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A process for identifying trends and correlations between Adverse Events with particular drugs compared to what would be expected and compared to that for other similar drugs. The concept is to monitor AEs which occur coincidentally and those which are actually related to the treatment or medication being provided.
WHO defines a pharmacovigilance signal as “reported information on a possible causal association between an adverse event and a drug, the relationship being unclear or incompletely documented previously”.
Signal Investigation by FDA:
1. New unlabeled adverse events, especially if serious
2. An apparent increase in the severity of a labeled event
3. Occurrence of serious events thought to be extremely rare in the general population
4. New product-product, product-device, product-food, or product-dietary supplement interactions
5. Identification of a previously unrecognized at-risk population (e.g., populations with specific racial or genetic predispositions or co-morbidities)
6. Confusion about a product's name, labeling, packaging, or use
7. Concerns arising from the way a product is used (e.g., adverse events seen at higher than labeled doses or in populations not recommended for treatment)
8. Concerns arising from potential inadequacies of a currently implemented riskminimization action plan (e.g., reports of seriousadverse events that appear to reflectfailure of a RiskMAP goal)
9. Other concerns identified by the sponsor or FDA
List of Associations:
• European federation on Pharmaceutical sciences
• The International Postgraduate Conference on Pharmaceutical Sciences
• Pharmaceutical Research and Manufacturers of America
• National Pharmaceutical Association
• American Pharmacists Association
• Academy of Managed Care Pharmacy (AMCP)
• American Association of Pakistani Pharmaceutical Scientists
• American Society of Pharmacognosy
• Arkansas State Board of Pharmacy
• Indian Pharmaceutical Association
• Kuwait Pharmaceutical Association
• Malaysian Pharmaceutical Society
List of Symposium or Workshops:
• WHO Training Workshop on Pharmacovigilance
• European Medicines Agency workshop on Pharmacovigilance
• Pharmacovigilance in the paediatric population workshop
• Regulatory and pharmacovigilance workshop.
ABOUT OMICS International:
OMICS International is an integration of Open Access publications and worldwide International Scientific conferences and events. OMICS International is a pioneer and leading Science event organizer, which publishes around 500 peer reviewed open access journals in all aspects of science, health, and technology. OMICS International world class International conference organizer successfully coordinates 500 peer reviewed open access journals to accelerate the knowledge transfer through debates, round table discussions, poster presentations, Symposia and Workshops and exhibitions. OMICS International is also pioneer in organizing the Pharmaceutical Conferences all around the globe. We are actively involved in conducting International Conferences across various continents such as Europe, USA (Baltimore, Philadelphia, Las Vegas, and San Antonio), China, Dubai, UK and other parts of the globe.
Related OMICS International Conferences :
Conferences and symposiums: Large numbers of conferences are organized across the globe related to drug delivery such as Pharmacovigilance August 10-12, 2015 London, UK, 6th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery SystemsMarch 07-09, 2016 Madrid, Spain,World drug delivery summit, August 17-19, 2015, Seattle USA., 2014
PDA Universe of Prefilled Syringes & Injection Devices, Drug Delivery Devices 2014 (DDD14)
4th Annual Partnerships in Drug Delivery (PODD)
3rd Medicon Valley Inhalation Symposium, Parenterals 2014
Oral Drug Formulation Innovations Summit
Inhaled Drug Delivery, RDD Asia 2014 and Drug Delivery Strategy: Advanced Mechanisms & Product Design.
Associations and societies:
Associations and societies related to drug delivery are
Controlled Release Society,
Inhalation Drug Delivery Association,
International society of drug delivery sciences and technology,
American Association of Pharmaceutical Scientists,
Japanese Society of Drug Delivery Systems,
Parenteral Drug Association,
International Association for Pharmaceutical Technology,
International Neuromodulation Society,
Society for Neuroscience,
and American Society for Clinical Pharmacology and Therapeutics.
Major companies associated with drug delivery are Medtronic, GB Biosciences, Leonardo Biosystems, Gilead, RJS Biologics Inc., Oncotherapy Solutions, Oncolytics Biotech, MedGenesisTherapeutix, GlaxoSmithKline, Aviva Biosciences, Halozyme Therapeutics, Nektar Therapeutics, Merck & Co., Inc, BioDelivery Sciences, PharmaIN, OncoGenex, Jubilant , and Bio-rad.
This page will be updated regularly.
This page was last updated on 16th Apr, 2015
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