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Call for Proposals
Learn more about our Call for Proposals
The 2025 ISPE European Annual Conference brings together pharmaceutical and biopharmaceutical professionals from all levels of the industry – from students and emerging leaders to the most senior executives in drug manufacturing, supply chain, devices, equipment and services, and global regulatory agencies.
This conference seeks to examine the application of the latest technological advancements such as artificial intelligence (AI) and machine learning, virtual and augmented reality, and smart manufacturing, as well as innovations relating to biopharmaceuticals and ATMPs. Attendees will engage in sessions addressing significant industry challenges including PFAS restrictions and drug shortages and access to medicines, as well as explore the keys to efficient project delivery.
We welcome you to participate at the 2025 ISPE Europe Annual Conference to learn and share progress, success stories, best practices and lessons learned.
Call for Proposals Timeline
| Date | Action |
|---|---|
| 22 July 2024 | Opens |
| 27 September 2024 | Submission Deadline |
| 28 October 2024 | Notifications |
Presentation Type
Abstract submissions may be proposed for any of the following:
- Workshop
- Proposal to develop and lead a 90-minute active, engaging workshop
- Include introduction, group activities, demonstrations, proto-typing and/or other creative learning elements
- Include proposed facilitators (other than submitter), credentials, and contact information
- Include actionable learning objectives for participants
- Oral Presentation
- Topical presentation
- 20 - 30-minute presentation, including Q&A. Presentation should focus on new and innovative trends, a specific real-world strategy or campaign, case study/use case, a “how-to" presentation intended to help attendees gain a better understanding of the initiative and best practices that can be applied to day-to-day objectives or overall mission.
- Rapid fire session
- Rapid-fire, Hot Topic Sessions are 30-minute sessions focused on a high-level overview of an emerging trend. These sessions are designed to be both cutting-edge and highly focused, requiring the presenter to share ideas and achieve learning objective(s) in 20 minutes, with the remaining 10 minutes open for interactive discussion. These sessions are intended for one speaker but if the topic warrants, can have a maximum of two (2) speakers.
- Topical presentation
Content Areas
The 2025 ISPE Europe Annual Conference Programme Committee is requesting proposals, with preference given to those aligning with the following themes.
1. Biotech – Large Molecule, Cell & Gene – ATMPs
The biotech sector, including cell and gene therapies (ATMP), has been the fastest growing market in the pharmaceutical industry for years and this is not expected to change in the next few decades. In addition to products already on the market and new products in development, the market will additionally grow in Biosimilars, Bio Better Products, Combined Products such as Antibody Drug Conjugates as well as in Cell and Gene and Tissue Engineering. We are seeking case studies focusing on Biotech – Large Molecules, Cell & Gene - ATMPs.
The case studies should include EU and international regulatory aspects.
- Innovative technologies and case studies related to biopharmaceuticals such as for example modular technologies, continuous manufacturing, stainless steel vs. Single-use system, sustainability, end-to-end solutions, etc.
- Innovative technologies and case studies related to ATMPs such as for example modular technologies, closed technologies, multi-product plant design preventing cross contamination, automation and robotics, biosecurity and implementation case studies, decentralized manufacturing facilities etc.
- Regulatory aspects and implementation such Annex 1, PIC/s GMP’s including Annex 1 and Annex 2A for ATMPs and EU EudraLex Part IV for ATMPs and all these aspects supported by Quality Risk Management ICH Q9.
2. Digital Transformation and Innovative Technologies
We are pleased to invite proposals for presentations, workshops, and panel discussions focused on Digital Transformation and Innovative Technologies in the pharmaceutical industry. These sessions will explore the latest advancements, case studies, and applications in areas such as the following:
- Digital Business Transformation / Pharma 4.0: Strategies, and best practices for implementing digital business transformation along the pharmaceutical product lifecycle.
- Artificial Intelligence: AI-driven drug discovery, predictive analytics, machine learning applications, and AI in clinical trials.
- GAMP: Latest updates, compliance strategies, and case studies in the validation of GxP-relevant Systems.
- Digital Technology Transformation: including IT/OT/IoT, automation, and real-time data analytics
- Virtual Reality (VR) and Augmented Reality (AR): Applications of VR/AR in pharmaceutical training, simulation, and patient engagement.
- Innovative Technologies/Smart Manufacturing: Advances in smart manufacturing technologies, digital twins, and advanced process control.
- Blockchain: Blockchain applications in supply chain management, data integrity, and traceability in pharmaceuticals.
- Pharmaceutical Process Modeling: New methodologies, tools, and applications for modeling pharmaceutical processes.
- Emerging Technology Trends and Innovation
- Case-Studies in Digital Transformation
3. Good Engineering Practice and Efficient Investment Management
Every day there are new needs and new ideas to transform and grow the pharma industry. Sooner than later, they will become a project. The success of the project will open the door to becoming a reality. The key to the door is Good Engineering and Efficient Project Management. As time goes by, there is a very strong demand for faster and efficient project delivery. The term “fast track” seems obsolete. Standardization, modularization, BIM, agile project delivery, efficient investment management, etc. are no longer concepts but are needs and a reality.
We are seeking proposals on Good Engineering Practice and Efficient Investment Management. This will be the space to learn from today’s engineering design trends, new digitalized engineering tools, project management, and construction management on real case studies that are shaping today’s project delivery landscape. Topics to cover include:
- Agile Project Management
- BIM
- New design trends
- Lean GMP manufacturing facilities
- Modularization
- Project risk management
- Project governance
- Lean qualification
- Sustainability project
- Engineering design integration
- GMP Regulatory impact on project design and implementation
- Stakeholder Alignment
- Permitting requirements – when and how to involve regulatory agencies
The goal is to offer interactive sessions and provide the audience with the opportunity to ask questions and contribute in an open and relaxed atmosphere away from day-to-day project work.
4. Innovation in Business Processes
Patients and industry have been confronted with the following main problems for years. All three problem areas are interrelated and can influence each other. In this track, innovations in technical and related business processes are presented in cause-and-effect chains to show how these problems can be effectively addressed.
- Drug Availability: Drug shortages limit the availability of medicines on the market. This affects commodity drugs for the treatment of trivial illnesses, as well as drugs for the treatment of serious illnesses and also vaccines. In this track, innovative approaches are shown on how to effectively increase supply chain resiliency.
- Access to Medicines: Timely and effective investments in product life cycles can help to reduce manufacturing cost and thus increase the availability of medicines and access to medicines in all markets. It will be demonstrated how ICHQ12 “Pharmaceutical product lifecycle management” can be used effectively in practice.
- Time to Market: The third topic, which can have a significant influence on the first two topics mentioned, is product transfer, both from development to production and from the initial manufacturer to other production sites worldwide. The most important topic in product transfer is the transfer of knowledge, combined with training of the know-how carriers at the receiving production sites.
5. Regulatory Trends
We request submissions related to pharma industry regulation. Presentations may include case studies linked to implementation of GMP documents or regulatory initiatives regarding risks for the patients. Proposals may focus on one or multiple of these subjects:
- Annex 1 implementation case studies. This document is now fully enforced and additional clarification from regulators may be released before the conference. Case studies relating to ATMP’s may also be included.
- Drugs shortages prevention and supply chain resiliency are key topic for patients, industry, and regulators. There are many initiatives across Europe and the FDA, as well as Asia, to address this issue. Presentations may also include case studies on improving market supply.
- ICH Q9R1 is a current hot topic. Proposals should include case studies for the implementation and understanding of this revision.
- Additional topics include updates on pharma GMP standards; draft Annex 15: Qualification and Validation; Annex 11; and Chapter 4 EudraLex vol. 4.
6. Sustainability
Sustainability is critical for the pharmaceutical industry. Europe is developing directives to improve sustainability of facilities and products. The ECHA plans restriction or bans for PFAS. The pharmaceutical industry is implementing initiatives for sustainable facilities and carbon footprint reductions, and some Member States and European countries have already implemented sustainable objectives in their regulation.
We are seeking proposals highlighting industry sharing initiatives, and managing sustainability for processes, building, and manufacturing facilities. Topics may include:
- HVAC: How to improve sustainability HVAC systems in clean air areas compliant with Annex 1?
- PFAS: Addressing the industry challenge of PFAS restrictions and bans, and identifying alternatives.
- Will regulatory inspections cover sustainability?
- Challenges of reducing energy consumption in the pharmaceutical industry.
Proposal Guidelines
- All presentations must be free of commercial intent. Incomplete proposals will not be considered.
- By submitting a proposal, you acknowledge that, if your proposal is accepted, the speaker will attend/present in-person at the event and the speaker’s attendance at the event will be supported by their organization.
- Accepted Europe Annual Conference speakers are responsible for their own travel and accommodation.
- Speakers receive full registration at a discounted rate.
- NOTE: Exhibitors who are accepted to present are required to register as a paid conference attendee (with discounted registration rate). Complimentary booth staffing registrations cannot be utilised for the presentations as these are part of the education sessions and not the exhibition.
- Consulting firms or vendor/suppliers are expected to include a speaker from an owner company to present.
- Regulators interested in submitting a proposal: Please contact Amanda Banninga to submit your abstract.