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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.

Guglielmo Migliori
E-mail: gmigliori@arena-international.com
Telephone: +44 (0) 207 936 6941

Overview

    • 08:00 - 08:45
      • Registration and refreshments

      • 08:45 - 09:00
        • Chair’s opening remarks

          Gail Tennyson Hicks, Associate Program Director, Genentech

        • 09:00 - 09:30
          • Speaker

            Lisa Kelsey – Head, Commercial Labeling, Genentech

          Achieving greater cooperation between cross-functional teams to streamline your product launch and change control systems

          • Achieving greater collaboration between package design/engineering, labeling, artwork, marketing, regulatory, manufacturing, and supply chain departments to meet deadlines for product launches and updates

          • Establishing clear lines of communication between cross-functional departments to streamline product approval protocol

          • Implementing an effective approvals tracking system to easily identify outstanding tasks that delay product launches and updates

          • Eliminating the guesswork involved in updating packaging, labeling and artwork within manufactured drugs

          • Maintaining and updating systems which promote built-in flexibility and consider changing global regulation

        • 09:30 - 10:00
          • Speaker

            Jackie Leslie – Director, Business Development, BLUE Software

          Mastering the complexities of Artwork Version Control

          • Tracking versions with constant change

          • Making sure regional variants are kept in sync with the masters

          • Managing overlapping regulatory requirements

          • Getting more granular – managing versions within versions

        • 10:00 - 10:45
          • Speaker

            Catherine Segura – Senior Manager, Systems Engineering Operations, BD Biosciences
          • Speaker

            Steve Kemmerrer – VP Engineering Operations, Inovio Pharmaceuticals

          Panel: Establishing perfect communication within different departments to improve every step in the development process

          • Encouraging regular cross function meetings across design process to ensure compatible packaging

          • Establishing pragmatic communication from the beginning for selection of materials and sterilization methods

          • Working directly with labeling group to review artwork and ensuring technical requirements are met

          • Building relationships and good teamwork through defined team structures to create structured action plans

          • Ensuring a successful launch through open communication and precise questioning to colleagues in different sites

        • 10:45 - 11:15
          • Morning refreshments and networking

          • 11:15 - 11:45
          • Assessing solutions to optimize your End-to-End artwork process

            • Unveiling the drivers of change in the packaging supply chain

            • Controlling a Global artwork process to ensure efficiency and transparency

            • Implementing a GMP compliant artwork process

            • Optimizing Vendor selection, managing outsourcing and developing long term business partnerships

            • Identifying how Asset Management and Workflow Techniques improve effectiveness

          • 11:45 - 12:15
            • Speaker

              Kenneth Tan – Senior Packaging Engineer, Amgen

            Assessing cryogenic secondary packaging operations

            • Analyzing challenges to ensure an optimal packaging a cryogenic product

            • Addressing solutions for a great packaging assembly in cryogenic temperatures

            • Exploring new possible labeling and packaging solutions in this field to overcome potential issues

          • 12:15 - 12:45
          • Learning why your labeling process is obsolete

            • Pinpointing common sources of errors in your labeling process

            • Using technology as a vehicle in improving processes

            • Modernizing the labeling process

            • Unveiling Case Study: ROI

          • 12:45 - 14:15
            • Lunch and networking

            • 14:15 - 15:00
            • Panel: Evaluating modifications to your packaging process to better adapt to your current study

              • Appreciating different processes solutions to adjust your approach on products’ unique characteristic

              • Working proactively with manufacturing organizations through meetings for developing common strategies

              • Organizing right number of audits to comply with FDA quality requirements and launch your products

              • Examining necessity to modify manufacturing process to ensure a rapid problem solving in case something unexpected happened

              • Changing swiftly a packaging component to shift to a new component needed

            • 15:00 - 15:30
              • Speaker

                Paul Reyland – Director of Sales Western North America, CCL Healthcare

              Transforming the Supply Chain with Digital Printing

              • Reducing time to market

              • Reducing Obsolescence

              • Reviewing Just-in-time printing & flexible qualities

              • Analyzing variable and serialized Printing

            • 15:30 - 16:00
              • Afternoon refreshments and networking

              • 16:00 - 16:30
              • Avoiding Labeling Misprints: The Truth Behind the Labeling Review Process

                • Exploring the day-to-day struggles of a real-life Labeling Manager

                • Learning best practices to improve your labeling review process

                • Increasing efficiency by reducing the number of correction cycles

                • Improving packaging quality and eliminate your risk of errors

              • 16:30 - 17:00
              • Teaching "how to fish..." - A packaging engineer’s perspective working in China

                • Explaining what it’s like living and working in China

                • Addressing packaging engineer’s challenges in Chinese medical device industry

                • Learing about keys to success as a packaging engineer in China

              • 17:00 - 17:15
              • Chair’s summary and close of day 1

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