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Preparation of FDA Submissions and Communicating with the FDA | Seminar 2018

Event Details

Preparation of FDA Submissions and Communicating with the FDA | Seminar 2018

Time: June 20, 2018 at 9am to June 21, 2018 at 6pm
Location: Hilton Zurich Airport
Street: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50
City/Town: Zurich
Website or Map: https://www.globalcompliancep…
Phone: 800-447-9407
Event Type: seminar
Organized By: John Robinson
Latest Activity: May 4, 2018

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Event Description



Why you should attend:

  • What do the regulations say?
  • Navigate the FDA drug and device approval system
  • Prepare, construct and submit well-written IND, NDA, BLA, PMA, 510(k) and IDE submissions and regulatory filings
  • Navigate the FDA review process
  • Identify the required regulations and guidance documents for drug and biologic submissions
  • Use regulations and guidance documents to outline and construct a variety of drug and biologic submissions
  • Formulate a working knowledge of regulatory submissions, publishing, and style guides
  • Create checklists that encompass timelines and sections needed from contributors
  • Strategic and technical guidance for drug and medical product development and regulatory review
  • Regulatory policy guidance
  • Regulatory Strategy planning and communications
  • FDA 510(k) submissions for obtaining FDA clearance
  • FDA Investigational Device Exemption (IDE) submissions for US clinical studies
  • FDA Requests for Classification and Requests for Determination
  • FDA Pre-Submission (Pre-sub) meetings
  • Attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion
  • Challenges and possible solutions will be discussed, and examples will demonstrate how the requirements can be put into practice
  • 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)?
  • How can the PMA be your friend (e.g. when a PMA is actually preferred over a 510k)?
  • What are the 'required contents' of a PMA submission?
  • How to decide amongst the types of PMA submissions (e.g. traditional, modular, streamlined, etc. and what are the advantages and disadvantages of each)?
  • What is the Summary of Safety and Effectiveness Data (SSED) and how is it used?
  • What are the differences in clinical trials for devices compared to drugs and biologics?
  • How can we design device clinical trials to maximize our success to market?
  • When can we combine pathways via label expansion?
  • Want to avoid the PMA? Consider the De Novo – using classification to your advantage!
  • How to use the PMA beyond the device world? i.e., using combination products: PMA+NDA/PMA+BLA, etc.
  • Define basic terms related to device research
  • Locate applicable regulations
  • Determine when an IDE is required
  • Describe Sponsor & Investigator responsibilities
  • Know contents and submission process for an IDE Application
  • Conduct IDE, PMA and 510(k) submission management activities
  • Regulatory strategy and regulatory planning for effective IND, NDA, ANDA and BLA submissions
  • Preparing for and conducting effective and efficient FDA meetings and communications
  • When to address and submit Post-Approval Supplements
  • Review and discuss pain points, challenges and solutions

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