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: Across the Regulatory, Research, and Clinical Care Environments: Sex and Gender Influences

Will be held on:

 April 23, 2019

Time:  1:00 pm to 2:00 pm (EDT)

To register for the online meeting, please visit:

https://collaboration.fda.gov/ddi042319/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 provide an overview of current regulatory practice regarding the consideration of sex differences, the importance of the Sex as a Biological Variable (SABV) initiative, and future opportunities to further integrate SABV through collaboration in regulatory, research, and clinical care environments. A brief overview of the regulatory history of the inclusion of women in research activities and clinical trials will be provided. 

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. Ouyang, Pamela et al. “Strategies and methods to study female-specific cardiovascular health and disease: a guide for clinical scientists” Biology of sex differences vol. 7 19. 31 Mar. 2016, doi:10.1186/s13293-016-0073-y.  
2. Institute of Medicine (US) Committee on Understanding the Biology of Sex and Gender Differences; Wizemann TM, Pardue ML, editors. Exploring the Biological Contributions to Human Health: Does Sex Matter? Washington (DC): National Academies Press (US); 2001. Available from: https://www.ncbi.nlm.nih.gov/books/NBK222288/doi: 10.17226/10028.  
3. Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs Pamela E. Scott, Ellis F. Unger, Margorie R. Jenkins, Mary Ross Southworth, Tzu-Yun McDowell, Ruth J. Geller, Merina Elahi, Robert J. Temple, Janet Woodcock. Journal of the American College of Cardiology May 2018, 71 (18) 1960-1969; DOI: 10.1016/j.jacc.2018.02.070. 

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

1. Review the role of the Office of Women’s Health internal and external to FDA
2. Recognize the integration of SABV into and its role within the regulatory environment.
3. Identify future areas for collaboration and funding opportunities to expand and disseminate SABV. 

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

Schedule:1:00 pm - 2:00 pm – FDA Drug Topics: Across the Regulatory, Research, and Clinical Care Environments: Sex and Gender Influences presented by Erin South, PharmD, in FDA’s Office of Women’s Health (OWH), and Marjorie Jenkins, MD, MEdHP, FACP, Director of Medical Initiatives and Scientific Engagement in FDA’s Office of Women’s Health (OWH).

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 1.00 contact hour(s).

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, 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:

• Jenkins, Marjorie, MD, MEdHP, Director of Medical Initiatives, FDA/OWH - nothing to disclose.
• South, Erin, PharmD, Pharmacist, FDA/OWH - My spouse and I received Salary from CVS Health for a role as Employee. My spouse received Stocks from CVS Health for a role as Employee. 

Planning Committee:

• Burke, Kara, PharmD, Team Leader/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.