Meet Medfiles’ dedicated animal health team – experts in CMC, regulatory affairs, pharmacovigilance and animal feed

Eeva-Maija Walin, Senior Pharmaceutical Chemical (CMC) Expert

When did you start at Medfiles and what is your educational and work background?

This year, I’m celebrating my five-year anniversary at Medfiles: I joined the Medfiles CMC Team in August 2019. I have a M.Sc. degree in chemistry and some supplementary studies in pharmacy and microbiology. Before Medfiles, I had worked in the pharmaceutical industry for nearly 20 years, with different CMC positions in quality control and some years in regulatory affairs, but the majority of these years in R&D.

What tasks does your VET-related work include?

My VET-related work consists mainly of pharmaceutical-chemical documentation, such as documentation for Part II & Part IC1 for new marketing authorisation or variation applications, responding to requests for additional information during marketing authorisation procedures, CMC response strategies, evaluating existing marketing authorisation dossiers against current regulatory requirements (gap analysis), classification and writing of variations and writing or reviewing of different types of plans and reports, such as those related to process validation or technical transfers.

In addition to documentation work, I am involved with CMC-related project coordination, problem-solving and scientific consultation. Lately, I’ve worked with extremely interesting cases, such as a new marketing authorisation with a new chemical entity.

What are your core competences and strengths in the VET field?

My experience in working with regulatory affairs, R&D and commercial product maintenance has provided me with a comprehensive view of the entire lifecycle of drug development. I know how to bridge the gap between a scientific innovation and regulatory compliance, which is crucial for successful product approval and market entry. In addition, having a dog in the family makes veterinary medicines feel all the more important and brings even more meaning to my work.

How is working with veterinary medicines different from working with human medicines?

Working with veterinary medicinal products (VMPs) brings more variety to my work. While the fundamental principles of CMC regulatory work are the same, there are differences in requirements and considerations. Veterinary and human medicinal products are regulated under different legislation. For example, the structure of the marketing authorisation dossier as well as the variation classification system are different for VMPs.

The CMC requirements for VMPs must take multiple species into account. This diversity leads to different formulations, dosages and routes of administration. And for VMPs intended for food-production animals, the CMC documentation must address residues of the drug in edible tissues. Environmental risk assessments (ERA) are required for both human and veterinary medicinal products, but for human medicinal products, the nature and scope of these are generally different and often less complex compared to those for VMPs.

Best thing about working at Medfiles?

Flexibility in ways of working and the possibility to influence the content of your work.

Elina Krannila, Senior Regulatory Affairs Expert

When did you start at Medfiles and what is your educational and work background?

I started at Medfiles back in 2011, fresh out of university. I initially focused on human medicinal products, but already in 2012 got the opportunity to also work with veterinary medicinal products. My educational background is in pharmacy, and I have a master’s degree in the field, with a specialisation in industrial pharmacy.

What tasks does your VET-related work include?

I mainly handle regulatory tasks related to marketing authorisations (MA) of veterinary medicines. Our team of RA specialists works daily with veterinary MA applications and maintenance tasks which concern veterinary medicinal products approved in the EU through the centralised (CP), mutual recognition (MRP), decentralised (DCP), subsequent recognition (SRP) and national (NP) procedures. We follow the latest news in the field closely and are well-versed in veterinary legislation and the applicable regulatory guidance, such as the EU Veterinary Medicinal Products Regulation, UK VMD guidance and the US FDA guidance.

What are your core competences and strengths in the VET field?

My core competence is in ensuring compliance with veterinary medicines regulations. My strengths are interpreting the regulatory requirements and communicating with a multidisciplinary team of experts, including the competent authorities. This means having an eye for detail and at the same time, being able to analyse the best approach and schedule for the overall regulatory process. Gaining approval for an MAA or a variation or bringing a veterinary product to the market is always a group effort, in which an experienced RA plays a crucial role.

How is working with veterinary medicines different from working with human medicines?

I would say the most significant difference is having completely different implementation deadlines and procedures for variations not requiring assessment (VNRAs) which are now handled for VET medicines via a separate portal, namely the UPD. On a more general level, another significant practical difference is that in some countries the competent authority is different for VET and HUM medicinal products. With the implementation of the new veterinary Regulation (EU) 2019/6, the differences are even greater between VET and HUM medicines. The benefit with the common VET Regulation is that within Europe, there is less variation from country to country as the regulation is in force as such and there are clear guidelines and templates in use specifically for VET medicines.

Best thing about working at Medfiles?

My colleagues: to be surrounded and supported by such friendly, enthusiastic and professional colleagues is heartwarming and something I truly enjoy every day.

The wide variety of interesting and meaningful projects: My favourite tasks are related to products reaching new markets. It is always a joy to be a part of such teamwork and to be able to contribute to this with my own expertise – and to gain more expertise along the way.

Saana Lamminjoki, Safety Manager

When did you start at Medfiles and what is your educational and work background?

I joined the Medfiles Pharmacovigilance Team in May 2021 and before that, I worked as a community pharmacist. I have a bachelor’s degree in pharmacy and a master’s degree in general toxicology.

What tasks does your VET-related work include?

My VET-related work involves a range of responsibilities, focusing on the safety and efficacy of veterinary medicinal products. My tasks include monitoring published scientific literature, signal detection and management, risk management activities and evaluating and processing adverse event reports originating from the EU, UK and third countries. We work in close collaboration with veterinarians to ensure that all safety issues are addressed at an adequate level. I’m also involved in the pharmacovigilance system master file (PSMF) and quality management system maintenance, and together with our team, we make sure that all our VET-related SOPs and processes are compliant with the current regulations. Recently, our VET team has been implementing the new Veterinary Medicines (Amendment etc.) Regulations 2024 that came into force in the UK in May 2024.

What are your core competences and strengths in the VET field?

My studies in toxicology have given me a great foundation for assessing the safety of products in different species. I approach my work with precision and efficiency, and I believe my skills in scientific writing are particularly valuable when producing reports, such as those needed for signal management. Additionally, my passion for the veterinary field in general drives me to contribute to the well-being of animals. This combination of competence and deep personal interest helps me to manage large-scale veterinary pharmacovigilance projects efficiently and with care.

How is working with veterinary medicines different from working with human medicines?

Working with veterinary medicines presents unique challenges compared to human medicines. For one, we deal with multiple species, each with its own physiological differences. Also, as animals cannot directly communicate adverse events, we must rely on observations from owners and veterinarians. This makes it more of a challenge to assess potential adverse events and safety signals. Since veterinary products have their own set of regulations, the requirements for pharmacovigilance in this field are also different from those of human medicines.

Best thing about working at Medfiles?

Medfiles has offered me an incredible opportunity for professional growth. Our pharmacovigilance team consists of experts with different backgrounds, and I’m happy to be able to learn and work together with them.

Mari Eskola, Senior Regulatory Affairs Expert (food, feed and cosmetics)

When did you start at Medfiles and what is your educational and work background?

I joined Medfiles in the summer of 2021. I have worked with food and feed regulatory safety from different angles since 1997, and I got my PhD in food science in 2002. For ten years, I analysed foods and feeds for contaminants and residues to establish their regulatory compliance at national food safety authorities and the Joint Research Centre of the European Commission. Between 2007 and 2017, I worked with human and animal risk assessments on contaminants at the European Food Safety Authority (EFSA) and acted as Head of the EFSA Unit on Contaminants. After that, I worked at an Austrian feed company developing new feed additives for the EU and US markets and at the European Chemicals Agency (ECHA), where I worked with biocides which are also used in food and feed production.

What tasks does your feed-related work include?

I assist Medfiles’ global feed clients with the regulatory aspects related to feed materials and feed additives. This could include regulatory positioning of feed ingredients: whether they are regarded as feed materials or feed additives in the EU, or whether they require a petition or GRAS evaluation in the USA. My feed tasks can also include writing gap analyses in order to identify the scientific data needed for EU/USA authorisations or writing application dossiers to apply for EU or US market authorisations.

I also often give regulatory advice, in smaller and bigger matters, to Medfiles’ feed clients who can contact me anytime they have open questions. And sometimes I also help our feed clients with REACH and CLP requirements.

What are your core competences and strengths in the animal health field?

My strongest expertise and key competence definitely lies in conducting chemical risk assessments for farm animals and pets. I also have good knowledge, gained at EFSA, on human and animal toxicology, also on livestock and pets. My long research expertise in food and feed chemistry and analytical chemistry is my other strength. And as I was raised at a dairy farm, it helps a lot with the overall understanding of animal husbandry and farming.

How is working with animal feed different from working with food products?

The biggest difference is that for food, there is only one consumer group, humans, while for animal feed, the consumers vary from different livestock animals to pets, ranging from dogs and cats to dairy cows, crustaceans and insects.

Best thing about working at Medfiles?

I love our clients – they are simply the best. The second best thing is the regulatory work itself, as I can contribute to making sure that the animals are fed with safe feeds and humans with safe foods across the world.