The Role of Post-Market Pharmacovigilance to Avoid Serious Adverse Events

Event Information
Product Format
Prerecorded Event
Charles H Pierce, MD, PhD, FCP, CPI
90 minutes
Product Description

A Webinar that Provides Invaluable Assistance to Professionals Responsible for Conducting Post-Market Clinical Trials in the Pharmaceutical, Biotechnology and CRO Industries.

There is a very real increase in the mandated frequency of real-time requests by the FDA for post-marketing surveillance and actual Phase IV trials and it seems that no one is well prepared. It is now reasonable to expect that the Sponsor’s should include Post-approval trials as part of the development of any new Investigational Medicinal Product (IMP). Investigators, as well as all site staff, must know how to assess Post market ADRs as safety of the public is in the balance.

This webinar by expert speaker Charles H. Pierce, MD, PhD FCP, CPI will help you learn the nature of the various Post approval surveillance processes through:

  • Industry Guidance on Post marketing Reporting of Adverse Experiences
  • Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, March 2005
  • Guidance for Industry: March 2005, Development and Use of Risk Minimization Action Plans
  • Guidance for Industry: Sept 2009, Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS)
  • March 2006, FDA Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees.  
  • ICH E2E Guidance: Pharmacovigilance Planning

Session Highlights:

  • What is “Pharmacovigilance” and why is it needed?
  • Various kinds of Phase IV studies
  • Phase IV studies: Nature of I/E criteria
  • The difference of Safety Monitoring Plan in Phase IV
  • What constitutes a “rare” adverse event?
  • What is the requirement of large studies in uncovering rare Serious Adverse Events?
  • The role and value of a DMC in large studies
  • When does the FDA looks once and finalizes they have approved a drug/device?
  • What agents have been pulled after approval and why?

Who Should Attend

This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology, and CRO industry who may be called upon to conduct a Post-Market Clinical Trials including: Sponsor Senior Management, Project Managers, CRA Managers, as well as QA/Compliance persons. In CRO’s and sites, those benefiting the most would be: Principal Investigators and sub investigators, Clinical Research Scientists (PKs, Biostatisticians ...), Safety Nurses, Clinical Research Associates (CRAs) and Coordinators (CRCs), QA / QC auditors and staff, & Clinical Research Data managers.



Order Below or Call 1-866-458-2965 Today


We Also Recommend
You can also order through:




About Our Speaker

Charles H Pierce

Charles H. Pierce, MD, PhD, FCP, CPI

From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 45+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 25+ years in the medical research industry (7 years as a Principal...   More Info
More Events By The Speaker

Why AudioEducator?
  • Save money on travel.
  • Meet your specific training needs.
  • Keep learning after the event.
  • Save time training your whole staff.
Join Our Mailing List
Our Accreditation Partners
Facebook Twitter Linkedin Youtube RSS Feeds Google Plus
Audio Educator


Dear Valued Customers


We regret to announce that ProEdTech LLC and all its affiliate brands will cease operations on April 1, 2019.


We are no longer able to fulfill online orders. We will fullfill all DVD and book orders already placed.


Customers of canceled webinars and subscription products may request a refund at (800) 223-8720 or You must do so by April 1, 2019.


Thank you for your business and loyalty over the years. We sincerely apologize for any inconvenience caused.


Best regards,

The ProEdTech Team