Day 1
1 April 2019
  • 1300 - 1310
    VP, European Operations
    ISPE Staff
    President and CEO
    VP Project Lead Biologics Expansion
    Janssen Pharmaceuticals
  • 1310 - 1350
    Global Success Factor: Innovation and Digitisation
    Industrial digitisation is a key enabler to drive innovation. Currently the industry is looking more at the whole value network instead of only the value chain. As all computerised systems can be connected to each other, based on internationally agreed technical standards, so far undisclosed potentials in all industrial sectors can be reached out. Pam Cheng will explain Astra Zeneca's approach to this new possibility.
    Executive Vice President of Global Operations & IT
  • 1350 - 1430
    Efficiencies Gained in Bioprocess Automation and Cyber Security
    Biopharmaceutical production has developed into the new technological hotspot for pharmaceutical manufacturers. Reliability and stability in processes can only be achieved by process automation. Cyber security has become also a key issue as the value of batches sometimes goes to millions of Euros/Dollars. One failure, blackout or wrong intervention in these processes can destroy high amounts of value, safety and confidence into a manufacturer's capabilities. Olivier will explain GE Healthcare's approach to a high-end automation.
    Placeholder Person Graphic
    General Manager, BioProcess
    GE Healthcare Life Sciences
  • 1430 - 1510
    Innovation in Biomanufacturing Plants
    Biopharmaceutical plants will look different in the future. Agility and flexibility for rapidly changing product portfolios, single-use technologies, continuous manufacturing, small batch manufacturing, personalised medicine manufacturing will not only change the face of a plant but will also require other logistics models. Chris will explain WuXi Biologics' approach to biological facilities of the future.
    WuXi Biologics (Shanghai) Co., Ltd.
  • 1510 - 1530
    Networking Coffee Break
  • 1530 - 1610
    Political Environment for Future Manufacturing in Europe
    The technical perspective on innovation has a political context. Europe is approaching the Brexit, the EMA will relocate from London to Amsterdam, the role of national competent authorities will probably change, and mutual recognition agreements will have an impact on the day-to-day inspections at manufacturers. Mary Harney, former Minister for Enterprise and Trade Employment and former Minister for Health and Children in Ireland, will give her perspective on future challenges for the pharmaceutical industry in Europe.
    Placeholder Person Graphic
    Former Minister for Enterprise, Trade & Employment, Minister for Health
  • 1610 - 1650
    Driving Continuous Improvement in a Digital Age - Prerequisits, Challenges and Opportunities
    Driving continuous improvement in a digital age needs a number of pre-requisites and face new challenges and opportunities. Transition management from legacy systems has to be managed. Operational excellence will be newly defined, with new approaches, new KPIs, new job requirements and much more. Thomas will explain these new elements in light of benchmarking the pharmaceutical industry with other industries.
    Director of Institute of Technology Management
    University of St. Gallen (Switzerland)
  • 1650 - 1730
    ICH Q 12: Making Change Easier
    The first ICH guideline Q12 addresses Product Life Cycle Management. After years of discussion, industry is underway to develop a clear profile for Product Life Cycle Management. How to better manage product transfers, how to minimise the scale-up risk and how to manage a structured product phase-out from the market without creating drug shortages and clear advice for doctors and patients what to do next is covered by Graham's presentation. Making changes easier!
    Senior Director
    Pfizer Pharmaceuticals
Day 2
2 April 2019
Day 3
3 April 2019

Speaker Qualifications

Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.