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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 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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