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:8/24/2017)... , ... August 24, 2017 , ... ... C. Jordan about the development and advances in Desensitization therapy to improve the ... Dr. Jordan talks about his remarkable journey of his 25 years of research ...
(Date:8/24/2017)... Los Angeles, CA (PRWEB) , ... August 24, ... ... being discharged from hospitals who are not fully recovered, or have a condition ... someone who has a chronic condition that needs monitoring until stable, such as ...
(Date:8/23/2017)... (PRWEB) , ... August 23, 2017 , ... The Arc ... developmental disabilities (I/DD), has launched a groundbreaking LGBTQ community organization for people with special ... first organization of its kind in the state of New Jersey – but the ...
(Date:8/23/2017)... Cornelius, NC (PRWEB) , ... August 23, 2017 , ... ... teeth whitening in Cornelius, NC. By taking advantage of this offer, valued ... smiles. With every regular six-month hygiene cleaning from the dentist, patients receive a complimentary ...
(Date:8/23/2017)... ... 2017 , ... The Stevie® Awards have announced the winners of the Best of the IBA ... awards competition. , Nominees in the 2017 IBAs were not able to apply for the ... the total number of awards won in the IBAs with a Gold Stevie win counting ...
Breaking Medicine News(10 mins):
(Date:8/4/2017)... Md. , Aug. 4, 2017 The ... or shortly after a physician/patient consult has long been ... and was a notable focus of the largest meeting ... is according to healthcare market research firm Kalorama Information. ... care testing (POCT) offerings or related supplies and software ...
(Date:8/2/2017)...  Life Flight Network and PeaceHealth Oregon Network announced they ... and operational efficiency for patients at hospitals in ... Cottage Grove , and Florence, Oregon ... Flight Network work collaboratively to move patients who require the ... time sensitive emergency exists. ...
(Date:7/31/2017)... , July 31, 2017 7D Surgical, developer ... Medical has purchased the 7D Surgical System to support its ... Washington D.C. and Virginia.  7D Surgical has ... for many of the premier medical facilities within those markets. ... ...
Breaking Medicine Technology: