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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
Free ‘Portfolio and Technology’ meeting with the European Medicines Agency
Hurry! Less than two weeks remaining to apply
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
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
Articles
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:
- EU Regulation, Guidelines & Initiatives
- UK Initiatives and Guidelines
- US Initiatives and Guidelines
- Real-World Data and Real-World Evidence
- Post Pandemic Initiatives
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