CDER Small Business and Industry Assistance (SBIA) Webinar: Financial Incentives for CDER Medical Products
June 10, 2019
Attendees will be able to identify and distinguish which FDA CDER financial incentive programs apply to different stakeholders. PDUFA waivers, small business waivers, refunds, BsUFA waivers, and Orphan Drug programs will be reviewed by subject matter experts.
- FDA Webpage: Economic Assistance and Incentives for Drug Development https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/economic-assistance-and-incen tives-drug-development
- Demonstrate how to apply the FDA economic assistance and incentives for drug development for different types of drug applications.
This activity is intended for physicians, pharmacists, and nurses.
Day 1 June 10, 2019
|10:00 - 10:05 AM||SBIA Webinar Overview||Forest Ford|
|10:05 - 11:05 AM||PDUFA Financial Incentives||Jeen Min|
|11:05 - 11:25 AM||BsUFA/GDUFA Financial Incentives||Beena Alex, MPH, MBA|
|11:25 - 11:35 AM||Break|
|11:35 - 11:55 AM||Panel Discussion||
Beena Alex, MPH, MBA
|11:55 - 12:25 PM||Lunch|
|12:25 - 1:10 PM||Orphan Drug Financial Incentives||Roberta Szydlo, RPh, MBA|
|1:10 - 1:55 PM||Exclusivity Financial Incentives||Rinku Patel|
|1:55 - 2:25 PM||PRV Financial Incentives||PETER CHEN|
|2:25 - 2:35 PM||Break|
|2:35 - 2:55 PM||Panel Discussion||
Roberta Szydlo, RPh, MBA
|2:55 - 3:00 PM||SBIA Closing||Forest Ford|
Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.
Pharmacists will need their NABP e-profile ID number as well as their DOB in MMDD format in order to claim CE credit.
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 10 weeks after the last session of the activity to obtain their CE credit.
- Alex, Beena, MPH, MBA, Lead Management Analyst, Food and Drug Administration - nothing to disclose
- CHEN, PETER, Pharmacist, FDA - nothing to disclose
- Ford, Forest, CSO, FDA - nothing to disclose
- Min, Jeen, Branch Chief, FDA - nothing to disclose
- Patel, Rinku, Pharmacist, CDER - nothing to disclose
- Szydlo, Roberta, RPh, MBA, Health Science Administrator, Food and Drug Administration - nothing to disclose
- Kleppinger, Cynthia, MD, Medical Officer, FDA - nothing to disclose
- Stodart, Brenda, PharmD, BCGP, RAC-US, Program Director, FDA - nothing to disclose
CE Consultation and Accreditation Team
- Lisa Thompson, MSHA, MBA, CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
- Giroux, Virginia, MSN, FNP-BC, Associate Director for Accreditation, FDA/CDER/OEP/DLOD - nothing to disclose
- Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Registration is complimentary, therefore refunds are not applicable.
Must attend 90% of the activity.
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