Explore diagnostic development: regulatory roles, approval pathways, quality systems. Understand reimbursement.
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.
A good regulatory strategy is essential to a good business strategy.
Gain a comprehensive understanding of DNA, proteins, and cells, explaining how they are manipulated to create innovative therapies and diagnostic tools.
Dive into FDA-required preclinical testing for IND approval. Learn dose estimation from dose-response curves using real-world examples.
Gain a systematic approach to producing a valuation that can be used in investment rounds, mergers/acquisitions, licensing deals or strategic development decisions in the pharma-biotech world...
Learn about antibodies and their role in diagnostics: sandwich immunoassays, chromatography, and more. Interpret diverse protein-based diagnostic results for improved patient care.
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’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.
Learn small molecule drug discovery basics: target screening, validation, lead optimization & transitioning to development
Dive deeper into small molecule drug discovery: screening, lead optimization, drug design, and data evaluation for development progression.
Gain a comprehensive understanding of DNA, proteins, and cells, explaining how they are manipulated to create innovative therapies and diagnostic tools.
Who are the FDA, OIG, PhRMA, AMA, and ACCME? Why do these organizations expect you to comply with their rules, codes, and...
A good regulatory strategy is essential to a good business strategy.
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.