Unwrapping FDA’s UFA Package: What’s Inside the Statute – What’s Next? - Session 1: PDUFA, GDUFA, and BsUFA Highlights

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Overview

Conference Overview
Presented by DIA and the Food and Drug Law Institute, this conference will provide a first look at the Food and Drug Administration Safety and Innovation Act (FDASIA). Signed into law by the President in July, this legislation includes PDUFA V, MDUFA III, GDUFA and BsUFA.

The content of these UFA packages will shape the timeliness of reviews of life-saving medicines and medical devices, the requirements of all phases of medical product development, and the industry’s ability to innovate and develop needed medical products. FDA will discuss the goals and commitments for their Centers, the changes of emphasis, and the potential impact on future programs. Reactor panels will provide the exchange of views on what the UFA provisions will mean for innovation, how they will improve patient access to needed medical products over the next five years, and next steps in preparing for 2017.

Session 1: PDUFA, GDUFA, and BsUFA Highlights
Key FDA officials will open this session with presentations on the drug, generic drug and biosmilars user fee packages enacted in FDASIA. Representatives from industry and the public interest community will respond and discuss, providing insight into the programs. The moderator and panelists will engage attendees in an interactive question-and-answer session.

This Archived Recording will be available for purchase until September 19, 2013.

This Archived Recording was recorded live during the PDUFA V Conference. Subsequently there may be short periods of time where the sound level may vary for any given presentation. During these short intervals, you may want to turn up the speaker volume on your computer.

Multiple speakers participated in each session. Some presenters did not provide slides, so only the audio presentation is available.

Who Should Attend

Professionals who work in pharmaceutical, biologics, devices, and diagnostics industries and are involved in:

Regulatory Affairs
Legal Affairs
Legislative and Government Affairs
Public Policy
Public Affairs
Patient Advocacy
Research and Development
Strategic Planning

Learning Objectives

At the conclusion of this conference, participants should be able to:

Review the specific provisions of the enacted PDUFA V, MDUFA III, GDUFA, and BsUFA
Describe how the provisions are expected to affect the goals, emphasis, and programs of the affected FDA centers
Discuss how the newly enacted UFAs will affect the industries’ability to develop new medical products
Discuss measures to evaluate the impact of the UFAs and to provide data for needed changes in the 2017 reauthorization of these acts

Special Offers

Buy More Save More!
15% off two or more sessions purchased
$249 entire package
$499 for both UFA and PDUFA V Conference recordings

Contact Information

For information contact:
Melissa Matta, Content Lead
Phone +1.215.442.6158
Fax +1 215.442.6199
Melissa.Matta@diahome.org

Technical Requirements

Please click here for system requirements.

Presenter(s)

Previous Next

Presenter(s) 1-3 of 7

Theresa M. Mullin, PhD

Associate Director, Office of Planning and Informatics, CDER
FDA, United States

Peter Beckerman, JD

Senior Scientific Policy Advisor
Office of the Commissioner, FDA, United States

Manju S. Thomas

Operations Research Analyst; Office of Planning and Analysis, CDER
FDA, United States

Presenter(s) 4-6 of 7

Rob Kowalski, PharmD

Global Head of Drug Regulatory Affairs & US Head of Development
Novartis Pharmaceuticals Corporation, United States

Marcie McClintic Coates, JD,MBA

Vice President adn Chief of Staff, Office of the CEO
Mylan, United States

Marc M. Boutin, JD

Executive Vice President and Chief Operating Officer
National Health Council, United States

Presenter(s) 7-7 of 7

Nancy Bradish Myers, JD

President
Catalyst Healthcare Consulting, Inc, United States

Agenda

Day 1 Friday, November 30, 2012

7:00AM - 11:59PM
Unwrapping FDA’s UFA Package: What’s Inside the Statute – What’s Next? - Session 1: PDUFA, GDUFA, and BsUFA Highlights
Speaker(s):
- PDUFA
  Theresa M. Mullin, PhD
  Associate Director, Office of Planning and Informatics, CDER
  FDA, United States
- GDUFA
  Peter Beckerman, JD
  Senior Scientific Policy Advisor
  Office of the Commissioner, FDA, United States
- BsUFA
  Manju S. Thomas
  Operations Research Analyst; Office of Planning and Analysis, CDER
  FDA, United States
- Reactor Panel
  Rob Kowalski, PharmD
  Global Head of Drug Regulatory Affairs & US Head of Development
  Novartis Pharmaceuticals Corporation, United States
- Reactor Panel
  Marcie McClintic Coates, JD,MBA
  Vice President adn Chief of Staff, Office of the CEO
  Mylan, United States
- Reactor Panel
  Marc M. Boutin, JD
  Executive Vice President and Chief Operating Officer
  National Health Council, United States
- Moderator
  Nancy Bradish Myers, JD
  President
  Catalyst Healthcare Consulting, Inc, United States

Registration Fees

Other Fees

Standard: $99.00

Group Discounts

A Series Discount is Available
A 15% discount is available if two or more archived recordings are purchased in one transaction for multiple recordings in this series, or the PDUFA V Conference archived recording series.

Buy More Save More!

Purchase an individual session for $99 and receive the Keynote and Closing sessions for free!
Purchase the entire archived meeting for $249!
Purchase both archived meetings (UFA and PDUFA) for only $499!

Cancellations: No refunds will be provided in the event of a participant’s cancellation since all costs for this archived recording have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.

Participants with Disabilities
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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