Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
Featured Sessions
FDA Oversight of Drug Quality - Compliance
Oct 14, 2024 | 1630 - 1700
Presenter: FDA
Explore how the reconfigured quality assessment offices and research divisions are creating a more streamlined, agile, and flexible organization, reinforcing connections between assessment, inspection, surveillance, research, and policy operations. Delve into the reorganization of the Office of Regulatory Affairs into the Office of Inspectional and Investigations, aimed at reducing duplication and streamlining actions for greater clarity and promptness in enforcement.
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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Miguelina Matthews, PhD
Mon, 14 Oct
1115 – 1145
Manufacturing - Quality Control - Operational Excellence
Miguelina Matthews, PhD, Sanofi Aventis
As part of the company transformation, Sanofi has embraced digitization tools to complement and improve quality decisions. During this presentation, we will describe one to two use-cases/tolls recently deployed. Both tools use elements of Artificial intelligence for collecting and analyzing data.One tool is a mobile and web app that delivers real-time, reactive data dashboards, giving a 360° view across our activities. The tool brings data from across Manufacturing & Supply, Supply Chain, QA, Regulatory, Clinical Operations, R&D into one, accessible place. And, through the power of AI, the tool uses this data to deliver actionable insights to help make informed decisions. For the presentation, we would focus on how the tool is used or Complaints. The second tool, for monitoring of deviations, uses machine and language learning. The tool has eliminated the need for manual and time-consuming searches, and it allows to identify deviation recurrence across multiple sites. The multifunctional tool is based on a search engine, a deviation cluster browser, a root cause analysis assistant, and performance dashboards., allowing manufacturing and quality to readily identify trends and prioritize specific topics, accelerating problem solving for Manufacturing & Quality personnel.
1600 – 1630
Digital Transformation
Ken Shitamoto, Gilead Sciences
Patrick Mullin, Sanofi
Philip Jarvis, Veqtor
Miguelina Matthews, PhD, Sanofi Aventis
Jeff Gensler, Kindeva Drug Delivery
Seneca Toms, U.S. Food and Drug Administration (FDA)
Stephen Ferrell, Strike Graph
Pierre Winnepenninckx, No Deviation Pte Ltd
Engage in a dynamic panel discussion moderated by industry experts as we delve into the wider applications of digital tools in pharmaceuticals. Explore the challenges, regulatory requirements, and industry perspectives surrounding digital validation tools, automated testing and monitoring tools, and innovative VR training tools. Gain valuable insights from established leaders in the field during this interactive session.
Ken Shitamoto
Executive Director, IT - Quality and Compliance
Gilead Sciences
Gilead Sciences
Patrick Mullin
Commissioning & Qualification Lead, Specialty Care GBU
Sanofi
Sanofi
Philip Jarvis
Director, Integrated C&Q and Paperless Strategy
Veqtor
Veqtor
Miguelina Matthews, PhD
Head External Liaison, Global Quality
Sanofi Aventis
Sanofi Aventis
Jeff Gensler
Vice President of Quality
Kindeva Drug Delivery
Kindeva Drug Delivery
Seneca Toms
National Expert, Drugs
U.S. Food and Drug Administration (FDA)
U.S. Food and Drug Administration (FDA)
Stephen Ferrell
Chief Strategy Officer
Strike Graph
Strike Graph
Pierre Winnepenninckx
CEO
No Deviation Pte Ltd
No Deviation Pte Ltd
1630 – 1700
Digital Transformation
Ken Shitamoto, Gilead Sciences
Patrick Mullin, Sanofi
Philip Jarvis, Veqtor
Miguelina Matthews, PhD, Sanofi Aventis
Jeff Gensler, Kindeva Drug Delivery
Seneca Toms, U.S. Food and Drug Administration (FDA)
Stephen Ferrell, Strike Graph
Pierre Winnepenninckx, No Deviation Pte Ltd
Hear how a leading healthcare company has leveraged a global tool to gain quality insights around deviations and complaints. Join our esteemed panelists as they delve into making informed decisions based on insights gleaned from existing digital tools. Don't miss this opportunity to gain valuable knowledge and insights from industry leaders.
Ken Shitamoto
Executive Director, IT - Quality and Compliance
Gilead Sciences
Gilead Sciences
Patrick Mullin
Commissioning & Qualification Lead, Specialty Care GBU
Sanofi
Sanofi
Philip Jarvis
Director, Integrated C&Q and Paperless Strategy
Veqtor
Veqtor
Miguelina Matthews, PhD
Head External Liaison, Global Quality
Sanofi Aventis
Sanofi Aventis
Jeff Gensler
Vice President of Quality
Kindeva Drug Delivery
Kindeva Drug Delivery
Seneca Toms
National Expert, Drugs
U.S. Food and Drug Administration (FDA)
U.S. Food and Drug Administration (FDA)
Stephen Ferrell
Chief Strategy Officer
Strike Graph
Strike Graph
Pierre Winnepenninckx
CEO
No Deviation Pte Ltd
No Deviation Pte Ltd
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.