Revitalizing the FDA's Generic Drug Program
In 2016, generics accounted for 89% of prescriptions dispensed but only 26% of total drug cost in the United States. They play a major role in our overall healthcare scene. The Food and Drug Administration (FDA), the agency responsible to protect and promote public health, has undergone some major organizational and cultural changes that have broad reach and impact on the FDA and in turn might have implication on generic drugs. It is relevant for pharmaceutical companies and related organizations to understand the potential impact of the Generic Drug User Fee Amendments (GDUFA). And, it is important to learn how female leaders are shaping these changes. Dr. Kathleen Uhl, director of the office of generic drugs, FDA will discuss transformation within her agency, and her role in leading major changes during a dynamic period in healthcare. Dr. Uhl will share anecdotes from her professional and personal journey that led her to the FDA, and discuss her insights as a female leader.
About the location
Lankenau Heart Institute and Main Line Health will be our host for the evening and will provide a tour of the heart pavilion and Brodsky Suites during the networking hour. The WHI is a dedicated program across Main Line Health, focused on educating women to be aware of heart disease and its associated risk factors and engaging them to take an active role in their heart health through the concept of "Learn. Act. Live." Join us for the networking hour to learn the truth about heart disease and the risk it poses for women. To learn more about the Women's Heart Initiative program, please check this link: www.mainlinehealth.org/whi
Agenda
5:30 - 6:30 PM Registration and networking session
6:30 - 6:45 PM Welcome and opening remarks
6:45 - 7:45 PM Presentation
7:45 - 8:30 PM Q&A, closing remarks and networking
Special instructions: Parking - Heart Pavilion (Garage D) - Street level entrance parking.
Self-parking is available in Garages A, B and D. There is also a handicapped accessible parking lot next to the Heart Pavilion. For your convenience, valet parking is available at the main entrance of the hospital and at the street-level entrance to the Heart Pavilion, Monday – Friday from 6:00 AM – 9:00 PM.
Parking rates (self-parking and valet):
• 0 – 30 minutes free
• 30 – 60 minutes $3
• 1 – 2 hours $4
• 2 – 3 hours $5
• 3 – 24 hours $7
Registration information
Event is open to: HBA members and nonmembers
Online registration deadline: October 27, 2017
Onsite (walk-in) registration: Is allowed
Cancellations/refunds
Is this event refundable? Yes
If yes, requests must be submitted in writing to events@hbanet.org by October 27, 2017; no refunds are available after this date.
Learning Objectives
1. Identify the revitalization journey at the FDA
2. Grasp significance of the generic market, generics account for 89% of prescriptions dispensed but only 26% of total drug cost in the United States
3. Know the potential impact of the Generic Drug User Fee Amendments (GDUFA) for drug companies
Featured Speakers
Kathleen
Uhl
Director, office of generic drugs in the center for drug evaluation and research,
U.S. Dept of Health & Human Services, Food & Drug Adminstration
Pricing
| 1 - Regular registration | $40.00 / €34.00 | $60.00 / €51.00 |
| 2 - West Pharmaceuticals employee registration | $40.00 / €34.00 | $40.00 / €34.00 |
| 3 - Women in Transition registration | $25.00 / €21.00 | |
Members receive up to 50 percent discount
Event Policies
Photography Policy
By registering for this event, you acknowledge that you may be photographed, videotaped, and/or audio-taped during the meeting and hereby give permission for your image, voice, or survey comments to be used in education, training, promotion, and/or trade and communications media by the Healthcare Businesswomen's Association in any and all media throughout the world, without restriction as to frequency or duration of usage.
COVID-19 Policy
The HBA requires that all persons who participate in in-person events do so at their own risk and that each participant agrees to the following agreement before taking part in the activity and urges all participants to act in such a manner as to protect their own safety and the safety of others.
By registering for this event, I fully understand that my participation in the program is purely voluntary. I desire to participate and agree to act reasonably and prudently under the circumstances. I further understand that any HBA volunteers participating in the activity will act individually and will not represent the HBA. As a condition to my participation the activity, I waive and release the HBA and their officers, employees, and agents from any claim that I may have for any damage to property or injury to my person that may result in whole or in part from my participation.
Special Needs Policy
The HBA will make reasonable modifications to policies and programs to ensure that people with special needs can enjoy all of its programs. Contact us if you require special accommodations for this event.