Why did you decide to participate in the Biomapas Academy?

The first time I heard about Biomapas Academy was from a friend who was already working in the pharmacy field. She sent me an advertisement for Biomapas Academy, which highly intrigued me. As I was in my last year of life science master studies, I wanted to discover my potential career possibilities and learn more about clinical trials. Therefore, without long thinking, I filled in the application form. I was very happy to be selected from quite many applicants and be invited to attend Biomapas Academy.

How was your experience during the three months?

We had four months of weekly lectures on different topics. They were related to the organization of clinical trials, regulatory affairs and pharmacovigilance of various medical products. Biomapas experts who resented the lectures even shared their personal experience and actual practical examples with us. We have been able to get acquainted with Biomapas company and its work specifics. Here we could expand our knowledge of the pharmaceutical industry.

 

How do you feel after graduating from the Academy?

I feel thrilled for taking a chance to participate in this unique project. After graduating from all the courses and tasks, I was absolutely honoured to be selected as the best student of Biomapas Academy 2020 and receive a scholarship. However, I mostly appreciate the valuable knowledge and experience I believe will be helpful for my future career. I think Biomapas Academy definitely contributes to the education of young professionals and is very useful, especially for those who want to get to know their professional opportunities better.

Biomapas Academy

What is Clinical Research? Regulatory Affairs? Pharmacovigilance?

Implementation of ISO 9001 and 13485 standards: what does it bring to company and clients?

Implementation of ISO 9001 and 13485 standards: what does it bring to company and clients?

Compliance with high quality standards is a non-negotiable performance parameter in Pharmaceutical and Medical Device industries. During 2016, Biomapas was re-certified according to the newest ISO 9001 standard version. Moreover, at the beginning of 2017, ISO 13485 implementation into BIOMAPAS Quality Management System was initiated. We discussed the influence of current changes to the whole company and its quality management with Egidija Pauriene, MD, Quality Assurance Director.

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Changing regulatory environment: eCTD submissions to become obligatory as of 2018

Changing regulatory environment: eCTD submissions to become obligatory as of 2018

A new challenge is about to be faced by the MAHs of medicinal products. Since online tools are becoming a bigger part of our daily lives, the competent authorities are also moving forward step by step. 1st Jan 2018, the European Medicines Agency will require that all regulatory submissions for medicinal products authorized via Decentralized or Mutual Recognition Procedure will be provided in eCTD format.

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Tuberculosis Medicines Clinical Development in Eastern Europe and CIS

Tuberculosis Medicines Clinical Development in Eastern Europe and CIS

World Tuberculosis Day is commemorated every year on 24th March to raise awareness of tuberculosis, which is still causing death of nearly 1.5 million people each year, mostly in developing countries. It marks the day in 1882, when Dr. Robert Koch announced that he had discovered the cause of tuberculosis, the TB bacillus. In comparison to other infectious diseases caused by a single infectious agent, tuberculosis is the second biggest killer worldwide.

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Biomapas announces the opening of a new office in Sweden

Biomapas has recently announced the opening of a new office in Stockholm, Sweden. This new location strengthens Biomapas’ presence in the Nordic countries and further accommodates the rapid growth of the company.

The expansion into the Nordics is in direct response to demand from Biomapas clients seeking local Regulatory and Pharmacovigilance support. The company already has offices in Switzerland, Lithuania, Russia, Georgia and Ukraine.

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Harmonization of EAEU GVP: CIS is getting more vigilant than ever before

Harmonization of EAEU GVP: CIS is getting more vigilant than ever before

On the 6-7 March, Biomapas Pharmacovigilance Department management and team from the CIS region participated in a meeting in Minsk. It was dedicated to strengthening collaboration between the team members as well as updating knowledge on latest PV trends. We discussed the most recent releases of legislation, such as Eurasian Economic Union Good Pharmacovigilance Practice harmonization and the importance of a teamwork approach with Biomapas’ PV Project Manager CIS, Aliaksandr Bakshtanovich, MD.

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European Union Funding

In July 2020 Biomapas started an EU funded project of research and development activities by creating an artificial intelligence (AI) tool for pharmacovigilance services.

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Biomapas receives Knowledge Economy Company 2016 award

26th January, 2016 Biomapas representatives attended the Knowledge Economy Forum award ceremony at the Presidential Palace of the Republic of Lithuania. The Knowledge Economy Company awards are granted each year from 2004 in order to honor the most progressive and innovative companies operating in Lithuania, creating high value-added products or services. The awards are patronized by the President of the Republic of Lithuania Dalia Grybauskaitė.

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