Drug Safety and Pharmacovigilance- DSURs and PSUR Requirements

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

Event Details

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

Organization Details

Online Compliance Panel (OCP) creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holistic and effective. OCP largely emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices and market trends.

We strive to incorporate high standards in developing a culture facilitating exchange of ideas resulting in functional excellence. OCP believes in nurturing ideas and thought processes through innovative e-learning methodologies. Our products and services are designed to offer customized solutions to industry and market. We bridge the gap between experience and knowledge thus delivering original and creative content.

Our objectives of employing interactive mediums ensure effective communication and mutual exchange of ideas. OCP closely follows best practices and regulatory trends in the global compliance scenario. We also observe and communicate trends witnessed in FDA, ISO regulations, process and design validation. All updates and additions to important laws can be accessed by our customers in real time.

Our mission is to empower compliance professionals through effective online training sessions. Our world class training methodologies stem from comprehensive understanding of client requirements. The content conforming to FDA and ISO standards is developed by well qualified and experienced industry leaders. Our offerings will exceed expectations and add value to your investment.

The content in various categories such as medical devices, pharmaceuticals and biotechnology will raise the bar in terms of quality already on offer .We hope to contribute to the creation of responsible organizations creating benchmarks in quality, integrity and transparency.

Online Event
38780 Tyson Lane, Apt 210
Fremont, CA 94536

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

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Contact Information

Organization: Online Compliance Panel LLC

Event Contact: OCP Panel

Phone: 15108575896