This webinar on Drug Utilization vs. Registry Study will cover definitions, responsibilities, regulatory requirements and strategies to understand the differences and conduct these types of studies. It outlines the processes a company must undertake to be able to conduct such studies in humans.
Why Should You Attend:
It is common to collect data on a sponsor’s drug after approval. This may be voluntary just to collect more information and to understand how the drug is being prescribed. This might shed light on possible new indications the sponsor may wish to undertake with randomized controlled clinical trials (RCTs).
It is also possible, that the regulatory agency has required such studies as part of approval of the drug to collect safety data in large numbers of subjects who may have concomitant medications and diseases. The legal and regulatory hurdles required depends on what type of study is being planned and where it will be conducted (e.g. US, EU, Japan, etc.) The decision on whether to conduct a Registry Study (RS) or what is often referred to as a Drug Utilization Study (DUS) (non-interventional or observational studies) depends on the nature and purpose of the study.
Areas covered in this webinar:
- What is the difference between a RCT, a Registry Study and a DUS?
- How to decide which one is appropriate for the company’s needs?
- FDA and European nomenclature and regulations.
- Who has liability for drug adverse events?
- Who provides financial support?
- Who provides drug supplies?
- Who write the informed consent?
- What are the regulatory reporting requirements?
- Who provides the study information on Clinicaltrials.gov (US) or European Clinical Trials Database (EudraCT Version 8.0, operational since 10 March 2011?
Who Will Benefit:
- Pharmaceutical Medical Directors in Clinical Research and Medical Affairs
- Pharmaceutical medical support personnel who work in clinical research or medical affairs who may initiate or oversee Post-Marketing studies by their company
- CRAs, CDAs, MSLs, Managers, etc.
- Physicians who commonly prescribe the drug
- Hospitals (admin, compliance)
- Coordinators at study sites who must manage the process
- Legal Affairs
Added by complianceonlinecom on November 5, 2012