Dr Carolin Hermann’s career has taken her from research on oncolytic viruses, through cell therapies, to the development of recombinant proteins and GMP-regulated manufacturing processes. Along the way, she has gained different perspectives across the medicinal product lifecycle – from research and development through manufacture and testing to quality assurance and GMP compliance.

She recently joined PharmaKorell as a senior consultant. In this interview, Carolin explains what has shaped her view of quality, which developments will shape the pharmaceutical industry in the years ahead, and why she finds the responsibility of the QP role particularly compelling.

You have worked with a wide range of biological medicinal products – from research on oncolytic viruses in Oxford, through ATMPs, to a recombinant fusion protein in clinical development. How has this shaped your view of quality?

All the medicinal products I have helped develop have one thing in common: they are novel and complex. Their manufacture requires innovative processes or unusual analytical assays, and there is often no regulatory precedent to draw on. That is why risk identification and risk assessment are, for me, at the heart of all quality assurance.

To me, quality means bringing together scientific understanding, GMP requirements and risk assessment. Ultimately, it always comes down to making a well-founded, traceable decision on the basis of all the available information – and thereby safeguarding patient safety.

Which principle guides you in quality decisions?

I always try to understand why something has happened before I assess how to deal with it.

In GMP systems, there are rarely simple yes-or-no decisions. More often, it is a matter of critically evaluating data, putting risks into perspective and understanding the context. My experience across different areas of the pharmaceutical industry helps me here.

My principle is therefore: quality does not come from blindly following rules, but from people who take responsibility and make well-founded decisions.

Where do you see the key developments that will shape the pharmaceutical industry in the coming years?

In my view, three themes will shape the industry in particular: robust supply chains, the growing use of digital technologies, and the further development of innovative therapies such as antibody-drug conjugates, antibody-radionuclide conjugates and ATMPs for in vivo cell therapy. At the same time, the central challenge remains unchanged: to provide patients with medicinal products that are safe, effective and of consistently high quality.

What attracts you to the role of Qualified Person?

The QP role brings together many of the aspects that have motivated me since the start of my career. It requires scientific understanding and regulatory expertise, combined with the ability to make balanced decisions.

What I find particularly compelling is the responsibility that comes with batch certification. Behind every decision lies the question of whether a medicinal product can be released for patients with a clear conscience.

Precisely because I have come to know development, manufacture and quality assurance from different perspectives, I see a future role as a QP as a natural progression of my professional path.

Our reflections on CPHI Milan would not be complete without the conversations at the Taiwan Pharma Pavilion.

We devoted an afternoon of CPHI Milan to the Taiwan Pharma Pavilion.

On Wednesday, Dr. Frank Wienen and Dr. Benedikt Ball joined the Taiwan–Italy Business Matching forum:

🎤 14:20: Frank Wienen addressed the forum on “Entering the European Pharmaceutical Market”, setting out the regulatory path into the EU step by step
🤝 15:00: five rounds of one-to-one business matching
🍽️ Evening: Taiwan Pharma Night

Our sincere thanks to the Taiwan Bio Industry Organization, and to Elijah Huang in particular, for the invitation, the flawless organisation and the warm hospitality, and to the companies of the delegation who took the time to meet us.

Some 9,500 km lie between Taipei and Lörrach. After Wednesday, the distance feels a good deal shorter.

If you want to know what drives Taiwan’s pharmaceutical industry, spend a morning at their booth.

On Wednesday at CPHI Milan, Dr. Benedikt Ball spent the morning at the booth of the Taiwan Pharmaceutical Alliance, meeting a number of its member companies.

The questions were practical and specific: what does it take to supply the EU market from Taiwan? The answers came down to three topics: on-site EU GMP inspection, EU import, and product certification by a Qualified Person.

Our sincere thanks to the Taiwan Pharmaceutical Alliance, and to Miranda Liang in particular, for the invitation and the thoughtful organisation, and to the participating companies for conversations of real technical depth, carried by genuine interest on both sides. 謝謝!”

👟 16,000 steps a day, each
📅 3 days
🤝 26 meetings
🌍 1 fairground so large that, on the long walks between halls, they could occasionally make out the curvature of the Earth

The two covered a lot of ground in Milan, in every sense. From hall 8 to hall 20 and back again, they met manufacturers and partners from India, China, Korea, Taiwan, Germany and France to talk about EU import, Qualified Person certification and inspection readiness.

Their feet have recovered. The follow-ups are under way.

Thank you to everyone who made time for us. If we missed you in Milan, send us a message. 

That was the thread running through nearly every conversation Dr. Frank Wienen and Dr. Benedikt Ball had at CPHI Milan this week. They met API and finished-product manufacturers, CDMOs and vaccine producers from India, China, Korea and Taiwan, all looking at Europe and asking what it takes in practice: EU import, Qualified Person certification and inspection readiness.

Thank you to everyone who took the time to meet us. We are heading home with a full notebook and a long list of follow-ups.

Didn't manage to catch us in Milan? Send us a message and we'll continue the conversation from our office in Germany.

Dr. Benedikt Ball and Dr. Frank Wienen are on site this week, meeting partners, clients and new contacts from across the global pharma community. It's great to see so many familiar faces and to have so many good conversations in one place.

Meet PharmaKorell at CPHI in Milan from 6th to 8th October!

As an independent German pharmaceutical consulting company, PharmaKorell has been supporting over 200 pharma and biotech companies worldwide in more than 30 countries since 2007. With a team of over 20 experts, we offer services such as quality management, import into Europe, QP certification, and pharmaceutical logistics.

Our team on site:

Dr Frank Wienen

Dr Benedikt Ball

We look forward to meeting you in person, exploring opportunities for mutual growth and discussing how we can best support you. Please feel free to get in touch via the event app or via email.

We would like to inform you today of an important change in the management of PharmaKorell GmbH.

As part of a long-term succession plan, Dr Ulrich Korell, founder of PharmaKorell GmbH, has fully transferred his management responsibilities to Dr Frank Wienen. Dr Korell has decided to step down from his role as Managing Director with effect from 31 July 2026.

Since founding the company in 2007, Dr Ulrich Korell has built and shaped PharmaKorell through his extensive professional expertise, entrepreneurial foresight and unwavering commitment to pharmaceutical quality. We are deeply grateful to him for his many years of dedication and his significant contribution to the successful development of the company.

Dr Frank Wienen will continue to lead the company, having served as Co-Managing Director of PharmaKorell GmbH since April 2023. As a pharmacist, he brings many years of experience in senior positions within the pharmaceutical industry and, together with the team, will continue to drive the successful development of the company. As the company’s founder, Dr Ulrich Korell will remain closely connected with PharmaKorell GmbH in the future.

For our clients, partners and employees, full operational continuity remains assured. Your contacts, ongoing projects and our high standards of quality and service will remain unchanged.

We owe Dr Ulrich Korell a great debt of gratitude for his lasting contribution as founder and Managing Director of PharmaKorell GmbH. As PharmaKorell enters this next chapter, we look forward to continuing our trusted and successful collaboration with our clients and partners.

Our clients and contractual partners will receive further information directly by email.

How many individual pieces come together to form one shared picture. That is what we experienced during our team outing.

At a painting studio in Basel, we tried our hand at Puzzle Painting: each person painted their own section of a Kandinsky art piece. On its own, each piece was difficult to interpret; only when brought together did the full picture become visible. Two paintings were created: one for our office in Munich and one for Lörrach.

We also incorporated small symbols representing our six company values into each painting. A fitting metaphor for how every individual contribution matters and how its full impact only unfolds through collaboration.

After lunch together, we enjoyed a guided tour of Rötteln Castle in glorious weather.

Thank you to paintiteasy.ch for the creative inspiration.

As part of regular internal workshops, we engage with our six company values: professionalism, cooperation, responsibility, trust, respect and appreciation. The central question is what these values mean for our day-to-day collaboration - both within teams across different sites and in our work with customers.

During these workshops, it became clear that the topic of failure culture is particularly closely linked to all six values.

This topic has significant practical relevance, especially in the GMP and GDP environment. Work in this area is shaped by regulatory requirements, defined standards and established processes. Deviations can have an impact on product quality, patient safety and the company’s reputation. It is therefore essential to prevent errors as far as possible while also ensuring that they are handled professionally.

Since human work cannot be made completely error-free, even in well-organised systems, the way errors are dealt with is just as important as prevention.

At PharmaKorell, clear processes, clearly defined responsibilities, well-organised quality management and a culture of trust all play an important role in preventing errors.

A resilient failure culture begins where errors occur despite preventive measures. For PharmaKorell, a good failure culture therefore means using errors as a starting point for learning and improvement. This requires the ability to speak about errors openly, objectively, solution-orientatedly and on an equal footing. In this context, both the factual level and the relationship level of communication are relevant.

To address this connection systematically, two consecutive workshops were held, prepared by Dr Cora Büttner together with an external company. While the first workshop was moderated externally, Cora actively contributed to the facilitation of the second workshop as co-moderator.

First workshop

During the first workshop in 2025, the three most common everyday errors were collected from all working areas at PharmaKorell. These errors were then assigned to categories and assessed using the risk classes anchored in the quality system. The assessment took into account both the severity of the impact and the frequency of occurrence.

After the workshop, it was reviewed whether additional error-prevention measures should be established for the top three errors identified in each area. This approach was deliberately based on the structured handling of errors as embedded in the GMP system.

Another key focus of the first workshop was communication about errors. It is precisely in this context that it becomes clear that factual analysis and interpersonal interaction cannot be considered separately.

Second workshop

Recently, the topic was explored in greater depth in a second workshop. The focus was broadened from communication about errors to respectful communication in challenging situations. Particular emphasis was placed on clarity, self-regulation and mutual respect.

The workshop built on the four sides of a message according to Friedemann Schulz von Thun, which had already been addressed previously. Schulz von Thun is a German communication psychologist who developed a communication model according to which every message contains several levels: factual content, self-revelation, relationship and appeal.

Communication on an equal footing means that conversation partners treat one another with the same level of respect and regard each other as equal, irrespective of role or situation. This is particularly relevant when dealing with errors, as factual clarification is most successful when communication is not dominated by superiority or subordination.

Transfer into everyday working life

A central topic of the workshop was how the content developed could be transferred into practice and how the company’s own communication in critical situations, as well as its failure culture, could be further developed.

At the end of the workshop, each team member formulated a personal future contribution to successful communication as part of a gallery walk.

In addition, it is planned to use the “Highlights” session in regular jour fixe meetings to exchange experiences and discuss improvements that have arisen from errors. Mutual feedback on one’s own communication style is also expressly welcome.