Presentation - Day 2 - Wednesday
Plenary session – Pharmaceutical traceability from manufacturer to patient
-
Standards in humanitarian work - Mr. Tom Woods, Chairman of the Global Steering Committee for Quality Assurance, World Bank, U.S.
-
Standards in humanitarian work - Dr. Ramy Guirguis, Senior Information Technology Advisor, USAID, U.S.
-
Early learnings from policy work on implementation of global standards - Mr. Yehulu Denekew, Director General, Food, Medicine, Health Care Administration and Control Authority of Ethiopia (FMHACA)
-
US FDA Drug Supply Chain Security Act (DSCSA) - Ms. Connie T. Jung, RPh, PhD, Senior Advisor for Policy, Office of Drug Security, Integrity, and Response (ODSIR), Center for Drug Evaluation and Research, Office of Compliance, U.S. Food and Drug Administration
-
Panel – DSCSA Implementation - Mr. Scott Mooney, Vice President, Distribution Operations, McKesson; Mr. Chris Reed, Lead, Product Serialization and Traceability, Johnson & Johnson, U.S.; Mr. Jeff Denton, Sr. Director, Global Secure Supply Chain, AmerisourceBergen, U.S.; Mr. Thomas McHugh, Sr. Strategist SC Systems, CVS Health, U.S.
-
European Union Falsified Medicines Directive - Mr. Mike Rose, Vice President, Supply Chain Visibility, Johnson & Johnson, U.S.;
-
Pharmaceutical traceability in Brazil - Ms. Bianca Zimon Giacomini Ribeiro, Deputy Chief Adviser for International Affairs, National Agency of Sanitary Surveillance (Anvisa), Brazil
-
Achieving single unit pharmaceutical traceability - Mr. Tjalling van der Schors, Pharm.D., Hospital Pharmacist, President NVZA, Director of Pharmacy, WestfriesGasthuis, Netherlands
-
Identification of Medicinal Products (IDMP) - Ta-Jen (TJ) Chen, Project Management Officer, FDA/CDER/ Office of Strategic Programs, U.S. Food and Drug Administration
Breakout sessions:
- Panel - Implementation of GS1 standards in clinical trials processes - Dr. Greg Koski, PhD, MD, Chairman of the Board of Directors, Co-Founder & President, CEO, ACRES - Alliance for Clinical Research Excellence and Safety, U.S.; Mr. Hans von Steiger, PMP Group Leader, Clinical Supply Chain Management, Pfizer, U.S.; Ms. Sylvia Bartel, VP Pharmacy, Dana-Farber Cancer Institute, U.S.; Mr. Sylvain Alberola, Head, Clinical Supply Chain Industrial Development, Sanofi, France
- Panel - The surge for data and information - Mr. David Brooks, Director of Engineering, Strategic Project Management, Medtronic, U.S.; Mr. Charlie Kim, President and CEO, 121nexus, U.S.; Mr. Feargal Mc Groarty, National Haemophilia System Project Manager, St. James’s Hospital, Ireland; Ms. Tatjana Pathare, Artworks and Regulations Specialist within the Serialisation Project, F. Hoffmann La Roche; Mr. Stefan Artlich, Director, Senior Project Manager 'Track&Trace', Bayer, Germany
- Panel - Pharmaceutical Traceability – learnings from around the world - Mr. Senthil Rajaratnam, Affiliate Serialization Account Manager, Eli Lilly and Company, U.S.; Mr. Lloyd Mager, Global Traceability Lead, AbbVie, , U.S.; Mr. Pascal Aulagnet, Senior Manager, Global Serialization - EMEA Client Partner, Pfizer, France; Mr. Stefan Artlich, Director, Track & Trace, Bayer, Germany
- Panel - UDI – AIDC Implementation experiences - Ms. Jackie Elkin, Global Process Owner Standard Product Identification, Global Regulatory Affairs, Medtronic, U.S.; Mr. John Terwilliger, GS1 Senior Consultant, Global Standards & Serialization Office, Abbott, U.S.; Mr. Mark Hoyle, Technical Director, UDI, Commercial Regulatory Affairs, Teleflex, Ireland; Mr. Georg Keller, Manager Regulatory Affairs, Labelling Coordinator, B.Braun / Aesculap AG, Germany