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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
1st Dec 2022 – Launch of Phase 2 of the Simultaneous National Scientific Advice (SNSA) Pilot
Enhancing the quality and consistency of scientific advice received by the applicant.
CDISC Interchange Europe in a Virtual World
Last year, CDISC had to turn the Interchange in Europe to a virtual one in matter of weeks. How will this year shape up?
Regulations & ICH Guidelines; Inspections; Initiatives across the World; RWD/RWE
Regulatory update compiled by our experts
Titanium dioxide in Medicinal Products
Impact of EU Commission Regulation 2022/63
Articles
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INDUSTRY INSIGHTS
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Featured in this issue of Industry Insights:
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- AI in Healthcare
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