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Industry Events

Cell Therapy Manufacturing & Gene Therapy Congress

4-6 December 2018, RAI, Amsterdam

Bringing together 300+ leaders and key influencers from pharma and biotech companies on 4 - 6 December 2018 in Amsterdam, Cell Therapy Manufacturing & Gene Therapy will provide you with the latest advice for transforming innovative research to prosperous cell & gene therapy manufacturing.
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News and Press Releases

Clinical and Regulatory Operational Excellence Forum

1. Innovative technologies are expected to take clinical development, licensing, and other regulatory processes to the next level in the future. What do you see are the biggest challenges facing companies when trying to cope with continued data growth in a fast changing environment? Pharmaceutical companies are heavily regulated and introducing change needs proof of acceptance by the authorities. The chance that authorities do not agree with that change makes the industry risk averse. Changes in a stable GxP environment are almost by default seen as a risk, however, not adapting to new technologies should also be seen as a risk! Therefore, ICH developed the ICH Q8, Q9, Q10, Q11, and Q12 guidelines, to anticipate change and implement changes much faster, with less of a regulatory burden. Nevertheless, industry is not picking up with the desired pace. Why not?
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