At the time, I had already finished my Bioengineering studies, but I was continuing them in the Medical Biology field. As for quite some time Biomapas has been stuck in my mind as a prestigious company in the life sciences industry, I would visit their website or social networks for the latest news from time to time.

This is also how I found out about the Biomapas Academy.

 

Why did you choose to become part of the Biomapas Academy?

Actually, it’s mostly because of one conversation that influenced my perspective towards career paths. I have a relative that has become a career consultant. So, at the end of my Medical Biology studies, I figured, why not have a conversation with her? And it turns out that the key takeaway for me was unexpected: I was not open-minded enough about the real-life application of my master’s degree. Now I can see that it was true, but at the time, it was a surprise. I thought that my degree would solely give me a license to work in clinical laboratories in hospitals, but that was not true.

I got convinced that it was time for me to broaden my horizons and look at all possible perspectives a life sciences background can bring. So, I could not resist applying to the Biomapas Academy when I saw the announcement.

 

What was the Biomapas Academy like?

It was great to see how well organized this educational project was and how much you could learn about the main three areas. The lecturers are real experts in their respective fields and share a lot of information. Furthermore, I was surprised by how eventful the field of drug safety can be – we do not see most of it in our daily lives.

What did you do after the Biomapas Academy?

Once I started going to the Academy, one thing led to another. I received an invitation to try myself out in the Pharmacovigilance department as an intern even before the end of the Academy itself. I didn’t doubt much about the offer as the pharmacovigilance field was the one that got my attention the most during the Academy course. You hear about clinical trials a bit more often than what happens after the products reach the market.

Halfway through my internship, the people management team reached out to me about an open position in the QPPV team. It was in an area that piqued my interest, so I decided to apply. After a few interviews, I got the great news that I got the position! The remaining few weeks of my internship were joyful, knowing that I would continue as an employee.

 

So, what is your role in Biomapas?

Currently, I am an assistant in the QPPV team, which operates in a wide range of various analytical tasks related to drug safety on a global scale. The acronym QPPV stands for a specific legally obliged person who is personally responsible for the pharmacovigilance process of a particular drug. The team I am part of is full of highly skilled and experienced QPPVs who have become my career mentors and advisors. It also means that this is the right team to be in if I want to become a QPPV myself one day.

 

Any wishes to the future participants?

If you keep considering what career path might be the best for you, I advise you not to doubt and apply to the Biomapas Academy. You will at least gain a broad understanding of how the drug development process works, and it’s a great addition to your resume. If you are lucky, this might become a much greater experience than just an interesting set of lectures and assignments – it could potentially lead your future career too, just like it happened to me.

From the moment I entered Biomapas, it has exceeded my expectations so far. Besides the ability to analyze medical information, I like that many other qualities are helpful in the job: from my natural proactivity to language skills. Even the sales background gained in several part-time jobs during studies reflects the versatile, client-oriented atmosphere here at work. So Biomapas is a place where all – my life science education, experience, personality, and skills – found a home, and Biomapas Academy was the project which led to finding that home.

We can never be sure of where life will bring us. And this is a fun, risk-free way to try the industry out and see if it’s the right fit for you.

Biomapas Academy

What is Clinical Research? Regulatory Affairs? Pharmacovigilance?

Biomapas appoints Head of Global Regulatory Affairs

Biomapas appoints Head of Global Regulatory Affairs

May 2020 – Olga Bernardova joins Biomapas as Head of Global Regulatory Affairs to lead the regulatory affairs department and to ensure the best processes and means to serve Biomapas growth and international expansion. As a functional and full outsourcing solution provider, with offices in Lithuania, Switzerland, Sweden, Russia, Georgia, Ukraine, Poland and Kazakhstan, Biomapas continues to expand its international team and further increases capabilities for client-oriented solutions.

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Regulatory Documents Translation Process – How to Ensure Consistency and Correctness

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Mistranslation of regulatory documents such as a summary of product characteristics, product information leaflets and instructions for use, could have a negative impact for the company and most importantly could lead to serious consequences to a patient’s health. In 2007, as a result of inaccurate translation, 47 patients had badly implanted knee prostheses. An outer package labelled in English included different information.

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Biomapas Opens a New Office in Kazakhstan

Biomapas has announced the opening of a new office in Central Asia. The new location in Kazakhstan strengthens Biomapas presence in the CIS region and further improves flexible and reliable clinical, regulatory and pharmacovigilance service delivery to the global life science industry in emerging markets. As a functional and full outsourcing solution provider, with a new office in Almaty, Biomapas continues to expand internationally.

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MAH is the Key to the Pharmacovigilance: 10-year Lithuania Statistics

MAH is the Key to the Pharmacovigilance: 10-year Lithuania Statistics

Even though the drug safety and reporting of the adverse effects is the responsibility of all Health Care Providers, pharmacists and patients, statistics show that the one in charge is Marketing Authorization Holder. During the National semi-annual conference „Pharmaceutical News“, State Medicines Control Agency presented the statistics of suspected ADRs reporting in Lithuania.

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Running a Clinical Trial in Ukraine

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Despite the fact that Ukraine is the largest country in Eastern Europe with a large population of treatment-naïve patients, well organized public health care sector and significant number of medical sites accredited for clinical trial conduction, country has utilized only 15% of its current potential for hosting clinical trials. During 2017, the European Medicine Agency (EMA) gave positive recommendations on 94 new drug applications and 49 of them were tested in clinical trials in Ukraine. During the same year, the US FDA approved 151 new drugs, and 28 of them were also studied in Ukraine.

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Biomapas appoints Head of Global Pharmacovigilance

Biomapas appoints Head of Global Pharmacovigilance

March 2020 – Clinical, regulatory and pharmacovigilance solution provider to the global life science industry, Biomapas, appointed leading pharmacovigilance professional Martijn van de Leur as Head of Global Pharmacovigilance. With offices located in Lithuania, Switzerland, Sweden, Russia, Georgia, Ukraine and Poland, Biomapas provides services in 60+ countries across 4 continents. As a functional and full outsourcing solution provider, Biomapas continues to strengthen its international team and geographical coverage of its services globally.

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Regulatory Affairs Outsourcing: From Baby Steps in Cost Savings to Long-Term Partnerships

Regulatory Affairs Outsourcing: From Baby Steps in Cost Savings to Long-Term Partnerships

The trend of outsourcing continues to grow in the life science industry. Global regulatory affairs outsourcing market was valued at US $5.7 billion in 2018, and is expected to witness a compound annual growth rate of 11.9% over the period to 2026. Regulatory affairs outsourcing may vary in extent (from stand-alone service to full-scope solution), length (project based or long-term partnership with selected vendor), model (insourcing a dedicated expert for specific project or functional service provision), etc.

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What is a Safety Signal?

What is a Safety Signal?

Occasionally we see the information of a safety signal for medical product, but what does it really mean? We can describe the safety signal as an indication for new and significant safety-related data for a marketed product. The new data could indicate a new potentially causal association between an adverse event, beneficial response and a medical product, or a new aspect of causal association that was previously known. Usually, a signal will be relevant for all products with the same active ingredient, including the combination products. Further, let’s look more at the main steps of the safety signal management.

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Rx to OTC Switches – 5 Things You Need to Know before Considering a Switch

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In the process of marketing authorization, competent authorities classify medicinal products as the subject or not-subject to medical prescription. However, the classification of medicinal products can be reevaluated and changed via a regulated procedure. When considering a switch, many factors like characteristics of market and population, local policies, advertising, confidence in regulatory authorities and other, influence the outcome. Though, the safety of patients has the highest priority. So, what questions should you ask?

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Local Literature Surveillance Challenges and Specifics in the EU, CIS and LATAM regions

Local Literature Surveillance Challenges and Specifics in the EU, CIS and LATAM regions

PV legislation introduced by the European Commission in 2012 and GVP guidelines together with local requirements committed each MAH to perform literature review in countries where their products are present. Compliance with mandatory requirements and guidelines is not always a simple task when local requirements and specifics come along. In this article, we will take a closer look at these challenges and specifics for local literature surveillance in different regions as EU, CIS and LATAM.

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Big Enough To Cover  All Your Needs. Small Enough To Care.

Discover the tailored solutions that Biomapas provides to accelerate your clinical trials and optimize your drug development process.

Clinical Research

Regulatory Affairs

Pharmacovigilance

Medical Information