Regulatory and Clinical Development Considerations for Chimeric Antigen Receptor (CAR) T Cells
Course DescriptionIn this talk, Kaitlin Morrison, PhD takes you through the what you should consider when doing preclinical, manufacturing and clinical work involving Chimeric Antigen Receptor (CAR) T cells.
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 Participation
The "Tiny" Details that Can Wreak Havoc with a Protocol: Improve Protocol Development to Avoid Amendments
Course DescriptionIn this talk, Kaitlin Morrison, PhD will take to you about the 3 major reasons that protocols requirement amendments and how to avoid them.
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 Participation
Site Perspective: Examine the Process for Maintaining Quality and Ensuring Results
Course DescriptionIn this talk, Kaitlin Morrison, PhD will take you through how to develop and implement a quality management plan to ensure you get good clinical trial results on your investigator-initiated trial (IIT).
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 Participation
Protocol Amendments vs. Administrative Letters
Course DescriptionIn this talk, Kaitlin Morrison, PhD discussing what an administrative letter is and when an administrative letter can be used to clarify a clinical protocol versus when a full amendment is required. 
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 Participation
IIT- Protocol Amendments
Course DescriptionNasrin Babadi, PhD takes you through LCCC’s processes for amending protocols and submitting them to FDA talking about key tips on how to best edit your protocol and applicable FDA regulations for submitting your protocol.
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 Participation
5 Tips for Developing and Maintaining an IND
Course DescriptionKaitlin Morrison, PhD takes you through a quick 5 tips that will help you and your team successfully manage an IND.
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 Participation
IND Boot Camp
Course DescriptionIn this talk, targeted at the CPO regulatory team, Kaitlin Morrison, PhD talks through how INDs are maintained at LCCC and the responsibilities of study team members.
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 Participation
IIT FDA Annual Reports
Course DescriptionNasrin Babadi, PhD takes you through how to write an IND annual report and the LCCC processes surrounding IND annual reports.
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 Participation
IND Safety Reporting- LCCC IITs
Course DescriptionIn this talk, Kaitlin Morrison, PhD covers how to fill out a MedWatch report form and how/when/why to notify FDA of an SAE.
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 Participation
Working with Investigational Assay Results
Course DescriptionKaitlin Morrison, PhD takes you through when a correlative assay is considered an FDA regulated device and what types of devices require different levels of IRB and FDA approval.
Category
Format
  • Self-Paced, Online Courses
Credits
  • 1.00 AMA PRA Category 1 Credit
  • 1.00 Participation

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