The United Kingdom (UK) submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union (EU). This means that the United Kingdom will become a ‘third country’ from 30 March 2019.
According to Directive 2001/83/EC the reference member state (RMS) must be a member of the EU. As a result the RMS role in Mutual Recognition and Decentralised Procedures (MRP/DCP) must be transferred to an EU country.
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.
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.
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.
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.
The Association of International Clinical Research Organizations (AICROS) is a network of small to mid-size CROs, which provide clinical research services to the pharmaceutical, biotech and medtech industries. Biomapas joined AICROS in 2014 and since then has been an active member of the association. On the 20-22 February, Biomapas’ CEO Audrius Sveikata participated in the AICROS Annual meeting, which took place in Tel Aviv, Israel. Audrius shared his insights about the meeting and the future perspectives of the association.
Biomapas a annoncé récemment avoir reçu de la part du Ministère de l’enseignement supérieur et de la recherche l’accréditation Crédit d’Impôt Recherche (CIR) pour une période de trois ans.
Biomapas has recently announced that it has received Research Tax Credit (Crédit d’Impôt Recherche; CIR) accreditation for a three-year period from the French Ministry of Higher Education and Research.
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In January 2017 Biomapas became active in an European Union funded project of strengthening international competitiveness by raising awareness in foreign markets.
On 11th June 2017, Biomapas team has participated in Citadele Kaunas Marathon, which took place in Kaunas old town. Watch the video with exciting moments from the run!
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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