Compliant Safety Reporting in Clinical Trials – Are You Following FDA Rules? | Oct. 3, 2012, 2-3 PM EST

Compliant Safety Reporting in Clinical Trials – Are You Following FDA Rules? | Oct. 3, 2012, 2-3 PM EST

January 30th, 2012 // 4:17 pm @

This Safety Reporting in Clinical Trials webinar on March 29 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.

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 Webinar 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.

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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.

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.

More Topics in the Webinar:

  • 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


About the Speaker:

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.

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