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

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

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jan-2012

Training CD / USB Drive

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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

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 ( ). 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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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