FDAnews Announces — Impact: FDA User Fees, Drug Competition and Pricing — An Inside View Webinar, June 13, 2017

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User fees affect drug competition at every level and user fees are set to rise. If drugmakers plan to remain competitive, it’s time to get up to speed.

Impact: FDA User Fees, Drug Competition and Pricing
An Inside View
**An FDAnews Webinar**
June 13, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/impact

User fees affect drug pricing and competition at every level. And make no mistake user fees are set to rise.

Flags are flying from the FDA, where a new chief, Dr. Scott Gottlieb, is soon taking charge, to the White House, where many major decisions remain on hold, to Congress where as usual anything can happen.

How much will user fees rise? How will drug policies be affected? And what will it all mean to business?

Drugmakers need clarity. Not when it’s too late to protect their interests ... but now.

Mark the calendar for Tuesday, June 13, when two well-placed insiders share insights, make forecasts, and help drugmakers deal with a fast-changing Washington landscape. Attendees will gain understanding of:

  •     How the FDA affects drug competition at every level: brand-to-brand, brand-to-generic, generic-to-generic, biologic-to-biosimilar
  •     Expedited approvals and economic incentives: how the FDA promotes drug competition
  •     Five ways Congress and the FDA can boost competition and the likelihood of each
  •     What to expect from the Gottlieb FDA
  •     And much more!

The guides are Alex Brill, policy director and chief economist to the House Committee on Ways and Means Committee during the Bush II years and former FDAer Nancy Bradish Myers Esq., a Washington lawyer with deep expertise in health care law, regulation, policy development, government relations and strategic positioning.

The Washington landscape is shifting. Discover what drugmakers need to know to stay competitive.

Meet the Presenters:
Alex Brill, CEO, Matrix Global Advisors. Prior to entering the private sector, Mr. Brill served as policy director and chief economist to the House Committee on Ways and Means Committee during the Bush II years, helping develop policy on taxes, health, pension, and trade. Previously he served at the White House Council of Economic Advisers. He is a Research Fellow at the American Enterprise Institute.

Nancy Bradish Myers, President, Catalyst Healthcare Consulting Inc., is a Washington-based attorney with deep expertise in health care law, regulation, policy development, government relations and strategic positioning. She previously held senior roles at the FDA, on Capitol Hill, at several trade associations and with investors.

Who Will Benefit:

  •     Auditors
  •     Clinical project specialists
  •     Clinical research associates
  •     Compliance officers
  •     Consultants/service providers
  •     Data management and statistics personnel
  •     Engineering and design controls teams
  •     Executive management
  •     General/corporate counsel
  •     Investigators
  •     Managers
  •     Manufacturing directors and supervisors
  •     Personnel new to the industry
  •     Pharmaceutical and cGMP auditors
  •     QA/QC personnel
  •     R&D staff
  •     Regulatory/legislative affairs professionals
  •     Risk management specialists
  •     Sales/marketing personnel
  •     Strategic planning and business development staff
  •     Study monitors
  •     Study research coordinators
  •     Study sponsors
  •     Training personnel
  •     Validation specialists, scientists, engineers

Webinar Details:
Impact: FDA User Fees, Drug Competition and Pricing
An Inside View
**An FDAnews Webinar**
June 13, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/impact

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/impact                                                                                        
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.

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Michelle Butler
FDANEWS
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