Bart Cobert

Bart Cobert

bcobert@gmail.com

Pharmacovigilance, Drug Safety and Regulatory Affairs Author & Expert

Bart is a pharmacovigilance and drug safety consultant with 30 years in the pharmaceutical industry. He was a founding member and working group chair in ICH, and has written 4 textbooks on drug safety. Bart offers expertise in all areas of strategic pharmacovigilance including data management committees, mock Advisory Committee meetings, FDA & EMA/MHRA/AFSSAPS interactions, compliance, training, risk management (REMS/RMPs), crisis management, medical & safety analyses & white papers, and organizational change management. He is also a board certified gastroenterologist.

DMCs and SACs

/ Jun 07, 2018

Bart Cobert examines the importance of, and differences between Data Monitoring Committees (DMCs) & Safety Assessment Committees (SACs).

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

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

/ May 07, 2018

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

/ Mar 29, 2018

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

/ Feb 15, 2018

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

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Expanded Access Trials, IITs and Safety Risks

/ Jan 25, 2018

Bart Cobert examines expanded access/compassionate use trials and investigator initiated trials in light of the FDA’s revised guidance, issued in October 2017.

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EMA Move

EMA Move – The Details

/ Dec 19, 2017

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)

/ Nov 16, 2017

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

/ Oct 26, 2017

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

/ Sep 14, 2017

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

/ Aug 22, 2017

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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