Why Pharmacovigilance (Phase IV Trials) will be increasingly seen: What do they tell us and why are they important?

Instructor: Charles H Pierce
Product ID: 701635
  • Duration: 75 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Training CD

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Read Frequently Asked Questions

This Phase IV Trials training will help you in understanding FDA’s mandate on Phase IV trial and best practices for successful studies that meet the complex requirements.

Why Should You Attend:

FDA-mandated post-market studies are coming. Phase IV studies are likely to be complex in design and large in scale (possibly 500,000 patients per arm), with exacting endpoints, and obligatory. The FDA appears to be abandoning a long-standing policy of negotiating post-market commitments with sponsors - and will now set mandatory objectives and timelines. There is no one-size-fits-all guidance to help a particular drug or drug class prepare for the studies. There are, however Guidance documents for “Risk Minimization Action Plans” and “Good Pharmacovigilance Practices and “Pharmacoepidemiologic Assessment” and there is also the ICH E2E Guidance of Pharmacovigilance Planning. The likelihood of Data Monitoring Committees being required is also expected to increase.

Learning Objectives:

  • What is the rationale for such large studies.
  • What is Pharmacovigilance and what questions are answered.
  • The design and scope, of the types of Phase IV studies.
  • What will be the role of DMCs in post-market studies.
  • Operational strategies for successful studies that meet the requirements.
  • Methodsworking in the post-approval arena even when guidance is unclear.
  • Areas Covered in the Seminar:

    • The Nature of the I/E criteria in Phase IV studies.
    • How does the Safety Monitoring Plan differ in Phase IV?
    • What constitutes a “rare” adverse event?
    • What are the types of Phase IV studies?
    • Why large studies are needed to uncover rare Serious adverse events?
    • What is the value of a DMC in large studies?
    • What endpoints is the FDA looking for once they have approved a drug/device?

    Who Will Benefit:

    This Webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be:
    • Holders of the IND for new products
    • Principal Investigators / Sub-investigators
    • Clinical Research Scientists (PKs, Biostatisticians)
    • Safety Nurses
    • Clinical Research Associates (CRAs) and Coordinators (CRCs)
    • Recruiting staff
    • QA / QC auditors and staff
    • Clinical Research Data managers

    Instructor Profile:
    Charles H. Pierce, MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message (via webinars, lectures and seminars) of Risk Management through knowledge of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. Dr. Pierce serves as an advisor to several clinical research organizations. He has been in the Clinical Research Industry for 20+ years, has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator and staff GCP training, and medical monitoring in both drug and device studies.

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