Drug Utilization vs Registry Studies – Differences and regulatory requirements

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).

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)