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Aivaras Aliukonis

Sebastien Duval joins Biomapas as Chief Business Officer to lead the business development department and extend Biomapas continued growth in the global life science industry.

Biomapas appoints Chief Business Officer

By | news1

March 2020 – Sebastien Duval joins Biomapas as Chief Business Officer to lead the business development department and extend Biomapas continued growth in the global life science industry. Sebastien Duval brings over 20 years of experience in the life science industry, previously acting as VP Sales Account Management at IQVIA, and further back in his career working as VP Business Development at Synteract, Executive Director, Global Head of Clinical Phase II-IV Business Development at QPS and as VP European Business Development at Premier Research.

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Oleg Kungurtsev, MD, Manager Clinical Operations, Country Manager Ukraine at Biomapas

Running a Clinical Trial in Ukraine

By | news1

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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Martijn van de Leur as Head of Global Pharmacovigilance.

Biomapas appoints Head of Global Pharmacovigilance

By | news1

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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Poland 2020

Biomapas strengthens its footprint in Poland in the run-up to its further growth in Central Europe

By | news1

February 2020 – Clinical, regulatory and pharmacovigilance solution provider to the global life science industry Biomapas announced strategic growth in Warsaw. With offices located in Lithuania, Switzerland, Sweden, Russia, Georgia, Ukraine and now in Poland, Biomapas provides services in 60+ countries across 4 continents. As a functional and full outsourcing solution provider, with a new office in Central Europe Biomapas will strengthen its international team and geographical coverage of its services.

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Regina Auškalnienė, Head of Clinical Operations at Biomapas

Regina Auskalniene will lead Lithuanian Good Clinical Practice and Regulatory Affairs Association

By | news1

Regina Auskalniene, Head of Clinical Operations at Biomapas, was elected to lead Lithuanian Good Clinical Practice and Regulatory Affairs Association. The association unites middle size and global CROs in the Baltic countries and is focusing on creating the most efficient environment in Europe to deliver clinical trials. „Everyone in our association agrees that we can run much more clinical trials in the Baltic states, thus creating an attractive place for clinical research in the future,” said Regina Auskalniene.

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

By | news1

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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Josefina Jakobsson, MSc Pharmacovigilance Specialist Biomapas

What is a Safety Signal?

By | news1, Uncategorized

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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Eglė Deimantavičiūtė, MSc, Medical Writer, Biomapas

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

By | news1

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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Oleg Kungurtsev, Manager Clinical Operations

What You Need to Know about Running a Clinical Trial in Russia?

By | news1

Russia is a very perspective country for international clinical trial conduction. The first international clinical trial was set up in Russia about 20 years ago only, and from than country kept a great potential for market development. In 2018 health authorities (HAs) approved 653 clinical trials (CT) in Russian Federation, less in overall numbers compared to the same indicator from 2016 – 898 approved CTs. However, this decrease was observed across all types of clinical trials except for international multicentre clinical trials (IMCT).

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Ramune Rukiene, Director Regulatory Affairs

Biomapas appoints Director Regulatory Affairs

By | news1

Ramune Rukiene joined Biomapas as Director Regulatory Affairs to further strengthen continued growth and geographic extension of Biomapas. Ramune will play an important role by leading regulatory activities, ensuring highest service quality and maximizing the efficiency of medicinal and veterinary product placement into the market. Furthermore, Ramune will work together with the management team to set a regulatory affairs strategy and to deliver unmatched service experience and quality in the market.

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