Navigation Links
FDAnews Announces — and the New Final Rule (42 CFR Part 11): What Strategic Decisions Do You Need to Consider? Webinar, Aug. 2, 2017
Date:7/18/2017 and the New Final Rule (42 CFR Part 11)
What Strategic Decisions Do You Need to Consider?
**An FDAnews Webinar**
Aug. 2, 2017 — 1:30 p.m. – 3:00 p.m. ET    

42 CFR Part 11, “Final Rule for Clinical Trials Registration and Results Information,” is a head-scratcher. After reading and re-reading its 177 pages, can manufacturers honestly say:

  •     They are certain they’re submitting everything it calls for?
  •     They are in compliance with all required timelines?
  •     They understand what changes under the final reg, and what remains the same?

What to do?

Announcing an all-new FDAnews webinar featuring a star of the FDA regulatory bar, Scott Cunningham Esq., deconstructing the new final regulation into everyday language.

In a mere 90 minutes, Mr. Cunningham will zero in on the trickiest aspects of the final rule:

  •     The four elements of an “applicable drug clinical trial,” and how the FDA will interpret what these words really mean
  •     Who must submit clinical trial results to
  •     Clinical trial data submissions deadlines
  •     The enforcement landscape: What the FDA can do to police non-compliance, and when enforcement might start
  •     Deciphering the “voluntary submissions” provisions
  •     Navigating provisions on “delayed submission” of results to
  •     FDA proposals for release of de-identified data — current status
  •     And much more!

Attendees will learn best practices in managing clinical trial disclosure requirements in the U.S. and hear some of the successes and failures that have occurred during the brief history of submissions.

It’s barely several months since compliance became mandatory. There is still time enough to clean house. Discover what manufacturers need to know before the next visit from the inspectors.

Meet Your Presenter:
Scott Cunningham Esq. is a partner in Covington & Burling’s San Francisco-based Food and Drug Practice Group, representing pharma, biotech, regenerative medicine, and medical device firms. His expertise covers the gamut of FDA regulatory issues, including new product development/approval, clinical trials, IRBs, Hatch-Waxman exclusivities, advertising/promotion, false claims compliance, orphan drugs, pediatric exclusivity, cGMP/manufacturing, import/export, controlled substances and SEC disclosure.

Who Will Benefit:

  •     Medical Affairs
  •     Clinical Operations
  •     Regulatory Affairs
  •     Publications Directors
  •     Clinical Trial Regulatory Directors
  •     Clinical Trial Information Disclosure Directors
  •     Global Clinical Safety and Pharmacovigilance Officers

Webinar Details: and the New Final Rule (42 CFR Part 11)
What Strategic Decisions Do You Need to Consider?
**An FDAnews Webinar**
Aug. 2, 2017 — 1:30 p.m. – 3:00 p.m. ET    

$287 per site

Easy Ways to Register:
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

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
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:
(Date:9/1/2020)... SEATTLE (PRWEB) , ... September 01, 2020 , ... ... that it has completed $3 million convertible note financing, which will be used ... , With the funds from this financing, the company will continue to expand ...
(Date:8/31/2020)... (PRWEB) , ... August 31, 2020 , ... ... Health Network (AHN), are joining biomedical engineers from Carnegie Mellon University (CMU) to ... for cardiac patients who have undergone open heart surgery. , The AGH/CMU team ...
(Date:8/31/2020)... ... August 31, 2020 , ... Want to get moving, break up your ... Foundation (CPARF) is thrilled to launch its fourth annual STEPtember campaign in the United ... STEPtember meets everyone wherever they are at this moment — encouraging people to move ...
(Date:8/31/2020)... ... August 31, 2020 , ... The pandemic and topsy-turvy economic outlook continues to put financial ... look for ways to trim the fat from our monthly expenses and put more into ... also important that you have a financial safety net in place in case something were ...
(Date:8/31/2020)... ... August 31, 2020 , ... Bonde ... for patients with advanced heart failure, today announced that the company has been ... of $555,358 from the National Heart, Lung, and Blood Institute of the National ...
Breaking Medicine News(10 mins):
(Date:8/26/2020)... BOLINGBROOK, Ill. (PRWEB) , ... August 26, 2020 ... ... recent infographic: How Chiropractic Care Helps Sports Injuries. The infographic breaks down ways ... to a quicker, healthier recovery. , According to ScripHessco “Athletes have an unusual ...
(Date:8/26/2020)... ... August 26, 2020 , ... ... announced that it has entered into definitive agreement to acquire ProCE, a ... on pharmacists and pharmacy technicians. , CEA represents a growing alliance ...
(Date:8/26/2020)... ... August 26, 2020 , ... The Lymphoma Research ... lymphoma research and serving the lymphoma community through education programs, outreach initiatives and ... LRF Gala and Charity Auction on Wednesday, Sept. 30 . The “Finding ...
Breaking Medicine Technology: