News & Articles
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Q3 2023 Newsletter – What’s New in Clinical Development Practices & Regulations
Regulatory update compiled by our experts
Draft EMA Reflection Paper on Artificial Intelligence
EMA considerations on the use of AI in the medicinal product lifecycle.
S-cubed Denmark (ApS) acquired by Phastar
We are happy to announce that S-cubed Denmark (ApS) has been acquired by Phastar.
EMA ‘OPEN’ initiative – extended scope
The scope of the EMA pilot ‘OPEN’ has been extended to include certain innovative medicines.
Windsor Framework
Medicines in Northern Ireland – What you need to know.
EDQM Launches CEP 2.0
What you need to know about the upcoming changes to the EDQM Certificate of Suitability
Q2 2023 Newsletter – What’s New in Clinical Development Practices & Regulations
Regulatory update compiled by our experts
Q1 2023 Newsletter – What’s New in Clinical Development Practices & Regulations
Regulatory update compiled by our experts
Q4 2022 Newsletter – Regulations & ICH Guidelines; FDA Guidelines; Clinical Trial Data
Regulatory update compiled by our experts
1st Dec 2022 – Launch of Phase 2 of the Simultaneous National Scientific Advice (SNSA) Pilot
Enhancing the quality and consistency of scientific advice received by the applicant.
Regulations & ICH Guidelines; Inspections; Initiatives across the World; RWD/RWE
Regulatory update compiled by our experts
Titanium dioxide in Medicinal Products
Impact of EU Commission Regulation 2022/63
Regulations & ICH Guidelines; EU/UK/US Guidance; RWD/RWE
Regulatory update compiled by our experts
Combined Review Process for Clinical Trials
Our Regulatory Team focus on the Combined Review process in the UK
EU Clinical Trial Regulation
EU Clinical Trial Regulation – What you need to know
COVID-19, New Regulations: Latest Industry Update
Regulatory update compiled by our experts
Clinical Trial Guidance and Legislation
Regulatory update compiled by our experts
Regulatory Guidance and News
All the latest regulatory updates you need to know
Clinical Trials Update: COVID-19
COVID-19 & much more in our latest Industry Update
Mark Baillet – A View from the Biometrics Managing Director’s Office
COVID-19 Vaccines trials …
Swiss-exit, Turkey-exit, BREXIT and Medical Device Regulation
Swiss-exit, Turkey-exit, BREXIT and Medical Device Regulation
Articles
Draft EMA Reflection Paper on Artificial Intelligence
EMA considerations on the use of AI in the medicinal product lifecycle.
Marketing Authorisation Holder GMP-related Responsibilities
Our latest regulatory update focuses on the responsibilities of the Marketing Authorisation Holder.
An overview of PRIME, Breakthrough Therapy & Fast Track procedures
This article provides an overview of PRIME, Breakthrough Therapy and Fast Track regulatory procedures intended to optimise the development of medicines that target an unmet medical need.
Optimising the path to commercialisation; Who can help and when?
Regulatory Affairs Expert Tony Mitchell co-authors a case study for a new IBS Drug This is case study for a joint project S-cubed worked on for a new drug for IBS – PharmaVentures was the lead company and they were providing market valuation expertise, Apex Healthcare...
INDUSTRY INSIGHTS
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Our Industry Insights features the latest news and developments from the pharmaceutical industry.
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Featured in this issue of Industry Insights:
- Updates to EU Pharma Legislation and ICH Guidelines
- Guidance Documents, Initiatives and Proposals
- AI and ML
- Medical Devices & IVDs
- Data Transparency and Data Protection
If you want to contribute or share something that you’d like to be listed in the next issue, please feel free to contact us.