Former Director of Regulatory Compliance& Policy
Workshop H:Improving Global Supply Chain Performance through Collaboration and Partnerships
Pharma is anxiously waiting for full scale customer collaboration programs to take off. With pressures from regulatory compliance agencies, labeling and packaging commissions, and user requirements, manufacturers and suppliers must communicate effectively in order to streamline the distribution process of their products. How can we use joint ventures, 3PL management consultants, and data sharing to improve our supplier relationships and promote collaboration across the supply chain?
What will you learn?
· Assess multiple distribution channels
· Increase urbanization, rising distribution costs, and growing demands for a sustainable supply chain
What strategies will be discussed?
· What are the best innovative solutions to enhance partnerships and collaboration?
· Harness agility and flexibility to deliver optimal performance
1:15 PM Regulatory Briefing: End to End Serialization & Traceability- How can we Meet the DSCSA November 2017 Serialization Requirements and Leverage Value-added Opportunities?
Now that we are up to speed on the “why”, it is time to focus on the “what & when” surrounding serialization. Regulations & guidelines are in practice across the globe, all with different requirements and deadlines, some without much guidance at all. The regulatory landscape is constantly evolving with new regions deciding to jump on the bandwagon and others reworking their current plans. With the US & EU leading the way, it is important to fully grasp the international scope of serialization requirements & reporting to ensure that you are fully compliant in all markets that you conduct business.
What you will learn:
• Overview of the DSCSA & EU FMD deadlines and expectations
• Review the regulatory changes coming out of Brazil, Russia & India
• How will emerging markets in the Middle East & Africa decide to map out their guidance’s on tracking and traceability
• Streamline your reporting to the various regions by understanding what is required
• How to ensure data integrity & security when operating in multiple regions