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Found 33 results for label/Berita.
EU Clinical Trial Regulation: Investigational Medicinal Product Labelling
In this blog post, Gemma Puckey, senior manager of regulatory affairs, explains the impact of the European Union (EU) Clinical Trial Regulation (CTR) 536/2014, specifically Annex VI, on labelling of Investigational Medicinal Products (IMPs).
Global Clinical Supplies
Our team provides complete life-cycle management
Regulatory Insights: ‘Right First Time’ Approach to Post-Authorization Strategy
Take a look at the importance of regulatory intelligence in anticipating challenges and mitigating risks during post-approval lifecycle maintenance.
Drug Discovery and Development Process
The drug discovery and development process is long but can result in new life-saving treatments and therapeutics.
A Practical Guide For IMP Supply Chain Planning Post-Brexit
Brian Brogan, senior logistics manager, provides guidance for clinical trial supply chain requirements post-Brexit and offers some practical solutions for affected U.K.-based life science companies.
New European Union Regulation to Change How Clinical Trials are Conducted
PPD experts explain what is changing and how to prepare for and navigate the transition to the EU Clinical Trials Regulation (EU CTR).