Regulation and compliance – Page 4
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ArticleEndotoxin testing: the international regulatory landscape
In this extract from EPR’s Pharma Horizon’s report, Evelyn Der, Lindsey Silva and Carmen Marín Delgado de Robles from Roche Group discuss the regulatory guidelines for bacterial endotoxin testing and the move towards adoption of recombinant methods.
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ArticleValidation of analytical procedures – ICH Q2(R2)
The recently updated ICH Q2(R2) guidance marks a significant milestone in analytical procedure validation. Dave Elder explains why.
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ArticleLive biotherapeutic products: bridging innovations and challenges in manufacturing
In our third instalment of EPR's exclusive ‘Microbiome therapeutics: microscope to medicine’ series, Tue Hodal, Chief Technology Officer and Lorenz Rindisbacher, Chief Quality Officer, Bacthera, explore how live biotherapeutic products (LBPs) represent a transformative shift in medicine, highlighting their unique challenges and potential.
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ArticleData integrity considerations in pharma and life sciences
In this Q&A, data expert Joseph S Boakai addresses decisive factors impacting data integrity in the pharma and life sciences industries.
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Article2024 Pharmaceutical industry trends - discover the latest pharma quality and manufacturing trends
Some of the most sought-after human experiences are health and happiness. Although pharmaceutical companies cannot determine personal happiness, they are working to improve personal health outcomes that can tip the scale. The demand for personalised medicines, cell and gene therapies, hyperresponsive and patient-centric healthcare, real-world data fuelled by artificial intelligence ...
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ArticleEuropean Pharmaceutical Review Issue 1 2024
EPR Issue 1 includes articles on separation & purification, process analytical technology and drug delivery. Register your details now to download this exclusive content.
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ArticleRare disease spotlight: first EU-approved treatment for Friedreich’s ataxia
In this exclusive article, Biogen’s Vice President and Head of the Neuromuscular Development Unit, Dr Toby Ferguson, discusses the current rare disease landscape and recent developments in treating Friedreich’s ataxia (FA).
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ArticleMaking ATMPs a reality for rare disease patients
Advanced therapy medicinal products (ATMPs) will be among the first to undergo joint clinical assessments at EU level in 2025 and these will form the basis for national value assessments and pricing negotiations. Here, Paolo Morgese from the Alliance for Regenerative Medicine discusses how methodologies for joint clinical assessments (JCAs) ...
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ArticlePharmaceutical industry: 2023 in retrospect
In this article, Dave Elder delves deeper into some ongoing developments in topic areas highlighted in European Pharmaceutical Review (EPR) during 2023.
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ArticleBridging the healthcare digital divide: a gradual approach to adopting ePI
As the global healthcare landscape moves towards a digital transformation, a balanced approach that unites electronic product information (ePI) with traditional paper leaflets can help ensure every European citizen, irrespective of their digital access, has unencumbered access to critical medical information. Here, Ataa Elfaquih from MLPS, a subgroup of the ...
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ArticleGenAI in pharma: where are we today?
EPR speaks to Henry Levy, President, Life Sciences at Clarivate to gain a sense of how artificial intelligence (AI), and particularly Generative AI (GenAI), is transforming the pharmaceutical industry.
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ArticleMicrobiome innovation: have we forgotten the basics?
Here, Chrysi Sergaki from the Medicines and Healthcare products Regulatory Agency (MHRA), UK, explores how innovators and regulators can navigate the challenges affecting the development and regulation of microbiome therapeutics to bring safe and efficacious therapies to patients as soon as possible.
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ArticleTransforming pharmaceutical manufacturing: The AI revolution
The integration of artificial intelligence (AI) in pharmaceutical manufacturing is set to open a brand-new chapter in this industry's development, as well as unprecedented opportunities for strengthening quality control and improving decision-making. In this article, Dr Gonesh Chandra Saha, Head of the Department of Computer Science & Information Technology at ...
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Outsourcing regulatory activities in pharma
Here, EPR's Caroline Peachey explores some key considerations, approaches and strategies for pharmaceutical companies looking to outsource regulatory activities.
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ArticleBiopharma dealmaking: predictions for 2024
EPR speaks to Subin Baral, EY Global Deals Leader, Life Sciences about biopharma dealmaking in 2023 and the investment outlook for 2024.
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OpinionTrends shaping capsule development
In this interview from CPHI Barcelona, Julien Lamps from Lonza CHI discusses trends shaping capsule development.
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ArticleEU pharmaceutical legislation revisions: what are the implications for biopharma?
Anne Dhulesia and Sean Dyson, Partners at L.E.K. Consulting, discuss the proposed revisions to EU pharma legislation and potential implications for biopharma companies operating in Europe.
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ArticleThe nitty gritty of biotherapeutics production
Caroline Peachey chats with Mahesh Bhalgat, COO at Syngene International Limited about the role of new technology in biotherapeutics production.
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ArticleYear in review: EPR’s top stories of 2023
EPR wraps up the year with a selection of top stories from 2023, highlighting key trends and topics such as environmental monitoring (EM), quality (QA/QC), manufacturing, regulation and clinical development.
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ArticleNitrosamines analysis with LC/MS-MS
This ebook provides a comprehensive overview of nitrosamine analysis for the pharmaceutical industry.