EDITORS' DESK

  • A Glimpse Into Thailand’s Ongoing Life Sciences Transformation
    A Glimpse Into Thailand’s Ongoing Life Sciences Transformation

    During my visit to Thailand, I was privy, not only to the particularly innovative research goals being pursued, but also to a number of challenges the country has recognized and hopes to address within the next few years to encourage a stronger, more diverse industry.

What Thailand Revealed About U.S. Pharma R&D

A few weeks ago, I was invited by the Thailand Board of Investment to attend a media trip to learn about the country’s budding life sciences industry. Entering Thailand, a country in which the government is pushing more investment and education in the sciences, was even more striking and meaningful to me given the current scientific climate in the U.S.

Top 5 Biosimilar Developments Of 2016

In the spirit of this list-making season, I compiled what I thought were the five most important biosimilar-related triumphs in the past year. Many of these events were widely covered by the media and will play an influential role in how the biosimilar industry unfolds through 2017 and beyond.

Are You The Future of Pharmaceutical Development?

Pfizer's Bernie Huyghe and ADC Therapeutics' Michael Mulkerrin get bushwhacked with this question in a public forum. Their open replies will help each one of you to your own personal assessment. Be prepared for some soul searching.

The Case For Moving The EMA To Ireland

Relocating an organization as large as the EMA, which employs upwards of 1,000 people in London, will be no easy feat. As such, IDA Ireland, an agency that supports companies in Ireland and promotes foreign direct investments in the country, is working to compile information on why Ireland would be a good location for the EMA.

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GUEST CONTRIBUTORS

  • Cheating In The Lab: 3 Data Integrity Pitfalls To Avoid In Laboratory Operations
    Cheating In The Lab: 3 Data Integrity Pitfalls To Avoid In Laboratory Operations

    FDA inspectors continue to observe CGMP violations involving data integrity during CGMP inspections of laboratory operations. At least 20 percent of all warning letters issued by the CDER Office of Manufacturing Quality in 2017 included explicit observations by inspectors of blatant data integrity violations in laboratory operations. While there has been an increase in warning letters issued to firms in China and India for flagrant data integrity violations, firms in the United States, Europe, and Japan have also been cited with similar violations.

  • Environmental Risks & The Life Science Supply Chain: Lessons Learned From Hurricane Maria
    Environmental Risks & The Life Science Supply Chain: Lessons Learned From Hurricane Maria

    The hurricane season of 2017 will be remembered as one of the worst, with some of the strongest tropical cyclones ever witnessed creating havoc in the Atlantic basin.

  • Identifying Outliers In Process Data Using Visual And Analytical Techniques
    Identifying Outliers In Process Data Using Visual And Analytical Techniques

    Identifying outlier data points using visual and analytical techniques is especially important for proper process validation, control, and monitoring in the FDA regulated industries. Additionally, properly identifying outliers can assist FDA regulated companies with the proper establishment of trending and excursion limits for complaint and nonconformance management, and other aspects such as environmental monitoring, which can trigger investigations or initiate the formal corrective and preventive action (CAPA) process.

  • An Analysis Of FDA FY2017 Drug GMP Warning Letters

    This article presents a detailed summary of the drug GMP warning letters issued in FY2017, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree agreements.

  • A Framework For Quality Risk Management Of Facilities And Equipment

    This two-part article focuses on risk management of facilities and equipment. It describes how a risk-based approach to facilities and equipment management fits into an integrated, effective quality systems structure. The principles discussed are equally applicable to all quality systems. Facilities and equipment represent a broad range of risk to product quality and are one of the key quality systems commonly identified in the pharmaceutical manufacturing industry.

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PHARMA ONLINE WHITE PAPERS

  • White Paper: Hard Gelatin Capsules Today — And Tomorrow White Paper: Hard Gelatin Capsules Today — And Tomorrow
  • The Quest For Clean Mixing

    Mixing is one of the most ubiquitous unit operations in the processing world. And oftentimes, improvements specific to the mixing step lead to overall big rewards that translate well in the balance sheet. The usual challenges include maintaining batch-tobatch uniformity and optimizing blend times, but could be as simple, yet equally important, as improving cleanliness.

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INDUSTRY INSIGHTS

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PHARMA INDUSTRY EVENTS

CAPA and Root Cause Analysis Essentials Post ICH GCP E6 (R2) Addendum January 22, 2018
11am-12:30pm EST, Online Training
Social Media in the Pharmaceutical Industry January 22 - 23, 2018
London
Pharmaceutical Microbiology UK January 22 - 23, 2018
London
R&D Data Intelligence Leaders Forum 2018 January 23 - 24, 2018
Basel
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TRAINING COURSES

CAPA and Root Cause Analysis Essentials Post ICH GCP E6 (R2) Addendum January 22, 2018
11am-12:30pm EST, Online Training
Sterility Failure Investigations – A Step-by-Step Process for Success January 24, 2018
1pm-2:30pm EST, Online Training
Quality Risk Management Post ICH GCP E6 R2 Addendum January 29, 2018
11:00am- 12:30pm EST, Online Training
Preparing eCTD Submissions: A Step-By-Step Guide January 30, 2018
1pm-2:30pm EST, Online Training
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