Regulation and compliance – Page 6
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ArticleNew quality requirements for tobacco products
Here, Dave Elder explores proposals for new FDA rules on tobacco product manufacturing. How could strategies for controlling tobacco-specific nitrosamines compare with those for nitrosamine drug substance-related impurities?
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Event2023 PDA BioManufacturing Conference
This conference will offer a forum for sharing knowledge to develop most innovative solutions for agile biomanufacturing and much more.
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Event2023 PDA Virus Conference
An update on regulatory expectations, presenting the scientific framework for virus safety of plasma-derived and biotechnology medicinal products, and more.
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Article
Innovating pharma at the edge
Solving the sector-specific challenges of life sciences while enabling innovation requires data integrity, with data collected and analysed at the source in real time, explains Greg Hookings, Industry Director, Stratus Technologies.
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ArticleEuropean Pharmaceutical Review Issue 2 2023
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…
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ArticlePharma within planetary boundaries
Regulatory changes along a drug’s lifecycle should ensure that the health benefits of pharmaceuticals, which have a large ecological footprint, do not cost the environment. Dorothea Baltruks, Research Associate at the Centre for Planetary Health Policy, outlines how forthcoming EU pharmaceutical legislation could pave the way to solutions.
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ArticlePsychedelic medicines: are they gaining traction in Europe?
Carissa Kendall-Windless and Sian Banks of law firm Pinsent Masons discuss the development of psychedelic medicines and the legal and regulatory challenges that must be overcome for psychedelics to become safe and effective treatment options in Europe.
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ArticleILAP: Improving access to innovative oncology treatments
With no new first-line treatment for de-differentiated liposarcoma in over forty years, Dr Christoph Zehendner, Medical Director of Boehringer Ingelheim UK and Ireland discusses the company’s ILAP designation of its investigational, innovative treatment.
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ArticleParallel import of medicinal products: regulatory update
Andrzej Siwiec and Katarzyna Bajer of DBS Law discuss recent rulings on the parallel import of medicinal products in the European Union.
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ArticleLearning from lecanemab: a breakthrough treatment
Here, Dr Michael Irizarry, Eisai’s Senior Vice President of Clinical Research and Deputy Chief Clinical Officer for Alzheimer’s Disease and Brain Health discusses its highly anticipated Alzheimer’s drug, lecanemab.
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ArticlePrioritising for a data-driven 2023
As the pharmaceutical industry continues to face unprecedented challenges, the need for greater regulatory compliance and process efficiency remains at the forefront. Here, Frits Stulp predicts how new waves of digital transformation can help support companies deliver the best possible patient outcomes.
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ArticleUPC opt-out – a strategic balancing act for pharma
The European patent landscape is expected to change in 2023 with the launch of the Unified Patent Court. Owners of classic European patents can decide now if their patent will be litigated in the UPC or withdraw from it. Here, Jules Fabre and Sarah Taylor, lawyers at Pinsent Masons, detail ...
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ArticleChallenges in pharmaceutical microbiology: looking to the future
Here, Edward C Tidswell, Executive Director Quality Assurance at Merck & Co, Inc., discusses the microbiology challenges for industry, pharmaceutical companies and microbiologists themselves.
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ArticleAccelerating drug development
Here, Dave Elder explores how a ‘quick-approval, quick-withdrawal from the market’ approach is used to accelerate drug development.
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ArticleMedicinal cannabis: the route to good manufacturing practice registration
Following on from the first GMP registration of a cannabis API for a UK pharmaceutical facility, EPR spoke with Celadon Pharmaceuticals about how it navigated the complex regulatory landscape.
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ArticleFive potential EU regulatory changes impacting the life sciences industry in 2023
Elizabeth Anne Wright, Head of the EU regulatory life sciences team at law firm Cooley, and associates Jessica Koffel and Edward Turtle look ahead at EU regulatory milestones for the life sciences sector in 2023. Five key areas of potential change include: clinical trials, medical devices, pharmaceutical legislation, class actions ...
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Articleebook: Extractables and leachables: a guide to analytical methods
This ebook takes an in-depth look at advanced analytical methods for extractables and leachables analysis in the pharma industry.