WEBINAR | Certificate of Suitability 2.0 (CEP)

May 9, 2024
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Discover the future of pharmaceutical regulation with the European Pharmacopoeia’s new Certification of Suitability (CEP) 2.0.  

Streamlining the certification process and enhancing transparency, CEP 2.0, launched in September 2023, is set to accelerate drug approvals and strengthen public health safeguards. It has been transforming the landscape for regulatory submissions and promises a more user-friendly approach, higher transparency, and the harmonization of quality standards. The result? A potential reduction in the time-to-market for drugs and an enhancement of public health protection. 

Join Asphalion expert Enrique Solana, our Scientific & Regulatory Affairs Senior Officer, as he dives into: 

  • New certificate format – CEP 2.0 
    • New format – CEP 2.0 
    • Certificate versions co-existing: Old/Hybrid/2.0 
  • CMC updates with CEP 2.0 
  • How to achieve successful CEPs submissions 

 

Register here: WEBINAR CERTIFICATE OF SUSTAINABILITY 2.0 

For further information you can contact us at: [email protected]  

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NEWS | Important Update from the FDA!

This guidance recommends steps manufacturers and applicants of active pharmaceutical ingredients (APIs) and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in drug products. The guidance also describes conditions that may introduce nitrosamine impurities. The unexpected finding of nitrosamine impurities, which are probable or possible human carcinogens, in certain drug products has made clear the need for a risk assessment strategy for the potential presence of nitrosamines in any drug product.

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