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Pharmacovigilance Brexit

Remaining Vigilant and Compliant after Brexit: What’s next? (Latest Updates)

By | news1

On 29th March 2017 UK submitted the notification of its intention to withdraw from the EU. This means that UK will become a ‘third country’ from 30th March’19. Even though leaving the EU with a deal remains the Government’s top priority, UK drug agency is publishing a series of guidance documents for industry and other stakeholders covering the proposed arrangements for the regulation of medicines, medical devices and clinical trials, if UK leaves EU with no deal.

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Biomapas receives Knowledge Economy Company 2016 award

By | news4

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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Tuberculosis Medicines Clinical Development in Eastern Europe and CIS

By | news3

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

By | news3

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

By | news3

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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Biomapas: Improving the Document Review Process

By | news3

Biomapas currently covers 64 countries across Europe, CIS and MENA regions. Being able to provide clinical trial, regulatory affairs, medical writing and vigilance solutions to all of these countries requires us to have a large repertoire of native speakers on staff.

Since providing top quality work to our customers has always been of paramount importance for Biomapas, we needed a way to ensure document accuracy, and therefore decided to look at proofreading software to help us maintain quality.

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Egle Pavyde, Mpharm, PhDc, Business Development Director

CIS and Eurasian Economic Union: high Pharma industry interest and new legislation

By | news3

The interest of pharmaceutical companies in expanding business across CIS region has been constantly growing. For the same reason, Biomapas has expanded presence and now covers the whole CIS region, providing core services: clinical research, regulatory affairs, pharmacovigilance.
Associate Director Business Development Egle Pavyde, shares some thoughts about region peculiarities, recent legislation changes and Biomapas experience providing RA and PV services in CIS.

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