2022 ISPE Europe Annual Conference

Conference topics

  • Track One: Sustainability - The Next Challenge

    We have been involved with sustainability for some time, but progression has been slow due to many influences – political, practical, sometimes a lack of understanding of the totality of its impact. Now, with the influence of the COVID-19 pandemic, is the time for a reboot.

    The conference sustainability track, using the United Nations definition of sustainability, will take us on the road to understanding how to achieve a sustainable pharmaceutical industry, one of the key challenges for our industry and society globally.

    The conference post-dates the UN IPCC COP26 summit on climate change with its expectation of achieving staged greenhouse gas (GHG) reductions and zero carbon targets. With this as a backdrop, we need go beyond climate change alone and address others of the 17 UN environmental sustainability goals.

    The track will consider the value chain from raw material provision to patient receipt and will review strong cases for a commitment to sustainable development. This is about challenging, replacing, or upgrading old, resource-intense, and unsustainable methodologies and assets, and reducing reliance on long production supply chains, carving out waste and showing that the circular economy can exist across a whole sector.

    This track is focused on re-awaking those targets set ten years ago and making them reality, rather than just reporting slow progress and incremental change; replacing it with care and consideration for our plant and our patients through a change in mindset and implementation of innovative methods in responding to this challenge for mankind.

    We owe it to the patients and our children.

  • Track Two: Successful Implementation of Annex 1

    After years of development and dialogue, it is expected that Annex 1 will officially come into force in 2022.

    Aseptic processing is increasingly becoming the standard technology for next generation drugs, like biologics and vaccines. After years of discussion and commenting on the Annex 1 document, industry will have to implement applied practice and realise operating applications in companies. This implementation will take some time and we would like to explore with you how industry will install compliance with this new regulatory document.

    Track two will focus on the successful implementation of Annex 1 and during this track we would like to focus on and examine this journey to Annex 1 implementation:

    • How will the implementation of a Contamination Control Strategy, and Process Risk Management in facilities be compliant?
    • How will innovations, in terms of sampling, analysis and barrier systems, assist and support industry to be fully compliant for sterile and aseptic processes?
    • ATMPs, with more manual processes, and how to achieve compliance with aseptic processes, but not increasing risks to patients, will be another focus area in this track
    • Annex 15 with robust process validation, and continuous verification will be addressed in this sterile products track
  • Track 3: Digital Quality Management

    The digital transformation accelerated by the Covid-19 is progressing with speed. The value of data as an asset and as a competitive imperative has been understood. In a regulated environment like the Life Science industry a holistic digitalization will not succeed with the digitalization of the Quality Management as it will drive Quality to a new dimension.

    In our track we will illuminate this new dimension by demonstrating industry-novel use-cases, inviting for interactive discussing on eye-opening topics and knowledge exchange by sharing practical transformation insights.

    Topics will include:

    • What does patient-centric Quality look like?
    • What is the framework of as KPI-driven Advance Pharmaceutical Quality?
    • How to transform towards a documentation-free QMS and what it looks like
  • Track 4: Trends in Engineering and Project Management

    The COVID-19 pandemic has influenced the pharmaceutical engineering environment immensely. The primary drivers are time-to-market and lean processes. Integrated process workflows need to allow rapid creation of manufacturing capacity with more focus on platform processes, agility, and multi-dimensional collaboration.

    At the same time, the results of technology improvements and risk-based-GMP are now realised in the new facilities entering production.

    The presentation in this track will focus on and include the following topics:

    • Rapid execution of projects by using elements of agile Project Management
    • Case studies on new facilities (ballroom and CNC spaces, continuous manufacturing, etc.)
    • Virtual Experiences with Commissioning and Qualification (for example remote FATs)
    • Latest information on new guidelines addressing engineering topics
    • European 2021 FOYA Award presentations

Executive Forum

The European Medicines Agency (EMA) have issued a network strategy to 2025 with the mission: Protecting Public Health at a Time of Rapid Change. The strategic focus areas are availability and accessibility of medicines, data analytics-digital tools and digital transformation, innovation, anti-microbial resistance, other emerging health threats, supply chain challenges, sustainability of the network and operational excellence.

This sets the framework for the 2022 ISPE Europe Annual Conference in Madrid in April. High level speakers from the European Commission, the European Federation of Pharmaceutical Industries’ Associations (EFPIA) as well as European National Competent Authorities engaged in sustainability will give input to ISPEs well known traditional Executive Forum. Special focus will feature industry speakers on learnings from the COVID-19 crisis and the management of vaccine production and logistics

Keynotes

The European Medicines Agency (EMA) and the Food and Drug Administration (FDA) will address the role of regional regulatory agencies by addressing current challenges for the pharmaceutical industry, the suppliers, and public health and safety. Top priority is given to avoid drug shortages, accessibility to vaccines, innovation and digital transformation, sustainability, and continuous improvement of quality and GXP compliance as the essential ground of patient safety.

The keynotes will also address the fastest growing sector of pharmaceutical drugs, biologics and among those Cell-and Gene therapy approaches, with focus on personalised medicines - a challenge for all functions in operations, from research and development to production, engineering, IT, quality, and supply chain excellence. Cross-functional teams is crucial to enable success in the future. ISPEs Factory of the Year (FOYA) category winners will be presented, with their lighthouse projects to unveil the future.


Who Should Attend

  • Professionals at all levels of the industry from young professionals to the most senior executives
  • Communities of Practice
  • Special Interest Groups
  • Pharmaceutical Industry Equipment and Services Supplier
  • Regulatory Professionals