Understanding Combination Products: Navigating the Rules and Regulations
Duration: 60 Minutes
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This training will help you understand what a combination product is, highlight some of the changes in how the FDA views combination products, the approval steps for combination products and proposed regulations for these types of products.
02/12/2018 10:00 AM02/12/2018 04:00 PMTraining Topic: Understanding Combination Products: Navigating the Rules and RegulationsInstructor: Charles H Paul
Objectives of the Presentation
Define the term "Combination Products"
Identify and explain the US Regulations that pertain to combination products
Explain the combination product approval process
Identify and explain the GMPs for combination products
Why Should you Attend
Combination products are the newest and most complicated of products regulated by the FDA and other global regulatory agencies. In general, a combination product is composed of two or more regulated products such as a medical device and a drug/biologic such that both are combined together and are required to achieve the intended result. The FDA’s Final Rule concerning combination products has been recently published and defines the regulations that apply to the various combinations of combination products. Navigating this rule and the regulations of our global neighbors is a challenge for manufacturers. This webinar is essential for those who are currently manufacturing combination products or anticipating submitting potential products for approval. This webinar will provide the knowledge necessary to determine the regulations that apply to common combination product types. GMPs for combination products will also be discussed in addition to a discussion of the particular challenges facing manufacturers today.
Combination product examples
Complexity surrounding combination products
Combination product regulations
Combination product approval process
Combination product cGMPs
Warning Letter case study review
Who will Benefit
Regulatory, quality, and clinical professionals involved with combination product development and oversight
Business development executives involved in combination product strategic partnerships