Simon Linke

AstraZeneca
Director - Pharmaceutical Development
Simon studied analytical chemistry at Portsmouth university before joining AstraZeneca. With more than 20 years’ experience within pharmaceutical development Simon has led a wide range of drug development projects across early phase, late phase and into commercialisation. Working across drug substance and drug product to developing holistic enhanced control strategies for inhalation, parenteral and oral products and with special interest in the establishment of specifications and the management of impurities.

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A Patient-Centric Review of ICH Q6A and ICH6B
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A Patient-Centric Review of ICH Q6A and ICH6B

The ICH Quality Discussion Group (QDG) has recommended contemporizing the specification setting guidelines ICH Q6A and Q6B. This provides an excellent opportunity to update ICH Q6A/B to align and work in a complementary manner with the science-, risk/knowledge-based concepts in ICH Q8–Q12. The ISPE Pharmaceutical Quality Lifecycle Implementation (PQLI) Patient-Centric Specification working...