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THE CURRENT ISSUE

  • Leadership Rules For The News Normal
    Leadership Rules For The News Normal

    It wasn’t long ago that normal meant slow and steady. Today, normal means expect the unexpected, requiring a new set of leadership rules. To help leaders fully engage people and strengthen their resilience in uncertain times, we took a fresh look at what leaders do when they are at their personal best. We identified six common strategies you should incorporate into your leadership practices to be successful in turning adversity into opportunity.

  • The FDA ’s Focus On Metrics, Performance, And Quality
    The FDA ’s Focus On Metrics, Performance, And Quality

    At the PDA Quality Metrics Conference in December 2013, FDA CDER (Center for Drug Evaluation and Research) Director Janet Woodcock set out her goals for the conference: “to shift [the FDA’s] focus to performance and away from compliance.” Under the FDA’s lead, the life sciences community will have no choice but to follow suit in its own operations and approaches to quality.

  • 6 Steps For A Sustainable Approach To R&D Through Big Data
    6 Steps For A Sustainable Approach To R&D Through Big Data

    Near the end of 2013, many in the life sciences industry were looking for clear evidence that the FDA was willing to work with industry to get more needed drugs to patients. Eyes were focused on the “scorecard” of new drugs approved, which for the first eight months of 2013 reached 18.

  • Are You Prepared For The New European Pharmacovigilance Guidelines?
    Are You Prepared For The New European Pharmacovigilance Guidelines?

    EVMPD (EudraVigilance Medicinal Product Dictionary) requirements have moved back up the agenda for pharma companies marketing products in Europe, now that new requirements on data maintenance have finally been published.

  • VAT and The Clinical Trial Enterprise
    VAT and The Clinical Trial Enterprise

    As clinical trials become more global, sponsors and CROs face a myriad of financial, contracting, and compliance challenges. One of the most pressing: understanding and managing the impact of Value Added Tax (VAT).

  • Biopharma Quality Management Best Practices: An Approach To Quality Initiatives
    Biopharma Quality Management Best Practices: An Approach To Quality Initiatives

    Quality management is an increasingly important focus for biopharmaceutical manufacturers looking to avoid production problems and failures. And it’s increasingly becoming a multifaceted, industrywide concern as regulators take a closer look. With this in mind, it’s useful to see how the industry is approaching quality management in terms of the initiatives being pursued.

  • Partisanship Scuttles Bipartisan Reform Of SGR
    Partisanship Scuttles Bipartisan Reform Of SGR

    March 15 — Something extraordinary has occurred in Washington: The three healthcare committees of jurisdiction quietly collaborated on a bipartisan basis to develop a replacement for the dysfunctional “Sustainable Growth Rate” (SGR) payment formula that dictates Medicare payments to physicians. Unfortunately, it was not to last. This substantial bipartisan achievement was soon scuttled and overtaken by the partisan bickering over the healthcare issue that has consumed the country for the past five years: implementation of Obamacare.

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LEADERSHIP AWARDS

Life Science Leader’s readership of pharmaceutical and biopharmaceutical executives have told us about their struggles in efficiently vetting potential CMO and CRO partners. In response to this input, Life Science Leader developed the Leadership Awards based on the industry leading research conducted by Nice Insight.

2014 CRO Leadership Award Supplement
2013 CMO Leadership Awards Supplement

 

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