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The imperative of fridge-free vaccines

European Pharmaceutical Review

Many of today’s vaccines are produced in ready-to-inject liquid formulations that must be kept cold to maintain stability. However, this greatly complicates both the worldwide distribution and stockpiling of vaccines and other drugs. A requisite cold chain has been designed and implemented to be uninterrupted from factory to patient.

Vaccines 111
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MHRA Chief Executive to step down

European Pharmaceutical Review

In 2012, Dame June was elected as the first chair of the European Pharmacovigilance Risk Assessment Committee, MHRA added. MHRA also noted that Dame June’s key interests are in monitoring the outcomes of regulatory action, risk communication and patient involvement in the regulatory process.

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

During the pandemic, the pharmaceutical industry faced challenges in the production of COVID-19 therapeutics and vaccines to meet global demand, as well as mitigation of drug shortages for non-COVID-19-related products, without compromising product quality or patient safety. Published May 2012. Published 2008.

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The impact of clinical trial decentralisation on the pharma supply chain

Pharmaceutical Technology

7,000 more clinical trials take place each year in the Asia-Pacific region compared with 2012, and 1,200 more in the Middle East and Africa. The global vaccine rollout would never have taken place without the advances in visibility and control over supply chains that it necessitated. The world of clinical trials is changing.

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The impact of clinical trial decentralisation on the pharma supply chain

Pharmaceutical Technology

7,000 more clinical trials take place each year in the Asia-Pacific region compared with 2012, and 1,200 more in the Middle East and Africa. The global vaccine rollout would never have taken place without the advances in visibility and control over supply chains that it necessitated. The world of clinical trials is changing.

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A history of Johnson & Johnson

pharmaphorum

In 2012, J&J agreed to pay US $181 million to 26 states in order to settle these claims – though another lawsuit related to the drug (for $8 billion, eventually reduced to $6.8 CEO Alex Gorsky, who was appointed in 2012. Risperdal is well-known due to the controversy in the US following its product launch in 1994.

Vaccines 126
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Contamination Trends & Proposed Solutions

ISPE

2 , 16 , 17 , 18 One example is the switching of tributyltin azide with sodium azide and dimethyl formamide by Zhejiang Huahai Pharmaceuticals (ZHP) in 2012 to reduce waste and to increase yield in the production of angiotensin II receptor blockers, resulting in the formation of N-nitrosodimethylamine (NDMA), a known carcinogenic impurity.