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SerializationRegulatory compliance, Case studies and best practicesתאימות רגולטורית, מקרי בוחן ושיטות עבודה יעילות
This session presents a strategic view of global track-and-trace compliance regulations and how pharma companies can build effective, sustainable serialization programs to ensure long-term business success.
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Issues to be covered
- Key global regulations in play and how companies have successfully approached them; case-study focus on EU FMD, US DSCSA, and Russia
- Planning and managing serialization programs in a context of uncertainty and imperfect information
- How investment in serialization can be a strategic differentiator in developing healthcare solutions
| 09:00 | Welcome and opening remarks BioForum / ProTechTiv |
| 09:15 | Educational session Serialization and Global Regulatory Compliance TraceLink, Mr. Allan Bowyer |
| 10:00 | Q&A session TraceLink & ProTechTiv |
| 10:30 | Coffee break |
| 11:00 | Customer Case Study Teva |
| 11:45 | Lunch |
| 12:30 | ProTechTiv session on Project Management and Best Practices |
| 14:30 | TraceLink overview |
| 15:30 | Close |
Who should attend
- Serialization program leaders
- Supply chain executives
- Anyone involved in a serialization project (project managers, IT Directors, QA Directors, Supply Chain Directors, Regulatory Affairs, Production Directors)
Benefits to the Participants
- Understand key considerations in designing a serialization program
- Be able to engage own company leadership in making investment decisions
- Ability to leverage serialization investments for value-added services and supply chain efficiency
About The Lecturer
Allan Bowyer
Director of Industry Marketing, TraceLink Allan Bowyer works with pharmaceutical
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