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Continuing Education Credits (CE) Released: 2/18/2016; Valid for credit through: 2/17/2019
For users wishing to have confirmation that they have completed this course, they may choose to receive a Certificate of Completion which comes with no CE credits.
The target audience for this course is healthcare professionals, including physicians, physician assistants, nurses, nurse practitioners, and pharmacists. The course can be taken for informational purposes or for Continuing Education (CE) credit.
Biosimilar products are a new type of biological product. In 2010, legislation gave the Food and Drug Administration (FDA) authority to approve and regulate biosimilar products for marketing in the United States. This course shares information about this important new approval pathway for biosimilar products to help participants make thoughtful and critical decisions when considering prescribing or dispensing biosimilar products. The course provides an overview of FDA’s general review process in considering biosimilar product development programs.
Upon completion of this activity, participants should be able to:
No commercial support was received for this activity.
The following table of disclosure information is provided to learners and contains the relevant financial relationships that each individual in a position to control the content of CE disclosed to IAHB, Amedco and FDA. All of these relationships were treated as a conflict of interest, and have been resolved. (C7 SCS 6.1--6.2, 6.5) All individuals in a position to control the content of CE are listed below and had no relevant financial relationship to disclose.
|Daniel Brounstein||Planner, Speaker||NA|
|Daniel Orr||Legal/Policy Advisor||NA|
|Emanuela Lacana||Planner, Reviewer||NA|
|Karen Canova||Planner, Reviewer||NA|
|Leah Christl||Reviewer, Speaker||NA|
|Sandra Benton||Planner, Reviewer||NA|
|Sue Lim||Planner, Reviewer, Speaker||NA|
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of QuroumEDU and the US Food and Drug Administration (FDA). QuroumEDU is accredited by the ACCME to provide continuing medical education for physicians.
QuroumEDU designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
QuroumEDU is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. This course is co-provided by QuroumEDU and FDA. Maximum of 1.5 contact hours.
Amedco is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Successful completion of this program qualifies for up to 1.5 contact hours. Full attendance is required. No partial contact hours will be awarded for partial attendance.
This program is approved for 1.5 contact hours of continuing education by the American Association of Nurse Practitioners. Program ID 15121995. This program was planned in accordance with AANP CE Standards and Policies.
AAPA accepts certificates of participation for educational activities certified for Category I credit from AOACCME, Prescribed credit from AAFP, and AMA PRA Category I Credit(s)™ from organizations accredited by ACCME or a recognized state medical society. Physician assistants may receive a maximum of 1.5 hours of Category I credit from completing this program.
Each physician will listen to each audio self-directed module while following along with the visual slides. Upon completion, each physician will answer evaluation questions and pass a posttest with at least a score of 80% to receive their CE certificate.
To access the course, users will need a computer with an Internet connection, and:
An HTML5 capable browser is required for video playback. Occasionally, other additional software may be required such as PowerPoint or Adobe Acrobat Reader. Viewing on a desktop, laptop or tablet is recommended.
Users are required to visit all screens before getting access to the Conclusion module and the posttest. To receive your certificate for CE credit, you must complete the posttest and receive a score of 80 percent or better and complete an evaluation form.
For questions about content or about technical issues, you may contact FDA:
(855) 543-3784, or