Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Application of Company Core Data Sheet (CCDS) in globally established medicinal products to ensure the accuracy of product information across international markets

Santy Kerb (Abschlußjahr: 2010)

Summary
Language: English
Differences of product information between countries are the rule rather than the exception for established medicinal products, particularly for nationally authorised medicinal products. It remains a challenge for companies to maintain the complete overview and to provide reliable and consistent data across the markets, as it is necessary to ensure patient safety. To overcome this challenge, the CCDS was proposed by CIOMS as a source document containing all relevant product characteristics including safety data. Subsequently, a CCDS represents the companys worldwide safety information, which is used as reference safety information for the PSUR.
A survey was conducted to identify how pharmaceutical companies handle and implement a CCDS concept in practice as the basis of product information worldwide and also as the Reference Safety Information (RSI) for the Periodic Safety Update Report (PSUR).
A proposal is given to generate a CCDS for globally established products together with the implementation and maintenance processes.
Page: 42, Appendixes: 18 pages