Overview:
FDA-mandated post-market studies are here. Phase IV clinical 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.
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) surveillance.
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 Pharmacovigilance Studies and there is also the ICH E2E Guidance of Pharmacovigilance Planning.
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)
Areas Covered in the Session:
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
What agents have been pulled after approval and why?
Learning Objectives:
Identify the main differences between Pre-market and Post-market studies
Contrast the elements of type II or rare Adverse Events with type I Adverse Events
Describe three AE mechanisms how an agent would be removed from the market after it had been approved
Who Will Benefit:
Pharmaceutical, Biological and Device Companies
Principal Investigators and Sub Investigators
Clinical Research Scientists (PKs, Biostatisticians) Research Managers
Safety Nurses
Clinical Research Associates and Coordinators
Recruiting staff
QA / QC auditors and staff
Study Monitors
Clinical Research Data managers
FDA-mandated post-market studies are here. Phase IV clinical 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.
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) surveillance.
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 Pharmacovigilance Studies and there is also the ICH E2E Guidance of Pharmacovigilance Planning.
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)
Areas Covered in the Session:
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
What agents have been pulled after approval and why?
Learning Objectives:
Identify the main differences between Pre-market and Post-market studies
Contrast the elements of type II or rare Adverse Events with type I Adverse Events
Describe three AE mechanisms how an agent would be removed from the market after it had been approved
Who Will Benefit:
Pharmaceutical, Biological and Device Companies
Principal Investigators and Sub Investigators
Clinical Research Scientists (PKs, Biostatisticians) Research Managers
Safety Nurses
Clinical Research Associates and Coordinators
Recruiting staff
QA / QC auditors and staff
Study Monitors
Clinical Research Data managers
