Insights & Resources
For Life Sciences Professionals.
Whether you’re a healthcare professional, a researcher, or simply interested in drug development, you’ll find valuable information and resources here that can help you stay informed and make informed decisions. Let us know what else you’d like to hear about!
Featured Insights
The Perfect Match: How Mid-Sized CRO–Site Network Partnerships Drive Clinical Trial Success – Watch the Recording
How medical writing supports every stage of the drug’s lifecycle
Discover how clinical research and medical writing intertwine across all phases of drug development, from drafting early trial documents to post-marketing activities.
Harmonizing Product Information Across Baltic Markets
In this case study, we share how one of our partner companies successfully harmonized their SmPC, PIL, and labelling across the Baltic region, working with our medical writing experts.
Topic
Remaining Vigilant and Compliant after Brexit: What’s next? (Latest Updates)
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.
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.
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.
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.
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.
