Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The Company Core Patient Information (CCPI) - a useful tool for regulatory compliance?

Theresa Löschmann (Abschlußjahr: 2021)

Summary
Language: English
The aim of this Master thesis was to evaluate if a Company Core Patient Information (CCPI) is a useful tool for regulatory compliance.
For this, the worldwide regulatory requirements for patient information, exemplified by the requirements from Australia, Canada, the European Union, Switzerland, the United States of America, and the World Health Organization prequalification program, were evaluated and could be summarized with the key words <lay language> and <clearly legible>. The requirements were then examined in terms of feasibility and applicablity for a company core safety information/ company core data sheet (CCSI/CCDS). This examination concluded that the CCSI/CCDS does not meet the requirements of a patient information and can therefore not serve as basis for creation of the patient information and thus the implementation of regulatory requirements.
Next, the creation of a CCPI as potential company strategy to fulfil the above mentioned health authority requirements was outlined considering the content, the writing itself and the addressed CCPI user: the local affiliate. The following questions were discussed:

  1. What should be transferred from CCSI/CCDS to CCPI?
  2. How to transfer the information from technical language into lay term language?
  3. Who should be involved in this process?
  4. When should the transfer take place?

Finally, a decision analysis was performed to assess the usefulness of such a tool based on classified objectives. The objectives included but were not limited to

  • Improve compliance with the company position as described in the CCSI/CCDS.
  • Improve patient safety by clearly legible patient information.
  • Reduce workload.

The decision analysis has shown that the CCPI fulfils all set objectives and is therefore a useful tool for regulatory compliance. However, the decision analysis has also shown that maintaining a CCPI is not the only strategy for a company to have patient information that are regulatory compliant and that corresponds to the company's position as described in the CCSI/CCDS.  

Pages: 42 (p.8-49)
Annex: 18 (p.54-72)

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