USP)

Introduction to Breakout Session and Heparin Case
10.00 am - 10.15 am Break
10.15 am - 11.15 pm
11.15 am - 12. 00 pm
12.00 am - 12. 30 pm
Readout summaries from small groups (10 minutes per group)
Summary of breakout session, questions and answers

Facilitators, all participants
12.30 pm - 1.30 pm Lunch
Focus Area 2: Good Distribution Practices (GDP)
1.30 pm - 3.05 pm
Good Distribution Practices: Essentials for Quality
    • Desmond Hunt Ph.D. ( Senior Scientific Liaison, USP); Prashant Yadav, Ph.D. (University of Michigan); Dave Ulrich (AbbVie); Glaucia Braga, Ph.D. (FURP Brazil); Chris Andersen (Cardinal Health); Marty Jeiven (Jeiven Pharmaceutical Consulting)
      • Good Distribution Practices and Product Quality
      • APEC RHSC Work Stream Efforts and Outcomes
      • Quality Management as a Foundation to GDP Compliance
3.05 pm -3.20 pm Break
Panel Session 3
3.20 pm- 5.05 pm
      • Temperature Control Management Through the Supply Chain Importation
      • Additional Considerations


Round Table Discussion: Participants Q&A
5.05 pm -5.10 pm Announcements & Close
6.30 pm- 9:00 pm Mid-Program Reception and Dinner: Rockville Hilton Hotel
6.30 pm- 7.30 pm
7.30 pm- 9.00 pm
    All Participants, Speakers, and Invited Guests
      • Reception
      • Dinner


Welcome: Kate Clemans, President, (C&M International and Advisor to the Co-Chairs, APEC Life Sciences Innovation Forum Executive Board)
Key Note: Dr. Mitchell Wolfe (Deputy Assistant Secretary for Global Affairs, U.S. Department of Health and Human Services)
Day 3; Thursday, March 30th 2017: Bache-Wood, USP
8.30 am - 9.00 am Arrival
GDP Breakout Session
9.00 am - 10.15 am
Case Study: Exploring GDP from a product quality perspective
    • CoE facilitators
      • Orientation to the facts of the case
      • Orientation to small group format
      • Breaking into small groups, participants will discuss from the GDP four pillars perspective, tool kit, and approaches to a historical case of substandard product quality
10.15 am - 10.30 am Break
10.30 am - 11.00 am
11.00 am - 11.30 am
11.30 am - 11.45 am
Readout summaries from small groups

Aide-Memoire on Product Returns: A Risk-Based Rationale for Inspecting Returns and its Impacts on GDP Compliance Assessment
Glaucia Braga, Ph.D (FURP Brazil)

Summary of breakout session, questions and answers
Facilitator and all participants
11.45 pm - 12.45 pm Lunch
Panel Session 4: Pharmacies’ Role in Delivering Quality Assured Medical Products
12.45 pm - 2.45 pm
12.45 pm - 1.45pm
1.45 pm - 2.45pm

A Dialogue in Two Realities: Implementing Good Practices in Clinical Retail Pharmacies and the Challenges of Internet Pharmacies

Victor Pribluda, Ph.D. (Program Manager- GPH, USP); Elizabeth Miler, Pharm.D. (Vice President-US Regulatory Affairs, USP); Libby Baney J.D. (Alliance for Safe Online Pharmacies-ASOP); Katie Neckers J.D. (US FDA)
Introduction of a Clinical and Retail Pharmacies Practices Tool Kit: Attempting to Address Diversity in Pharmacy Settings
Victor Pribluda, Ph.D. (Program Manager- GPH, USP)

Challenges in Assuring Quality, Product Integrity and Medication Management in Clinical and Retail Pharmacies: Case studies on (a) Compounding and (b) Medication Management and Dispensing Processes
Magaly Rodriguez de Bittner, PharmD, FAPhA (Professor and Associate Dean, University of Maryland School of Pharmacy)

Audience Reaction and Participation: Discussion will be centered on the use of the Tool Kit as a resource and the identification of action items to address challenges observed in the illustrative cases

Panel: The Challenges of Internet Pharmacies

Elizabeth Miller, Pharm.D. (Vice President-US Regulatory Affairs, USP); Libby Baney, J.D. (Alliance for Safe Online Pharmacies-ASOP); Katie Neckers, J.D. (US FDA)
Moderator: Katherine Bond Sc.D (Vice President, International Public Policy and Regulatory Affairs, USP)

2:45 pm -3.00 pm Break
Focus Area 3: Detection/ Screening Technologies
3.00 pm - 4.20 pm
4.20 pm - 4.30 pm
Introductory Remarks
Lukas Roth, MPH (Program Manager-GPH, USP)

Introduction to development and current role of screening technologies
Dialogue: Experiences in the APEC Regions

Moderator: Tony Zook, Ph.D. (Executive Director - Product Integrity, Merck)

CoE participants will share how screening technologies are being used in their economies as well as challenges they face related to their implementation

Screening technologies and the APEC toolkit
    • Mingzhe Xu, Ph.D. (Deputy Director - General Management Department, NIFDC)
      • Introduction of APEC detection technologies resources
      • Guidance document
      • Toolkit

Mini Break
4.30 pm- 5.30 pm Showcase : Selected examples of screening technologies
Nicola Ranieri (US FDA); Ravi Kalyanaraman, Ph.D. (BMS); Victor Pribluda, Ph.D. (USP);
Roman Galeev, Ph.D. (Rosdravnadzor); Sarah Bliese (Notre Dame);
Jason Rodriguez, Ph.D. (US FDA)

    • Speakers will show examples of technologies, speak to their values for stakeholders, and opportunities for supporting quality supply chains
      • CD+
      • Near IR
      • Minilab
      • Ramam
      • Paper Analytical Device
      • IMS
FOLLOWS SHOWCASE Marketplace: Screening Technologies
Participants will have an opportunity to interact with the technologies and discuss the technologies further with speakers
5.30 pm - 5:35 pm Announcements and Close
Day 4; Friday, March 31st, 2017: Bache-Wood, USP
8.30 am - 9.00 am Arrival
Panel Session 5: Screening Technologies
9.00 am - 10.00 am
  • Screening technologies - their value, challenges, and future
    • Roman Galeev, Ph.D. (Roszdravnadzor, Russia)
    • Marya Lieberman, Ph.D. (Professor, Notre Dame University)
    • Nicola Ranieri (US FDA)
    • Ravi Kalyanaraman, Ph.D. (Bristol-Myers Squibb)
    • Victor Pribluda, Ph.D. (Program Manager-GPH, USP)

Moderator: Lukas Roth, MPH (Program Manager-GPH, USP)
Invited panelists will discuss the value of screening technologies, their limitations, how they are used in various settings and the future of the field
Screening/Detection Technology Breakout Session
10.00 am - 11.00 am
Case Study: Exploring Detection/Screening Technology from a product quality perspective
Facilitators: Lukas Roth, MPH (Program Manager-GPH, USP)
    • Orientation to the facts of the Case
      • Orientation to small group format
      • Need
      • Role
      • Selction
      • Implementation
Breaking into small groups, participants will discuss how detection technologies and tool-kit can apply to a historical case of substandard product quality. Speakers will help facilitate group work and provide their experience and insight.
11.00 am - 11.15 am Break
11.15 am - 12.30 pm Tour of USP's Facilities and Historical Library
12.30 pm - 1.30 pm Lunch; proceed to Splading Suditorium
1.30 pm - 2.30 pm Summary of Breakout Session, Discussion, Questions and Answers
Facilitator, and all participants
2.30 pm - 3.30 pm Discussion - Next Steps
    • Facilitator: Katherine Bond Sc.D. (Vice President, International Public Policy and Regulatory Affairs, USP)
      • Topics for proposal for follow-up CoE meetings
      • Next steps for APEC economies
      • Other issues
3.30 pm - 3.45 pm Break
3.45 pm - 4.00 pm Closing Remarks
Tony Lakavage J.D. (Senior Vice President, Global External Affairs, USP)
4.00 pm - 4.30 pm Presentation of Certificates of Participation
USP & APEC RHSC representatives
4.30 pm - 5.00 pm Wrap up. Official Close.