Pharmacovigilance in Combination Products and Regulations

Let us guide you through the Pharmacovigilance in Combination Products and Regulations topic and get the necessary knowledge and skills to do it right

  •  Award
  •  180min workload
Pharmacovigilance in Combination Products and Regulations
Pharmacovigilance in Combination Products and Regulations

This course intends to

  • Give with a brief overview of types of combination products and the final rule to define their “primary mode of action” (PMOA)
  • Review of current laws, regulations and guidelines for combination products
  • Description of principles of risk‑based quality and safety management for combination products
  • Strategy on how to develop relevant metrics as quality and performance indicators for risk-based quality management (RBQM) pharmacovigilance systems, while developing combination products
  • Framework for identifying safety signals and developing management strategy based on current regulatory requirements
  • FDA’s Final Rule for postmarketing safety reporting for combination products

What will you learn

At the end of the course, you will be able to

  • Know the different types of combination products and select safety monitoring strategy based on streamline approach and primary mode of action
  • Identify applicable regulations and guidelines for safety management throughout lifecycle of combination products
  • Develop and effectively implement postmarketing safety reporting strategy for combination products
  • Develop adverse event reporting systems based on Compliance Policy for combination product postmarketing safety reporting

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 in Combination Products and Regulations 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 in Combination Products and Regulations!
  • 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)