Biomanufacturing introduces the intricacies and difficulties involved in manufacturing biologics. Biologics are produced in living cells, unlike small molecule drugs that are synthesized in glassware. To understand the biopharma industry, you need know how biologic medicines are produced. Biomanufacturing is for everyone in the biopharma industry, especially for those new to drug production, drug development or product launch.
OSHA Bloodborne Pathogens Regulations details current OSHA Bloodborne Pathogen Regulations, how to determine if your organization is subject to its laws, and how to properly integrate them into existing medical surveillance, health, and safety programs.
What are considered good publication practices for communicating company-sponsored medical research and how do these practices impact publication development and planning? Learn more in this pub planning module.
What are considered good publication practices for communicating company-sponsored medical research and how do these practices impact publication development and planning? Learn more in this pub planning module.
Experienced dealmakers will prove a deep dive on early capitalization from investors (not grants).
Learn the science of immunotherapy, cell and gene therapy, RNA-based drugs, and more.
Learn the foundational science and the regulatory approval process for gene therapies.
Learn how to develop and gain regulatory approval for medical devices.
What’s the difference between primary, secondary, and tertiary references and which are acceptable for use and why? Learn more in this referencing module.
Under what conditions can companies find a safe harbor for communicating investigational data? How and why is scientific exchange codified in the Code of Federal Regulations (CFR). Learn the FDA regs and more.
Statistical Features of Diagnostics surveys the measurements used to assess a diagnostic’s accuracy.
Understand the biopharma industry by focusing on cells, DNA, and proteins and how these are manipulated by researchers to develop new health care products.
The Regulatory Process provides a summary of the regulatory bodies involved in approving both small molecule drugs and biologics.
Who are the FDA, OIG, PhRMA, AMA, and ACCME? Why do these organizations expect you to comply with their rules, codes, and...
What are the basic rules governing prescription product communications? Can you make a claim about an additional use of a drug that has not been approved by the government? Learn the FDA regs and more.
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