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

Date: April 2, 2025
Duration: 60 Minutes
Time: 12 PM EST

Timely and adequate reporting of adverse events to FDA is the primary responsibility of the sponsors of INDs. FDA 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. The rules also require a safety database and trends data on adverse events to be submitted at least annually. 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 recently 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.
 
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 are 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 to be compliant but processes to document how you address safety events in your clinical trials.
 

Areas Covered in the Session:

  1. Current regulatory requirements.
  2. Grades of adverse events and metered reporting requirements
  3. Role of clinical investigators and sponsors.
  4. What SOPs are needed for adverse event reporting
  5. Training requirements for personnel
  6. Good documentation practices for safety monitoring

Who will benefit:

  1. Safety reporting professionals
  2. QA/QC/Compliance/Regulatory affairs professionals
  3. Clinical trial professionals (e.g., CRAs, coordinators, nurses, pharmacists)
  4. Investigators participating in clinical trials
  5. Sponsors and investigator-sponsors of clinical trials
  6. Pharmacovigilance professionals
  7. Clinical trial specialists
  8. Project Managers
  9. People investing in FDA-regulated product development projects

Speaker: Mukesh Kumar

​PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

We accept credit card, debit card, and PayPal. 

Cancellations & Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.

Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.

In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.

For any information on the training agenda and logistics, please call +1 410-501-5777 or email: info@fdamap.com