Blog

Sciformix is committed to sharing ideas and insights with the life science industry and support the development and commercialization of safe and effective products. Our employees and partners share their knowledge and thought leadership.

Signal Management and Its Role as a Critical Component of Pharmacovigilance


Mitchell Gandelman

Introduction Signal management is one of the most crucial steps in pharmacovigilance and is defined in numerous guidelines to various degrees (EMA Guideline on Good Pharmacovigilance Practices (GPV) Module IX – Signal Management1, FDA Guidance for Industry, Good Pharmacovigilance Practices and Pharmacoepidemiology...

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David Balderson, Vice President of Global Safety Operations

What is ICSR Quality and How Is It Measured?


David Balderson

In my experience of being in the operational side of Safety for the last 16 years, I have learned that the perception of what ICSR (Individual Case Safety Reports) quality means often varies between the company’s perspective as an MAH (Marketing Authorization...

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Optimizing Global Labeling Operations


Boris Jankowski

From my experience and interacting with labeling professionals around me, I can safely say that 10 years ago labeling development by itself was sometimes very disconnected from the drug development process. When we look back we see a Target Product Profile (TPP)...

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Patient Reported Outcomes of Adverse Events (PRO-AEs) for Better PV Outcomes


Supriya Desai

The Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium was convened to improve safety reporting by better incorporating the perspective of the patient. PROSPER comprises industry, regulatory authority, academic, private sector and patient representatives, interested in the area of patient reported outcomes of...

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