Pharmacovigilance Archives

MAH is the Key to the Pharmacovigilance: 10-year Lithuania Statistics

by Nick | Apr 21, 2020 | Pharmacovigilance

Even though the drug safety and reporting of the adverse effects is the responsibility of all Health Care Providers (HCP), pharmacists and patients, statistics show that the one in charge is Marketing Authorization Holder (MAH). During the National semi-annual...

Biomapas appoints Head of Global Pharmacovigilance

by Nick | Mar 13, 2020 | Pharmacovigilance

March 2020 – Clinical, regulatory and pharmacovigilance solution provider to the global life science industry, Biomapas, appointed leading pharmacovigilance professional Martijn van de Leur as Head of Global Pharmacovigilance. With offices located in Lithuania,...

What is a Safety Signal?

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...

Local Literature Surveillance Challenges and Specifics in the EU, CIS and LATAM regions

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...

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

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...

Harmonization of EAEU GVP: CIS is getting more vigilant than ever before

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...

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MAH is the Key to the Pharmacovigilance: 10-year Lithuania Statistics

Biomapas appoints Head of Global Pharmacovigilance

What is a Safety Signal?

Local Literature Surveillance Challenges and Specifics in the EU, CIS and LATAM regions

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

Harmonization of EAEU GVP: CIS is getting more vigilant than ever before

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MAH is the Key to the Pharmacovigilance: 10-year Lithuania Statistics

Biomapas appoints Head of Global Pharmacovigilance

What is a Safety Signal?

Local Literature Surveillance Challenges and Specifics in the EU, CIS and LATAM regions

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

Harmonization of EAEU GVP: CIS is getting more vigilant than ever before

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