Pharmacovigilance for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT-Ps)

Let us guide you through the Pharmacovigilance for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT-Ps) topic and get the necessary knowledge and skills to do it right

  •  Award
  •  180min workload
Pharmacovigilance for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT-Ps)
Pharmacovigilance for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT-Ps)

This course intends to provide you with:

  • Overview and classification of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)
  • HCT/Ps development and regulatory requirements
  • Overview of Current Good Tissue Practice (CGTP) and additional requirements for manufacturers of HCT/Ps
  • Overview of FDA’s regulatory approvals process and safety monitoring requirements for HCT/Ps
  • Applications of FDA guidance documents and most recent policies/ updates for regenerative medicine and  stem cell technologies in pharmacovigilance
  • Strategies on investigating and reporting adverse reactions related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
  • Applicable good manufacturing and good laboratory practices
  • Product labeling, marketing and advertising
  • Considerations for post-licensure requirements and safety reporting 

What will you learn

At the end of this course, you should be able to:

  • Become familiar with different types of HCT/P products and select safety monitoring strategy based on streamline approach and primary mode of action
  • Acquire knowledge on Current Good Tissue Practice (CGTP) and additional requirements for manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) as it can contribute to safety of these products due to their specific nature
  • Identify applicable regulations and guidelines for safety management throughout lifecycle of human cells, tissues and cellar and tissue –based products
  • Develop adverse event reporting systems based on current regulatory guidelines and requirements
  • Develop and effectively implement postmarketing safety reporting strategy for HCT/Ps products

What’s included

  • Videorecorded lectures
  • Lecture slides and supplemental reading materials
  • Continuous individual progress assessments
  • Final exam quiz
  • Certificate of Completion for the course Pharmacovigilance for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT-Ps) issued by the Am2P partners

Who made this course

Dr Marina Malikova
Expert
Boston University School of Medicine
Nasop Experts Group
Reviewer
ISoP's North American chapter

How does it work

  • Sign up with minimal personal information, or sign in if you already have an account
  • Register to this course immediately and get access for 12 months
  • Follow the different course activities at your own pace
  • At the end of the course, you will pass a final examination and, upon success, you will get a Certificate of Completion for the course Pharmacovigilance for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT-Ps)!
  • In case of failure, you can review course activities and retake the final examination quizzes, as long as your 12 months active period is on!

Enrollment

Register now and get access to the course for 12 months!

Plan Price
Individual 300 € / 350 $
Groups Please contact us (price discounts based on group size)