First Master of Pharmaceutical Regulatory Affairs
5 years ago, Medicademy and the University of Copenhagen launched a new Master’s Degree Program in Pharmaceutical Regulatory Affairs.  By end February this year, the first student graduated.
In 2006, the Regulatory Affairs Manager at Johnson & Johnson Consumer Nordic, Lisbeth Thyregod, embarked on an educational journey with Medicademy. A journey, that would take her all the way to a Master of Pharmaceutical Regulatory Affairs. This February, she passed the last exam and became the very first student to obtain the prestigious Master’s Degree. However, a Master’s Degree was not part of her plans, when Lisbeth Thyregod began her studies.

»My goal was to obtain a Diploma in Pharmaceutical Regulatory Affairs, but when Medicademy and the University of Copenhagen established a graduate program, I decided to strive for the Master’s Degree. There will always be a need for qualified employees within regulatory affairs,« says Lisbeth Thyregod of her motivation for studying and continues:
 »With the increasing regulatory requirements, it is important that the pharmaceutical industry has access to dedicated and qualified employees within regulatory science, who know their way around the regulatory procedures and are able to ensure a fast and efficient registration process. Fact is, if there is no license to sell, there is no business.«

A wish to access markets faster
A fast and efficient registration process influences sales positively, because the products reach the market faster. This is of great importance to the company, and Lisbeth Thyregod’s superior of three years is happy to have a dedicated employee.

»No one doubts Lisbeth’s dedication to regulatory affairs.  It is a gift to any employer to have dedicated employees. The graduate program has provided her with the latest, updated knowledge within regulatory affairs, and she knows exactly where to find information, when she needs it. That is a great advantage to our company, « says Head of Regulatory Affairs Nordic Region, Lisa Andersson, stressing that Lisbeth Thyregod is able to support the organization with valuable input.
»Lisbeth knows how to interpret various guidelines, and she has the ability to support our projects with strategic inputs and thereby ensure that we do the right things at the right time, « says Lisa Andersson.

A better employee
Lisbeth Thyregod has gained more confidence in her own skills and has no doubt that she is an even better employee now, than she was before her studies, because her regulatory confidence has improved significantly.
»I am now able to ask the right questions at the right time, my regulatory confidence has grown, and the program has groomed me to be a regulatory project leader. I am able to make fast, strategic, and regulatory assessments of nearly any matter within regulatory affairs and not least to communicate my assessment in a clear language, « says Lisbeth Thyregod, and does not wish to pin-point a “best part” of the graduate program, since each module has increased her knowledge and overview of the three pillars of Regulatory Science: efficacy, quality and safety.

The end of a long journey
After 5 years of part-time studying, it is almost surreal for Lisbeth Thyregod to add “Master of Pharmaceutical Regulatory Affairs” to her CV. It has been a long, but very fruitful journey.
»It will probably take a while for me to get used to the fact that I no longer need to plan my days around lessons and exams, and that I don’t have to consider, which regulatory issues I should write about in my next project. I have spent numerous summer holidays studying, so I owe it to my very patient family to spend more time with them. I think, I have proved that you can juggle both a busy job and a family with good planning – and in the process obtain a Master’s Degree, « concludes Lisbeth Thyregod and recommends the program to anyone interested in regulatory affairs.

To find out more about Medicademy Pharmaceutical Regulatory Affairs, please visit www. Medicademy.net or contact Program Director Mrs Tina Jensen: tj@medicademy.net