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Sustainability
This session will explore how innovation in product design and manufacturing can deliver for medicines manufacturing & explore how alternative CMC regulatory tools and approaches, based on principles of science & risk used to enable rapid access to medicines, can enable the transformation of medicines and manufacture. The session will also look at how the modernization of the variations framework and reliance enable change. The session will reference positions of ISPE, EFPIA and EMA on enabling sustainability in product design and manufacturing and use EFPIA companies examples of sustainability change programs.
We have also examined how these changes to EU chemicals legislation are reflected in EU pharmaceutical policy and legislation and related guidance documents, as well as in position papers and other documents produced by the pharmaceutical industry, interest groups, and other stakeholders. In addition, semi-structured interviews have been conducted to explore how different actors (5 pre-defined groups) in the pharmaceutical sector perceive changes in EU chemicals policy and legislation and whether these changes may have influenced the practices and measures taken toward green transformation. The preliminary results of the interviews with the pharmaceutical industry will be presented.
The Material of Concern Workstream, initiated by BioPhorum, addresses the regulatory and environmental challenges posed by materials of concern such as PFAS, EtO, and Triton X 100. This initiative emerged as a result of a number of industry consultations led by the European Chemicals Agency (ECHA) and the US Environmental Protection Agency (EPA), which highlighted the significant impact of proposed changes on the biopharma sector. The workstream aims to enhance understanding and management of these materials through a collaborative approach involving various teams and communicating closely with the relevant regulatory and government bodies.
The workstream is divided into two teams:
1. Reactive Team, which responds to current materials of concern, these teams have submitted a number of regulatory responses to agencies as well as collaborated with FDA, EPA, ECHA, BARDA, US centre and congress etc through a number of face-to-face or online meetings
2. The Proactive Team establishes systems to handle new potential concerns. The proactive process involves capturing material alerts, evaluating impacts, assessing industrial implications, and engaging with regulatory bodies during consultation periods. The ultimate goal is to position biopharmaceutical manufacturing as a globally recognized 'Use Case' that warrants attention from regulatory agencies.
The team ultimately wish to foster an environment where process and collaboration is in place in order to ensure that the proposed standards protect both environmental and public health without compromising the availability of critical biological products.
This approach is being applied in the PharmECO project, a public-private partnership co-funded by the Innovative Health Initiative that is set to integrate sustainability considerations into every phase of pharmaceutical manufacturing. The industrial consortium members belong to the most influential pharmaceutical global players, ensuring a substantial impact on the footprint of the pharmaceutical industry.
Sustainability requirements must be followed as Quality requirements all through a project. A parallel will be done between Sustainability and Quality requirement management. This presentation will highlight some examples of integration of Sustainability objectives through technical studies: building thermal studies, multi-criteria analysis with sustainable criteria for HVAC Hot Water production solutions, energy saving by design using Water For Injection membrane production, workfront management, and digitalization during construction (reduce rework, reduce waste). This presentation aims to open discussion regarding problems encountered during recent projects on Sustainability topics.
Case studies will demonstrate the successful implementation of NZC principles, such as reducing CO2 emissions by 37% through local material sourcing and design modifications. However, challenges remain, including policy barriers, data gaps, and the need for technological advancements and behavioral changes within the industry. The conclusion emphasizes a comprehensive design approach - LEAN, MEAN, and GREEN - along with energy modeling, early carbon-impact identification, and collaboration as critical to achieving Net Zero goals, with carbon offsetting as a last resort.
This presentation will provide insight into the source of carbon in pharmaceutical buildings with case study findings on reducing embodied carbon and facility operational carbon emissions. An overview of future regulatory requirements on life cycle assessment for carbon emissions of new buildings will be provided including the challenges & design strategy opportunities required to comply with EU Directives.
1 - Methods: For greenfield sites, the installation of geothermal, water source or air-source heat pumps can be included in the project's design phase, allowing the infrastructure to maximize efficiency. Brownfield sites can be more complex and will require retrofitting heat pumps into existing systems. Key items to consider are examining closely utility load profiles and interfacing with existing systems.
2 - Design Strategies: Optimal design strategies include conducting thorough energy assessments to determine the most efficient heat pump configuration. Integration with other renewable technologies can further enhance energy efficiency. Smart energy management systems can be employed to monitor and adjust Utility heat generators in real-time, ensuring the heat pump operates at peak efficiency.
3 - Benefits: Key benefits include significant reductions in carbon emissions.
This presentation will explore the compelling business case for sustainability and demonstrate how the digital thread's "seamless flow of data and processes throughout the value chain” enables sustainability initiatives. Integrating digital technologies allows businesses to optimize energy consumption, reduce resource waste, and enhance operational efficiency. Digital technology plays a transformative role in achieving net-zero goals, enhancing operational efficiency, and driving long-term growth while minimizing environmental impact.
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.
Agenda Changes
Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.