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Q4 2025 Newsletter – What’s New in Clinical Development Practices & Regulations
Regulatory update compiled by our experts
Orphan Medicinal Products in the EU
Summary of Orphan Drug Designation
Aligned pathway
Parallel decision making by MHRA and NICE
Q3 2025 Newsletter – What’s New in Clinical Development Practices & Regulations
Regulatory update compiled by our experts
PRIME at the EMA
Summary and metrics for PRIME
Q2 2025 Newsletter – What’s New in Clinical Development Practices & Regulations
Regulatory update compiled by our experts
The Innovative Licensing and Access Pathway (ILAP) in the UK
Relaunched for 2025
Q1 2025 Newsletter – What’s New in Clinical Development Practices & Regulations
Regulatory update compiled by our experts
EMA’s Data Management Services; an introduction to SPOR
Introduction to Substances, Products, Organisations and Referentials (SPOR)
S-cubed Ltd is excited to announce that it has joined the athagoras group
Joining the athagoras group at this exciting time will allow us to expand the range of services that we currently offer to our clients…
Q4 2024 Newsletter – What’s New in Clinical Development Practices & Regulations
Regulatory update compiled by our experts
EMA New Fee Regulation
Update following EMA webinar
Q3 2024 Newsletter – What’s New in Clinical Development Practices & Regulations
Regulatory update compiled by our experts
Q2 2024 Newsletter – What’s New in Clinical Development Practices & Regulations
Regulatory update compiled by our experts
Clinical Data Publication
Transparency requirements for publication of clinical data
Proposal to amend the MDR and IVDR
Extension of transition period for certain IVDs, gradual introduction of EUDAMED, and mitigation of supply shortages
Q1 2024 Newsletter – What’s New in Clinical Development Practices & Regulations
Regulatory update compiled by our experts
Clinical Data Publication
Relaunch of Policy 70
Q4 2023 Newsletter – What’s New in Clinical Development Practices & Regulations
Regulatory update compiled by our experts
Proposed EMA fee regulation
New proposed regulation to revise the fees charged by the EMA
Clinical Trial Legislation in the UK
MHRA announces a new notification scheme for low risk clinical trials
Articles
S-cubed Ltd is excited to announce that it has joined the athagoras group
Joining the athagoras group at this exciting time will allow us to expand the range of services that we currently offer to our clients…
Clinical Trial Legislation in the UK
MHRA announces a new notification scheme for low risk clinical trials
Draft EMA Reflection Paper on Artificial Intelligence
EMA considerations on the use of AI in the medicinal product lifecycle.
INDUSTRY INSIGHTS
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Featured in this issue of Industry Insights:
- Pharmaceutical Regulations
- ICH Guidelines
- Enhanced Access to Clinical Trials and Medicine
- Publications, Articles and Guidance
- AI in Healthcare
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