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Regulatory science research needs list - version 1
biomarkers by EMA and HTA (and potentially payers). To gain an understanding of how standards differ among regulators and HTA/Payers and the evolution of these over time. To evaluate, in collaboration with HTAs, payers and patients, the impact of treatment on clinical outcomes measured by biomarkers, and develop joint standards for
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Q12 Step 2b Technical and regulatory …
www.ema.europa.euICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management EMA/CHMP/ICH/804273/2017 Page 3/36
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