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Drug Safety and Pharmacovigilance- DSURs and PSUR Requirements

Friday, May 26, 2017 at 10:00AM - 1:00PM

Online Event

  • May 2017

    26 Fri

    10:00AM

  • May 2017

    26 Fri

    1:00PM

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Drug Safety and Pharmacovigilance- DSURs and PSUR Requirements

Friday, May 26, 2017 at 10:00AM - 1:00PM

Fremont, CA

No tickets available

Description
This course provides a background to safety reporting. There is a refresher on the definitions and reporting requirements of AE, SAE, AR and SUSARs, within a clinical trial. We look at the sources of safety information and discuss the evidence that points to the causality of an event. The change in the regulatory environment is reviewed and the role of conditional approval and PASS and PAES studies is also discussed.

The requirement of a DSUR (development safety update report) and PSUR (periodic safety update report) is covered.

Objectives of the Presentation
  • Meet regulatory requirements for product safety
  • Signal detection algorithms and methods used
  • Hazard modeling
  • Collect, assess and report adverse events
  • DSURs and PSUR requirements
  • Identify differences between U.S. and European regulatory requirements
Why Should you Attend
Timely reporting and management of serious adverse events (SAEs) in clinical trials is vital to patient safety and compliance with regulatory requirements. One of the reasons for good clinical practice (GCP) is to protect the subjects in a research trial. In all research the subjects’ well-being should be paramount. Safety checks, procedures, and reporting are fundamental to any research study involving human subjects. This includes the timely detection and management of, adverse events (AE), serious adverse events (SAE), adverse reactions (AR), and suspected unexpected serious adverse reactions (SUSAR).

In addition, excellent record keeping, follow-up, and reporting are essential so that appropriate decisions can be taken relating to study participants as well those which help steer the course of the study, based on emerging safety information. It is also important to collect safety information even when a treatment is on the market. In fact many marketing authorization procedures require PASS studies be performed (post authorization safety studies) in order to collect additional safety information. PSURs (periodic safety update reports) are required for post marketed drugs and companies having an obligation to collect any safety information for the lifetime of the product.

Areas Covered
  • AE, SAE, AR and SUSAR defined
  • How to determine causality
  • Reporting timelines
  • Sources of information, preclinical clinical, clinical and post marketing
  • Changes in the regulatory environment i.e. conditional approvals
  • PASS and PAES
  • Regulatory reports DSURs PSURs
  • Signal detection and hazard modeling
  • Differences between US and EU requirements
Who will Benefit
  • Clinical Research Professionals
  • Compliance Departments
  • Regulatory Departments
  • Drug Safety Professionals
  • Pharmacovigilance Professionals
  • Research and Development
  • CROs
  • AROs
  • Quality assurance/compliance
  • Any personnel that may be involved in safety reporting when conducting clinical trials or following the marketing authorization of a product
  • Anyone who would like to enhance their knowledge and understanding of drug safety
For Registration
http://onlinecompliancepanel.com/webinar/DRUG-SAFETY-PHARMACOVIGILANCE-504550/MARCH-2017-ES-EZEVENT

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