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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?
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Customising the Cold Chain

World Courier

Of all the statistics emerging around the global pharmaceutical industry this year, two big numbers capture the attention of both manufacturers and their logistics partners: $248 billion, the amount the “BRIC” nations (Brazil, Russia, India and China) are poised to account for in pharmaceutical sales for by 2016; and $8 billion, the amount global pharma will spend on cold chain logistics in 2014. Why are these two numbers so noteworthy? They demonstrate that as R&D goes, so goes logistics. As products evolve to meet demands for more targeted therapies, demand for more targeted logistics solutions grows as well. And that means a need for customization for everything from clinical trial samples to finished product.
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World Advanced Therapies & Regenerative Medicine Congress 2019

15-17 May 2019, Business Design Centre, London

The World Advanced Therapies & Regenerative Medicine Congress is an exhibition and conference that has grown to become one of the best and most established cell and gene events in the world today.     The 2019 edition will be in its 14th year and it continues to grow and attract a large audience of biotech, pharma, start-ups, investors, research and technology companies from around the world. The conference and exhibition will host over 1000 attendees, 250 speakers and 80 exhibition booths. Over 500 different global companies are represented every year at this event. 
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