Tuesday 25 July, 2017
08:30 Breakfast & Registration
09:00 Chair’s Opening Remarks
Regulatory & Compliance In Supply Chain Operations
09:10 U.S. Customs & Border Protection Transition To Centers Of Excellence & Expertise
- Kenneth Schonewolf Supervisory Import Specialist, Pharmaceuticals, Health, & Chemicals Center of Excellence & Expertise, U.S. Customs & Border Protection
- Increasing industry-based knowledge within CBP
- Facilitating legitimate trade through effective risk segmentation
- Enhancing enforcement and addressing industry risks
09:40 IATA’s Certified Program For Compliance
- Ronald Schaefer Project Lead, CEIV Pharma, International Air Transport Association (IATA)
- IATA’s perspective on future pharma supply chain operations and compliance – key trends and challenges
- CEIV progress and milestones
- What does this mean to your global supply chain operations in terms of air freight partners and hubs?
10:10 Morning Refreshments & Speed Networking
11:00 Rethink Your Distribution & Channel Strategy
- Kevin Cook VP Supply Chain North America, Sandoz
- Get inspired and be open-minded: cross industry learning
- What channels are available to pharma and biotech to get closer to your healthcare providers, POS and patients?
- What are the risks and what are the benefits?
- How to implement and restructure while ensuring compliant operations?
11:30 Roundtable Discussion: What If? Contingency Planning and Risk Mitigation Strategy
- Davon Soltis Senior Consultant, Sedlak Management Consultants, Inc.
- Karl Sliwinski Manager, Sedlak Management Consultants, Inc.
- How to define responsibility and liability with your 3PLs upfront?
- What contigency planning is needed for an un-disrupted supply chain operations?
- Can you start hedging: physical, financial and analytical mitigation?
- How to ensure a good distribution network and trustworthy 3PLs who can help mobilize in an unforeseen event?
12:00 Lunch & Networking
Ensuring Smooth & Global Operations 24/7
13:30 What does the FDA Expect from Drug Importers?
- Russell Vandermark Import Specialist, FDA
- Importation requirements and process
- What is ACE (Automated Commercial Environment) – CBP’s Single Window Interface for Shipment Info submissions into the US
- Raw materials vs. medicinal product requirements
- Country of origins definitions differences between CBP and FDA
- Do’s and Don’ts on FDA Investigator interaction and communication
- Progress and updates on supply chain security act
14:00 Roundtable Discussion: It’s All Down to Planning – Demand Forecast & Moving Towards S&OP
- Mark Chockalingam Founder & President, Demand Planning LLC
- Assessing your current status and thinking of S&OP – collate your data for better manufacturing and supply planning
- Looking beyond and anticipate on unexpected market demand to prevent shortages – how are you coping?
- Integrating demand forecast into your core supply chain operations and business planning