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INDUSTRY RESOURCES

11
Jun
Integrating Risk Management Into Your QMS — An Essential Toolkit

Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. Risk-based thinking can and should be applied to the organization’s strategic and tactical planning processes.

Posted in:Manufacturing,
Tags:QMS,risk-based thinking,
11
Jun
Closing The Loop For Bioelectronic Medicine

To fully realize the potential of bioelectronic medicine, medical device developers will need to find ways to move beyond “set and forget” biostimulation devices to closed-loop systems that can provide more responsive and personalized treatments.

Posted in:Device,
Tags:bioelectronic medicine,biostimulation,
01
Jun
Cross-Sector Intelligence: The Prospects For Data Convergence In Biopharma

This two-part series of articles looks at how the application of new technologies around data analytics has proven beneficial for the biopharmaceutical industry and regulators alike. The first article explored how technological advancements such as use of real-time data, predictive modeling, and artificial intelligence are gaining regulators’ acceptance and enabling the more efficient development of effective drugs and treatment solutions. This article examines the current environment of collaboration in the industry, along with technologies that will open opportunities to utilize data across life science sectors, including cross sector intelligence (CSI), the convergence of information across multiple sectors, enabling intelligent data-driven decision making.

Posted in:Manufacturing,
Tags:biopharma,cross sector intelligence,CSI,data,
31
May
CRO Partnerships 101: What Sponsors Need To Know

Much of the focus these days, especially after the release of ICH E6(R2), has been on how Sponsors can better monitor and oversee the performance of their CRO partners. This discussion, and resulting effort, around CRO oversight is worthwhile and useful, but too often it is narrowly focused on metrics. A holistic approach to successfully partnering with CROs is needed, starting with the initial assessment of outsourcing drivers all the way through to trial completion.

Posted in:Clinical,R&D,
Tags:CRO,partners,sponsors,
28
May
Quality Risk Management 101: A Review Of Required Reading For QRM Practitioners

Following the publication of ICH Q9, industry eagerly embraced the opportunity to share ideas and best practices related to QRM. The cadence of publication steadily increased as ICH Q8, ICH Q10, and ICH Q11 emerged, as thought leaders sought to provide practical guidance to industry on the application of QRM. This article will focus on selected publications addressing general, rather than specific, applications of QRM.

Posted in:Manufacturing,Training,
Tags:FMEA,HACCP,ICH Q9,PDA,QRM,quality risk management,
24
May
Assessing The Value Of Wearables In Interventional Clinical Trials

Advancements in biosensor technology are becoming increasingly common in the consumer space, with wrists adorned with Fitbits or similar devices, clothing embedded with “intelligent” fibers, and personal safety devices seen in healthcare facilities across the nation. Our culture is increasingly accustomed to tracking health metrics through smartphones and simple recreational wearables. In the pharmaceutical space, we are now seeing where success in the consumer segment can translate to value-adds for clinical trials.

Posted in:Clinical,FDA,
Tags:data,data analysis,wearables,

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