The International Conference of Harmonisation has at last finalized its organizational reforms that are expected to encourage the group's expansion beyond its current membership of regulators from five regions (Canada, the EU, Japan, Switzerland and the US) and three research-based pharmaceutical industry associations (from the EU, Japan and the US)1.
The International Conference of Harmonisation has at last finalized its organizational reforms that are expected to encourage the group's expansion beyond its current membership of regulators from five regions (Canada, the EU, Japan, Switzerland and the US) and three research-based pharmaceutical industry associations (from the EU, Japan and the US)1.
As reported previously in Scrip Regulatory Affairs, the new organization will still be known as ICH. However, this will stand...
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
