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Found 35 results for label/kegiatan.
EU Clinical Trial Regulation: Investigational Medicinal Product Labeling
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).
FSP Global Clinical Supplies
PPD FSP global clinical supplies solutions help biotech, biopharmaceutical and medical device companies optimize clinical trial supplies lifecycle.
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 life cycle 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.