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New Trends & Requirements from Digitalization, Annex 1, Continuous Manufacturing & High Potent Manufacturing

ISPE

In this blog, we will briefly explore the challenges and opportunities of digitalized aseptic production, fully contained and automated production and collaborative work with CMOs. We will also address the ways in which these approaches can help to improve adherence to new Annex 1 and the overall quality and safety of pharmaceutical products.

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Navigating Life Sciences Construction in California

ISPE

Navigating Life Sciences Construction in California Trudy Patterson Thu, 09/28/2023 - 11:40 iSpeak Blog iSpeak Navigating Life Sciences Construction in California Gul Dusi 28 September 2023 Few industries have as deep a footprint in California, USA as life sciences. billion a year.

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New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry

pharmaphorum

The Guidance applies to all member companies of EFPIA and IFPMA, but also acts as useful guidance for all pharmaceutical companies as to how the authorities will interpret the legislative provisions to social media channels. However, the involvement of the company should always be stated.

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Medical Legal Regulatory (MLR) Review Process in Pharma

Viseven

Promoting content worldwide When a pharmaceutical company publishes content, it often considers the norms and laws of the country in which it operates. But what if this company decides to expand worldwide? The truth is that MLR reviews are needed in 90% of cases, whether it is a website blog post or an important research paper.

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The 20 Key Moments in the 340B Program's 30-Year History

Omnicell

There was bipartisan support for the program at the hearing and support for measures such as requiring pharmaceutical companies to publish their prices in a password protected site on HRSA's website. Four of the five staffers originally involved in the investigation now work for or lobby for the pharmaceutical industry.

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ISPE Advancing Pharmaceutical Quality Program Complete

ISPE

ISPE Advancing Pharmaceutical Quality Program Complete. iSpeak Blog. ISPE Advancing Pharmaceutical Quality Program Complete. ISPE is pleased to announce the complete Advancing Pharmaceutical Quality Program (APQ) Program is now available with the release of the fifth and final guide. Trudy Patterson. 28 November 2022.

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Annex 1, ATMPs and Pharma 4.0 - How Do They Fit Together

ISPE

How can hardware, software, and process understanding be combined to create good GMP validation documents? ™ and Annex 1 Conference on 11-12 December 2023. What aspects remain unchanged? What are essential points for environmental monitoring topics? A good way to build in quality by design! Join us at the 2023 ISPE Pharma 4.0™