510(k) Submissions to the FDA: Hands-On Workshop
Date: March 27-28, 2025
Time: Starts at 10 AM EST
Duration: 2 Days
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.
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:
- Current regulatory requirements.
- Grades of adverse events and metered reporting requirements
- Role of clinical investigators and sponsors.
- What SOPs are needed for adverse event reporting
- Training requirements for personnel
- Good documentation practices for safety monitoring
Who will benefit:
- Safety reporting professionals
- 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
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Day One (10:00 AM - 3:30 PM EST)
10:00 AM – 11:00 AM: The Law and Regulations
- The legal basis for a 510(k): The potential consequences of not submitting a 510(k)
- Different types of 510(k)s
- How to determine if a 510(k) is needed
- How to select the appropriate type of 510(k)s
- Review of bundling 510(k)s
- The 513(g)
11:00 AM – 12:00 PM: Strategy and Planning
- Factors to consider when developing a strategic and regulatory plan
- How to define the role of the regulatory professional
- How to use FDA guidance when planning and organizing the 510(k)
- Risk Assessment and strategic presentation
12:00 PM – 12:30 PM: Break
12:30 PM – 2:00 PM: Assembling the 510(k)
- How to select a predicate device
- How to collect and organize the data and actually prepare the 510(k)
- Standards Data Report
- Potential Pitfalls
2:00 PM– 2:15 PM: Break
2:15 – 3:30 PM: Assembling the 510(k) (Continued)
- Sections of the 510k application
- Best Practices for filling the 510(k) checklist
- The traditional and e510k format of application
- Gap Analysis and 510k strategy
Day Two (10:00 PM - 2.00 PM EST)
10:00 AM – 11:00 AM: FDA’s 510(k) Refuse to Accept
- What happens once you submit the 510k
- FDA’s internal review process for new 510k
- Discussion of the “Refuse to Accept” checklist
- Common reasons for rejection and potential solutions
11:00 AM – 12:00 PM: The FDA Review Process
- The review process for traditional 510(k)s
- Interacting with FDA before and during the review process
- The role of the regulatory professional in resolving disputes
- How the FDA “holds” process work
- Tips and hints
12:00 – 12:30 PM: Break
12:30 – 2:00 PM: 510(k) Post-Clearance Process
- Deciding when to submit a new 510(k) for a device modification
- Obtaining information about another company’s devices
- Modifications
- Life cycle considerations
- Promotional practices
- Post-clearance exercise
Register Online (By clicking on the links below)
Prices are in US Dollars.
The registration fee includes the workshop and all related course materials.
Terms & Conditions to register for the Workshop
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this seminar, please email us at info@fdamap.com
Payment:
We accept credit card, debit card, and PayPal.
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 20 working days prior to the start date of the event will receive a refund — less a $200 administration fee per person. No cancellations will be accepted — nor refunds issued — within 20 working days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future FDA Map event and a credit note will be issued.
