The Leader in Quality Life Science Training

Introduction to Medical Combination Products

  • Slide title

    "There was a lot of interaction, which was great.  I enjoyed the course director's enthusiasm and the various case studies discussed. I am not from a regulatory affairs background so it provided me with sufficient information on combination products."


    Michelle M., GxP Compliance, BioMarin

  • Slide title

    "Best training ever, I learned so much and it gave me a new way of thinking about regulations of combo products."


    Kristi F., Prin. RAS, Medtronic

  • Slide title

    "Course was exceptional compared to other regulatory courses I've taken. Great use of real world examples to demonstrate concepts."  


    Steve B. Director of R&D, DSM Biomedical

  • "The most useful part of the course was learning about new technologies and how to apply regulatory strategy.  The course was much more practical with real life examples."


    Shirley A., Senior Manager, Chugai Pharmaceutical

Course Director

Course Fee

$2650.00 Regular Registration

$2450.00 Early Bird Pricing (Register 30 Days in Advance)

Course Description

This 20 hour course covers current FDA regulatory compliance with respect to developing and marketing Combination Products. A focus is placed on relevant aspects of FDA regulations as well as the practical aspects of getting the Combination Product to market. Several example products will be highlighted to provide practical, hands-on instruction.


The first part of the course provides general context for the overall topics surrounding combination products. Later, a more in-depth discussion on implementation within a complete combination product development environment is presented. FDA's regulations, guidance documents, and on-line informational resources will be highlighted and used throughout the course.

Who Should Attend

This course will be most valuable to medical device/product professionals who need a firm understanding of how to gain FDA approval for combination products. The course is geared toward personnel that are newer to the industry or need to gain perspective of how to develop a successful combination product. Engineers, managers, supervisors, scientists, technicians, and other personnel involved in product development, manufacturing, quality assurance, or regulatory affairs that do not have an in-depth knowledge of Combination Products will benefit from this course.

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FAQs

  • Learning Objectives

    Upon completion of this course, attendees will have an understanding of the framework for the specific FDA Combination Product regulations required to speed product to market. The course will also provide an overview of medical device, drug, and biologic product regulations to the extent that they relate to combination products. Emphasis will be placed not only on the regulatory aspects of product development, but also on overall medical product strategy and the development environment. Instructional emphasis is focused on taking an efficient, cost-effective approach to obtaining FDA approval on your Combination Product, thus avoiding unnecessary spending and wasted time.


    Exercises will be used to reinforce the key concepts. Attendees will receive extensive course notes that can be used as reference material once the course is completed.

  • Agenda


    Context for Course and FDA's Combination Products

    • Context of Combination Products
    • History and reason for special treatment
    • Definitions

    Medical Device Overview

    • Regulations related to Medical Devices
    • Overview of Medical Device Quality System regulations
    • Overview of Medical Device classifications, exemptions

    Overview of Drugs and Biologics

    • Regulations related to Drugs and Biologics
    • Overview of cGMP quality system regulations
    • Biologic specific regulations

    Overview of Various Types of Medical Product Submissions

    • NDAs = New Drug Applications
    • BLAs = Biologics License Applications
    • PMAs = Premarket Approval Applications
    • 510(k)s = Premarket Notifications
    • Medical Device Exemptions
    • INDs = Investigational New Drug Applications
    • IDEs = Investigational Device Exemptions
    • HDEs = Humanitarian Device Exemptions
    • What do these mean in terms of Combination Products

    Overview of Combination Products

    • Regulations related to Combination Products
    • Combinations that are not within the context of the regulation
    • FDA guidance documents related to Combination Products
    • FDA's office of Combination Products

    Product Examples – Medical Devices, Drugs, Biologics and Combinations

    • Medical device examples
    • Drug examples
    • Biologic examples
    • Combination product example

    Overview of FDA's Office of Combination Products (OCP)

    • Purpose and Mission
    • Organization
    • OCP Reports
    • What can be expected from OCP
    • Statistics

    Use of Request for Designation (RFD)

    • What is a Request for Designation
    • Guidance related to constructing the RFD
    • Contents of the RFD

    Using the CGMP Guidance for Combination Products

    • Introduction and Background
    • Current Good Manufacturing Practice
    • Communicating with FDA

    Using Other General Guidance related to Combination Products

    • Early Development Considerations for Innovative Combination Products
    • Application User Fees for Combination Products
    • Submission and Resolution of Formal Disputes Regarding Timeliness of Premarket Review of a Combination Product

    Classification and Jurisdictional Information

    • Intercenter Agreements
    • Jurisdictional Transfers
    • Jurisdictional Updates
    • RFD Jurisdictional Decisions

    Assignment Algorithm

    • Review of the assignment algorithm the agency uses for RFD
    • Examples cited by FDA

    Wrap-up


  • Testimonials

    "This course was much more interactive and engaging than other courses I've taken.  The instructor really put us on the spot to think and contribute, thereby making me much more likely to remember the content.  The case studies brought the concepts to life."

    Gillian T., Assoc Dir Analytical Services, Particle Sciences


    "There was a lot of interaction, which was great.  I enjoyed the course director's enthusiasm and the various case studies discussed. I am not from a regulatory affairs background so it provided me with sufficient information on combination products."

    Michelle M., GxP Compliance, BioMarin


    "The most useful part of the course was learning about new technologies and how to apply regulatory strategy.  The course was much more practical with real life examples."

    Shirley A., Senior Manager, Chugai Pharmaceutical


    "This course was very well structured and taught. The instructor was eloquent, engaging, humorous and sufficiently diligent. It was one of the best courses I've taken."

    Kishan N., Manager, PCQA, Astellas


    "Best training ever, I learned so much and it gave me a new way of thinking about regulations of combo products."

    Kristi F., Prin. RAS, Medtronic


    "Absolutely, positively, the best presentation I have ever attended in 30 years of working life."

    Osman T., Associate Director, CSPV/Otsuka


    "Course was exceptional compared to other regulatory courses I've taken. Great use of real world examples to demonstrate concepts."

    Steve B. Director of R&D, DSM Biomedical


    "Better than courses I've taken with other providers. Fantastic!"

    Molly W., Senior Engineer, DSM Biomedical

  • Does the course go beyond combination product information for the US market?

    No. The course covers FDA's regulations which govern the US market only.

  • What materials come with the course?

    A course notebook is provided that contains the slides that are presented, publicly available reference materials from FDA and other entities, class exercises, and example documents.

  • Are there particular types of combination products emphasized?

    The course necessarily covers a broad range of combination products. There is greater emphasis on the process related to Combination Products as compared to deeper evaluations of the specific technologies for any given product.

  • Does the course provide guidance on how to write combination product applications (in order to get to market)?

    The course does not provide in-depth evaluation of important aspects such as style, format, level of detail, and other aspects that can only come from experience gained in the medical device, drug, or biologics industry(ies) or potentially looking at other application examples. Emphasis is placed on how the product will be regulated and what product applications would be required. Further, emphasis is placed on regulations outside of product applications. One key example is how to manage a Combination Product in terms of quality systems. Considerable emphasis is FDA's available resources.

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.

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