Navigation Links
FDAnews Announces — Medical Device Premarket Regulatory Pathways: Maximizing Efficiency—Saving Time, Money & Resources Webinar, June 7, 2017
Date:5/18/2017

Medical Device Premarket Regulatory Pathways:
Maximizing Efficiency—Saving Time, Money & Resources
**An FDAnews Webinar**
June 7, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/mdpremarketreg                        

A trail being blazed by provisions of the 21st Century Cures Act and proposed Medical Device User Fee Amendments (MDUFA) IV goals not to mention a business-friendly White House promise to decrease premarket-approval costs and speed new products to commercialization.

All devicemakers have to do is figure it all out.

FDAnews is here to help. Mark the calendar for Wednesday, June 7, and the Medical Device Premarket Regulatory Pathways webinar when two NSF Health Sciences senior consultants guide manufacturers down this new path to speedier premarket approvals. Attendees will discover:

  •     The game-changers lurking within the 21st Century Cure Act and pending MDUFA goals
  •     When and how to take advantage of them
  •     Sorting through the FDA feedback process, early feasibility/first-in-human and expedited-access pathways, de novo classification process, pre-submissions and more
  •     Product classification: Where and how to get precious regulatory information on it
  •     How to focus communications with the FDA based on best pathways for products
  •     And much more!

The presenters boast a wealth of premarket-approval experience. Caroline Rhim Ph.D. was Branch Chief-Anterior Spinal Devices, Office of Device Evaluation, CDRH, with deep experience involving premarket submission of novel orthopedic and cardiovascular devices. Meaghan Bailey RAC is an expert on preparing sponsors for Medical Devices Advisory Committee meetings and other premarket FDA interactions, and has been involved with premarket approval of in vitro diagnostics, and devices to treat and manage women’s health and diabetes.

Greater profits, lower costs and speedier premarket approvals await the devicemaker who figures out these new advantages early on.

Who Will Benefit:

  •     CEO/COO/CFO/CMO
  •     Regulatory Affairs
  •     Quality
  •     Marketing/Sales
  •     Product Management
  •     Clinical and Medical Affairs
  •     Reimbursement
  •     Market access
  •     Government affairs

Webinar Details:
Medical Device Premarket Regulatory Pathways:
Maximizing Efficiency—Saving Time, Money & Resources
**An FDAnews Webinar**
June 7, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/mdpremarketreg                        

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/mdpremarketreg                                                                                        
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Read the full story at http://www.prweb.com/releases/FDAnews/mdpremarketreg/prweb14341362.htm.


'/>"/>
Source: PRWeb
Copyright©2017 Vocus, Inc.
All rights reserved


Related medicine news :

1. FDAnews Management Report: Managing Contract Manufacturers and Testing Labs
2. FDAnews Management Report: Implementing Risk-Based Verification and Validation
3. FDAnews Announces CDRH’s Office of Compliance Reorganization: A “One-On-One” with Office Director Steve Silverman, Webinar, Feb. 5, 2014
4. FDAnews Announces Device Software Verification and Validation: Get Ready for a New Breed of Investigators, On-Demand Webinar, Aug. 12, 2014
5. FDAnews Announces — Improving Your FDA Import Success Rate: Tips for Thinking Ahead of the FDAWebinar, Aug. 7, 2014
6. FDAnews Announces — Choosing the Right Drug Name: How to Increase Your Chances for Approval Webinar, July 22, 2014
7. FDAnews Announces — New Job Board Now Available on FDAnews.com
8. FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC
9. FDAnews New Workshop, 2 Weeks to Register — Innovative Process Validation Strategies for Medical Devices, Aug. 26-27, 2014, Bethesda, MD
10. FDAnews Announces Choosing the Best Device Sample Size for Verification and Validation: Tools to Safely Speed Your Device to Market, On-Demand Webinar, Aug. 27, 2014
11. FDAnews Announces — What to Do Now for UDI: Don’t Lose Your Customers by Getting Locked Out of the Market Webinar, Sept. 9, 2014
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/22/2017)... ... 22, 2017 , ... Happy Living’s mission - to improve the health and ... the entertaining and delicious worlds of theatre and wines. , After watching Scott ... to turn his play into a book. The Greener The Grass ( https://www.happyliving.com/books/the-greener-the-grass ) ...
(Date:9/22/2017)... Overland Park, KS (PRWEB) , ... September 22, ... ... to Insulate Plus, a nutritional supplement produced by Native Remedies that helps promote ... a top priority for many individuals. However, some prescription-based approaches can have negative ...
(Date:9/22/2017)... San Francisco, CA (PRWEB) , ... September 22, ... ... a way to help you brush more effectively even on the go. Their ... diseases like gingivitis and gum inflammation, with UV sanitizing technology. Combining leading edge ...
(Date:9/22/2017)... ... September 22, 2017 , ... The freshly released ... doorstep. According to Smart Mart, customers can now order vegetable, fruit, snacks, dairy, ... customers can find clothing at discounted prices. Apart from this, Smart Mart has ...
(Date:9/21/2017)... CA (PRWEB) , ... September 21, 2017 , ... With ... so fun and easy to do. Users can select from up to two layers ... with a click of a mouse all within Final Cut Pro X. ...
Breaking Medicine News(10 mins):
(Date:9/9/2017)... , Sept. 8, 2017 ... Mobile MRI Unit coming to Washington DC ... When: Tuesday, September 12 th – Monday, September 18 ... D.C. offering free MRI brain scans to the public.Where:  ... be parked at 501 K Street NW, Washington, D.C.What:BTF brings its nationwide ...
(Date:9/7/2017)...  Eli Lilly and Company (NYSE: ... to more efficiently focus resources on developing new ... workforce reductions, including those from a U.S. voluntary ... 3,500 positions. With the streamlining ... approximately $500 million that will begin to be ...
(Date:9/7/2017)... NuvoAir (formerly called Pond Healthcare Innovation), ... partnership with Novartis Pharma AG to distribute NuvoAir,s spirometry technology ... leading mobile spirometry platform and Novartis, commitment to address the ... ... ...
Breaking Medicine Technology: