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Ex-Merck & Co scientist accused of stealing trade secrets could face jail

pharmaphorum

In a document outlining the charges against Shafat Quadri, of North Potomac, Maryland the US Department of Justice (DoJ) referred only to “one of the largest pharmaceutical companies in the world” based in New Jersey.

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Envision acquire dDOC, hires Manish Goel as tech solutions head

pharmaphorum

Comms company Envision Pharma Group has acquired doDOC Corp, a document collaborative review, editing and authoring firm. doDOC enables simultaneous collaboration in the review, editing, and authoring of documents among multiple users.

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PAN-TB’s Phase II trials take a shot at shorter TB regimens

Pharmaceutical Technology

Earlier this month, the World Health Organisation (WHO) released a new guidance document with a strategic plan to counter TB on a national level. This guidance is in line with the WHO’s End TB Strategy, which aims for an 80% fall in worldwide TB incidence and a 90% decrease in TB deaths by 2030, compared with 2015.

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CoP Leader Profiles: Christian Wölbeling

ISPE

He is currently co-leading the team working on an ISPE guidance document addressing Pharma 4.0™. We developed recipe management and manufacturing software which controlled and documented these processes.” After the reunification of Germany, many pharmaceutical companies were being built.

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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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ICH Q13 and What Is Next for Continuous Manufacturing

ISPE

1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Q13 Development Timeline The process of drafting the new guidance document was initiated in earnest in November 2018 when the concept paper 2 and business plan were endorsed.

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2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients

ISPE

CDER and OPQ (established in 2015) focuses on quality throughout the produce life cycle, but it faces the challenge of the global nature of the industry, he said: over three quarters of API sites are outside the US; over half of finished drug formulation sites are outside the US. FDA Activities in Support of Quality. Next Slide ??.

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