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Industry Events |
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PDA Parenteral Packaging 2019
19-20 March 2019, Hilton Molino Stucky, Venice, Italy
PDA Europe’s Conference has become a
must-attend event for all professionals in the Parenteral Packaging arena. Join
us in Venice in March 2019 to continue and further deepen scientific
advancements and our ongoing professional discourse of latest on primary
packaging technologies and business trends. This conference and the
accompanying exhibition address quality of components and containers,
container closure development and integrity testing as well as aspects of
processing, product distribution and storage.
More info >> |
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News and Press Releases |
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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?
More info >> |
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