Ken VanLuvanee’s Post

In the EU, regulatory CMC flexibilities have been implemented for certain licenced biological medicinal products. While the legislative requirements for quality, safety and efficacy still apply, flexible approaches can be taken at critical stages of the product lifecycle, such as postponing some CMC requirements to the post-authorization phase or leveraging of prior knowledge (PrK). Find out more from my colleague David Murray.

In the EU, regulatory CMC flexibilities have been implemented for certain licenced biological medicinal products. While the legislative requirements for quality, safety and efficacy still apply, flexible approaches can be taken at critical stages of the product lifecycle, such as postponing some CMC requirements to the post-authorization phase or leveraging of prior knowledge (PrK). Find out more from my colleague David Murray.

In the EU, regulatory CMC flexibilities have been implemented for certain licenced biological medicinal products. While the legislative requirements for quality, safety and efficacy still apply, flexible approaches can be taken at critical stages of the product lifecycle, such as postponing some CMC requirements to the post-authorization phase or leveraging of prior knowledge (PrK). Find out more from my colleague David Murray.

In the EU, regulatory CMC flexibilities have been implemented for certain licenced biological medicinal products. While the legislative requirements for quality, safety and efficacy still apply, flexible approaches can be taken at critical stages of the product lifecycle, such as postponing some CMC requirements to the post-authorization phase or leveraging of prior knowledge (PrK). Find out more from my colleague David Murray.

In the EU, regulatory CMC flexibilities have been implemented for certain licenced biological medicinal products. While the legislative requirements for quality, safety and efficacy still apply, flexible approaches can be taken at critical stages of the product lifecycle, such as postponing some CMC requirements to the post-authorization phase or leveraging of prior knowledge (PrK). Find out more from my colleague David Murray.

In the EU, regulatory CMC flexibilities have been implemented for certain licenced biological medicinal products. While the legislative requirements for quality, safety and efficacy still apply, flexible approaches can be taken at critical stages of the product lifecycle, such as postponing some CMC requirements to the post-authorization phase or leveraging of prior knowledge (PrK). Find out more from my colleague David Murray.

In the EU, regulatory CMC flexibilities have been implemented for certain licenced biological medicinal products. While the legislative requirements for quality, safety and efficacy still apply, flexible approaches can be taken at critical stages of the product lifecycle, such as postponing some CMC requirements to the post-authorization phase or leveraging of prior knowledge (PrK). Find out more from my Parexel colleague, David Murray.

In the EU, regulatory CMC flexibilities have been implemented for certain licenced biological medicinal products. While the legislative requirements for quality, safety and efficacy still apply, flexible approaches can be taken at critical stages of the product lifecycle, such as postponing some CMC requirements to the post-authorization phase or leveraging of prior knowledge (PrK). Find out more from my colleague David Murray.

In the EU, regulatory CMC flexibilities have been implemented for certain licenced biological medicinal products. While the legislative requirements for quality, safety and efficacy still apply, flexible approaches can be taken at critical stages of the product lifecycle, such as postponing some CMC requirements to the post-authorization phase or leveraging of prior knowledge (PrK). Find out more from my colleague David Murray.

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