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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research
Activity Outline
CDER Small Business and Industry Assistance (SBIA) Webinar: Financial Incentives for CDER Medical Products
June 10, 2019
Live Webinar

Activity Coordinator:
Lisa Misevicz (Lisa.Misevicz@fda.hhs.gov)
Description

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.

References
  • FDA Webpage: Economic Assistance and Incentives for Drug Development https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/economic-assistance-and-incentives-drug-development
Learning Objectives
  • Demonstrate how to apply the FDA economic assistance and incentives for drug development for different types of drug applications.
Target Audience
This activity is intended for physicians, pharmacists, and nurses.
Agenda
Day 1 June 10, 2019
Time Topic Speaker
10:00 - 10:05 AM EDT SBIA Webinar Overview Forest Ford, PharmD, R. Ph
10:05 - 11:05 AM EDT PDUFA Financial Incentives Jeen Min, R. Ph
11:05 - 11:25 AM EDT BsUFA/GDUFA Financial Incentives Beena Alex, MPH, MBA
11:25 - 11:35 AM EDT Break
11:35 - 11:55 AM EDT Panel Discussion Jeen Min, R. Ph
Beena Alex, MPH, MBA
11:55 - 12:25 PM EDT Lunch
12:25 - 1:10 PM EDT Orphan Drug Financial Incentives Roberta Szydlo, RPh, MBA
1:10 - 1:55 PM EDT Exclusivity Financial Incentives Rinku Patel, PharmD
1:55 - 2:25 PM EDT PRV Financial Incentives PETER CHEN, R. Ph
2:25 - 2:35 PM EDT Break
2:35 - 2:55 PM EDT Panel Discussion Roberta Szydlo, RPh, MBA
Rinku Patel, PharmD
PETER CHEN, R. Ph
2:55 - 3:00 PM EDT SBIA Closing Forest Ford, PharmD, R. Ph
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 4 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 4.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-19-051-L04-P for 4.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 4.00 contact hour(s).
Requirements for Receiving CE Credit

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.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving 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 8 weeks after the last session of the activity to obtain their CE credit.
Disclosure

Faculty
  • Alex, Beena, MPH, MBA, Lead Management Analyst, Food and Drug Administration - nothing to disclose
  • CHEN, PETER, R. Ph, Pharmacist, FDA - nothing to disclose
  • Ford, Forest, PharmD, R. Ph, CSO, FDA - nothing to disclose
  • Min, Jeen, R. Ph, Branch Chief, FDA - nothing to disclose
  • Patel, Rinku, PharmD, Pharmacist, CDER - nothing to disclose
  • Szydlo, Roberta, RPh, MBA, Program Management Officer, Food and Drug Administration - nothing to disclose

Planning Committee
  • Kleppinger, Cynthia, MD, Medical Officer, FDA - nothing to disclose
  • Stodart, Brenda, PharmD, MS, BCGP, RAC, 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 Information
Registration is complimentary; therefore refunds are not applicable.
Requirements for Certificate of Completion (Non CE)
Must attend 90% of the activity.