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.
Meet the Expert: Elina Koli, Senior Consultant QP (ATMP)
Located in: Leiden, the Netherlands
What do you do at ProPharma Group?
I am a Senior Consultant Qualified Person (QP) for Advanced Therapy Medicinal Products (ATMPs). ATMPs are a fascinating and diverse group of modern medicines based on engineered tissues, manipulated cells or recombinant nucleic acids. Cell and gene therapies are typical ATMPs. QP has a pivotal role to ensure the safety of patients.
The main responsibility of a QP is to ensure that every drug batch going to patients meets the required quality, meaning it is safe and effective. To fulfill this duty, QP inspects, oversees, and audits different functions of a drug manufacturer. The role of QP is set in law (Directive 2001/83/EC) and the job comes with personal responsibility over the quality of any drug (clinical or commercial) that the QP releases for patient use. ProPharma Group has its own MIA license with named QPs who can perform batch release for clients within EU/EEC. Alternatively, ProPharma Group QPs can be named on client’s own MIA license.
What do you like best about working with clients?
Every client is unique and with each one I get the chance to apply my knowledge into a different scenario. Having the chance to work with clients offers repeated opportunities for certain operations that I would come across very rarely in case I would work for a single employer. Luckily for me, the most interesting and challenging projects tend to be those most often outsourced.
Describe the biggest challenge facing our clients/industry today. How are we addressing this?
The ATMP field has been moving forward very fast with regulatory bodies playing an active role to open the path for these therapies to patients. If client’s regulatory knowledge is not up to date, a major challenge for the client from my point-of-view is how to take full advantage of the shortcuts laid out by the regulatory bodies – to have an efficient regulatory strategy. The continuous internal and external training made possible by ProPharma Group ensures that our personnel have the up-to-date knowledge on regulatory possibilities.
What is a current trend you’re seeing in the industry and how does it impact our clients?
I’d like to mention two: First, digitalization is making steady progress on the ATMP front and new players in the field should definitely take advantage of these. Laboratory information management systems (LIMS) and electronic quality management systems (eQMS) streamline the path forward towards the markets.
Second, I am glad to see that the ATMP industry is moving very fast from open to closed processing steps. For some areas this has been the standard for years, but some are still moving there. These improvements may require major investments from our clients, but the benefits outweigh the cost in almost every imaginable case, not least because of operator and patient safety considerations.
What’s one thing you’d like for potential clients to know about ProPharma Group?
We have incredible body of knowledge in our organization and even if it is just one of us performing an activity for a client, there are numerous experts to review and verify the plans or results before delivery. Let’s take an audit performed on behalf of a client as an example: I will create and write the audit documents as an auditor, but the documents go through a review in our internal audit group before being sent forward to the client. These fail-safes allow us to learn from each other and ensure high-quality results.
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