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.
Explore diagnostic accuracy measurements: false negatives, false positives, variability, sensitivity, specificity. Essential for regulatory approval."
Discover the expanding molecular diagnostics field, saving lives by pinpointing disease causes and guiding personalized treatments."
Explore PCR, microarrays, gene sequencing & microRNA in diagnostics. Learn machines, workflow & result interpretation.
Explore drug approval process for small molecules & biologics: regulatory bodies, application process, preclinical to clinical studies, final approval.
Do you need to understand the drug development process, including details about a drug's life cycle from its discovery through post-marketing studies? This is the course for you.
Explore biologics discovery: target screening, validation, optimization & transition to preclinical development.
Dive into therapeutic antibody discovery: checkpoint inhibitors & candidate selection. Learn transition criteria.
A digital strategy can no longer lie within a siloed digital or innovation team. It’s critical to integrate digital across the enterprise to maintain a competitive edge.
Comprehensive review of the Do's and Don'ts for AD/Promo Tactics: covers types of drug and medical device advertising, promotional labeling (booklets, brochures, direct mail, exhibit booths, file cards, monographs, publications, sales aids, videos).
Detailed review of content do's and don'ts including comparative/superiority, charts/graphs, competitor information, “cherry-picking”, disclaimers, references, market research data, quality-of life claims, company spokespeople.
Do we correct information about our drug in a company’s sponsored chat room? What types of websites shouldn’t we link to? Learn the FDA regs and more.
Do we correct information about our drug in a company’s sponsored chat room? What types of websites shouldn’t we link to? Learn the FDA regs and more.
How do you “frame” risk information for a prescription product? What are misleading ‘signals’ in audio or visual promotion? Learn the FDA regs and more?
What are the requirements for posting on Twitter? What happens if you decide to correct misinformation on the Internet? Learn the FDA regs and more.
How should reprints with off-label information be issued once they have appeared in peer-reviewed medical journals? Learn the FDA regs and more?
What are the three basic requirements for press releases? How do you know whether a press release is fairly balanced? Learn the FDA regs and more.
What are the FDA requirements for prescription drug advertising versus promotional labeling? Can secondary endpoints be used in product promotion? Learn the FDA regs and more.
Do we correct information about our drug in a company’s sponsored chat room? What types of websites shouldn’t we link to? Learn the FDA regs and more.
What are the members of the promotional review team and why are these functional roles important for Medical, Legal and Regulatory (MLR) Review? Learn about MLR and more.
Learn about AAV viral vector platforms, Triple Transient Transfection, upstream & downstream bioprocessing, packaging, & CMC regulatory aspects.