Module 9 2021

For biologicals in particular

• The relatively new concept of advanced therapy medicinal products (ATMPs) is now a reality

• The principles apply globally but the EU has erected a dedicated supporting regulatory framework

• The unknown hazard/unquantified risk position is uncomfortable for any emerging technology, consequently the precautionary principle is prominent and risk-based safety evaluation is preferred

Regulation of Gene and Cell Therapy Sergio Fracchio

The Organisation for Professionals in Regulatory Affairs

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And now we are here…

• Thank you for your attention

• Enjoy the Masterclass

The Organisation for Professionals in Regulatory Affairs

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