Module 3 Presentations

07/05/2024

The CMC Challenge

Are we opening Pandora´s Box by applying new processes (“the product is the process”- true?) and technologies?

Cheaper and faster, but … new CMC (and RA) challenges and related risks …

How to mitigate risks, how to gain control of these changes and how to keep the desired quality?

CMC Project Management

The Organisation for Professionals in Regulatory Affairs

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Impact of Increasing Regulatory Oversight For The Pharma Supply Chain (1) Science has already outpaced quality regulations (2) Quality regulations are likely to be required to keep up with the development of new product formats, digitalization and new technologies (3) Due to more complex supply chains , policy makers worldwide are enforcing stricter regulations for manufacturing and logistics (4) By developing and maintaining the ability to adapt their supply chains , companies in the pharmaceuticals sector will be well prepared to seize the opportunities ahead (5) Quality regulations, and industry, may have to continually adapt to address these challenges

CMC Project Management

The Organisation for Professionals in Regulatory Affairs

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