Agenda
Our comprehensive education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharmaceutical industry.
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Regulatory - Compliance - Quality
Mon, 14 Oct
Tue, 15 Oct
1000 – 1030
FDA Oversight of Drug Quality – Application Assessment
Regulatory - Compliance - Quality
Regulatory Representative (Invited)
This presentation will discuss US FDA's recent organizational changes and ongoing initiatives related to application assessment.
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.
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.
1030 – 1100
Use of Physiological Biopharmaceutical Based Models
Regulatory - Compliance - Quality
Gregory Rullo, AstraZeneca
Modeling plays a critical role in drug manufacturing by providing a systematic and data-driven approach to optimize and streamline various production of pharmaceuticals. Physiological models are used to elevate drug product quality by providing a more accurate and holistic understanding of how drugs interact with the human body. These models are based on the integration of physiological, pharmacological and pharmaceutical data to simulate and predict drug behavior in vivo. Recently significant progress has been made to advance Health Authority acceptance of Physiological Based Biopharmaceutical Models, PBBMs.
Using PBBMs, researchers can simulate the pharmacokinetics (PK) and pharmacodynamics (PD) of a drug under different scenarios, including different formulations, dosing regimens, and patient populations. By leveraging PBBMs, scientists can potentially predict how changes in formulation or other factors may affect drug exposure and therapeutic outcomes. In some cases, regulatory agencies may accept well-validated PBBMs as a substitute for certain types of BA studies.
The presentation will provide an overview of the application of Physiological Based Biopharmaceutical Models including in drug development, set specifications and managing post approval change. Additionally, a summary of the significant progress in the regulatory landscape and acceptance of PBBMs.
1100 – 1130
Translational Technologies and Precision Medicine
Regulatory - Compliance - Quality
James Wabby, AbbVie, Inc.
Combination products are emerging as innovative medical products due to their contribution to advancing medical care and are thus expected to have major impact in the coming years. Future technologies are most appealing to patients with ongoing medical conditions that require consistent treatment with daily injections or weekly procedures and unmet medical needs. Overall, the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges. New tools of computational modeling and simulation, novel technologies such as artificial intelligence, needs of developing new standards, evidence-based research methods, new approaches including the designation of innovative, or breakthrough medical products have been developed and could be used to assess the safety, efficacy, quality, and performance of combination products. Taken together, the fast development of combination products with great potential in healthcare provides new opportunities for the advancement of regulatory review as well as regulatory science.
1300 – 1330
Global AI Healthcare Regulations: Trends and Future
Regulatory - Compliance - Quality
Attrayee Chakraborty, Northeastern University
Artificial intelligence (AI) has disrupted almost every sector, including that of healthcare. As of December 2023, the FDA has cleared more than 520 artificial intelligence (AI) medical algorithms since 1995, with 171 AI-enabled medical devices added to the list in 2023. However, international harmonization on AI is far from achievable currently.
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.
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.
1330 – 1400
A “One-Click” Submission with AI and Digital Authoring
Regulatory - Compliance - Quality
Kabir Ahluwalia, Amgen
In response to the need for faster regulatory timelines and growing patient demand, this session proposes a technological shift in CMC submissions through structured content and generative AI (GenAI). We aim to transition from manual, siloed processes to a seamless, technology-driven approach, enhancing efficiency and data integration. The presentation will: 1) Demonstrate the synergy between structured content and GenAI throughout the authoring process; 2) Highlight the advantages of a structured, standardized, interoperable ecosystem, addressing adoption barriers; and 3) Provide real-world examples showing the impact of this integration on regulatory submissions.By embracing technological advancement, the biopharmaceutical industry can achieve significant strides in reducing submission timelines and accelerating the delivery of therapeutics. We aim to provide a comprehensive overview that not only showcases the potential of AI and structured content in regulatory affairs but also inspires a shift towards more dynamic and technology-driven processes by providing real-world examples that can be implemented today. However, it is essential to bring industry and regulators together to collaboratively build towards a future vision. As such, this proposal would benefit from additional speakers building similar authoring technologies, and more so, from regulators who can speak to considerations and expectations from the health authority perspective.
1400 – 1430
Artificial Intelligence in Good Manufacturing Practices
Regulatory - Compliance - Quality
Loganathan Kumarasamy, Zifo Technologies
As a service industry head, I have the opportunity to work with various different companies and large pharmaceuticals on their digital transformation programs. We are noticing a very high trend of AI/ML implementation on R&D as well as in Manufacturing arena. The regulations does not clear explain the needs to remain compliance when implementing ML models in GMP but various companies and quality assurance departments approaches based on their understanding. This proposal will combine the best of best practices implemented at various companies and examines the regulatory considerations when implementing AI/ML in Good Manufacturing Practices (GMP) arena. The session will also cover certain use cases implemented in the industry.
1530 – 1600
The Quality Risk Management
Regulatory - Compliance - Quality
Tiffany Baker, Valsource Inc
The pharmaceutical and biopharmaceutical industries have struggled to implement effective quality risk management (QRM) programs and risk assessment strategies since the inception of ICH Q9 in 2009. In ICH Q9’s infancy, industry began performing risk assessments, lots of risk assessments without a holistic strategy or thought to an organization’s overarching risk assessment portfolio. A historic lack of emphasis on QRM planning is a plausible reason why the industry has struggled with the administration of the QRM program and the creation of myriad risk assessments with no holistic vision. The lack of strategic planning could also contribute to a siloed approach to QRM application and risk assessment performance. By outlining overarching objectives for the QRM program, the use of a Quality Risk Management Master Plan can enable the pharmaceutical and biopharmaceutical industries to spend less time “doing QRM” and more time managing risk to the patient. This plan would be a living document over time to demonstrate the current state of the program, as well as updating the future of QRM implementation.
1600 – 1630
Legal Citation of Compliance Data
Regulatory - Compliance - Quality
George Kwiecinski, The Cooper Union for the Advancement of Science and Art
This presentation will offer a novel perspective on interpreting compliance data by charting significant trends in legal citations within the public domain. We will dissect how these patterns can influence corporate compliance strategies and operational frameworks. By integrating data analytics with legal insights, the session aims to provide attendees with actionable knowledge to navigate the complex regulatory environment effectively. Emphasis will be on practical applications, enhancing attendees’ ability to forecast regulatory shifts and implement preemptive compliance measures. This forward-thinking approach is essential for professionals aiming to maintain robust regulatory adherence amidst an evolving legal landscape. Overall, an open forum and additional facets can be added to the presetation to best add dubstance beyond pure data analysis.
1630 – 1700
FDA Oversight of Drug Quality – Compliance
Regulatory - Compliance - Quality
Regulatory Representative (Invited)
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.
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.
1015 – 1045
Regulatory Considerations on Complex APIs Sameness
Regulatory - Compliance - Quality
Regulatory Representative (Invited)
As part of the abbreviated new drug application (ANDA) evaluation, FDA recommends applicants fully understand the potential for changes in or to the active ingredient during the manufacturing process. Complex APIs are often mixtures of different components and can contain a distribution of molecular weight. Due to their complexity in both composition and structure, complex APIs cannot be characterized by typical analytical techniques. To demonstrate the sameness of a complex API in a generic drug product, a “totality-of-the-evidence” approach is generally employed during regulatory assessment. This approach includes three key components: manufacturing process understanding, orthogonal characterization, and comparative biological activity analysis, if necessary. Unlike well-defined small molecule APIs, manufacturing processes are especially critical in ensuring the consistency of composition and properties for complex APIs. This presentation will provide an overview of key regulatory considerations on demonstrating complex API sameness. We will focus on unique aspects of complex API manufacturing processes and facility inspection data, including data obtained through remote regulatory assessments (RRAs). Additionally, we will present regulatory resources that are available to facilitate the development of complex generic drug products containing complex APIs.
1045 – 1115
Current Trends in In-Country Testing of Medicines
Regulatory - Compliance - Quality
Joerg Garbe
In a concerted effort to collect data, industry experts have put together a study that presents and analyses changes in global in-country testing (i.e., registration and import testing) requirements of the recent years. In addition, the implications of in-country testing and the industry position are presented.The review identified about 40 changes in testing requirements in more than 25 countries across the globe. The predominant trend derived from the analysis is waiver schemes based on unilateral reliance on reference countries with a mature regulatory system. A second trend is the replacement of routine in-country testing by post-marketing surveillance testing.The results show that countries increasingly acknowledge the limited value of in-country testing compared to the benefit of full or partial testing waivers. Furthermore it shows, that more countries extend the unilateral reliance approach to testing to further reduce duplications and associated delays in patient access to medicines.Testing waivers can help to make progress in two important concerns: substandard and falsified products as well as supply interruptions. Patients around the world would benefit from accelerated access to safe products manufactured in facilities inspected for GMP/GDP compliance by mature NRAs, which is a clearly demonstrated benefit of reliance, including for testing.
1115 – 1145
FDA Oversight of Drug Quality - Quality Surveillance
Regulatory - Compliance - Quality
Regulatory Representative (Invited)
This presentation will discuss US FDA's recent organizational changes and ongoing initiatives related to quality surveillance.
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 surveillance include Quality Metrics and Quality Management Maturity.
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 surveillance include Quality Metrics and Quality Management Maturity.
1530 – 1700
Unpacking Recent ICH Guidelines
Regulatory - Compliance - Quality
Regulatory Representative (Invited)
Eli Zavialov, GlaxoSmithKline
Stuart Finnie, PhD, AstraZeneca Ltd
Qinggang Wang, Bristol-Myers Squibb
Global Adoption Status and Implementation Strategies for Q2(R2)/Q14and Q12
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.
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.
Programme Changes
Programme is subject to change. Last minute changes due to functional, private, or organisational needs may be necessary. The event organiser accepts no liability for any additional costs caused by a change of programme.