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FOPE, PharmaState Academy, complete one year of the PULSE program

Express Pharma

A key topic was the outdated NPPA conversion charges from 2012; panellists agreed that cost structures should now reflect current requirements related to GMP, EHS, training, validation, and documentation. On the topic of multi-location production, it was confirmed that manufacturing tablets in Plant A and packaging in Plant B is feasible.

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Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. International Council for Harmonisation (ICH), 2012. International Council for Harmonisation (ICH), 2005. Q9 Quality Risk Management.

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Regulating decentralised manufacturing in the UK – a legal perspective

European Pharmaceutical Review

In the EU, the EU pharmaceutical package of reform 5 includes a proposed new Directive, 6 which will replace the current Medicines Directive (2001/83/EC). Available from: [link] Human Medicines Regulations 2012 and Medicines for Human Use (Clinical Trials) Regulations 2004. Internet] UK Government. Under the Human Tissue Act 2004.

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Is DTC pharma advertising coming to an end?

PharmaVoice

An attempt by the agency to prohibit pharma ads was shot down by a court in 2012, for example, on the grounds that they’re protected by First Amendment rights, Politico reported. But a ban enacted through legislation is more likely to hold up in court than a policy change by the FDA. Is DTC pharma advertising coming to an end?

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FDA creates new priority review voucher scheme to boost US interests

Pharmaceutical Technology

The PRV programme for rare paediatric diseases, signed into law in 2012, expired in late 2024 after it failed to make it into a US Congress funding package. This effectively pushed the programme into its ‘sunsetting phase’. Give your business an edge with our leading industry insights.

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Bavarian Nordic nets $160m from priority review voucher sale

Pharmaceutical Technology

By GlobalData Learn more about Strategic Intelligence Sale figures increasing after dip PRVs were introduced in 2012 to incentivise development into non-lucrative disease areas. Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. Give your business an edge with our leading industry insights.

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AstraZeneca CEO Pascal Soriot’s £17m pay package under fire

The Guardian - Pharmaceutical Industry

Governance thinktank asks whether he has earned a hundred times that of many of his employees AstraZeneca’s chief executive, Pascal Soriot , received a pay package of nearly £17m last year, cementing his position as one of the best-paid FTSE 100 bosses as he drew criticism from corporate governance experts.

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