Pharma IQ Members

Elie Magdalani

Pharmacoepidemiology and Pharmacovigilance

As an important arm for pharmacovigilance, recently many voices are raised to consider using clinical trials in the post-marketing surveillance phase and not only depending on non-clinical or experimental methods to study drug safety issues after marketing the drug.

by: Elie Magdalani
Published: July 4, 2011
Tags: Elie Magdalani, pharmacoepidemiology, pharmacovigilance, epidemiology, drug safety, clinical pharmacology, adverse drug reactions, Adverse Drug Reaction, ADRs, Adverse Event, AE, pharmacovigilance activity


Elie Magdalani

Medication Errors - A Shared Responsibility

We can not separate pharmacovigilance from medication errors, pharmacovigilance had always been concerned with minimizing the risks of adverse drug reactions and medication errors. Pharmacovigilance contributes to the detection and prevention of medication errors, collaboration of all parties will improve the quality of data collected, and enhancing patient safety. A shared responsibility, in detecting Medication Errors depends on the collaboration of the patient, the pharmaceutical companies, the pharmacovigilance centers, and poison control centers.

by: Elie Magdalani
Published: June 3, 2011
Tags: Elie Magdalani, Ranbaxy Egypt, medication errors, ME, pharmacovigilance, detection medication errors, prevention medication errors, pharmacovigilance ADRs, patient safety, drug safety, error analysis, drug labeling and packaging


Elie Magdalani

Global Drug Safety and Risk Management

The role of pharmaceutical companies is to decide how to manage the results of an AE signal. Some drug companies develop and prepare the safety programs that are implemented from the moment drugs when enter their product portfolio. Also collecting and analysing data in an advance way is an important tool in drug safety and risk management program. In this concern, whatever the approach selected, each program needs to be reasonably relevant to the nature of the risk. When a signal of a potential side effect is detected it should be documented with its response.

by: Elie Magdalani
Published: May 6, 2011
Tags: Elie Magdalani, Ranbaxy Egypt, pharmacovigilance, drug safety, Risk Management, global drug safety, reported adverse events, AEs, adverse events, ADR, risk assessment, signal detection, AE signal


Elie Magdalani

Patients Safety and Clinical Trials

Emerging new safety data may result in an action plan by the pharmaceutical company producing a drug to review its data retrieved during the clinical trail phases and especially in Phase II conducted to demonstrate and assess the product’s safety.

by: Elie Magdalani
Published: February 7, 2011
Tags: Elie Magdalani, Ranbaxy Egypt, pharmacovigilance, Clinical Trials, drug safety, AE, ADRs, post-marketing surveillance