How did you decide to participate in the Biomapas Academy?

The first thing that caught my attention was the Biomapas Academy poster hanging on my university’s bulletin board. Shortly afterwards, the faculty management shared Biomapas’ invitation to register for the first Biomapas Academy. I wanted to learn more about this company, so I decided to take my chances and apply to the Academy. I was thrilled when I received a call with the happy news that I had successfully passed the selection process and was invited to attend the Academy.

 

What was your experience during the three months?

I listened to many interesting lectures, during which we got to know the company and its areas of activity. We listened to lectures on clinical trials and their organization, pharmacovigilance, regulatory affairs, bioethics, drug registration, and more. I believe that the knowledge gained at the Academy is valuable and helpful for all participants of the Academy and their future careers.

What did the future hold for you after the Academy?

I mainly was interested in pharmacovigilance, so we agreed on an internship in this department during the summer. Interesting fact: the first Biomapas poster I saw was about pharmacovigilance! And the best thing is that after the internship, I was able to join and become a part of this great team. I am happy to be here and to learn from real professionals in this field.

 

What would you say to the future participants?

I want to encourage everyone who is thinking about participating in the Biomapas Academy. Being at the Academy is exciting and worthwhile. By joining the Academy, you will broaden your horizons, learn from global professionals, improve your life sciences knowledge, and gain valuable experience. I wish good luck to all participants. See you soon at Biomapas!

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

Regulatory Documents Translation Process – How to Ensure Consistency and Correctness

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

Running a Clinical Trial in Ukraine

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

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

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