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HomeMedical Device TrainingThe Premarket Approval Pathway: Ensure Successful Regulatory Submissions

The Premarket Approval Pathway: Ensure Successful Regulatory Submissions

Teachers
Michael Drues
Category:
Medical Device Training/ On-Demand Courses/ Regulatory & Compliance/
Clear
Duration: 90 minutes
On-demand
Includes handouts
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

The premarket approval (PMA) is the second most commonly used pathway to market for medical devices in the United States.  In fact, nearly 10% of medical devices are brought to market using this important pathway.  However, since the PMA is reserved for the highest “risk” (i.e., class III) devices, the requirements are much more complex compared to more common premarket notification (PMN) a.k.a. the 510k.  This makes for a confusing process, and not having a concise, data-driven submission can seriously jeopardize your product approval efforts.  Fortunately, there are ways to ensure that your PMA meets regulatory requirements while clearly outlining the therapeutic benefits of your product.

Using real examples, this course will outline some of the common pitfalls experienced during the PMA process, while providing the tools needed to ensure success for your submission.  Additionally, you will receive a brief primer in the difference between device, drug and biologic clinical trials to establish a foundation for crafting your PMA.

LEARNING OBJECTIVES

Using a case study approach, you will learn:

  1. Where does the PMA fit into the medical device universe (e.g. how to decide whether to use the PMA or another pathway to market)?
  2. How can the PMA be your friend (e.g. when a PMA is actually preferred over a 510k)?
  3. What are the ‘required contents’ of a PMA submission?
  4. How to decide amongst the types of PMA submissions (e.g. traditional, modular, streamlined, etc. and what are the advantages and disadvantages of each)?
  5. What is the Summary of Safety and Effectiveness Data (SSED) and how is it used?
  6. What are the differences in clinical trials for devices compared to drugs and biologics?
  7. How can we design device clinical trials to maximize our success to market?
  8. When can we combine pathways via label expansion: HDE à PMA
  9. Want to avoid the PMA? Consider the De Novo – using classification to your advantage!
  10. How to use the PMA beyond the device world? i.e., using combination products: PMA+NDA / PMA+BLA, etc.

Although this course will focus on US FDA requirements, suggestions on how to leverage your data with international submissions will also be discussed.

Who Should Attend

WHO SHOULD ATTEND

Geared for both experienced medical device professionals as well as those new to the industry, this webinar is designed for those who need a better understanding of the regulatory requirements necessary to bring medical devices to market via a premarket approval (PMA).    This unique seminar demonstrates important regulatory requirements and concepts using case study discussions of real products from a variety of clinical specialities.  Strategies for using regulation as a competitive advantage will also be discussed. Scientists, engineers and technicians working on device design and development, product and product development managers, business development managers, marketing managers, QA/QC personnel, regulatory affairs professionals, investment and acquisition specialists and field service engineers will all benefit from this webinar.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

Michael Drues
Works regularly for the FDA, Health Canada, the US and European Patent Offices, and other regulatory and governmental agencies worldwide.

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Clear
Duration: 90 minutes
On-demand
Includes handouts

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The Life Science Training Institute helps pharma, biotech, and medical device companies build knowledgeable, compliant workforces by providing training from drug discovery through commercialization. We are dedicated to advancing careers of those working to develop new therapies and to protect patient safety.

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