Samantha McDonald, Senior Regulatory Manager, Benchmark Animal Health
While my background is in animal health, previously working as a Study Director for a global research organisation, aquaculture was completely new to me when I joined Benchmark Animal Health. As someone driven by high quality work and an eye for detail, I knew Benchmark would be the perfect fit. I jumped at the opportunity to help drive sustainability in aquaculture, by being involved in the development of new medicines and technology to improve fish welfare, while protecting the environment.
The only constant part of my ‘typical’ day is a strong coffee to get me started!
There is an element of unpredictability in regulatory affairs, and so I have to combine being organised with the ability to be flexible, depending on what comes up each day. My remit covers both sides of the Atlantic, so while I may have planned out my day in advance, this could shift entirely based on emails or requests coming through overnight!
Over the last 3 years I have predominantly supported the team with the regulatory lifecycle of Salmosan® Vet.
I oversee all regulatory aspects for Benchmark’s sea lice treatment, Salmosan® Vet which has registrations in the UK, Norway, Faroe Islands, Canada and Chile (under the trade name Purisan®). This is a product which we have been continuously working to improve, both in terms of efficiency for customers, but also in terms of being more sustainable for the natural environment.
Given we are present in different markets across the globe, a significant portion of my time is spent ensuring Salmosan® Vet complies with any regulatory changes. This can be a challenge across the various regions, which all have different rules and guidelines! My role is grounded in providing support on product development, providing regulatory advice on ongoing projects, alongside preparing, writing and submitting key regulatory documents.
My proudest achievement so far has been helping lead a significant label change to Salmosan® Vet in Canada
As a team, we have achieved great things with Salmosan® Vet. However, my proudest achievement to date has been my involvement in helping lead a major label change to our Salmosan® Vet product in Canada.
By working closely with regulatory bodies in Canada, in December 2021, we were able to update to a three-hour treatment time label change. This was then followed by an amendment to the number of treatments permitted per year in 2022. For customers, this means improved efficacy with reduced variability, and increased flexibility for performing treatments throughout the production lifecycle of the fish – resulting in a much stronger tool for use in an integrated pest management programme.
I thoroughly enjoyed working closely with numerous people from across the Benchmark Animal Health team, including quality, operations and marketing. The role I played is a source of great pride and saw me awarded the Commercial Award at Benchmark Global’s ‘Living our Values’ awards at the end of 2022. I was delighted to be recognised, but truly I couldn’t have delivered the project on my own. As always at Benchmark, it was a full team effort.
Next on the list is working with the relevant regulatory bodies to replicate this label change in other regions.
Keeping up with the ever-changing regulatory landscape can be a challenge.
I joined Benchmark in 2015, and at the time there were only two people in the regulatory affairs team – so I had to learn quickly! Today our team is still small, but has doubled to four with people based throughout the UK and in Portugal. We work closely with our Pharmacovigilance team, and our colleagues in Chile and the USA who provide us with local insights into our key markets.
Over the last few years, we’ve seen a number of major changes impacting regulatory affairs in aquaculture, particularly in the EU. With Salmosan® Vet being registered in the UK, I have seen first-hand the impact of Brexit on the industry, and the challenges of navigating the new regulatory landscape.
The second major change in recent years was the implementation of the new Veterinary Medicines Regulation (EU 2019/6) in 2019. This resulted in several modifications to the European regulatory framework, which we need to comply with. As you can imagine, keeping up to date with all these regulatory changes, and their impact on our products and licenses, can be a challenge!
Looking forward, CleanTreat®, our water purification system used alongside our sea lice medicine Ectosan® Vet in Norway, provides exciting opportunities for the aquaculture industry.
Benchmark has been at the forefront of improving the sustainability of sea lice management through the use of medicinal bath treatments. The potential of our CleanTreat® water purification system is huge, helping reduce the environmental impact of treating sea lice while reducing the risk of microbial resistance – two of the biggest challenges in the sector.
I’m excited to see what the future holds and looking forward to playing my part in Benchmark’s continued success.
