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INDUSTRY RESOURCES

inventory
07
Nov
Best Practices For Managing Clinical Supply Inventory

It is critical to maintain patients on drug supplies during clinical trials, both for the success of the study and for the health of the patient. In this second part of this series on ensuring adequate drug supply, we will look at some specific strategies for successfully managing the clinical supply inventory.

Posted in:Clinical,
Tags:direct to patient,drug supply,DTP,IRT,logistics,
Registries
03
Nov
How To Conduct More Efficient Clinical Trials Using Registries

Integrating clinical trials within registries offers several opportunities: avoiding duplicative data collection, identifying and recruiting patients more efficiently, and accelerating decision making, to name a few. These efficiencies have the potential to reduce clinical trial costs — especially when a registry is used to conduct multiple clinical trials.

Posted in:Clinical,
Tags:clinical registry,data,registries,
Pill Production
01
Nov
A Semi-Continuous Operations Model For Solid-Dose Manufacturing

The estimated timeline for a drug product from discovery to market is 10 to 15 years. However, less than 12 percent of drug candidates that enter clinical trials will ultimately receive FDA approval. The Orphan Drugs Act of 1983 ensured that there were adequate incentives offered to drug developers working on therapies to treat fewer than 200,000 patients in U.S.

Posted in:FDA,Manufacturing,
cleanroom microbiology
25
Oct
Best Practices For Keeping Human Error Out Of The Cleanroom

Contamination control activities aim to permanently ensure a sufficient level of cleanliness in controlled environments. This is accomplished by maintaining, reducing, or eradicating viable and non-viable contamination for sanitary purposes or to maintain an efficient rate of production.

Posted in:Manufacturing,Training,
Tags:aseptic,contamination,controlled environment,
amazon
24
Oct
How Amazon Could Disrupt The CRO Model

Based on Amazon’s approach to building its business, it is logical to conclude that the online retailer would be an amazing CRO. Amazon’s competitive strategy is to aggressively discount prices to win market share. Plus, its customer obsession and disruptive innovation are second to none. Let’s imagine what an Amazon-run CRO would look like.

Posted in:Clinical,
Tags:CRO,risk-based monitoring,
Pharma Packaging and Labeling
18
Oct
How To Successfully Manage Packaging And Labeling During Pharma Product Launches

If you are charged with any of the tasks that lead to a successful product launch in the pharmaceutical industry, you know how critical it is to execute a multitude of steps successfully. Among these are agreement by marketing on the look and design of the campaign, completion of clinical trials, project management, testing of active pharmaceutical ingredients, the completion of a trial production batch, receipt of all materials at the production site, production scheduling, regulatory agency submissions, trademark registration, and a host of others.

Posted in:FDA,Manufacturing,
Tags:GMP,labeling,packaging,quality assurance,

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