FDA:- Adverse Event Reporting for Combination Products

The FDA has published two key documents, 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. 
In this webinar expert speaker Charles H. Paul will defines the post-marketing safety reporting for combination product and specifies and clarifies the FDAs policy for combination product post-marketing safety reporting. These and many more topics will be discussed in this webinar. 

Session Highlights: 
  • 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 time frames 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 
  • Record-keeping requirements 
Why You Should 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. 
Who Should Attend: 
  • Regulatory & legal affairs personnel 
  • Post-market surveillance/pharmacovigilance staff 
  • Quality assurance
  • Quality systems
  • Medical affairs positions 
  • Product Stewards
  • Drug Development Professionals 
  • Business Development Executive involved in combination products
  • Combination Product Professionals

Ask your question directly from our expert during the Q&A session following the live event.

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