Basak Clements
Company: Roche
Job title: Global Head of Materials Sciences Cell & Gene Therapy
Seminars:
Panel Discussion: Delving into the Regulatory Frameworks Governing the Use of Raw & Starting Materials, Including GMPs & Exploring Strategies to Achieve Compliance 3:15 pm
Navigating current regulatory guidance on biological raw materials for ensuring approvals in all regions Discussing regulator’s expectation on translating from research to the clinic with proprietary materials to ensure patient safety and clinical approval Discussion on areas of future policy for cell and gene therapy raw and starting materials to accelerate development of safe, scalable…Read more
day: Conference Day 2
Deep-Dive Workshop: Shining a Spotlight on Key Considerations & Strategic Plans for the Sourcing of Safe & Reliable Raw Materials to Accelerate Production of Cell & Gene Therapies 9:00 am
Many safety considerations need to be thought through when sourcing raw materials, as when, where and how the raw material was made can have a major impact on the final drug product. Understanding the impacts and advantages of the different sources of each raw material is essential for ensuring safe and high-quality materials are bought…Read more
day: Conference Day 2
Chair’s Opening Remarks 8:50 am
day: Conference Day 1