Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
I work as Senior Director Compliance & Quality Assurance (CQA) in Europe. I manage a team of 20 QA consultants across EU. We provide services mainly in GMP/GDP with highly experienced Qualified Person (QP), Responsible Person (RP) and QA-managers. We also have our own manufacturing and importation authorization (MIA) for QP-certification of client's batches.
In my role I make sure, together with my line managers, that our team is correctly allocated, that we provide good quality of service, support our Business Development in client interactions and work together with Talent Acquisition making sure we have the right SME ready to support our clients' projects.
That every client and project is unique. I have been working here for 8 years, but I am constantly exposed to new challenges and hurdles that our clients face that require our support. For every project I have learned something new that I take with me in discussions with new clients. You never stop developing!
To help clients solve problems. They come to us because they have a need, to fill a gap, or solve an issue. It's very satisfying to provide a solution that will make the client happy.
Well, you cannot avoid talking about the elephant in the room here. It's a lot of emailing, but that's a part of the game. To keep on top of everything that is going on you need to communicate, so a big part of my time is spent emailing, chatting and meetings with clients, my team, and other stakeholders at ProPharma. Between that, I review and approve proposals, calculate budgets, interview consultants, and plan our resources together with my colleagues in the management team.
The biggest challenge today is for the regulators to keep up with pace on the development in new technologies. There is so much going on in the industry right now. For example, in advanced technologies, in gene therapy and in AI. We can really bring better treatments to patients, but the regulations and laws defining the pharma industry are based on how we did drug developments 20-30 years ago. I think the pandemic and the fast development of new vaccines really showed that if the industry and the regulators come together, it's possible to do amazing things on a very short time. Let's bring that spirit also to other therapies!
Personalized medicines. If pharma 20-30 years ago was all about block busters (one size fits all), today it's about finding the right therapy for each patient. This can be done in numerous ways but one of the strongest trends is ATMP and gene therapy. But it doesn't need to be as complex to change a patient's genome, it can also be to identify patient's gene-set up to tailor the treatment to a specific subtype of the population.
To connect with Anders or our other experts, contact ProPharma.
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