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CMC: Best Practice in Effective IND and IMPD writing

by Nick | Aug 6, 2020 | Regulatory Affairs

Previously, we have discussed the importance of dedicated team for CMC writing as well as project management aspects for effective IND/IMPD writing (previous text here). This time we will focus on technical writing and preparation for it. Also, I will provide some...

What do you need to know while preparing RMP for EAEU and CIS region?

by Nick | Aug 4, 2020 | Pharmacovigilance

Preparation of Risk Management Plan (RMP) for a specific medicinal product usually is the responsibility of the Qualified Person Responsible for Pharmacovigilance (QPPV) and its team. Thus, QPPVs and their team’s should be familiar with legislation requirements...

CMC: Effective Writing of IND and IMPD

by Nick | Jun 17, 2020 | Regulatory Affairs

Do we truly know how to ensure IND or IMPD Quality (CMC) part is written in good quality, consistent and clear technical language? How to effectively manage the writing process? In this article, I will focus on these questions and the initial IND/IMPD, required to...

Running a Clinical Trial in Ukraine

by Nick | Mar 24, 2020 | Clinical Research

Despite the fact that Ukraine is the largest country in Eastern Europe with a large population of treatment-naïve patients, well organized public health care sector and significant number of medical sites accredited for clinical trial conduction (more than 800...

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,...

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CMC: Best Practice in Effective IND and IMPD writing

What do you need to know while preparing RMP for EAEU and CIS region?

CMC: Effective Writing of IND and IMPD

Running a Clinical Trial in Ukraine

Biomapas appoints Head of Global Pharmacovigilance

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CMC: Best Practice in Effective IND and IMPD writing

What do you need to know while preparing RMP for EAEU and CIS region?

CMC: Effective Writing of IND and IMPD

Running a Clinical Trial in Ukraine

Biomapas appoints Head of Global Pharmacovigilance

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Clinical Research

Regulatory Affairs

Pharmacovigilance

Medical Information

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PV System & QPPV

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