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Safety Reporting in Clinical Trials: Are you Compliant with the Current FDA Rules?

Instructor: Mukesh Kumar
Product ID: 701921
  • Duration: 60 Min

recorded version

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Read Frequently Asked Questions

This Safety Reporting in Clinical Trials webinar will review FDA's recent major revisions to IND safety reporting requirements. It will explain FDA's current expectations of sponsors, investigators, IRBs, and other personnel responsible for reporting safety related information while conducting clinical trials with a new investigational product or a generic drug.

Course "Safety Reporting in Clinical Trials: Are you Compliant with the Current FDA Rules?" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

If your company or organization is involved in clinical trials, if you are a clinical site or safety monitoring/pharmacovigilance organization, if you with an IRB overseeing clinical trials, or if you are not sure of your compliance status with the current regulations, you can get valuable tips and training in less than an hour.

This seminar will discuss the current requirements, differences from the older requirements, and tips to not only be compliant but processes to document how you address safety events in your clinical trials.

Topics covered include:

  • What has changed from earlier?
  • How do these changes impact ongoing and recently completed clinical trials?
  • Best practices to implement new safety reporting processes
  • Do's and Don'ts of safety reporting.

Areas Covered in the Seminar:

  • Current regulatory requirements.
  • Rationale for these changes.
  • Role of clinical investigators and sponsors.
  • Amending existing SOPs and/or creating new ones.
  • Training requirements for personnel.
  • Good documentation practices for safety monitoring.

Learning objectives:

Learn how to be compliant with current FDA requirements for safety reporting while maintaining high levels of patient confidence in your clinical trials and timely addressing adverse events.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

  • QA/QC/Compliance/Regulatory affairs professionals
  • Clinical trial professionals (e.g., CRAs, coordinators, nurses, pharmacists)
  • Investigators participating in clinical trials
  • Sponsors and investigator-sponsors of clinical trials
  • Pharmacovigilance professionals
  • Clinical trial specialists
  • Project Managers
  • People investing in FDA-regulated product development projects

Instructor Profile:

Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD ( www.amarexcro.com ). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

Topic Background:

Recently FDA announced several major revisions in its IND safety reporting requirements. These rules define the agency’s current expectations of sponsors, investigators, IRBs, and other personnel responsible for reporting safety related information while conducting clinical trials with a new investigational product or a generic drug. Also, the bioavailability and bioequivalence (BA/BE) studies (studies done for generic drugs) are subject to these IND safety reporting rules.

There are stricter requirements for sponsors and investigators for evaluating a given adverse event before reporting it to the FDA and/or the IRB. Several definitions in the regulations have been revised and rules have been harmonized with internationally acceptable practices for safety reporting in clinical trials. The new requirements were inserted into the regulations to allow FDA the authority to enforce the same. Sponsor, investigators and all relevant personnel are supposed to be compliant with these rules or face penalties for non-compliance.

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