Pharmaceutical News and Updates
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The Cost-Effectiveness of Pharma Design Limited: A Practical Alternative to Traditional CROs for European Regulatory Support
In the competitive landscape of pharmaceutical development, regulatory affairs play a pivotal role in bringing innovative therapies to market. For developers, particularly those based outside Europe, navigating the complexities of EU and UK regulations can…
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MHRA’s New Guidance on Non-Standard Trial Designs: Unlocking Flexibility for UK CTIMPs
On October 15, 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) released draft guidance on non-standard Clinical Trials of Investigational Medicinal Products (CTIMPs), marking a pivotal step in modernizing the UK’s clinical research framework.…
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EMA meets industry stakeholders on scientific advice and clinical trial coordination
On 3rd July 2025 EMA conducted its annual meeting with representatives of industry stakeholders to address topics of evidence generation along the medicine’s life cycle and related product-development support activities, such as scientific advice…
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CTA Applications in Europe
What distinguishes Pharma Design from other service providers is that we offer cost-saving, targeted and dedicated support with a team of very specialised consultants. Our prices are competitive thanks to our lean and flexible business…
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Serious clinical development players should avoid ‘hype’ and ‘hope’
Hype and hope are markers of bias and should be excluded from the scientific method. This approach has been obvious since the 19th century, when the most ‘revolutionary’ early researchers have been skeptical about their…
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Individualised mRNA cancer immunotherapies do not meet the definition of vaccines, so stop calling them so.
Individualised mRNA cancer immunotherapies do not meet the definition of vaccines, therefore the very sexy terminology of ‘cancer vaccines’ is inappropriate. MHRA’s clarifies own definitions (https://assets.publishing.service.gov.uk/media/6799ef4d9a6dc0352ab34225/Individualised_mRNA_cancer_immunotherapies_0.6.5.pdf). More appropriately, MHRA states that such products are individualised…
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We are hiring a business manager
We are looking for a business manager to work up to 3 days a week, from anywhere in the UK on a contract basis. RequirementsSignificant experience in the pharmaceutical services sector (Regulatory Affairs, Pharmacovigilance, Clinical…