The FDA has published two key documents that (1) defines the post-marketing safety reporting for combination products and (2) specifies and clarifies the FDAs policy for combination product post-marketing safety reporting.  These two guidance documents provide significant guidance to manufacturers of combination products.  The guidance clarifies the regulations in terms of the provisions requiring applicants to submit additional types of adverse event and product problem reports to the FDA. The regulations also require mandatory sharing of adverse event information between companies manufacturing the individual constituent parts of a combination product.  Since these guidance documents have been recently published it is critical for manufacturers to fully understand their implications and individual applicant responsibilities under the post-marketing provisions in terms of how the regulations are clarified and interpreted.

Course Objectives:

At the completion of this webinar participants will be able to:

• Explain the function and importance of Post-marketing Safety Reporting
• Explain the specific types of post-marketing safety reports that are required, when they must be submitted, and the timeframes for submittal
• Explain how the application of post-marketing safety rules apply to companies marketing combination products without an approved or cleared application
• Explain the FDA handling process for post-marketing safety requirements in terms of timing to implement and enforcement.

Why Should You Attend:

The overall incentive for the audience with this webinar is the understanding gained of the content contained within these two documents as it relates to the establishment of a compliant Post-marketing Safety Reporting system and the level of enforcement and scrutiny to be expected from the FDA.  Two valuable takeaways, if you are charged with establishing and/or managing this important aspect of a combination product’s life cycle management process.

Course Outline:

This webinar will address the following content areas relevant to this subject:

• Post-marketing Safety Reporting defined in terms of function and importance
• The specific types of post-marketing safety reports that are required, when they must be submitted, and the timeframes for submittal
• The impact that the requirements have on periodic safety reporting
• How the application of post-marketing safety rules apply to companies marketing combination products without an approved or cleared application
• FDA handling of the post-marketing safety requirements in terms of timing to implement and enforcement.
• Key considerations and implications concerning implementation
• Recordkeeping requirements

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Complaint handling personnel
• Compliance personnel
• Regulatory affairs (associates, specialists, managers, and directors)
• Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
• Research and development (associates, scientists, managers, directors and VPs)
• Product and development (associates, scientists, managers, directors and VPs)
• Marketing (associates, specialists, managers, directors and VPs)
• Site managers, and consultants
• Contract manufacturing organization (associates, scientists, managers, directors and VPs)
• Contract research organization (associates, scientists, managers, directors and VPs)
• Senior and executive management (VPs, SVPs, Presidents and CEOs).
• Contractors and subcontractors