Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
Featured Sessions
Unpacking Recent ICH Guidelines
Oct 15, 2024 | 1530 - 1700
Presenters: Multiple
Join us at the Global Implementation Strategies Forum to engage with industry experts and regulators on the Global Adoption Status and Implementation Strategies for ICH Q2(R2)/Q14 and Q12 guidelines. Discover how these science- and risk-based approaches to lifecycle management are ensuring the continued quality of drug substances and drug products worldwide. Explore how ICH Q12 provides tools for effective post-approval change management and regulatory reporting, while ICH Q2(R2)/Q14 focuses on the development, validation, and lifecycle of analytical procedures.
ISPE Regulatory
Town Hall
Town Hall
Oct 16, 2024 | 0950 - 1120
Presenters: Multiple
Join us at the Regulatory Town Hall where you can engage with International Regulators and Industry thought leaders on topics including progress on Mutual Reliance, new methodologies on information sharing between industry and regulators, new product development paradigms, the use of mechanistic models to support physiologically based pharmacokinetics useful in product development and evaluations of medicines and vaccines.
All session times are listed in Eastern Time (ET). Find your personal viewing time on the World Clock.
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Nikolai Makaranka
Mon, 14 Oct
Tue, 15 Oct
1045 – 1115
Digital Transformation
Nikolai Makaranka, Bristol Myers Squibb
There is a lot of buzz surrounding AI and its potential to revolutionize various industries, including pharma. However, despite the hype, the adoption of AI often lags, and its actual implementations remain limited to proof-of-concepts. This presentation will bridge this gap by showcasing an in-house-built AI solution that leverages the latest advancements in NLP for deviations analysis.The presentation will walk the audience through practical aspects of building and scaling an AI solution, focusing on key points such as preparing data and training a model. It will delve into the business impact of the solution and, whenever possible, demonstrate examples where the solution adds value. Specifically, it will demo search capabilities, similarity or recurrence analysis, and automated trending. Furthermore, the presentation will address a crucial aspect of building an AI solution -- assessing solution's performance. It will discuss what a validation protocol might look like for AI solutions to ensuring their reliability and effectiveness.Lastly, the audience will be guided through steps to kickstart the adoption of AI for Quality within their organizations. By the end of the presentation, attendees will have a clear understanding of how to leverage AI to reengineer and enhance quality processes.
1530 – 1700
Digital Transformation
Michael Schmeiszer, Sanofi
Nikolai Makaranka, Bristol Myers Squibb
Seneca Toms, U.S. Food and Drug Administration (FDA)
Michael Crowthers, Deloitte & Touche LLP
Nick Armstrong, CAI
Brandi Stockton, The Triality Group, LLC
Nader Shafiei, Sanofi
1530-1600: Responsible Use of AI in a Regulated Environment by Michael Schmeiszer and Nader Shafiei
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.
1600-1700: AI Discussion Panel - Reflections on Past Missed Opportunities (QbD, PAT) and How to Navigate AI for Success
Join our expert panel as we reflect on missed opportunities in QbD and PAT, exploring how the biopharmaceutical industry can learn from past experiences to successfully navigate AI implementation. While AI holds immense potential to revolutionize the industry, adoption has been uneven. We'll delve into the challenges faced, including data quality, regulatory hurdles, talent shortages, and ethical considerations, discussing how to overcome these obstacles and leverage AI's transformative power in a rapidly changing technological landscape.
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.
1600-1700: AI Discussion Panel - Reflections on Past Missed Opportunities (QbD, PAT) and How to Navigate AI for Success
Join our expert panel as we reflect on missed opportunities in QbD and PAT, exploring how the biopharmaceutical industry can learn from past experiences to successfully navigate AI implementation. While AI holds immense potential to revolutionize the industry, adoption has been uneven. We'll delve into the challenges faced, including data quality, regulatory hurdles, talent shortages, and ethical considerations, discussing how to overcome these obstacles and leverage AI's transformative power in a rapidly changing technological landscape.
Michael Schmeiszer
Head, Digital Risk & Compliance, Strategy & Governance
Sanofi
Sanofi
Nikolai Makaranka
Director, Manufacturing Analytics
Bristol Myers Squibb
Bristol Myers Squibb
Seneca Toms
National Expert, Drugs
U.S. Food and Drug Administration (FDA)
U.S. Food and Drug Administration (FDA)
Michael Crowthers
Managing Director
Deloitte & Touche LLP
Deloitte & Touche LLP
Nick Armstrong
Sr Director, Digital Enablement
CAI
CAI
Brandi Stockton
Founder | Managing Partner
The Triality Group, LLC
The Triality Group, LLC
Nader Shafiei
Head, Digital Risk & Compliance – Data and SaMD
Sanofi
Sanofi
Hear From Top Industry Thought Leaders and Regulators on the Challenges and Solutions Impacting 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.