Comparison of a global submission of new biological or chemical entity

Strategic decisions and criteria for implementation

Autori

• Andrea Herrmann-Strenge

Parametri

• 268 pagine
• 10 ore di lettura

• Salute & Medicina

Maggiori informazioni sul libro

The dissertation focuses on creating a comprehensive global regulatory strategy for marketing authorization applications of new chemical and biological entities. It involves a thorough analysis of pharmaceutical legislation and regulatory requirements across over 190 countries, highlighting both commonalities and differences. The objective is to equip stakeholders with the necessary knowledge to navigate diverse regulations effectively, ensuring successful submissions for marketing authorization in various regions worldwide.

Lingua: Inglese

Pubblicato: 2012

(In brossura)