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Programme

If you have any unique case studies or topics you would like to see covered on the agenda please contact the program director below if you have any questions or queries.

Guglielmo Migliori
Conference Producer
Email: guglielmo.migliori@arena-international.com
Telephone: +44 (0) 20 79366941 <

Overview

    • 08:15 - 08:50
      • Registration and refreshments

      • 08:50 - 09:00
        • Speaker

          M. Dave Malenfant – Executive Vice-President, Industry Liaison | Director, Center for Supply Chain Innovation, BSMA (Biotech Supply Management Alliance) | Neeley School of Business, TCU (Texas Christian University)

        Chair’s opening remarks

      • 09:00 - 09:30
        • Speaker

          Mary Y. Zhang – National Account Manager, US Customs and Borders

        Presenting US Customs and Border Protection Centers of Excellence and Expertise (CEE)

        • Analyzing goals of Centers

        • Unveiling Center divisions

        • Assessing regulatory trade Authorities

        • Presenting C-TPAT and ISA Program

        • Presenting Trusted Trader Program

      • 09:30 - 10:00
        • Session reserved for Sensitech

          Content TBC

        • 10:00 - 10:30
        • Supporting temperature excursions throughout the product life cycle

        • 10:30 - 11:00
          • Morning refreshments and networking

          • 11:00 - 11:30
            • Speaker

              Keyur Doshi – Validation Manager, Validation Manager

            Strategies for designing a robust Shipping Validation Program in an evolving regulatory and expanding business environment for start-ups and SMEs

            • Understanding and complying with the regulatory landscape: what are my inspectors looking for?

            • Moving away from one-time studies and adopting a Shipping Validation Lifecycle approach of Planning, Qualification and Maintenance

            • Specifying, finalizing and documenting Packaging and Shipping Configurations and Procedures

            • Shipper Qualification (DQ, OQ & PQ): ‘Partnering’ and not just ‘Leveraging’ Vendor Qualification Packages and Services

            • Case Study: Investigation and resolution of a failed passive shipping container PQ study

          • 11:30 - 12:00
            • Session reserved for QUICKSTAT

              Content TBC

            • 12:00 - 12:30
              • Chair

                M. Dave Malenfant – Executive Vice-President, Industry Liaison | Director, Center for Supply Chain Innovation, BSMA (Biotech Supply Management Alliance) | Neeley School of Business, TCU (Texas Christian University)

              Event's chairman session

              Content TBC

            • 12:30 - 13:30
              • Lunch and networking

              • 13:30 - 14:00
                • Speaker

                  Paul Raffile – Global Security Analyst, Alexion Pharmaceuticals

                Protecting global supply chains: Case Studies using social media and online investigations

              • 14:00 - 14:30
                • SESSION AVAILABLE TO SPONSOR

                • 14:30 - 15:00
                  • Speaker

                    Ed Ram – Senior Director, Supply Chain, Sagent Pharmaceuticals

                  Working successfully with CMOs to ensure a smooth journey to have your drug getting to destination as quickly as possible with no major excursions

                  • Choosing CMOs with local depots in foreign countries to reduce time of drug approval and quicken your overall operations

                  • Picking CMOs that can lead you in meeting foreign countries' regulations to save time and money

                  • Working with experienced CMOs to manage distribution in the best way possible in terms of foreign qualifications about temperature requirements

                  • Maximizing collaboration with your partner to enter your new market to have consonant features

                  • Discussing biopharmaceutical supply chain future to use all of the new technologies readily

                • 15:00 - 15:30
                  • Afternoon refreshments and networking

                  • 15:30 - 16:00
                  • Evaluating temperature management solutions to decide how to move your product and not run into unexpected events during its shipment

                    • Discussing best practices to find answers to have exemplary temperature in your room for temperature controlled product

                    • Approaching new testing methods to organize your performance qualification and possibly using less time and resources

                    • Making shipment qualification tests from the head start to find the best conditions and determine what temperature is ideal to have your drug constantly at the perfect conditions

                    • Assessing performances of passive temperature protection options to be prepared about new requirements

                    • Comparing several alternatives to get needed information to avoid regulatory limitations on utilizing your supply chain

                  • 16:00 - 16:30
                  • Discovering new global challenges to become familiar with emerging markets and expand your business

                    • Underlining preclearance paperwork importance to avoid audits by the FDA and make your shipment go ahead with no restrictions

                    • Communicating with your partners through your compliance team to be aware of what issues may arise to be organized to work together and fix them

                    • Testing your qualification method several times to be sure of what kind of customs you’re going to go through and not waste time once there

                    • Finding solutions to comply with precise information needed in South America to spend less time to export your products in the region

                    • Focusing on how to be aware of which products can be introduced in the Asian market to enter this market properly

                  • 16:30 - 16:45
                    • Chair’s summary and close of day one

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