Breast Cancer Management in North Carolina: Updates for 2021 SPOC
Yara Abdou, MD, from the UNC Lineberger Breast Oncology group will describe relevant updates in systemic therapy for breast cancers for health care providers throughout the state of North Carolina.
Category
  • Research to Practice
Format
  • Self-Paced, Online Courses
Credits
  • ACPE Pharmacist
  • ACPE Pharmacy Tech
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • ASRT
  • NCPD/CNE
  • 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
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • 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
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • 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
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • 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
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • 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
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • 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
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • 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
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • Participation
Everything a PI Needs to Know about LCCC as an IND Sponsor
Course DescriptionKaitlin Morrison, PhD takes you through the sponsor responsibilities outlined by Good Clinical Practices (GCP) and FDA regulations and what LCCC infrastructure and processes are used to meet those obligations.
Category
Format
  • Self-Paced, Online Courses
Credits
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • Participation
Gene Therapy- FDA and Local Considerations
Course DescriptionIn this talk, which was presented to FDA, IRBs and study teams throughout the US, Kaitlin Morrison, PhD takes you through gene therapy trials and what you need to know about them beyond your typical IIT process.
Category
Format
  • Self-Paced, Online Courses
Credits
  • AMA PRA Category 1 Credit
  • AMA PRA Category 1 Credit™ - Non-physician
  • Participation

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