The European Medicines Agency (EMA) launches the DRAFT "Guideline on quality, non-clinical and clinical requirements for investigational advanced medicinal medicinal products in clinical trials".
It is a multidisciplinary guide that provides guidelines on structuring and presenting data in submissions of exploratory and confirmatory clinical trials for pharmaceutical research products in advanced therapies, or Advanced Therapy Investigational Medicinal Products (ATIMPs).
The deadline for contributions to the material began today (February 21) and will be closed on 08/01/2019.
The document can be accessed at the link below:
https://www.ema.europa.eu/documents/scientific-guideline/draft-guideline-quality-non-clinical-clinical-requirements-investigational-advanced-therapy_en.pdf
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A Agência Europeia (EMA) acaba de disponibilizar o DRAFT "Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials".
It is a multidisciplinary guide that provides guidelines on structuring and presenting data in submissions of exploratory and confirmatory clinical trials for pharmaceutical research products in advanced therapies, or Advanced Therapy Investigational Medicinal Products (ATIMPs).
The deadline for contributions to the material began today (February 21) and will be closed on 08/01/2019.
The document can be accessed at the link below:
https://www.ema.europa.eu/documents/scientific-guideline/draft-guideline-quality-non-clinical-clinical-requirements-investigational-advanced-therapy_en.pdf
____________________
A Agência Europeia (EMA) acaba de disponibilizar o DRAFT "Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials".
Trata-se de um guia multidisciplinar que apresenta orientações sobre a estruturação e apresentação de dados em submissões de ensaios clínicos exploratórios e confirmatórios para produtos investigacionais farmacêuticos em terapias avançadas, ou ATIMPs (Advanced Therapy Investigational Medicinal Products).
O prazo para contribuições ao material iniciou hoje (21/02) e será encerrado no dia 01/08/2019.
O documento pode ser acessado no link abaixo:
