Implementation of ISO 9001 and 13485 standards: what does it bring to company and clients?
June 5, 2017
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. Therefore, we have discussed about the influence of current changes to the whole company and its’ quality management with Egidija Pauriene, MD, Quality Assurance Director. (more…)
Changing regulatory environment: eCTD submissions to become obligatory as of 2018
April 26, 2017
A new challenge is about to be faced by the Marketing Authorization Holders of medicinal products. Since online tools are becoming bigger part of our daily lives, the competent authorities are as well moving forward step by step. As of 1st January 2018, European Medicines Agency will require that all regulatory submissions for medicinal products authorized via Decentralized or Mutual Recognition Procedure would be provided in eCTD format.
Tuberculosis Medicines Clinical Development in Eastern Europe and CIS
March 24, 2017
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 designates the day in 1882, when Dr. Robert Koch announced that he has 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.
Future Perspectives of Clinical Pharmacologists: CRO Setting
February 27, 2017
Since 2015, Biomapas is an official partner of Lithuanian University of Health Sciences in the training program of Clinical Pharmacology Residency. During the third year of their studies, young professionals have a Drug Development module and as a part of it they have a month of practice in Biomapas.
Biomapas receives Knowledge Economy Company 2016 award
January 27, 2017
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 a high value-added products or services. The awards are patronized by the President of the Republic of Lithuania Dalia Grybauskaitė.