In this article, we shine the spotlight on Gunilla Ingemarsson. Gunilla has been with NDA since 1999 and her focus is on CMC, covering the entire life cycle of medicinal products, from early development through clinical studies, marketing authorization applications and post-authorization activities.
The pursuit of lifelong learning
NDA’s Senior Consultant, Gunilla “Nilla” Ingemarsson, loves a good challenge. After 34 years within regulatory affairs, she still explores new areas where she can confront the bureaucracy of regulatory affairs and learn more about what it takes to put safe drugs on the market. Because of this drive, a year ago she was elected as a member of an expert group within the EDQM, the European Directorate for the Quality of Medicines & Healthcare.
EDQM works with the contents of the European pharmacopoeia (Ph. Eur.), an official collection of regulations and methods concerning the design, manufacturing, and quality of medicines.
“I have consulted the European pharmacopoeia in my day-to-day work for so many years, I thought it would be very interesting to understand the process behind it” Gunilla Ingemarsson says.
Normally, she would already have been in Strasbourg at the first two annual meetings with her task group, but these have, as so much else, been moved into the digital arena. The pharmacopoeia exists in order to help companies have a quality control that is equal to all making the same substance and using the same testing methods, not least the generics makers.
“When there is a new substance for pharmaceutical use, the relevant expert group begin preparing a monograph (substance specification), often together with the original manufacturer, but also together with government agencies and the academic world”.
The monograph establishes the criteria to which a substance or test method should conform to be considered acceptable for the manufacture of medicinal products and to be approved by regulatory agencies. The approved monograph should be used by any manufacturer who needs to know the regulations around what tests and analytical procedures applies to the substances they intend to use in production.
Gunilla Ingemarsson is slightly ambivalent to the task:
“There is so much nitty-gritty to wrap one’s head around, but on the other hand, all that nitty-gritty is essential to the manufacturers and therefore of outmost importance” she says.
The process of shaping a monograph may take several years as the specification is to be scrutinised and rewritten a number of times. Having had a first glimpse into the work, Gunilla Ingemarsson has got a better understanding of why it takes such a long time to create new or alter such specifications, something she has previously been wondering about.
“It is interesting to get a better insight into how it works and what can be found in the pharmacopoeia, but also to be able to pass that knowledge on within NDA”, she says.
Gunilla Ingemarsson has a degree in pharmacy and started out working at a pharmacy but was early on up for a challenge as she was employed as a chemistry and pharmaceutical assessor of corporate applications for approval at the Swedish Medical Products Agency.
She explains that she during her longstanding career in regulatory, continuously has been refining her knowledge and experience within the technical documentation concerning the chemistry, manufacturing, and control (CMC) of medicines. To perform well you need to have an attention to detail, communication and ability to learn as you go along, and the demand for Gunilla Ingemarsson’s support speaks for itself.
“CMC should not be the bottleneck in the development process”, she says.
And she sure likes her job.
“It is the variety that comes with the different projects that is so appealing”, she says. “It could be a big, new project where I have to learn everything about the product from scratch, but it could also be about supporting an SME with no prior knowledge about regulatory. It really is a jungle with all the rules and regulations and talking to the agencies can be daunting if you can’t follow in the discussions. I want every client to feel safe and comfortable in the process.”
Gunilla Ingemarsson humbly says that she just uses common sense, a sense that has proven to be very reliable as it is based on her experience and trusting what she knows. She has learned that, as a consult, you do not have to have all the answers yourself.
“The value you add is not just your own knowledge on a certain subject”, she says. “It is the capability of knowing where to find further information but also standing on the shoulders of a whole team of joint knowledge. It’s Invaluable”.
And Gunilla Ingemarsson just keeps on learning. She would like to continue working together with the EDQM group for another period.
“It takes time to master the procedures, and it is good to have new goals to achieve”, she concludes.