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From the PTO to The FDA: What to Consider When Branding Clinical Trials Depending on the clinical trial design, clinical trial spon-sors should take care that the trial name or branding does not compro-mise the trial blinding plan, introduce bias in study groups, or compromise the trial’s data integrity
Regulations For Clinical Trial Labeling • Premium Label Packaging . . . Clinical trial labeling for investigational drugs should comply with appropriate requirements in order to preserve the integrity of the trials as well as protect clinical trial participants' health, safety, and rights
Microsoft Word - 5534fnl. doc In some cases, making the information in the CLINICAL STUDIES section of labeling more useful to prescribers could warrant significant departures from past labeling practices
Investigational Medicinal Product Labelling | PPD Inc 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)
Pharmaceutical Labelling | Requirements | Pharma | Clinical Trials - Oximio In many instances relabelling, or additional labelling, may be required for the modification of investigational medicinal product (IMP) labels to meet regulatory requirements from country to country Key points about the importance of pharmaceutical labelling within clinical trials include:
Production Control of Clinical Trials Labels The Clinical Trials Pharmacist will need to approve the new version and sign the Master Label Amendment Form (Pharm F34), ensuring they sign across both the new label and form