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- Keynote Presentation: Exploring and appreciating the scale of the illegal trade in medicines and determining how product packaging can help mitigate the threat
Presenting an overview of the anti-counterfeiting threat as it stands today for the pharmaceutical industry Investigating the potential offerings and limitations to product packaging in mitigating the threat to product security Forecasting a realistic view of the future for product security and the impact of anticipatory measures within the industry Assessing how flexibility will be the key to the influence of product packaging on improvement of security
Simeon Wilson, Director Global Security, Astrazeneca
Ensuring your business is effectively prepared for full compliance to regulatory requirements within the set timeframe
Understanding the true timeframe for compliance to highlight any potential movement of deadlines Learning from the initiative of big pharma in Belgium; identifying the trend in speed of uptake across Europe Ensuring preparations are made for additional anti-counterfeit measures so as to mitigate costly investment further down the line Drawing from experience within France and Turkey to produce accurate estimates of timelines and costings Debating ownership of the data; once the product is dispensed which stakeholder is said to own data collected from serialisation/track and trace? Determining the impact of data ownership on further actions including product recalls
Jim Thomson, Chair, EAASM
GS1 Auto-Identification and Data Capture (AIDC) Standards and their implementation on product packaging
Introducing GS1 and GS1 Healthcare; who they are, what they do, current status, benefits and future trends Exploring GS1 Standards and their importance to the industry; understanding what this means for pharmaceutical companies Identifying the relationship between GS1 Standards and the Directive for Falsified Medicines, how GS1 can help you to achieve compliance Sharing practical implementation case studies, including any challenges, hurdles or considerations for your company
Janice Kite, Traceability Director Healthcare, GS1 Global Office
Case Study: Gaining insight into the effects of amending a packaging line to attach a 2D bar code
Setting the strategy; identifying the required system updates/changes to effectively perform product bar-coding Evaluating the market to select a solution which works with your current line Appreciating the scale of task; realistically estimating the timelines from investment and set up to results Assessing the impact of additions to the line on speed of product packaging in the short and long-term Ensuring project cycles are adjusted to counter additional production time Anticipating concurrent effects on the speed of the system and neighbouring equipment
Michael Lawlor, Senior Automation Engineer, Genzyme Ireland Limited
Optimising serialisation as a method to add complete traceability of your products in the supply chain
Forecasting the potential of full traceable pharmaceutical product lifecycles · Investigating automated authentication through coding standards, RFID, 2D-matrix · Evaluating the impact of serialisation as a solution for anti-counterfeiting and event logging for forensic research · Optimising Integration with SAP through standardised components · Uncovering and interpreting serialisation regulations
Wim De Bruyn, Product Manager, Inxites Serialisation Solutions
Combating counterfeit medical supplies and optimising business processes with web-based, serialisation-ready labelling
Exploring the key issues in keeping your products safe from counterfeiting Understanding the creation of unique serialisation codes for individual products during the production process Managing secure high speed printing and verification of these codes Having complete confidence in the subsequent efficient storage and retrieval of any of these millions of codes at any point within the lifecycle of a product and beyond
Ray Collia - Suzuki, Systems Sales Manager, ProsymID
Sharing practical considerations and challenges from experience implementing serialisation and 2D matrix coding onto the product packaging line
Anticipating the need to purchase an entire suite of solutions to enable random-number generation, printing, storage and assessing the cost implications Anticipating the degree of flexibility the system should be able to handle to honour future requirements Planning for the technical complexities of implementation and integration of these systems with current operations Creating or investing in a large scale fully-integrated data repository to collect, clean and store figures from serialisation Developing a strategy for optimal management of the huge quantities of data generated from the process Ensuring product and administrative teams are fully educated and trained on the rationale, implementation, usage and maintenance of new systems Ensuring reliability of the entire packaging line to guarantee heavy investment does not result in poor maintenance and setbacks Reflecting on challenges and hurdles come across during implementation and forecasting the likely impact on product packaging lines in the future
Klaus Hjoortgaard Olen, Head of Department Text and Graphics, H Lundbeck A/S
Keynote Presentation: Pinpointing key strategies to meet the ever-increasing pressure to reduce costs on the production line
Exploring various means by which Lundbeck have reduced costs on the production line Utilising LEAN principles to reduce manufacturing costs Assessing the potential of in-sourcing to meet potential demand in a timely manner whilst minimising the need for training Making informed decisions about whether to in-source or outsource/ make or buy Looking into packaging complexity as a method of minimising use of materials thus reducing cost and promoting sustainability Investigating standardisation as a means to reduce costs of packaging design, materials and equipment
Bo Hilligsoe, Vice President Finished Goods Production, Lundbeck
Investigating challenges and uncovering opportunities in optimising pharma packaging and labelling management
Sharing the value proposition of implementing packaging and labeling artwork ""right"" first time Assessing the supply chain packaging challenges to mitigate business risk Developing a route map to success. Bringing together process, people, systems and suppliers in an optimized artwork supply chain The Role of the specialist pack management function and the supporting toolkit ""Looking to the future"" - Considerations for ongoing success in a constantly changing regulatory, commercial and technological environment
Mark Wilkinson, Managing Director, Pinnaculum Ltd
Uncovering strategies to reduce approval times and minimise the risks associated with the printed packaging workflow
Exploring he benefits of implementing artwork standards to your production process in terms of reducing timelines Assessing the risks in your packaging workflow in order to effectively minimise them through technological offerings and improvement in lifecycle management Taking a closer look at new technologies available on the market to automate, improve and manage the entire production process Building and ensuring true quality into your product packaging through a look into QbD
Peter Muller, VP Business Development, Global Vision
Panel Discussion: Utilising expertise from other areas of the business to uncover innovative methods used for process optimisation to apply to your production line
Identifying key areas of inefficiency, time or cost consumption within the production line as key areas for improvement Sharing best practices of process optimisation and waste minimisation to discover new areas for optimisation Drawing trends from experience with other operating lines which can be brought into commercial packaging Identifying key lean principles which you should be considering to improve efficiency, cost and minimise waste Exploring innovative technology offerings for automation of processes as a method of increased efficiency
John-Paul Manning, Head of Packaging Strategy, Novartis
Michael Spallek, Director Packaging Development, Boehringer Ingelheim
Keynote Presentation: Linking patient adherence to profits; understanding why the pharma industry should pay full attention to patient compliance
Anticipating the shift in packaging strategy away from pharmaceutical and towards consumer requirements Appreciating the degree of non-compliance occurring within the population and the impacts on global health and healthcare spending Looking at differences in the profitability of products with good vs. poor compliance Addressing the impact of non-compliance on the perception of product efficacy and in turn sales, prescription volumes and reputation Finding ways to measure the degree of patient compliance to your products
Robert Winter, Director Materials Management, Pfizer
Designing and developing blister packs which enhance patient compliance; history and success stories
Assessing the cost of patient non-compliance to the industry based on figures of $290 billion US dollars and 10-25% hospitalisations Investigating the role of packaging with regards to compliance vs non-compliance Establishing the multiple factors which can implement packaging in patient non-compliance Highlighting strategies from success stories to show how companies can tackle the many aspects of patient non-compliance Developing a comprehensive approach to creating successful health outcomes
Justin Schroeder, Senior Director, Marketing and Development Services, AmerisourceBergen Packaging Group
Promoting appeal for pharmaceutical products to enhance patient compliance
Investigating the potential to convey messages through product packaging Revolutionising pharmaceutical packaging from the traditional ‘compliant but ugly’ image Drawing from experience of other industries such as cosmetics to establish key drivers for patient choice Determining the extent to which appearance impacts pharmaceutical sales Forming a dedicated group to conduct thorough market research with pre-defined representative patient groups Utilising expertise from other industries more advanced in responding to consumer needs within packaging
Tassilo Korab, Director, Healthcare Compliance Packaging Council Europe (HCPC)
Day Two:
Keynote Presentation: Case Study: Ensuring a systematic approach to generation of a solid, accurate core data sheet
Aiming for a concise document to promote accuracy and specificity of information for further product information documentation and labelling Ensuring the reliability of your core data sheet to stand up against any product disputes later down the line Allowing your core data sheet to fully support your product by focussing on dedicated carry out Forming a group of the most representative experts to truly interpret relevant information Sharing best practices of core data sheet production
Petra Baddack, Head of Europe Regulatory Affairs Coordination, Solvay
Keynote Presentation: Case Study: Encompassing holistic product design when determining the packaging of your product; with specific focus on adherence, sustainability and patient centricity
• Meeting the challenge of increased focus on packaging and functionality (service beyond the product itself) • Understanding sustainability of packaging and building a sensible road-map to extract business value • Understanding and addressing the needs of Patients, Caregivers and the supply chain in different global markets • Bringing Adherence as a foundational element into product design • Dealing with the trade-offs (cost, complexity, flexibility, etc.) during decision making
John-Paul Manning, Head of Packaging Strategy, Novartis
Exploring late stage customisation of pharmaceutical packaging as a method to promote efficiency and flexibility on the production line
Summarising how market demands drive the need for increased flexibility of a pharmaceutical packaging operation Investigating how flexibility in production and the resulting packaging complexity reduce the effectiveness of packaging lines Exploring how late stage customisation can compliment a lean pharmaceutical packaging process and improve OEE Outlining the changes in production methodology required for late stage customisation Sharing a case study and highlighting the benefits
James MacKenzie, Sales Director, HAPA AG
Implementating quality by design (QbD) in drug development: How to select the right bottle for sensitive formulations?
Outlining Quality by Design (QbD) for drug pre- and formulation Exploring drug excipient compatibility and stability testing (DECS-testing) Investigating sensitivity of active pharmaceutical ingredients (API) against hydrolyis and oxidation Determining the importance of WVTR (water vapor transmission rate) and OTR (oxygen transmission rate) Delving into the complexities with shelf life (temperature and relative humidity in different climate zones) Comparing customized passive and active barrier plastic bottle
Hans Wiech, New Business Development Manager, LOG Plastics
Case Study: Sharing best practice to reduce costly, resource-intensive lags throughout the procedures for regulatory approval for product labels
Minimising the back and forth submissions of draft texts and mock-ups to regional affiliates through enhancing knowledge of local requirements in advance Optimising the preparation of draft labelling texts, mock-ups and samples considering the need of national applications, decentralised and centralised procedures and Blue Box requirements Ensuring your readability testing is conducted effectively and at the right time; finding the right partner to deliver appropriate constructive feedback Optimising the linguistic review process of translations for new applications and variations
Horst Kastrup, Director Regulatory Affairs and Quality Assurance, MEDA Pharma
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