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.
Can you use a competitor’s data in your promotion; or open-label data in your print ad? Learn the FDA regs and more.
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...
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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