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Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
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Enhance your leadership style as we explore how understanding individual and team communication preferences can enhance collaboration and job satisfaction.
In this workshop, powered and led by ISPE’s Women in Pharma, we will explore leadership agility, team dynamics, and the diverse tapestry of communication styles that weave a fabric of connectivity in the workplace. This dynamic session is designed to propel you into action, providing a platform for self-reflection on your leadership approach, exploring professional "love languages," and insights into effective self-motivation and team empowerment.
Who should attend?
- Senior Leaders stand to refine their leadership ethos and embrace novel strategies to nurture a thriving workplace ambiance.
- Mid-level executives can unlock invaluable insights, enhance team synergy and communication, and hone their unique leadership persona, priming themselves for the next career milestone.
- Emerging Leaders on the brink of their journey can craft the foundational pillars of their leadership identity, mastering the art of adaptation and interpersonal communication amidst the diverse tapestry of the workforce.
Students poised at the threshold of their careers can seize an early grasp of these pivotal concepts, recognizing the pivotal role of effective communication and collaborative prowess in the realm of leadership.
1. Decentralized Clinical Trials- Risks and concerns with the use of eClinical Platforms, e.g., ePRO, eCOA, IRT/RTSM; Roles and responsibilities for systems and validation; challenges in distribution of IMP; BYOD
2. Good Clinical Laboratory Practice- Consider the risks and concerns with the use of partners; data transfer; systems and validation
3. Data Science and AI-Enabled systems
4. Real World Data / Real World Evidence.
In 2024, two major reorganizations occurred in FDA that significantly changed where and how drug quality oversight is conducted. First, the quality assessment offices (formerly ONDP, OLDP, OBP) and research office were reconfigured, with the intent to create a more streamlined, agile and flexible organization and to reinforce the connections between assessment, inspection, surveillance, research and policy operations. Second, the Office of Regulatory Affairs is being reorganized into the Office of Inspectional and Investigations, with the intent to reduce duplication and streamline actions, hopefully leading to more clarity and promptness in enforcement actions for regulated industry.
These changes, in conjunction with ongoing initiatives to streamline and modernize FDA's internal review process, should make FDA more adaptable to public health emergencies, new pharmaceutical technologies, and market dynamic for pharmaceutical quality. Ongoing quality assessment initiatives include Knowledge-Aided Assessment & Structured Application (KASA), Emerging Technology Program (ETP), and the ICMRA pilots for international joint assessment and inspection.
Join us as we delve into the realm of lifecycle management considerations for cell and gene therapy products. In this enlightening presentation, the audience will learn more about regulatory strategies aimed at broadening patient access while fostering affordability in the realm of transformative medical innovations. The presentation will illuminate the challenges and opportunities inherent in the lifecycle management of cell and gene therapy products. From initial development stages to post-market considerations, attendees will gain invaluable insights into the regulatory pathways crucial for navigating the dynamic healthcare ecosystem.
Particle control in cellular ATMPs (Advanced Therapy Medicinal Products) presents a unique challenge to the industry. This presentation will cover a lifecycle approach to understanding and controlling the presence of particles in your product, integrating both regulatory requirements and quality considerations to ensure compliance and product quality
I will delve into the regulatory landscape surrounding the utilization of AI in the medical device industry across the globe, offering insights into the diverse philosophies shaping such regulations. The primary emphasis is on examining international initiatives, notably the WHO's comprehensive principles governing ethical AI and its regulatory frameworks and also conduct an in-depth exploration of country-specific regulations, spotlighting the regulatory approaches of the EU, UK, China, India and Saudi Arabia while also providing an overview of emerging regulations in Japan and Italy. I will also focus on how to validate and build reliance on AI systems used internally within companies through risk-based methodologies to effectively use AI solutions in the workplace.
Join us for an engaging and interactive session led by Dave DiProspero, featuring esteemed FOYA judges and category winners as they delve into the intricacies of their 2024 FOYA award-winning facility projects. Through a dynamic roundtable type panel discussion, we'll uncover the motivations behind FOYA submissions, dissecting the challenges faced and the innovative award winning solutions devised. From forging strong partnerships to embracing patient-centric design, each various aspects of project development and execution will be explored. This interactive session isn't just about celebrating achievements—it's about sharing insights and lessons learned to inspire future excellence in facility projects. Don't miss this opportunity to interact and gain firsthand knowledge from industry leaders and key players, shaping the future of pharmaceutical facility design, construction and operations.
This session will compare the regulatory requirements and review timelines in several global markets spanning the US, EU and several Asia-Pacific markets, outline a case study to demonstrate true-to-life consequences, and propose regulatory solutions. Extensive requirements and long review timelines can discourage the global implementation of new technologies or process/method improvements, and can delay critical updates of suppliers or manufacturing sites that can sustain drug supply. These delays can mean new medicines aren’t available to patients globally, and that products that are already on the market are at risk of drug shortage. Looking forward, there may be reliance models that global regulatory agencies could adapt that could ease the reviewers’ burdens, accelerate review, and reduce drug shortages.Please note that this speaker is not a regulator, but it would be good to have a regulator speak in a session with this talk bundled with one or more of the Drug Shortage sessions. US FDA Drug Shortage Staff (E. Thakur or team) are suggested.
Gretchen Smith is a highly accomplished manufacturing executive with an impressive track record spanning over 25 years in the pharmaceutical industry. Currently serving as the Senior Vice President of Manufacturing and Site Head at Advanced Medicine Partners, she plays a pivotal role in leading the establishment of a cutting-edge Contract Development and Manufacturing Organization (CDMO) facility. This state-of-the-art facility is dedicated to providing unparalleled chemistry, manufacturing, and controls (CMC) capabilities for advanced medicines, including gene and cell therapies. Gretchen's expertise allows her to address the critical challenges of product quality and scalability that are often encountered in the development and production of highly technical medicines.
These changes, in conjunction with ongoing initiatives to streamline and modernize FDA's internal review process, should make FDA more adaptable to public health emergencies, new pharmaceutical technologies, and market dynamic for pharmaceutical quality. Ongoing quality assessment initiatives include Knowledge-Aided Assessment & Structured Application (KASA), Emerging Technology Program (ETP), and the ICMRA pilots for international joint assessment and inspection.
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Gilead Sciences
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Sanofi
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Sanofi Aventis
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Kindeva Drug Delivery
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No Deviation Pte Ltd
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
Background: Germfree, an innovator in biosafety and containment technologies, has been at the forefront of deploying more than 100 mobile cleanrooms in seven years. Challenge: Healthcare faces ongoing challenges in patient access, drug shortages, manufacturing inefficiencies, and the need for rapid response to patient needs. Traditional centralized manufacturing models often struggle to adapt quickly to these demands, creating a pressing need for innovative solutions.Solution: Germfree responded to this challenge by developing and deploying advanced mobile cleanroom technologies. These units are designed to be flexible, scalable, and capable of meeting the stringent requirements for aseptic processing and manufacturing of cell and gene therapies, as well as other pharmaceutical products.Implementation: The case study will detail the deployment process of these mobile cleanrooms, including site selection, logistics, setup, and integration into existing healthcare and pharmaceutical frameworks. Lessons Learned:Future Outlook: Looking ahead, Germfree's work signals a shift in pharmaceutical manufacturing, highlighting the potential for decentralized models to make healthcare more accessible, efficient, and patient-centered. The case study will conclude with predictions for the industry and the role of mobile cleanroom technology in shaping the future of pharmaceuticals.
This presentation will focus on transformative initiatives within Office of Quality Surveillance (OQS) in FDA's Center for Drug Evaluation and Research (CDER) aimed at enhancing and modernizing the agency's approach to drug quality oversight. OQS plays a pivotal role in safeguarding dug quality by leveraging various data sources and analytical methods to monitor, assess, and report on the state of drug product quality and manufacturing facilities. The OQS speaker will discuss key advancements and implementation of innovative programs that enhance FDA’s oversight of drug quality. These programs include the New Inspection Protocol Project which streamlines inspection processes; the Drug Quality Sampling and Testing Program which ensures that the drugs sold in the US meet rigorous standards; and the Quality Management Maturity Program aimed at elevating industry quality oversight. Attendees will gain insights on how these programs enhance FDA’s quality oversight and encourage continual improvement from manufacturers.
The guidelines ICH Q12 (2019) and ICH Q2(R2)/Q14 (2023) embody a science- and risk-based approach to lifecycle management to ensure the continued quality of the quality of drug substances and drug products. ICH Q12 describes the tools that can be utilized for effective post approval change management and regulatory reporting, while ICH Q2(R2)/Q14 focus on development, validation, and lifecycle of analytical procedures; and covers concepts such as the Analytical Target Profile (ATP) and the applicability of enhanced knowledge to manage Q12 concepts such as Established Conditions. There are many expected benefits which include harmonizing scientific approaches and terminology, enabling effective knowledge and risk management to facilitate continual improvement, and improving communication between health authorities and industry. This session will talk about real-life examples from industry and the challenges encountered when implementing these guidelines both from the sponsor and regulator perspectives. Topics presented from industry (the ISPE PQLI ICH Q2(R2)/Q14 and Q12 teams) will include platform analytical procedures, enhanced approaches to development practices, change management utilizing the principles of ICH Q12 and Q2(R2)/Q14 and how ECs can work, and the status of guideline adoption across various companies and health authorities. These presentations from four major companies will be followed by an extended panel discussion including regulators to provide a format for a candid exchange of experiences and ideas to address the perceived challenges.
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GlaxoSmithKline
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AstraZeneca Ltd
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Bristol-Myers Squibb
Pfizer, Inc.
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Health Canada
1600-1700: AI Discussion Panel - Reflections on Past Missed Opportunities (QbD, PAT) and How to Navigate AI for Success
The rapid evolution of Artificial Intelligence (AI) brings immense opportunity to the pharmaceutical and biotech industries to boost drug discovery, accelerate development, and increase efficiency in manufacturing. At the same time the regulatory environment is still very much in flux and robust regulatory guidance does not yet exist.The combination of rapid innovation and uncertain regulatory context creates a high-risk environment for companies that want to adopt AI at scale across the value chain.We will discuss a framework to assess AI-related risks and implement appropriate controls in a pragmatic way, leveraging existing system life-cycle processes, to enable both innovative and responsible use of AI in a regulated environment.
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.