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The Board Certified Biologics and Biosimilars Specialist Program (BCBBS) Recertification
Recertification - Modules
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Accredited by IACET/ANSI
The Board Certified Biologics and Biosimilars Specialist Program (BCBBS) is a self-paced, online, board certification program that strives to set the standard of excellence in the field of biologics and biosimilars. The BCBBS program has made it its mission to establish expertise among professionals involved in the optimization of biological therapy. The BCBBS enhances your understanding of the regulatory and analytical landscape of biologics and biosimilars allowing you to power your career in a rapidly expanding field.
$499.99
Complete 4 / 6 Modules
6 Months Access
100% Online & Self Paced
24/7 Live Chat
Learning Objectives
Clinical Considerations
Clinical Considerations when using biologics & biosimilars
Pharmacoeconomics
The pharmacoeconomics of biologics & biosimilars, including the payer & provider environment
Decision Drivers
Decision drivers that influence the uptake of biologics & biosimilars in the healthcare marketplace
Policies and Legislation
Policies and legislation influencing the biologics & biosimilars field
Challenges & Market Opportunities
Challenges & Market Opportunities that Drive Value & Access. Use of real-world evidence to inform the future of the marketplace and enhance pharmacovigilance
Regulatory and Compliance
Regulatory and compliance requirements (FDA, IFPMA, EMA, CFDA etc,). Medicare, 340B Program, Inflation Reduction Act, Biosimilar User Free Act, etc.
Expansion of Biosimilars
Expansion of biosimilars into the pharmacy benefit reimbursement space and their role in specific therapeutic areas (autoimmune, gastroenterology, oncology, endocrinology)
Master These Skills
Biologic Medicines
Regulatory
Compliance
Biosimilars
Clinical Guidelines
RWE
FDA Resources
International Biosimilars
Pharmacoeconomics
Policies & Legislation
All ACMA certifications are accredited by IACET/ANSI
25k+
Users
80+
Countries
250+
Companies
Module Breakdown
Module 1
Biologic Medicines: A History and Their Importance
All specialists in this field should have a good grasp of biologics and biosimilars' history. Dive into the drug development process, the scientific nature of biologics, the manufacturing process, and the treatments that fit the biologic's definition.
Module 2
Regulatory and Scientific Concepts for Biologics
There's a right way to do things, and it's through the approval process. Become a master of approval pathways, learn the management of manufacturing changes with biologics, understand interchangeability and extrapolation, and finally, biosimilars labeling.
Module 3
Biosimilars in the U.S. Today
Learn the relationship patients and providers have with biosimilars in the United States. Understand the current landscape of biosimilars, the adoption rates and product prevalence, and provider perspectives between therapeutic areas.
Module 4
Economic Considerations With Biosimilars
Payer options vary depending on many factors. Learn about biosimilar reimbursement methodologies, particularly in Medicare Part B vs. Medicare Part D, and pass-through status eligibility and meaning for acute reimbursement.
Module 5
Clinical Guidelines and Real World Evidence
Learn about integration into national treatment guidelines, such as NCCN, ASCO, ASR, and more.
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