Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
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Workshops
Mon, 12 May
1300 – 1500
Workshops
Maria Amaya, PhD, Genentech, A Member of the Roche Group
Vanessa Bennett, European Medicines Agency
Jean-François Duliere, ISPE
ISPE is organizing a workshop on Drug Shortages Prevention—a critical topic for the industry and all stakeholders in the pharmaceutical world, including regulators.
The workshop will address drug shortages from the perspective of Cultural Excellence. ISPE is currently revising its GAP Assessment Tool, based on the 12 domains outlined in the new Drug Shortage Prevention Model. During the workshop, attendees will gain insights into the progress of this initiative.
Additionally, ISPE is pleased to confirm the participation of the European Medicines Agency (EMA) in this workshop. Attendees can expect valuable insights into EMA's approaches to improving drug shortage prevention and communication.
Through participation, attendees will develop a deeper understanding of the GAP Assessment Tool, its value to the industry as a whole, and how it can support global drug shortage prevention
The workshop will address drug shortages from the perspective of Cultural Excellence. ISPE is currently revising its GAP Assessment Tool, based on the 12 domains outlined in the new Drug Shortage Prevention Model. During the workshop, attendees will gain insights into the progress of this initiative.
Additionally, ISPE is pleased to confirm the participation of the European Medicines Agency (EMA) in this workshop. Attendees can expect valuable insights into EMA's approaches to improving drug shortage prevention and communication.
Through participation, attendees will develop a deeper understanding of the GAP Assessment Tool, its value to the industry as a whole, and how it can support global drug shortage prevention
1300 – 1500
Workshops
Martin Heitmann, D-fine GmbH
Kevin Bailey, MHRA
Frank Henrichmann, Q-FINITY Quality Management
Brandi Stockton, The Triality Group, LLC
Paige Kane, MSD
Workshop “Digital Transformation and GAMP: Implementing an AI Solution in a Pharma 4.0 Context”
Integrating innovative AI solutions serves as a cornerstone in the transition toward data-driven organizations and digital transformation. At the same time, ensuring patient safety, maintaining, and achieving regulatory compliance remain priorities within GxP-regulated areas. Examples of Pharma 4.0 principles and GAMP® concepts help in achieving these goals, where specific maturity assessments and risk management techniques have been established for application in an AI context.
This interactive workshop delves into practical aspects of implementing AI in a GxP-regulated environment, guided by the principles and guidance established in ISPE Pharma 4.0® and GAMP®. Participants will explore maturity assessment techniques to evaluate organizational readiness for digital transformation, focusing on critical factors such as infrastructure, culture, and existing processes. They will also have the chance to explore a comprehensive risk assessment methodology tailored to AI solutions, focusing on methods for identifying and mitigating risks to patient safety, data integrity, and product quality.
Through real-world examples and hands-on exercises, attendees will gain actionable insights into aligning AI implementation with digitization objectives while fulfilling quality expectations and adhering to regulatory requirements.
Integrating innovative AI solutions serves as a cornerstone in the transition toward data-driven organizations and digital transformation. At the same time, ensuring patient safety, maintaining, and achieving regulatory compliance remain priorities within GxP-regulated areas. Examples of Pharma 4.0 principles and GAMP® concepts help in achieving these goals, where specific maturity assessments and risk management techniques have been established for application in an AI context.
This interactive workshop delves into practical aspects of implementing AI in a GxP-regulated environment, guided by the principles and guidance established in ISPE Pharma 4.0® and GAMP®. Participants will explore maturity assessment techniques to evaluate organizational readiness for digital transformation, focusing on critical factors such as infrastructure, culture, and existing processes. They will also have the chance to explore a comprehensive risk assessment methodology tailored to AI solutions, focusing on methods for identifying and mitigating risks to patient safety, data integrity, and product quality.
Through real-world examples and hands-on exercises, attendees will gain actionable insights into aligning AI implementation with digitization objectives while fulfilling quality expectations and adhering to regulatory requirements.
1300 – 1500
Workshops
Estelle Darnon, Technip Energies
Ester Barle, PhD, Takeda
Louise Loughran, Eli Lilly
Kirsty Reid, EFPIA
Michaela Fuetsch, F. Hoffmann-La Roche AG
Matt Popkin, PhD, GSK
ISPE will organize a workshop on Substances of Concern and Sustainability at the 2025 ISPE Europe Annual Conference in London—a highly relevant topic within the pharmaceutical industry and ISPE.
In this workshop, attendees will take a deep dive into the potential impact of the European Commission's proposed PFAS ban. Additionally, the session will explore the implications of TiO₂ and EthO regulations.
The workshop will feature presentations from various companies and organizations (e.g., Takeda, Roche, EFPIA, and GSK) to provide a holistic view of the current challenges. EFPIA and ISPE have already collaborated on this topic, providing feedback to the European Commission (EC), and in 2023, ISPE launched a survey to assess companies' understanding of the potential impact of upcoming regulations.
Engaging discussions between attendees and speakers will help deepen knowledge, address concerns, and foster an open dialogue on how these product restrictions could affect the pharmaceutical industry. Are alternative solutions available? These key questions will be explored through an enhanced Q&A session designed to facilitate comprehensive discussions.
This workshop is part of Track 1: Sustainability, which addresses the multiple topics and challenges associated with this evolving field.
In this workshop, attendees will take a deep dive into the potential impact of the European Commission's proposed PFAS ban. Additionally, the session will explore the implications of TiO₂ and EthO regulations.
The workshop will feature presentations from various companies and organizations (e.g., Takeda, Roche, EFPIA, and GSK) to provide a holistic view of the current challenges. EFPIA and ISPE have already collaborated on this topic, providing feedback to the European Commission (EC), and in 2023, ISPE launched a survey to assess companies' understanding of the potential impact of upcoming regulations.
Engaging discussions between attendees and speakers will help deepen knowledge, address concerns, and foster an open dialogue on how these product restrictions could affect the pharmaceutical industry. Are alternative solutions available? These key questions will be explored through an enhanced Q&A session designed to facilitate comprehensive discussions.
This workshop is part of Track 1: Sustainability, which addresses the multiple topics and challenges associated with this evolving field.
Estelle Darnon
Head Life Sciences Process Department
Technip Energies
Technip Energies
Ester Barle, PhD
Head of Product Sustainability and Stewardship
Takeda
Takeda
Louise Loughran
Health & Safety Advisor
Eli Lilly
Eli Lilly
Kirsty Reid
Director, Science Policy
EFPIA
EFPIA
Michaela Fuetsch
F. Hoffmann-La Roche AG
Matt Popkin, PhD
Senior Director, CMC Excellence
GSK
GSK
1300 – 1500
Workshops
Francesca Grattarola, Lilly
This workshop aims to bring together industry leaders and digital transformation champions to explore the latest advancements and strategies in the pharmaceutical sector. The agenda is structured into three key parts:
Part 1: Digital Transformation Champions:
Representatives from leading pharmaceutical companies will share their insights on digital transformation. This session will provide an overview of innovative approaches and strategies being implemented across the industry, setting the stage for a deeper exploration of digital transformation. Some additional areas to be discussed include the business drivers and capabilities, how to navigate the high costs, what are the challenges, what are problems that digital solutions can support.
Part 2: Interactive Panel Discussion with Digital Transformation Champions:
This next session will feature an engaging dialogue between our Digital Transformation Champions. The panel will delve into the challenges and opportunities of digital transformation, fostering a collaborative environment for knowledge exchange and highlighting innovative solutions that drive progress. Questions will be asked such as “Who was the sponsor of the digital transformation initiative”.
Part 3: Interactive Discussion with Audience:
This highly interactive session will focus on identifying the critical success factors for implementing digital transformation initiatives. Participants will engage in discussions on practical approaches, such as determining the most suitable program sponsors or initiators within their organizations (e.g., CIO, CDO, Digital Technologies Leader). Additionally, the session will cover strategies for achieving these goals, sharing valuable tips and lessons learned. Emphasis will be placed on achieving success and driving innovation, while navigating the challenges associated with digital transformation journeys, such as CAPEX and OPEX costs, workforce considerations, and other potential obstacles or challenges.
Join us for an insightful and dynamic workshop that promises to equip you with the knowledge and tools to navigate the evolving landscape of digital transformation and driving innovation in the pharmaceutical industry.
Part 1: Digital Transformation Champions:
Representatives from leading pharmaceutical companies will share their insights on digital transformation. This session will provide an overview of innovative approaches and strategies being implemented across the industry, setting the stage for a deeper exploration of digital transformation. Some additional areas to be discussed include the business drivers and capabilities, how to navigate the high costs, what are the challenges, what are problems that digital solutions can support.
Part 2: Interactive Panel Discussion with Digital Transformation Champions:
This next session will feature an engaging dialogue between our Digital Transformation Champions. The panel will delve into the challenges and opportunities of digital transformation, fostering a collaborative environment for knowledge exchange and highlighting innovative solutions that drive progress. Questions will be asked such as “Who was the sponsor of the digital transformation initiative”.
Part 3: Interactive Discussion with Audience:
This highly interactive session will focus on identifying the critical success factors for implementing digital transformation initiatives. Participants will engage in discussions on practical approaches, such as determining the most suitable program sponsors or initiators within their organizations (e.g., CIO, CDO, Digital Technologies Leader). Additionally, the session will cover strategies for achieving these goals, sharing valuable tips and lessons learned. Emphasis will be placed on achieving success and driving innovation, while navigating the challenges associated with digital transformation journeys, such as CAPEX and OPEX costs, workforce considerations, and other potential obstacles or challenges.
Join us for an insightful and dynamic workshop that promises to equip you with the knowledge and tools to navigate the evolving landscape of digital transformation and driving innovation in the pharmaceutical industry.
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.