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

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.

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