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Securing Europe’s competitiveness in life sciences
Digitalisation, R&D and AMR were highlighted as key areas of focus to support European competitiveness up to the end of the decade, as set out in new Political Guidelines for Europe.
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European Federation of Pharmaceutical Industries and Associations (EFPIA)
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EFPIA sets out targets for pharma environmental sustainability
To drive environmental sustainability in pharma, EFPIA strives “to go beyond compliance on the targets set within the various EU legislative requirements as part of the EU Green Deal initiatives under the Zero Pollution, Circular Economy and Climate Action plans”.
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EFPIA reaction to European Parliament plenary vote
Following the recent European Parliament plenary vote, EFPIA asserts that aligning the next revision of the pharmaceutical legislation to increase Europe’s competitiveness will be a challenge.
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EU pharma legislation key in tackling AMR
According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), the EU general pharmaceutical legislation has potential to shape the future of EU actions against antimicrobial resistance (AMR).
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Mitigating medicines shortages in Europe
The pharmaceutical industry must work together, applying new initiatives and harnessing digital tools to address Europe’s medicines shortages in 2023 and beyond, regulators and other organisations assert.
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European PFAS restriction could jeopardise pharmaceutical manufacturing
Pharmaceutical manufacturing in Europe is at risk of critical medicine shortages, states the European Federation of Pharmaceutical Industries and Associations (EFPIA), if the widest chemical substance restriction, concerning Per- and Polyfluoroalkyl Substances (PFAS), is put in place.
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Pharma responds to proposed EU pharmaceutical legislation reform
Industry bodies EPFIA and the Alliance for Regenerative Medicine and law firm Pinsent Masons have responded to the recent proposed revision of the EU pharmaceutical legislation.
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Framework to enable re-use of patient clinical data
A patient-centric legal framework intends to return clinical trial data to study participants, ready for re-use in further research or healthcare practice.
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Is TEE the key for novel antibiotics?
Research suggests a Transferable Exclusivity Extension (TEE) system is “the only existing option capable of incentivising antibiotic R&D in a sustainable manner” for Europe.
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2022 spells change for EU pharmaceutical legislation
With almost every aspect of pharmaceutical regulation currently under review across Europe and the proposal for changes expected in December 2022, in this article, Maarten Meulenbelt, Partner at Sidley Austin LLP, discusses with European Pharmaceutical Review some of the more controversial amendments under consideration and emphasises why industry participation is…
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Big Pharma shares substance data to decrease animal testing
Four Big Pharma companies have shared previously unpublished hazard data for drug substances to enhance database-dependent computational tools and help reduce animal testing.
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Recommendations published on medicine procurement across the EU
The EFPIA has published 10 recommendations to ensure that procurement practices across the EU are effective and sustainable, delivering high quality medicines for patients, in the right quantities and at the right time.
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Ways to promote patient access as a European healthcare priority
We are experiencing a time of polarity in our healthcare systems with breakthrough treatment options developed, but access prohibited. Here, Catherine Owen, SVP of Major Markets at Bristol Myers Squibb, explains why, despite continued COVID-19 pressures, the time is ripe to rectify this situation.
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Less than lifetime limits for N-nitrosamine mutagenic impurities
Here, Dave Elder discusses the determination of less than lifetime (LTL) limits for highly potent N-nitrosamine compounds and how to ensure safety in dosing.
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EFPIA calls for harmonisation of GMO procedures in investigational drugs
The European Federation of Pharmaceutical Industries will implement a new regulation to co-ordinate genetically modified organism procedures.
