Regulatory update compiled by our experts
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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)
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
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