Transparency requirements for publication of clinical data
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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
Free ‘Portfolio and Technology’ meeting with the European Medicines Agency
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EMA revised transparency rules for CTIS
EMA announces removal of the deferral mechanism for clinical trial publications
Implementation of the Windsor Framework
Planned changes to UK MAs and the impact on product packaging
The future of Orphan Medicines in the EU
Impact of EC draft changes to the Pharmaceutical Regulations.
Q3 2023 Newsletter – What’s New in Clinical Development Practices & Regulations
Regulatory update compiled by our experts