Programme

Here is an overview of the conference programme. You can browse by category to see full details of the sessions you are most interested in or click on the tabs on the interactive calendar to see what's on each day. Clicking on any of the speakers or sponsors will show you more information about them and why they are supporting this event.

Overview

    • 08:30 - 08:45
      • Registration and Refreshments

      • 09:00 - 09:35
      • Handling the end to end labeling process to ensure optimal efficiency

        • Assessing early and upfront target labeling to ensure efficiency in cost and time

        • Analysing the end to end process of labeling to understand potential struggles on a global scale

        • Investing in packaging development team to ensure what is in the patients hands are accurate and readily available

        • Exploring a proactive approach to holistic labeling in order to better handle changes in structure and roles

        • Using LEAN methodologies in order to successfully apply global solutions and harmonise different company environments

      • 09:35 - 10:10
      • CASE STUDY Exploring SPL, the USPI in XML format and its history to further identify and implement the use of SPL in a company

        • Investigating how SPL got started in order to gain a better understanding of its background

        • Discovering its original use and the subsequent changes to analyze the impact of its evolvement

        • Identifying drug listing information in order to streamline your manufacturing process and understand its relation to U.S. customs

        • Case study examples of SPL use in order to transfer it to your company needs

      • 10:10 - 10:45
      • Clarifying an update on SPL and its downstream use; thinking outside the box, how else can SPL be used?

        • Outlining a brief history and definition of SPL, DailyMed and drug listing

        • Exploring what the next steps are for SPL; thinking outside the box

        • Ensuring labeling on DailyMed is up to date and understanding the reasons why this is paramount

        • Exploring the possibilities with SPL outside of product labeling in terms of public safety and quantifiable cost savings

        • Taking the necessary steps to ensure that you achieve a return on investment with SPL

        • Investigating the use of SPL throughout the pharmaceutical industry; case study experiences

        • Understanding the value of the permanent link and use on websites

        • Understanding the value of the permanent link and use on websites

        • Discovering the possibilities with SPL use on handheld devices

        • Taking a look at consumer use of SPL

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

        • 11:15 - 11:50
        • Investigating FDA verification for SPL in order to better understand the submission process and obstacles

          • Assessing the difficulty of getting documentation in order to forecast the timeline of the FDA process

          • Exploring techniques of approval information acquisition in order to ensure successful SPL FDA verification

          • Examining the advantages of onsite SPL in order to ensure easier FDA verification approval and avoid certain obstacles

          • Debating methods of better communication with the FDA in order to avoid rejections and effectively warn companies when regulation changes have been made

          • Analyzing the FDA’s intention on implementing serialization and standardization across the field in order to help companies fully prepare

        • 11:50 - 12:25
        • Exploring strategies to reduce approval times and risks involved in the printed packaging workflow

          • Investigating the benefits of implementing artwork standards

          • Identifying key risks in your packaging workflow in order to develop mitigation strategies

          • Taking a closer look at new technologies needed to improve and manage the entire process

          • Effectively demonstrating artwork changes

        • 12:25 - 13:40
          • Lunch and networking

          • 13:40 - 14:15
          • Uncovering practical application needs of serialization within the U.S in order to fully understand the advantages and disadvantages

            • Investigating methods of educating employees on serialization in order to achieve operational efficiency within departments

            • Considering the shortcomings of serialization in order to ensure patients have a realistic sense of security

            • Analyzing the benefits serialization will bring to the pharma business in order to ensure confidence in serialization investment

            • Examining how making serialization mandatory will affect wholesalers, manufacturers, and retail outlets in order to analyze who will pay for the mandate

            • Exploring how serialization could be used for authentication purposes in order to upgrade the verification of codes since counterfeiters are able to duplicate certain codes

          • 14:15 - 14:50
          • Investigating methodologies in increasing patient adherence among patients to avoid loss of patient and physician loyalty to products

            • Addressing the main reasons why patients are not adherent to their medications in order to successfully calculate the extent of solutions needed to increase compliance

            • Determining the extent patients taking drugs improperly cost pharma companies in order to understand the need for large investment in patient compliance measures

            • Examining the need for making directions easier to read and understand to decrease patient issues with administration of drugs

            • Discovering ways pharmacists can aid in patient compliance and educating patients to increase patient knowledge of medications on a personal level

            • Highlighting if online usage to find medication information can aid in patient compliance in the midst of the effort to eliminate paper patient inserts and instructions

          • 14:50 - 15:20
            • Afternoon refreshments and networking

            • 15:20 - 15:55
            • Overview of the changes in the labeling and PLR regulations

              • Clarifying timeframes for implementation of PLR

              • Major revisions and differences in the new and old formats

            • 15:55 - 16:30
            • Acquiring understanding of country to country specifications in order to minimize packaging and labeling time, effort, and cost

              • Exploring ways of working with vendors from different countries in order to ensure consistency in packaging

              • Examining the EU’s more advanced guidelines for bulk packaging and carton labeling and how it differentiates from the U.S. to discover ways for increased efficiency and decrease in medication errors

              • Evaluating on a global scale the way packages should look and information required in order to properly assess the variation of packaging and labeling country to country specifications

              • Evaluating labeling needs of countries with more than one language to avoid the costs of using third party labelers

              • Discerning which countries have different requirements for cartons and outer packages to ensure less mistakes and repackaging hassle

            • 16:30 - 16:40
            • Chairman's summation and close of day one

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