Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Challenges and Considerations in Developing a Regulatory Compliance Department in a Medium-sized German Pharmaceutical Company ***

Dr. Christian Strube (Abschlußjahr: 2017)

Summary
Language: English
Regulatory compliance indicates the conformity of the manufacturing instructions with the details deposited in the Marketing Authorisation. After its approval by a regulatory authority, the manufacturing process of a medicinal product reflects the current technological standard of manufacturing. It is relatively easy to be compliant and to produce the medicinal products according to the Marketing Authorisation at the moment of approval. However, during its life cycle, each drug product undergoes a number of changes, which also bring the risk of potential non-compliance.
There are different approaches in the way large and small companies deal with regulatory compliance challenges. Small- and medium-sized companies may have fewer financial and human resources; nevertheless, they have to comply with all the relevant regulations and laws in the same way and to the same extent as "Big Pharma". Regulatory compliance is not negotiable, and smaller companies have to find methods to handle the challenges that accompany constant shifts and changes in the regulatory environment.
This master thesis provides some considerations and suggestions to help manage regulatory compliance and to develop a Regulatory Compliance Department. It looks at two major aspects: achieving regulatory compliance and maintaining it. Additionally, regulatory intelligence aspects and the diverse departments as well as the key personnel involved in regulatory compliance are examined - showing that a Regulatory Compliance Department alone is not able to ensure regulatory compliance. The whole company beginning with the senior management carries responsibility for it.
Pages: 35, Annexes: 1 pages 26