The scope of the EMA pilot ‘OPEN’ has been extended to include certain innovative medicines.
Articles filtered by tag
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