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 intermediate overview of the scientific concepts about biological products and the scientific and regulatory basis for the biosimilar pathway. The webinar will build on past biosimilar webinars and further explores the science of biological molecules, including size, complexity, and structure. In addition, we will review practical information regarding the use of these products, such as labeling, terminology, and pharmacy substitution. To enhance understanding, we will review a case study to highlight the data that can support biosimilarity. This webinar will also demonstrate the functionality of the enhanced Purple Book resource that is available to health care professionals. References: 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. Learning Objectives: After completion of this activity, the participant will be able to: -
Describe how biologics differ from small molecules (size, complexity, manufacturing) and explain why some biologics cannot be copied exactly. -
Compare and contrast the development, statutory requirements, and approval process for new biologics and for biosimilars/interchangeables. -
Compare and contrast the requirements for generics and biosimilar/interchangeables and discuss the availability of insulin products. - Review a case study of an approved biosimilar product.
- Describe and explain the new resources available for health care providers to learn more about biosimilar and interchangeable products through the enhanced Purple Book and other FDA educational resources.
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: Biosimilar and Interchangeable Biological Products: An Updated Review of Scientific Concepts and Practical Resources, presented by Nina Brahme, PhD, MPH, Scientific Reviewer at CDER's Office of Therapeutics Biologics and Biosimilars (OTBB), Leila Hann, Science Policy Analyst at OTBB, and Sarah Ikenberry, MA, Senior Communication Advisor at OTBB. 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 JA0002895-0000-21-002-L03-P**, and ACPE Universal Activity Number JA0002895-0000-21-002-L03-T** for 1.00 contact hour(s). **ACPE category "03" for "Law (related to pharmacy practice)" CNE
FDA 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 survey via the CE Portal (ceportal.fda.gov). Final activity evaluations must be completed within two weeks after the activity - no exceptions. Attention Pharmacists and Pharmacy Technicians: 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, 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: -
Brahme, Nina, PhD, MPH, Clinical Analyst, FDA/ CDER/OND/OTBB/SRS - May reference off-label use. -
Hann, Leila, Science Policy Analyst, FDA/ CDER/OND/OTBB/PS - nothing to disclose -
Ikenberry, Sarah, MA, Health Communication Specialist, FDA/CDER/OND/OTBB - nothing to disclose 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 -
Kapoor, Rama, MD, Medical Officer, FDA - nothing to disclose -
Navin, Lesley, RN, MSN, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose -
Nguyen-Chu, Thanh Tam, PharmD, BCPS, Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose CE Consultation and Accreditation Team: -
Thompson, Lisa, MSHA, MBA, CE Consultant, 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. |
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