fda-combination-products-regulations-and-requirements

FDA :- Combination Products Regulations and Requirements

Pre Recorded

  • 60 minutes
  • 0 Day Left
     Feb 09, 2018 - Feb 16, 2018
  •   08:00 AM - 09:00 AM ET
    05:00 AM - 06:00 AM PT

Combination products are the newest and most complicated of products regulated by the FDA and other global regulatory agencies over the past few years. 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 rules concerning combination products define the regulations that apply to the various combinations of combination products. Navigating these regulations is a crucial skill to the successful design, development, and marketing of these products.

Most medical device and pharma/biologic professionals have a very limited view of combination products. Combination products can even involve more than just pharmaceuticals, biologics, and medical devices. Today combination products can also include foods, nutraceuticals or cosmeceuticals. From a regulatory standpoint, combination products present significant challenges to the Life Sciences professional.

In this webinar expert speaker Charles Paul will help the professional to understand the process of selecting the appropriate regulations that apply and the selection of the regulatory strategy to follow and advocate for to achieve the easiest regulatory path to approval.

Session Highlights:

  • Definition of Combination Products

  • Combination Products and US Regulations

  • Combination Product Approval Process

  • GMPs for Combination Products

  • Warning Letter Case Study Review

Why You Should Attend:

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.

Who Should Attend:

  • Product stewards

  • Drug Development Professionals

  • Medical Device and Diagnostics Professionals

  • Bio-logic's Professionals

  • Regulatory Professionals

  • Quality Professionals

  • Clinical Professionals

  • Business development executives involved in combination product strategic partnerships

  • R&D and product testing professionals

  • Combination product supply chain professionals


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

Charles H. Paul

Charles H. Paul

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.

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