Submissions and Approvals

ARTICLES

PRODUCTS

Combination Products and Cross-Center Reviews - Webinar CD/Transcript

$187.00
Mapping out a regulatory pathway for drug/device/biologic combination products remains one of the most difficult regulatory challenges for life sciences innovators. Join David M. Fox — Partner, Hogan Lovells — for a close look at the FDA’s new authority governing combination products and several new provisions under the 21st Century Cures Act that could usher in a new era of interdisciplinary product reviews at the FDA. View

The 21st Century Cures Act & Regenerative Medicine - Webinar CD/Transcript

$287.00
The biologics license application (BLA) is perhaps the most burdensome and lengthy premarket review process that the FDA imposes. To address that, Congress created the Regenerative Advanced Therapy (RAT) designation. View

How to Integrate FDA Device Approval and Reimbursement - Webinar CD/Transcript

$287.00
Join Steve Terman — Principal Attorney, Olson Frank Weeda Terman Matz — and Gordon Schatz — President, Schatz Reimbursement Strategies — as they explain how to strategically blend reimbursement with FDA regulatory issues and identify the need for outcomes data, comparative evidence, professional society guidelines and how to meet Medicare and managed care reimbursement standards. View

New Medical Device and In Vitro Diagnostic Regulation in the EU - Webinar CD/Transcript

$187.00
Join Michael M. Gaba — Life Science Partner, Holland & Knight LLP, USA — and Shayesteh Fürst-Ladani — founder and CEO, SFL Regulatory Affairs & Scientific Communication Ltd., Switzerland — for a discussion on the biggest anticipated changes to the EU and U.S. medical device framework and their impact on global go to market strategies, including the extent to which a company can harmonize its regulatory effort for the global market. View

The Reality of Doing Business in Cuba in 2017 - Webinar CD/Transcript

$287.00
Join Jennifer Diaz — a board certified international attorney — as she discusses the realities of doing business in Cuba including whether the new Trump administration will continue with efforts to open up Cuba to U.S. business or if we will see a return to the more closed and distant relationship of the past. View

The 21st Century Cures Act’s Impact on Medical Devices - Webinar CD/Transcript

$287.00
The passage of the 21st Century Cures Act means you will be scrambling to meet new mandates… regulations and guidances in several key areas — including data development and maintenance, technical support, clinical approvals, breakthrough devices, device inspections and reviews, and humanitarian device exemptions. View

China Medical Device Regulatory Changes - Webinar CD/Transcript

$287.00
If you’re doing business in China or want to — you need to know the latest device regulatory requirements for manufacturing devices there. This session will cover developments in manufacturing regulations including new GMPs, self-inspections, foreign inspections and trends in enforcement. View

New Trump Administration, New Republican Congress - Webinar CD/Transcript

$287.00
The US has a new president, a new Congress, and almost assuredly a new agenda for the FDA — with different policies and priorities than the current administration. What does this mean for FDA regulated industries? View

Top Ten Data Integrity Traps: How to Find and Fix Problems

$177.00
The Top Ten Data Integrity Traps report shows you where most data integrity problems occur and helps you create a plan to weed them out — and keep them out. View

How Does Cybersecurity Fit in Your QMS? - Webinar CD/Transcript

$287.00
Learn the best practices for integrating medical security processes with the organization’s QMS and the ongoing role of Quality in securing connected medical devices. View

Conducting a Connected Medical Device Security Risk Assessment - Webinar CD/Transcript

$287.00
How should you conduct a risk assessment for your connected medical devices? Security risk specialists Russel Jones and Nick Sikorksi — both with Deloitte & Touche — discuss how security risk assessments need to be conducted and how to develop remediations to reduce risks to an acceptable level. View

False Claims Act Liability for Regulatory Noncompliance - Webinar CD/Transcript

$287.00
The Department of Justice’s interim final rule virtually doubles penalities for those that violate the False Claims Act. How can you avoid liability under the FCA? Join Anna Laakmann — Counsel, Greenberg Traurig — explains how regulatory noncompliance can form the basis of an FCA enforcement action by the government. View