by Nick | Jan 6, 2020 | Pharmacovigilance
Occasionally we see the information of a safety signal for medical product, but what does it really mean? We can describe the safety signal as an indication for new and significant safety-related data for a marketed product. The new data could indicate a new...
by Nick | Jul 4, 2019 | Pharmacovigilance
Pharmacovigilance legislation introduced by the European Commission in 2012 and GVP guidelines together with local requirements committed each marketing authorization holder (MAH) to perform literature review in countries where their products are present. According to...
by Nick | Mar 8, 2019 | Clinical Research, Pharmacovigilance, Regulatory Affairs
On 29th March 2017 United Kingdom (UK) submitted 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 30th March 2019. Even...
by Nick | Apr 8, 2018 | Pharmacovigilance
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...
