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Q2 2026 Newsletter – What’s New in Clinical Development Practices & Regulations
Regulatory update compiled by our experts
EDQM publishes new guidance on reliance-based and fast-track assessment of CEP applications
Significant reduction in time to approval
Medical Device and In Vitro Diagnostics Regulations
Proposed amendments
Revision to the Guideline on the Chemistry of Active Substances
Effective September 2026
ICH M4Q(R2) Common Technical Document Quality Guideline
Major revision
Q1 2026 Newsletter – What’s New in Clinical Development Practices & Regulations
Regulatory update compiled by our experts
EU Paediatric Investigation Plan; mechanism of action
Potential for future change to Paediatric Investigation Plan (PIP) waivers following the introduction of the new Pharmaceutical Regulations
New UK Clinical Trial Regulations Transition
Transitional Arrangements for Clinical Trials
New UK Clinical Trial Regulations
The UK will undergo the biggest overhaul of clinical trials law in two decades.
Antimicrobial resistance
Problems and possible EU solutions
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
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.
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Featured in this issue of Industry Insights:
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- ICH Guidelines
- Industry Initiatives and Proposals
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