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: FDA Regulation of Color Additives in Drug Products
Will be held on:
November 6, 2018
Time: 1:00 pm to 2:00 pm (EST)
To register for the online meeting, please visit:
https://collaboration.fda.gov/
https://collaboration.fda.gov/
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.
The U.S. Food and Drug Administration (FDA) regulates color additives under the authority of the Federal Food, Drug, and Cosmetic Act. Color additives must be pre-approved by the FDA and listed in Title 21 of the Code of Federal Regulations before they may be used in drugs and other FDA-regulated products. This webinar will give you an overview of FDA's regulation of color additives in drug products. You will learn about the color additive petition process and how a color additive is listed for use in drugs.You will also learn about the two types of color additives, certified and certification exempt, and how the certification process works.The webinar will discuss the labeling requirements for color additives in drug products and how FDA enforces these regulations.
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:
- Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices http://www.fda.gov/
ForIndustry/ColorAdditives/ ColorAdditiveInventories/ ucm115641.htm
Session Learning Objectives: After completion of this activity, the participant will be able to:
- Recognize a color additive.
- Describe color additive petition process.
- Identify certification exempt color additives.
- Identify certified color additives.
- Summarize certification process for color additives.
- Identify enforcement tools.
Target Audience: This activity is intended for physicians, physician assistants, nurses, pharmacists, pharmacy technicians, students, and other health care professionals.
Schedule:
1:00 pm - 2:00 pm – FDA Drug Topics: FDA Regulation of Color Additives in Drug Products, presented by Bhakti Petigara, PhD, Research Chemist, FDA, Center for Food Safety and Applied Nutrition.
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.
CME
FDA 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.
CPE
This 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).
CNE
FDA 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 survey 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 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.
Disclosure:
Faculty:
- Petigara, Bhakti, PhD, Research Chemist, FDA, Center for Food Safety and Applied Nutrition - nothing to disclose
- 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.
- 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
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.
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