OT

First name
Trudy
Last name
Patterson
Submitted by Trudy Patterson on
Industry Panel: Global Harmonization of the Drug Approval Process
Global harmonization of the drug approval process aims to align technical requirements for drug development and evaluation across different regions, streamlining processes and improving efficiency. This involves efforts to create common standards and guidelines for drug development, manufacturing, and quality control, ultimately leading to faster access to new medicines for patients and reduced costs for the pharmaceutical industry.
First name
Trudy
Last name
Patterson
Submitted by Trudy Patterson on
Addressing Current Challenges in Biomanufacturing with Reliability, Efficiency, Agility, and Differentiation
The biopharmaceutical sector is currently producing vast amounts of data, a trend set to amplify with new tech like smart sensors, PAT, and process automation. This presentation will highlight the significance of a holistic digital strategy, incorporating AI, machine learning, predictive modeling, and data visualization, to spearhead the evolution of biomanufacturing. Emphasizing enhanced efficiency and innovation, this strategy will enable the efficient manufacture of complex biologic molecules with reliability of supply, agility, and differentiation.
Submitted by Anonymous on
Thriving in Expansion: Compliance & Improvement Blueprint
This keynote will explore the strategic journey of a leading medicine company’s manufacturing expansion, highlighting data-driven decisions that have led to industry leadership. The presentation will share key innovations such as the integration of digital technologies, robotics, and advanced process technologies. It will emphasize the importance of site culture and staffing philosophy. Additionally, the session will underscore the value of partnerships with external manufacturersand collaborations with academic and industry institutions.
Submitted by Anonymous on
Data Management Requirements for Sterile Manufacturing Processes
This presentation will highlight the requirements for data management in the light of sterile manufacturing. The inspector will share experiences with the implementation of Annex 1 in reference to Chapter 4 and Annex 11 based on new developments in the field. They will highlight expectations on successful contamination control strategy implementation and on data driven manufacturing processes and quality oversight.
Submitted by Anonymous on
AI as an Enabler for a Sustainable Quality Transformation
Global Quality Takeda is reimagining our quality commitments across the value chain. By harnessing data, digital, and emerging technologies like AI, we aim to accelerate product delivery, foster a culture of learning and innovation, and ensure environmental sustainability. We are simplifying, standardizing, and digitalizing quality processes with increased automation and AI, demonstrated through case studies such as one-day batch release, investigation reports, and APQRs. These examples highlight how AI can enable sustainable quality transformation.