Tag Archive: FDA

Data Security, Protection and the US-EU Privacy Shield: Part 2

Data Security, Protection and the US-EU Privacy Shield: Part 2

Bart Cobert reviews the key requirements for the US-EU Privacy Shield, including implications for US Firms, Pharma Companies, and Drug Safety & Pharmacovigilance

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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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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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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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AEs in Children

Drug Safety and AEs in Children

As the saying goes, children are not small adults. Thus the approach of pharmacovigilance to AEs in children needs to be different from that in adults.

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Remote PV Audits & Inpsections

Remote PV Audits & Inspections

The advantages and disadvantages of remote audits and inspections – also called virtual inspections, distant inspections, paper inspections, web inspections, and telephone inspections.

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Adverse Events: Not Just a Concern for Healthcare

Frank Pettinato discusses the FDA database which catalogs adverse event and product complaint info for foods, dietary supplements, and cosmetics.

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CURES Act of 2016 and Drug Safety

A look at the somewhat controversial law was passed in late 2016 known as The 21st Century Cures Act - and its implications for drug safety.

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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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