Tag Archive: Pharmacovigilance

Data Security and Privacy Part 1

Data Security, Protection and the US-EU Privacy Shield: Part 1

Bart Cobert reviews the HIPAA and current EU data privacy system and their impacts on drug safety and PV.

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Going 75 Miles an Hour

Bart Cobert explains the risk to a company when drug safety and PV are not done correctly.

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EMA Move

EMA Move – The Details

It’s decided: the EMA is moving to Amsterdam, The Netherlands by March 30, 2019. Less than two years away. Bart Cobert highlights the PV/Drug Safety concerns of the EMA move.

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FDA Adverse Events Reporting System (FAERS)

FDA operates one of the largest and most complete databases of adverse events on drugs marketed in the US. FAERS data is now easily searchable online.

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Online Drug Safety

Safety of Drugs Bought Abroad or Online

Many US patients are obtaining drugs from online and foreign pharmacies. Bart Cobert examines this trend, and its impact on drug safety.

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EU Update: EMA Relocation & EU Inspections

The EU is in turmoil as the Brexit EMA relocation continues to percolate, particularly behind closed doors. Also EU inspections are being discussed.

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Laws, Regulations, Guidances, Guidelines and Best Practices

Bart Cobert attempts to clear up the confusion around Drug Safety and PV requirements in different regions of the world, with a focus on US and EU requirements.

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Brexit, Again

Brexit, Again

The UK has given official notice that they will withdraw from the EU. With Brexit seemingly moving ahead, Bart Cobert looks at its effects on the world of pharmacovigilance.

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7 Steps for Managing Adverse Events in Social Media

Any time a pharma organization engages in social media monitoring, they have to be prepared to uncover potential adverse events. Here are 7 best practices for managing this process.

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When Medical Information Becomes a Drug Safety Issue

Closely-tied Medical Information and Drug Safety departments, with a seamless adverse event intake and hand-off processs, offer better quality control, scalability and risk mitigation.

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The Experience Matters.

As an industry leader in business process outsourcing, C3i Solutions delivers global, multi-channel engagement solutions. The Experience Matters. Let us show you why.

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