Live CE Webinar sponsored by the Division of Drug Information - Drug Information Update

FDA’s Division of Drug Information is presenting a series of continuing education webinars targeting the needs of all health care professionals.

FDA Drug Topics: Building Confidence in Generic Narrow Therapeutic Index (NTI) Drugs

Will be held on:

 September 18, 2018

Time:  1:00 pm to 2:00 pm (EDT)

To register for the online meeting, please visit:https://collaboration.fda.gov/ddi091818/event/registration.html

 

After registering, you will receive a calendar invitation with details on how to join the online meeting.

Activity Outline 

Description: This series of educational webinars is designed to aid physicians, physician assistants, nurses, pharmacists, pharmacy technicians, other health care professionals, and students, to provide better patient care by knowing how to find relevant FDA regulatory information that will improve drug safety. 

This webinar will introduce the general characteristics of Narrow Therapeutic Index or NTI drugs and discuss FDA's innovative approach and criteria for generic NTI drug equivalence evaluation. In addition, we will discuss results from a bioequivalence study comparing brand and generic tacrolimus (an NTI drug) capsules in stable transplant patients to address patients' and health practitioners' questions regarding substitutability of generic immunosuppressant drugs. 

Series Objectives:

• Explain how to utilize FDA’s drug information, medication safety resources, and regulatory guidance, to improve delivery of patient care and optimize outcomes.
• Describe and inform health care providers of recent labeling changes which would impact prescribing and medication management to optimize patient care.

References:

1. Jiang W, Makhlouf F, Schuirmann DJ, Zhang X, Zheng N, Conner D, Yu LX, Lionberger R.A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion. AAPS J. 2015 Jul;17(4):891-901. 
2. Alloway RR, Vinks AA, Fukuda T, Mizuno T, King EC, Zou Y, Jiang W, Woodle ES, Tremblay S, Klawitter J, Klawitter J, Christians U. Bioequivalence between innovator and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial. PLoS Med. 2017 Nov 14;14(11). 
3. Yu LX, Jiang W, Zhang X, Lionberger R, Makhlouf F, Schuirmann DJ, Muldowney L, Chen ML, Davit B, Conner D, Woodcock J. Novel bioequivalence approach for narrow therapeutic index drugs. Clin Pharmacol Ther. 2015 Mar;97(3):286-291. 

Learning Objectives: After completion of this activity, the participant will be able to:

1. Recognize general characteristics of NTI drugs .
2. Describe FDA’s approach and criteria to evaluate the bioequivalence of generic NTI drugs. 
3. Explain how FDA’s approved generic NTI drugs demonstrated bioequivalence in patient populations using one example.

Target Audience: This activity is intended for physicians, physician assistants, nurses, pharmacists, pharmacy technicians, other health care professionals, and students. 

Schedule:1:00 pm - 2:00 pm – FDA Drug Topics: Building Confidence in Generic Narrow Therapeutic Index (NTI) Drugs, presented by Wenlei Jiang, Senior Science Advisor, Office of Research and Standards/Office of Generic Drugs/CDER.

Continuing Education 

Accreditation:

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.

This activity was planned by and for the healthcare team, and learners will receive 1.00 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.

CMEFDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1 AMA PRA Category 1 Credit(s)^™.  Physicians and physician assistants should claim only the credit commensurate with the extent of their participation in the activity.
CPEThis knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-18-027-L04-P, and ACPE Universal Activity Number JA0002895-0000-18-027-L04-T for 1.00 contact hour(s).
CNEFDA Center for Drug Evaluation and Research designates this activity for 1 contact hour.
Requirements for receiving CE Credit:
Physicians, physician assistants, nurses, pharmacists, pharmacy technicians, 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). Final activity evaluations must be completed within two weeks after the activity - no exceptions.
Pharmacy participants: partial credit cannot be awarded, therefore you must attend the entire activity to receive CPE credit. No exceptions. Pharmacists and pharmacy technicians will need their NABP e-profile ID number as well as their DOB in MMDD format in order to claim CE credit.

Important Note regarding completion of evaluations and receiving creditAttendees 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.
Disclosure:

Faculty: 

• Jiang, Wenlei, Senior Science Advisor, Office of Research and Standards/Office of Generic Drugs/CDER - nothing to disclose

Planning Committee:

• Burke, Kara, PharmD, Team Leader/Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose 
• DeFronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose 
• Giroux, Virginia, MSN, FNP-BC, Associate Director for Accreditation, FDA/CDER/OEP/DLOD - nothing to disclose 
• Navin, Lesley, RN, MSN, CSO, FDA/CDER/OCOMM/DDI - nothing to disclose 
• Weinstein, Edward, M.D., Ph.D., Medical Officer, CDER FDA - My spouse received Salary from EndoCentre of Baltimore for a role as Employee. 

CE Consultation and Accreditation Team:

• 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 Fees and Refunds: Registration is complimentary therefore refunds are not applicable.

Please direct your comments or questions via email to DDIWebinars@fda.hhs.gov.

To learn more about future dates and registration, please visit: www.fda.gov/DDIWebinars.