Spring Intro 2023

03/03/2023

The Nonclinical Overview(2.4) The Non-clinical overview is submitted with every MAA and should consist of a critical evaluation of the investigations carried out on animals and bring out all the data relevant for evaluation. It should be worded so as to enable the reader to obtain a good understanding of the safety, and the advantages and disadvantages of the medicinal product. It should provide an integrated overall analysis and should not exceed about 30 pages.

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The Nonclinical Overview The Expert must have the “Necessary Technical or Professional Qualifications.

Reports written by non-toxicologists are not acceptable.

The qualifications and experience of the Pharmaco- Toxicological Expert should, therefore, be briefly summarised.

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