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: An Overview of Pharmacovigilance in the Center for Drug Evaluation and Research (CDER) 

Will be held on:

 March 26.2019

Time:  1:00 pm to 2:00 pm (EST)

To register for the online meeting, please visit:

https://collaboration.fda.gov/ddi032619/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, certified public health professionals, 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 give an overview of how the FDA conducts pharmacovigilance activities, detects safety signals, and communicates safety findings.

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:

• World Health Organization. The Importance of Pharmacovigilance: Safety Monitoring of medicinal products. (2002). 
• Textbook of Pharmacoepidemiology 5th edition. Edited by Brian Storm. 
• Federal Register - Code of Federal Regulations. 21 CFR 314.80 (a); U.S. Food and Drug Administration. FDA Adverse Event Reporting System (FAERS) Public Dashboard. 
• U.S. Food and Drug Administration. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. 
• U.S. Food and Drug Administration. MedWatch Consumer Voluntary Reporting (FORM FDA 3500B).
• U.S. Food and Drug Administration. Biosimilar Product Information.

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

1. Define pharmacovigilance.
2. Describe the Division of Pharmacovigilance’s (DPV’s) key safety roles in FDA’s Center for Drug Evaluation and Research (CDER).
3. Explain components of postmarketing drug safety surveillance.
4. Describe the role of MedWatch for reporting postmarketing safety information.
5. Discuss how adverse event reports are collected and analyzed by FDA/CDER/DPV.

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: An Overview of Pharmacovigilance in the Center for Drug Evaluation and Research (CDER), presented by Kim Swank, PharmD, Safety Evaluator in the Office of Surveillance and Epidemiology’s Division of Pharmacovigilance II. 

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 JA0002895-0000-19-020-L04-P, and ACPE Universal Activity Number JA0002895-0000-19-020-L04-T for 1.00 contact hour(s).

CNEFDA Center for Drug Evaluation and Research designates this activity for 1 contact hour.

AAPA:

This activity is designated for 1.00 AAPA Category 1 CME credits. FDA Center for Drug Evaluation and Research has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. PAs should only claim credit commensurate with the extent of their participation.

CPH:

Up to 1.00 CPH Recertification Credits may be earned at this event.

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: 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, attest to your attendance, and complete the required evaluation survey, to claim credit. Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 10 weeks after the activity to obtain their CE credit.

Disclosure:
Faculty:

• Swank, Kim, PharmD, Pharmacist, FDA - may reference off-label use

Planning Committee:

• Burke, Kara, PharmD, Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
• Cao, Christian, MPAS, PA-C, Safety Evaluator Team Leader, FDA/CDER/OSE/DPV - 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, Consumer Safety Officer, 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:

• 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 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.