Simplifying Global Compliance
Impact: FDA User Fees, Drug Competition and Pricing - Webinar CD/Transcript
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Impact: FDA User Fees, Drug Competition and Pricing — An Inside View
User fees affect drug competition at every level. And user fees are a hot topic during the current budget cycle.
Even as you read this, top-level meetings are under way at the FDA, the White House and in Congress. Policy is being hammered out amid great uncertainty under a new FDA administrator, Scott Gottlieb and a new White House that boasts no special background in drug policy or regulation.
If you plan to remain competitive, it’s time to get up to speed.
Washington insiders Alex Brill and Nancy Bradish Myers Esq. share insights, make forecasts, and help you deal with a fast-changing regulatory and policy landscape. You’ll gain an 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 Washington landscape is changing fast. Stay competitive! Discover what you need to know now.
- 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
Meet Your 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.