PRESS RELEASE
Contact: Michelle Butler
Marketing Manager
FDAnews
703-538-7665 phone
mbutler@fdanews.com

Prepare to dive deep into regulatory policy details. Take the move to new “dashboards” and compliance tools. This shift in FDA direction is evolving so rapidly, many drug and device makers are having trouble keeping up.

FALLS CHURCH VA USA – Jan. 24, 2017

FDA’s New Enforcement Strategy

A Carrot, a Big Stick and Whistleblowing

**Presented by FDAnews**

March 23, 2017, Washington, DC

www.fdanews.com/fdanewenforcementstrategy 

Enforcement strategies. Inspections and recalls. Self-regulation and best practices. New whistleblowing policies. New data manufacturers are required to collect and maintain. What “quality” will mean going forward. All that, and more will be revealed Thursday, March 23, 2017, at this top-level sit-down with the men and women who oversee drugs and devices.

Attendees will hear the latest thinking from these invited speakers and/or their deputies:

  • Office of Regulatory Affairs (ORA): Melinda Plaiser, Director
  • Center for Devices & Radiological Health (CDRH): Robin Newman, Director-Compliance
  • Center for Drug Evaluation & Research (CDER): Janet Woodcock, Director

And discover:

  • New FDA enforcement initiatives that could affect your market position
  • New thinking on FDA penalties and how to avoid them
  • New approaches to reducing the likelihood of inspection visits
  • New information on the push for more structured whistleblowing  

Prepare to dive deep into regulatory policy details. Take the move to new “dashboards” and compliance tools. This shift in FDA direction is evolving so rapidly, many drug and device makers are having trouble keeping up. How are these new initiatives meshing, and what will the impact be on inspections and enforcement? Come to the briefing and find out.

  • For drugmakers, CDER has discussed a pilot dashboard program starting with generic drugs. How will this be applied to innovator products? And does the ORA endorse the approach?
  • For devicemakers, CDRH just announced a new whistleblower site. How will implementation take place? And how might it affect ORA enforcement priorities?

The event takes place in the conference rooms of McGuireWoods LLP, a top Washington law firm specializing in FDA regulatory matters. The host and moderator is Senior Counsel Brian Malkin, leader of the McGuireWoods FDA regulatory team and a co-editor of the FDA Life blog covering news and trends affecting the FDA and life science industries.

Conference Details:

FDA’s New Enforcement Strategy

A Carrot, a Big Stick and Whistleblowing

**Presented by FDAnews**

March 23, 2017, Washington, DC

www.fdanews.com/fdanewenforcementstrategy 

Tuition:

Early Bird Registration: $797 (until March 3, 2017)

Regular Registration: $979

Easy Ways to Register:

Online: www.fdanews.com/fdanewenforcementstrategy

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.