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LIFE SCIENCE TRAINING INSTITUTE

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INDUSTRY RESOURCES

07
Sep
Can New York City Lead In Life Sciences?

New York City has long aspired to become a life sciences hub, but while the city seems to have all the elements necessary to foster such industry growth, it has continually fallen short of this goal. New York currently ranks a distant third behind both Greater Boston and the San Francisco Bay Area, and there’s some work to do if it hopes to catch up.

Posted in: Clinical, Device, Manufacturing, R&D,
relationships
05
Sep
5 Rules For Managing Relationships With Your CROs And Other Vendors In Clinical Trials

Clinical research is becoming more and more complex due to many factors, including increased regulations, competition for patients, and cost of conducting clinical trials. Most of the smaller pharmaceutical and biotech companies (sponsors) do not have the workforce to provide proper oversight of a clinical trial. This forces companies to outsource much, if not all, of the trial oversight to contract research organizations (CROs) and service providers (vendors).

Posted in: Clinical,
Tags: Clinical Trials, FPI, master services agreements, SOW, vendor,
biocontainment
04
Sep
Biocontainment: An Introduction To Control Levels & Practical Design Concepts

Our discussion continues with the physical application of GMP design practices as influenced by the CDC and NIH regulations. The first part of our design discussion covers various processes and their applicable BSL levels, to understand the risk levels and what types of processes must be contained.

Posted in: FDA, Manufacturing,
Tags: biosafety, containment, GMP,
Serialization
01
Sep
State Of Serialization: Where FDA & The Pharma Industry Currently Stand

Serialization in the pharmaceutical sector is a direct response to the problems of counterfeit, stolen, and gray-market drugs. There’s been a huge incentive for counterfeiters to duplicate high-profit-margin products. According to the 2016 Brand Protection and Product Traceability Market Research Report from PMMI, the black market for counterfeit drugs is about $75 billion annually.

Posted in: FDA, Manufacturing,
Tags: distribution, DSCSA, identification, supply chain,
brexit
25
Aug
Brexit & The Biopharma Industry: 3 Important Developments To Watch

There have been considerable updates in the Brexit situation since April 2017, including, the surprising result of the U.K. general election. If anything, news regarding Brexit and the biopharma industry has started to heat up in recent months, and there have been a number of relevant developments that manufacturers must keep their eye on.

Posted in: Manufacturing,
Tags: authorization, biopharmaceutical, pharmaceutical, regulatory,
Amazon
25
Aug
Could Amazon Revolutionize The Patient Experience In Clinical Trials?

Wall Street is wondering what’s next on Amazon’s shopping list, and pharmaceuticals may be a leading contender. Here are four patient touch points where Amazon can leverage its existing capabilities in conducting clinical trials and pharmaceutical development.

Posted in: Clinical,
Tags: Clinical Trials, EHRs, pharmaceutical development,

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