Meet the Dopharma Team!

In the first edition we introduced the Area Managers at Dopharma International: Suzanne Dirven and Frank Bokkers.

Next in line are Marja van Schie and Irma van Deurzen from our regulatory department.

Can you tell us something about yourselves?

Marja: I’m Marja, born and raised in Breda in a family of 5 children. I’ve lived in Oosterhout for the past 28 years, a city about 10 km’s from the Dopharma office. I have a partner, 2 daughters aged 21 and 25 and a cat. My hobbies are cooking, reading, travelling, and running.

Irma: Hi! I’m Irma, born and raised in Tilburg, about 40 minutes by car from Dopharma, where I still live with my partner. I have 1 daughter, 2 bonus sons, and 4 bonus grandchildren. My hobbies include travelling, art, attending concerts, and reading.

What is your role within Dopharma and what are your daily responsibilities?

Marja: I’ve been at Dopharma for 23 years, and since 2015 I am Manager Regulatory Affairs Assistance. My team of 6 handles all administrative tasks for new registrations, variation requests, and renewals worldwide. I review the compiled dossiers before they are signed by Irma. I’m responsible for the correct submission, followed by the necessary follow-up until approval of the submissions.

Irma: I am the Managing Director of Dopharma Research, overseeing product development and regulatory affairs worldwide. My focus (together with my team) is on new developments resulting in new marketing authorisations and optimizing and maintaining existing marketing authorisations. The team comprises 27 employees spread across a pharmaceutical product development laboratory (FRL), a bio-pharmaceutical research laboratory (BFRL), an experimental farm and regulatory affairs staff. Besides I work closely together with the Regulatory Affairs team in Dopharma France.

What does the regulatory affairs process look like broadly? Who do you work closely with?

Irma: Firstly, a GO/NO GO assessment is made: besides scientific feasibility, the business case should be strong. After approval of the GO by the board, the project starts with pharmaceutical development (= formulation studies, manufacturing process, analytical control methods and stability studies). Depending on the product type, research on safety (for the animal, user, consumer and environment) and efficacy (dose finding and confirmation, field trials) is performed. The overall research process spans several years. We then compile a registration dossier for submission. Following this, we engage in question-and-answer sessions with regulatory authorities. Our initial aim is European registration, with submissions made accordingly, choosing the most suitable procedure. Depending on the product and procedure, development time ranges from 3 to 7 years.

Marja: Irma’s team provides the dossiers which we meticulously review for spelling and typographical errors, we complete the application form, add specific attachments and gather literature and reports. We coordinate with the leading authority on submission timing, adhering to their timetable. Following the deadlines mentioned in the timetable we submit responses to questions and make sure the Product Information is amended accordingly. After approval we make sure all relevant departments are informed

What does a typical workday look like for you?

Marja: First, coffee! I check my emails, assist my team with any queries, and review their work submissions. I also check Irma’s schedule to coordinate document signings, enabling colleagues to progress with tasks. In addition to internal meetings, we attend various meetings, such as with colleagues from Dopharma France. Irma and I have biweekly meetings, monthly team meetings, and joint team meetings every six weeks. We also attend monthly MT-Business meetings. Launch meetings for new products also crop up, so the day fills quickly with appointments and tasks. I’m also active in AnimalhealthEurope, participating in the Telematics working party and a TaskForce concerning Product Information.

Irma: My day is similarly unpredictable, often focusing on strategic discussions with the management. I also troubleshoot issues as they arise, check, approve and sign documents, liaise with colleagues from Sales, Marketing, Technical Support, and Production. Additionally, I am quite active in European industry organizations like AnimalhealthEurope (Management Committee, Technical Regulatory Committee and several task forces) and Fidin, participating in biweekly or monthly meetings.

When do you leave work with a smile on your face?

Marja: It’s most satisfying when we conclude a challenging procedure and still maintain a positive team atmosphere. Those days leave me content as I head home with a smile.

Irma: I agree. Registration and variation procedures can be very challenging. Several rounds of questions and answers are part of these procedures. In EU procedures member states can have different opinions, sometimes contradictory to each other. If we succeed in getting them all aligned and receive positive feedback/approvals, it is really gratifying. Also, a full office bustling with activity adds to the positive energy. A good laugh amidst the work also ensures a cheerful departure.

What has your work brought you, and what have you learned most?

Marja: The work is inherently fulfilling, and I take pride in it. The appreciation received adds to the satisfaction. I’ve learned that learning never stops. Despite 23 years in the same department, it’s never been dull; new challenges and corporate changes constantly present themselves.

Irma: For me too, despite significant growth, the family-owned aspect of Dopharma stands out. The board is still approachable for everyone in the company, and there are genuine opportunities for career advancement. Several colleagues have made rewarding careers here, which is very nice to see!