Worldwide Harmonization of CTA-procedures in J&J companies
Sander Hortensius on his internship at Centocor, June 2010
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“Six months ago I applied for a traineeship at the Regulatory Affairs (RA) department of Johnson & Johnson. The project was related to the management of clinical trials and the organizational processes when implementing changes. With only little knowledge about the role of regulatory affairs, I started in December 2009 with this assignment. During my study, clinical research was described in detail; however this was only focused on the scientific value of the trials without mentioning the registration part. This new point of view offered me lots of interesting learning possibilities and the company stimulated me to fully explore this field. In addition the trainee period offered me the possibility to experience the pharmaceutical industry and orientate towards my future career.
My assignment was the harmonization of the process and the procedural documents of the Clinical Trial Application (CTA) coordination group. This group within the RA department is responsible for getting approval for a clinical trial. Due to historical factors, the group had multiple procedures for the same process, causing unnecessary confusing within the team, and in addition causing troubles when people were working on the same project. It was my job to make a process overview, organize all these different procedures and develop one harmonized procedure which is in compliance with the current regulatory requirements.
During the project I have made a process overview of the submission of a CTA, I have studied the current regulatory requirements (e.g. the European Directive on clinical trials). In addition I attended meetings with an internal quality control department within JNJ to ensure compliance of the developed harmonized procedural documents. With this project I depended on the input of multiple stakeholders in the process. Due to the priorities of these people, the willingness to provide the necessary input was sometimes not ideal. Although this problem is common in large organizations, it was sometimes causing delays and frustration.
Despite some challenging moments, my goals and objective were accomplished at a satisfactory level. In addition the view on my career is changed. I really enjoyed working in this section of the pharmaceutical industry; the work offers an interesting combination of strategic analysis, scientific input and regulatory requirements. After graduation I hope to get my first job in this particular field of interest.”Find more information on SBB internships and more SBB internship experiences on our website.
