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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.

Charlie Abrines
E-mail: charlie.abrines@arena-international.com
Telephone: +44 (0) 207 832 4393

Overview

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

      • 08:50 - 09:00
        • Chair’s opening remarks

        • 09:00 - 09:30
          • Keynote Speaker

            Patricia Walsh – Director, Head of Global Labeling, Jazz Pharmaceuticals
          • Speaker

            Christy Wood – Senior Manager Global Labeling, Jazz Pharmaceuticals

          Establishing an accurate global labeling tracking system to ensure your end-to-end labeling is inspection ready

          • Appreciating complexities in tracking labeling changes when managing multiple teams across global sites to minimize challenges encountered due to variations at the individual country level

          • Recognizing current difficulties in ensuring end to end labeling to determine regulatory repercussion on your company

          • Evaluating current labeling tracking systems and suggesting improvements to your internal procedures to ensure preparedness for pharmacovigilance inspections

          • Establishing reporting systems which enable non-compliance changes to be detected quickly and prevent safety update delays and backlogs

          • Emphasizing improvements in end to end labeling to minimize risk and improve safety

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

          • 10:00 - 10:30
          • Evaluating your inspection readiness strategy to guarantee you are on top of the changing labeling landscape and ready to comply

            • Establishing internal tracking and reporting structures which allow you to react to global guideline alterations without compromising your current timelines

            • Designing cross departmental reporting systems that allow label amendments in your product portfolios within allocated timelines stipulated by regulators to ensure compliance

            • Ensuring your labeling documentation is adequately set up to handle inspections by regulators and prevent audits

            • Developing internal strategies to guarantee labeling information changes are quickly rolled into the supply chain to maximize patient safety

            • Determining whether internal rearrangements are best achieved through in-house restructuring or outsourcing to guarantee you are prepared for your next inspection

          • 10:30 - 10:45
            • Tech Spotlight Session reserved for CCL Label

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

              • 11:15 - 11:45
                • Past Speaker

                  Guido Schmitz – Director of Packaging Design, Bayer

                Harnessing branding as a story telling tool; remaining relevant in both the present and the future

                • Appreciating brand loyalty as a mechanism to generate a bond between your customer and your company that lasts a lifetime and increases your revenue

                • Developing a branding strategy with a clear target audience that focuses on generational differences and expectations to ensure your customer loyalty

                • Recognizing the need for you brand to adapt through time; pinpointing sustainability as a key focus of millennials and the impact this will have on your business model and strategy

                • Appreciating the role of consistent branding across markets to increase your companies global image

                • Assessing ways through which branding can differentiate your products from that of the competition to win a competitive advantage

              • 11:45 - 12:15
                • Session reserved for BlueSoftware

                • 12:15 - 12:45
                  • Past Speaker

                    Garry Tuggle – Special Agent in Charge, U.S. Drug Enforcement Administration

                  Understanding the worst drug epidemic in US history: the link between prescription opioid and heroin abuse

                  • Explaining the US history drug epidemic to describe the increasing drug abuse in the States

                  • Describing how prescript drug leads to heroin abuse to raise awareness of the seriousness

                  • Highlighting DEA’s efforts to reduce the abuse nationwide

                  • Generating solutions to protect the public health

                • 12:45 - 13:45
                  • Lunch and networking

                  • 13:45 - 14:15
                    • Speaker

                      Remon Zakhary – Senior Group Lead Packaging Services, Bayer

                    Sourcing the right contract manufacturers throughout the globe to supply what you need, when you need it

                    • Assessing logistical complexities of engaging with multiple contract manufactures around the globe and suggesting ways to simplify this process

                    • Outlining mechanisms to reduce timelines in finding compliant partners set out by global headquarters to guarantee supplier conformity

                    • Establishing partnerships with in-country suppliers to ensure you do not need to ship low value supplies and incur added costs

                    • Ensuring all packaging components can be produced by one supplier to streamline processes

                    • Improving partnerships between CMO’s and pharma to improve working relationships and prevent relationship disintegration

                  • 14:15 - 14:45
                    • Session Reserved for Global Vision

                    • 14:45 - 15:15
                      • Speaker

                        Matt Sample – Sr. Director, Secure Supply Chain, BluePoint Laboratories

                      Finalizing the serialization process; uncovering the final components needed to ensure compliance

                      • Assessing FDA’s push back for serialization guidelines and its implication on your implementation timeline

                      • Enhancing serialization knowledge to ensure you are fully compliant with regulatory requirements

                      • Reviewing serialization implemented around the world to decipher lessons learned to minimize errors

                      • Ensuring your manufacturing partners are adequately equipped to comply with serialization to prevent delays

                      • Examining serialization retroactively to understand how current systems can be improved before November 2018

                    • 15:15 - 15:45
                      • Afternoon refreshments and networking

                      • 15:45 - 16:15
                      • Improving in-house department relationships as a simple and effective solution to guarantee in-house efficiency

                        • Outlining the need to pinpoint departmental priorities to guarantee internal awareness and prevent silos

                        • Establishing strong connections between packaging and labeling teams to ensure there is a structure of interdepartmental cooperation which prevents task duplication

                        • Harnessing technology to streamline internal communications and ensure optimal efficiencies in the packaging and labeling process

                        • Determining methods for an internal communication strategy which can be traced throughout departments to ensure all parties involved are aware of timeline alternations

                        • Considering how horizontal reporting structures can improve departmental relationships by establishing a clear responsibility framework

                      • 16:15 - 16:45
                        • Session reserved for Amplexor

                        • 16:45 - 17:15
                        • Uncovering FDA’s final guidance’s on Nonproprietary Naming of Biologics and Biosimilars and what this means for your current labeling strategy

                          • Appreciating highly complex manufacturing processes required for biologics to determine how the new guidelines will support pharmacovigilance efforts and minimize improper substitution

                          • Uncovering nonproprietary naming and the importance this holds in today’s labeling practices to guarantee you are up to speed with current regulations

                          • Outlining difficulties in ensuring adequately labeled suffixes no all bio-similar products to ensure compliance with strict FDA requirements

                          • Modifying your manufacturing process to ensure it is equipped to cope with additional labeling needs required by the guidelines

                          • Assessing ways to ensure compliance with incoming regulations with regards to electronic prescribed information databases and its effect on biologics

                        • 17:15 - 17:30
                          • Chair’s summary and close of day 1

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