Explore life sciences/healthcare innovation from the vantage point of the world’s most successful startup ecosystem – Silicon Valley.
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.
Can you use a competitor’s data in your promotion; or open-label data in your print ad? Learn the FDA regs and more.
A first-time CEO's playbook to empower you to navigate the commercialization journey effectively.
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.
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.
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.
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.
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.