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Meet the Expert: Ewelina Czerniec-Michalik

March 4, 2020 by Ewelina Czerniec-Michalik, Consultant

Meet Ewelina Czerniec-Michalik, a member of our team supporting clients with nitrosamine assessments in accordance with EMA guidelines.

ProPharma Group has launched a “Meet the Expert” series introducing you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to support clients’ complex challenges throughout the complete product lifecycle.

Meet the Expert: Ewelina Czerniec-Michalik, Consultant

Can you tell us what you do?

As a consultant in the life sciences department I’m involved in a wide range of quality driven projects – from advising on the structure of the quality management system, performance of risk assessments, to complex technology transfers. My role requires extreme flexibility as it may be purely technical, advisory or focused on team leadership, people management or both.

What do you like best about working with clients?

Consultancy requires being open to diversity. Similar projects and discussions, even within the highly-regulated pharmaceutical industry, are heavily impacted by the specific interpretation and working culture of people who are involved in them. My role is to find the right solution taking into account client’s expectations while following the applicable quality standards.

What are the biggest challenges on the horizon for our clients?

Regardless whether we are working on innovative therapeutics, gene modifications or generics, we are constantly facing regulation changes and observing new discoveries which may affect our quality and safety targets. Often the time to respond to these changes is very limited. One of the examples can be the EMA advice on nitrosamines, impacting marketing authorization holders of all synthetic medicinal products.

What is one lesson you’ve learned in this industry that has stuck with you?

Project teams or even entire companies very often take strategic decisions based on unverified assumptions. As external parties we are able to spot these situations and direct activities back to the compliant path. No internal employee is able to analyze the problem with this degree of objectivity.

What’s one thing you wish clients knew about ProPharma Group?

At ProPharma Group we support you by designing customized solutions using expertise of multiple consultants. Each project team is composed to meet the expectations and needs of our clients in the rapidly changing pharma environment.

 


To connect with Ewelina or our other experts, contact ProPharma Group.

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