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INDUSTRY RESOURCES

14
Nov
Help! My Isolator Is Taking Too Long To Degas — What Should I Do?

Probably one of the most significant developments in sterilization and aseptic practices in pharma is that of vaporized hydrogen peroxide (VHP) as a contact or “cold” sterilizing agent. The use of VHP in contained environments has allowed us to decontaminate working spaces, equipment, and materials and has led to the development of the reliable isolator.

Posted in:Manufacturing,
Tags:aseptic,isolator,sterile,vaporized hydrogen peroxide,VHP,
13
Nov
Implementing An End-To-End Clinical Development Process Framework

If we take for granted that there will always be new and changing processes, systems, and digital platforms and the organizational complexity within Big Pharma will not abate, how do we ensure we optimize the entire clinical trial process and make the best use of our technology and process investments?

Posted in:Clinical,
09
Nov
Health-Based Exposure Limits: How Do The EMA’s Q&As Compare With New And Forthcoming ASTM Standards?

The EMA Q&As and their updates mark an important turning point in the pharmaceutical industry regarding cleaning validation and quality risk management. The new ASTM standards will provide guidance to the industry on the appropriate development of health based exposure limits, for the implementation of science- and risk-based approaches to cleaning validation, and on the use of statistical techniques for measuring the risk in cleaning and assessing the effectiveness of cleaning processes.

Posted in:Manufacturing,
08
Nov
Real World Evidence And The Collision Between Pharma R&D And Healthcare

The true effect of an intervention is often not seen until real-world usage takes place, but with such a delay between R&D and healthcare delivery, how can the industry close the gap? And what is needed to deliver more effective interventions that patients really want?

Posted in:Clinical,FDA,Manufacturing,R&D,
07
Nov
How Will New Trade Agreements Impact The Pharma Industry … And Patient Access To Medicines?

The new trade regime unleashed by President Trump has not only heightened trade tensions, it has the potential to affect patient access to affordable medicines. His administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs highlighted foreign governments “freeriding” off of American investment in innovations.

Posted in:Manufacturing,
Tags:drug prices,trade,trade agreements,TRIPs,
06
Nov
Designing Clinical Trials With The Payer In Mind

Imagine your company just received FDA approval of a new pharmaceutical, the result of years of clinical research and difficult regulatory scrutiny. The product is being manufactured and is shipping to distributors and wholesalers. Providers and patient advocacy groups seem excited for the launch, and sales goals are considered aggressive. However, one key variable remains: coverage.

Posted in:Clinical,

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