RMP and REMS
Risk Management Plan (RMP) is for European products. Risk Evaluation Mitigation Strategy (REMS) for products in the U.S. marketplace.
Adverse Event Received Date Vs. Onset
Adverse Event Received Date vs. Adverse Event Onset Date (aka Event start date) vs. Case Received Date Many companies uses Oracle Argus version 8.1.2 do not enter Adverse Event Received date because the date entered for initial/follow-up is the date of AE onset. Details… (cont)
Default; Built-in; Out-of-the-box; COTS
Meaning “standard” custom off the shelf (COTS)
Not Otherwise Specified (NOS)
NOS requires separate post??!!! Oh come on… NOS is a big deal in Medicines. Lets me brief….
Individual Case Safety Reports (ICSRs)
Individual Case Safety Reports (ICSRs) Every country has representative who reports Medicines’ side effects to World Health Organizations (WHO). Each side effect related “a drug” (aka Primary Suspect Drug) must be reported to WHO. Valid ISCR: A Case created in the Safety system that includes the following four (4) minimum data elements: 1. Product…
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Empirica Signal and Topics – What’s new in version 8.1.0.2
Empirica Signal and Topics – What’s new in version 8.1.0.2 (difference between version 7.3.2 and 8.1.0.2) How to add Comment (aka Outcome) and Detail Comment (aka Disposition) under “Signal” tab?
Therapeutic areas
Bone / Osteoporosis Immunology Orthopaedics Cardiovascular Infectious diseases (including HIV) Pulmonology CNS Inflammation Psychiatry Dermatology Internal diseases Respiratory Diabetes Metabolic diseases Rheumatology Endocrinology Nephrology Surgery ENT Neurology Urology Gastroenterology Oncology Vaccines Haematology Ophthalmology Thrombosis
MGPS vs. RGPS
Regression-Adjusted GPS Algorithm (RGPS) vs. Multi-item Gamma Poisson Shrinker (MGPS) RIR, ROR, MGPS, etc methods do not adjust for the effects of polypharmacy—patients taking multiple drugs at the same time, and that drugs for the same indication will show up in the same patient reports, creating confounding issues and other potential statistical biases. Hence, RGPS comes in.…
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PMDA JADER database
Where to download JADER data? http://www.info.pmda.go.jp/fukusayoudb/CsvDownload.jsp Food and Drug Administration (FDA) vs. Pharmaceuticals and Medical Devices Agency (PMDA) Food and Drug Administration (FDA) Pharmaceuticals and Medical Devices Agency (PMDA) United States of America Japan CIOMS Started accepting electronic study data (estudy data) submissions, beginning October 2016 Since 1962 3.5 year transitional period
What is Pharmacovigilance?
What is Pharmacovigilance aka Drug Safety? Yeah, that is not in the dictionary. Pharmacovigilance (PV) means, Medicine(s) to watch out. Per World Health Organization, it is “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems.” Why do Pharmaceutical companies do that ? As…
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