Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
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General Session
Discover the art of navigating these tides with Abbas Yar-Khan, Lilly's Group Vice President of Global Parenteral Products and Devices. Dive into an inspiring session where agility meets urgency and learn how Lilly's accelerated efforts are shaping a healthier future for patients across the globe.
· Gene therapy offers tremendous potential and is continually evolving.
o Today the industry is tackling incurable diseases, providing durable cures and modifying diseases for relatively small patient populations.
o In the not-too-distant future gene therapy will provide permanent cures for much larger patient populations, enhancing existing treatments with precision medicine and preventing disease altogether.
· Almost by definition, the evolving nature of gene therapy drives the need for continual changes in technology, talent, platforms and development – all with the requirement for inherent flexibility.
· Spark Therapeutics developed and launched the very first gene therapy for a genetic disease approved in both the US and EU.
· As a leader and driving force in gene therapy, Spark is continually evolving ahead of the industry and working to achieve its vision of a world where no life is limited by disease.
· Join Chris Stevens, Spark&rs
Join us as the ISPE Regulatory Steering Committee (RSC) provides an update on ISPE’s current regulatory activities and initiatives. Gain valuable insights into the groups that are bringing visibility and solutions to challenges faced by the industry with regard to regulatory/quality aspects and facilitating the flow of information between ISPE members and global Health Authorities. Don't miss this opportunity to stay informed and engaged in the latest developments within ISPE's regulatory landscape.
Explore the integration of innovation into pharma operations, updates on Pharma Legislation for 2025, and the transformative potential of AI/ML in Pharma Operations. Gain valuable insights into the EU harmonized approach to Drug shortages, including outcomes from HERA and related activities from EMA, as well as international collaboration efforts between EMA/FDA and EMA/Industry.
A Regulatory Town Hall Meeting focused on the challenges and opportunities to expand innovation, improve product quality assurance and patient access to medicines relies on global regulatory harmonization and collaborative approaches in establishing effective policies. This paradigm shift is predicated on transformation that only a future-looking workforce can deliver.
The pharmaceutical industry is advancing through an unprecedented innovative transformation, driven by the development of new product modalities, the emergence of innovative technologies, the evolution of alternative and adaptive regulatory frameworks, and the expeditious approaches introduced and leveraged in response to the COVID-19 pandemic experience.
The Regulatory Town Hall will cultivate a compelling discussion among several panelists on the merits, opportunities and challenges associated with the introduction of innovative technologies, the use of modelling, artificial intelligence, and digital platforms that are shaping the future of pharmaceutical development and commercialization. The key messages from this event will provide a template for the attributes and qualities necessary to enlist and engage a skilled and competent workforce capable of adapting to the fluid demands and expectations of patients and health care providers globally.
The panel will include six representatives from industry and regulatory authorities who will address the following evolving topics:
1. Mutual reliance: How can the industry and regulators leverage the existing frameworks and initiatives, such as the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the Mutual Recognition Agreement (MRA), and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), to enhance the mutual recognition and reliance of inspections, assessments, and standards across different jurisdictions?
2. Information sharing: How can the industry and regulators enhance the information sharing and communication between and among themselves, as well as with other stakeholders, such as patients, health care professionals, and the public, using the available and emerging digital platforms and tools?
3. Modelling: How can the industry and regulators increase the global acceptability and use of modelling and simulation techniques, such as mechanistic models, physiologically based pharmacokinetic (PBPK) models to support the design, development, and evaluation of medicines and vaccines?
4. AI algorithms: How can the industry and regulators ensure the quality, reliability, and validity of the artificial intelligence (AI) algorithms and systems that are increasingly used in the pharmaceutical sector, such as for drug discovery, clinical trials, pharmacovigilance, and manufacturing?
5. Inspection harmonization: How can the industry and regulators harmonize the implementation and interpretation of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (GMP), especially the Annex 1 on the manufacture of sterile medicinal products?
6. Supply chain management: How can the industry and regulators improve the resilience, transparency, and security of the global pharmaceutical supply chain, especially in the post-pandemic context, where the demand and supply of medicines and vaccines are subject to unprecedented fluctuations and disruptions?
7. Structuring the data: How to address the terminology when submitting data to different regulatory agencies? How to harmonize the data? What kind of standard should be used?
We invite all the participants to share their questions on these topics and engage in a constructive and productive dialogue on charting the direction for innovation in the industry to embrace the future that is now!
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.