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Regulatory And Development Strategies For Gene & Cell Therapies

Post thumbnail Regulatory And Development Strategies For Gene & Cell Therapies

The launch of a product is one of the most critical moments in its life-cycle. The product trajectory is firm within the first six months for 85% of pharmaceutical launch. Understand the end goal and product-specific requirements. Rely on science and experience as it is a strong scientific rationale which wins more often than not. Lastly, keep in mind that strong relationships and appropriate interactions with the FDA can reduce development timelines.

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    presentation by

    Mike Day
    Michael Day, PhD
    Senior Director a Regulatory Science
    As Senior Director Regulatory Science at VCLS, Michael (Mike) is responsible for providing both regulatory strategy and CMC consulting services…
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