ComplianceOnline, Online Event
2012-11-15
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.
This session is designed for clinical research professionals either at pharmaceutical companies who are considering conducting post-marketing studies and would like more information on the process to be able to abide by international regulations as well as understanding the process of how a company and sponsor collaborate.
The goal is to help the clinical research professionals avoid liability, identify opportunities for improving the processes for conducting post-marketing studies and to describe ways companies and study sites can best interact. 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
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