1. Why Pharmacovigilance (Phase IV Trials) will be increasingly seen: What do they tell us
and why are they important
Description:
FDA-mandated post-market studies are here. 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.
There are a number of points that are only seen in Phase IV (PV) studies and why these are
important in the Drug Development process will be covered. These studies (and there are several
types of Phase IV/Post Marketing studies) answer important safety questions and because of this
and the duration of these studies, they are almost always associated with Data Monitoring
Committees (DMC’s).
Why Should you Attend:
With the increasing complexity of therapeutic agents – now involving more "biologics" – and an
increase of use of new agents beyond the original intention and testing, it is essential to know as
early as possible any untoward and unexpected Adverse Events and other serious toxicities. The
well known examples of Drugs pulled from the market after approval attest to the need for Phase
IV (Post marketing approval) studies
Objectives of the Presentation:
 What are the types of Phase IV studies
 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?
 Why large studies are needed to uncover rare Serious Adverse Events
 What is the role and value of a DMC in large studies
 What endpoints is the FDA looking for once they have approved a drug/device
Who can Benefit:
Those benefiting the most would be the Principal Investigators and sub investigators, Clinical

2. Research Scientists (PKs, Biostatisticians, ...), Safety Nurses, Clinical Research Associates
(CRAs) and Coordinators (CRCs), Recruiting staff, QA / QC auditors and staff, & Clinical
Research Data managers In addition, the holders of the IND for new products i.e. the Sponsors
will benefit.