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8th Global Pharmacovigilance & Drug Safety Summit, will be organized around the theme “Innovations in Pharmacovigilance for Systematic safety and Management”
Global Pharmacovigilance 2017 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in Global Pharmacovigilance 2017
Submit your abstract to any of the mentioned tracks.
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Drug Safety or Pharmacovigilance (PV or PhV), is the science of Pharmacology related to study of adverse effects with drug products. In this Track, Drug safety and its applications in various fields such as softwares, Training etc. will be discussed Drug safety included data collection, detection, assessment, monitoring, and prevention of the adverse effects.Globally, pharmacovigilance software market or drug safety software market is poised to grow at a CAGR of 6.5% during 2014-2019, and will reach a value of $154.1 Million in 2019.
- Track 1-1Drug Safety Updates
- Track 1-2Drug Safety Solutions
- Track 1-3Drug Safety Training
- Track 1-4Drug Safety Surveilance
- Track 1-5Drug Safety Services & Softwares
- Track 1-6Drug Safety Reporting & Monitoring
An Adverse Drug Reaction (ADR) is an injury caused by taking a medication. Many adverse drug reactions represent an over effectivness of the drug's therapeutic effects. In Classification of various adverse drug reactions we know about the different types of Adverse Drug Reactions and its effect. For understanding Adverse Drug Reactions, we need to know about the mechanism of drug reactions. Assessing and reporting adverse drug reactions are very important to maintain drug safety systems. hospitalized patient populations have placed much higher estimates on the overall incidence of serious ADRs. The studies estimate that around 6.7% of hospitalized patients are suffering fromserious adverse drug reaction with a fatality rate of 0.32%. If these estimates are true, then there are more than 2,216,000 serious ADRs in hospitalized patients, causing over 106,000 deaths annually. Examinig all these facts, ADRs are the 4th leading death causing —ahead of other diseases like AIDS, diabetes and automobile deaths.
- Track 2-1Classification of various adverse drug reactions
- Track 2-2Mechanism of adverse drug reactions
- Track 2-3Assessing and reporting adverse drug reactions
- Track 2-4Expected and un-expected drug reactions and its reporting
- Track 2-5Post marketing reports on adverse effects
Concept of Pharmacovigilance and its Significance and Scope to present the case for the importance of pharmacovigilance, to record its growth and potential as a significant discipline within medical science, and to describe its impact on patient welfare and public health and to know what is pharmacovigilance. In this Track we discussed about the Significance of pharmacovigilance. The global market for alzheimer’s disease reached $10.2 billion in 2012. The market is expected to decrease to $9.5 billion in 2017 for a CAGR of -1.5%.
- Track 3-1Significance of pharmacovigilance
- Track 3-2Pharmacovigilance and healthcare system
- Track 3-3Pharmacovigilance legislation
- Track 3-4Role of pharma industries in the improvement of pharmacovigilance system
- Track 3-5Detection and evaluation of drug safety signals through manual and medical devices reporting
- Track 3-6Ecopharmacovigilance (EPV), pharmacoenvironmentology and pharmacovigilance in herbal medicines
- Track 3-7Methods of pharmacovigilance
Continental Pharmacovigilance helps to ensure compliance with local and international requirements. To operate more effectively across multiple regions and health authorities. The global liver diseases therapeutics market totaled nearly $24.5 billion in 2014 and is projected to approach $33.8 billion by 2019, registering a compound annual growth rate (CAGR) of 6.7% through 2019.
- Track 4-1Pharamcovigilance USA
- Track 4-2Pharamcovigilance EUROPE
- Track 4-3Pharamcovigilance MIDDLE EAST
- Track 4-4Pharamcovigilance ASIA PACIFIC
Good Pharmacovigilance Practice means to maintain the Good reporting practices to avoid major problems in risk management. Also it is important to concentrate on Signal investigation via observational studies and Interpreting safety signals.
- Track 5-1Role of pharmacovigilance and pharmacoepidemiology in risk management
- Track 5-2Good reporting practices
- Track 5-3Signal investigation via observational studies
- Track 5-4Interpreting safety signals
- Track 5-5Randomized clinical trials
The new turn in Drug industry is to use Information technology in pharmacovigilance companies. Drug industry need to promoting companies in pharmacovigilance practice and the Review of softwares used in pharmacovigilance and clinical trials. The U.S. market for food-safety testing was valued at $3.3 billion in 2011 and is projected to increase slightly in 2012. In 2017, the market should reach nearly $4.4 billion after increasing at a five-year compound annual growth rate (CAGR) of 5.6%.
- Track 6-1Information technology in pharmacovigilance and promoting companies
- Track 6-2Review of softwares used in pharmacovigilance and clinical trials
- Track 6-3Risk communication: Interface between pharmacovigilance, sales and marketing
- Track 6-4Monitoring unlicensed, off labels and orphan drugs
Medical device Pharmacovigilance is the monitoring of safety profile of medical devices, from the processing and reporting of single adverse incidents through to the removal of products from the market as part of a Field Safety Corrective Action. This to ensure that patient’s and healthcare professional’s safety is monitored and action taken as soon as a safety concern with a medical device arises.
Drugs undergo, Pharmacokinetics and Pharmacodynamics and toxicity testing through animal testing. This data helps researchers to allometrically estimate a safe starting dose of the drug for clinical trials in humans. In this track mainly we will focuss on Advances in pharmacodynamic interactions, Drug and substance abuse, Drug-drug interactions. The global market for needle free technologies reached $963.6 million in 2013. This market is expected to grow to $1.1 billion in 2014 and $2.1 billion in 2019, with a compound annual growth rate (CAGR) of 14.3%.
- Track 8-1Advances in pharmacokinetic interactions
- Track 8-2Advances in pharmacodynamic interactions
- Track 8-3Drug and substance abuse
- Track 8-4Drug-drug interactions
Veterinary medicinal products only receive marketing authorisation if the assessment of the data concerning their quality, safety and efficacy shows that the benefits linked to their use are greater than the risks incurred.Pharmacovigilance thus aims to detect any emerging signs as quickly as possible, both unexpected adverse effects and known adverse effects with an unexpected frequency or severity. This post-MA monitoring sometimes results in adjusting risk management measures, which may include providing additional precautions for use on the package leaflet, or in certain cases withdrawal of the MA.
The main goals of Pre-Clinical and Clinical Trials are to determine the safe dose and start to assess product's safety profile. In Designing of trials there are pre-clinical studies and different phases of clinical trials. In this trails they estimate the Bioassay and its types. New technologies and the outsourcing of clinical trials to lower-cost countries will slow the recent annual increases in expenditures in the U.S. to a 3.3% compound annual growth rate (CAGR) over the forecast period. Clinical trial spending in 2010 is an estimated $25 billion and is expected to reach $28.5 billion by 2014.
- Track 10-1Designing of trials: pre-clinical studies and different phases of clinical trials
- Track 10-2Bioassay and its types
- Track 10-3Data collection and quality control
- Track 10-4Alternative trials design and models
- Track 10-5Multi center trials and monitoring
- Track 10-6Regulatory authorities and ethics committee
- Track 10-7Advanced Information technology in clinical trials and promoting companies
- Track 10-8Clinical trials on drugs used in respiratory disorders.
With the rapid spread of information across the globe, increased communication across borders, easy access to variety of medicinal products and increasing public expectation of safety, there is a need for careful strategic planning adopting a holistic approach to meet the additional challenges. We need continuing and dynamic progress of all aspects of pharmacovigilance to improve public health and safety. There is a need for new global network to share information and intelligence about benefit and risk of medicinal products
In This track we will discuss about the Recent clinical trials on AIDS, Clinical trials on benign and malignant tumors, Clinical trials on cardiovascular diseases, Clinical trials on diabetes, Clinical trials of monoclonal and polyclonal antibodies, Clinical trials on drugs used in psychological disorders The current research mainly focus on Applications of biomarkers in clinical trials. The global orphan drug market totaled nearly $123 billion in 2014 and will continue to grow to reach nearly $191 billion by 2019, demonstrating a compound annual growth rate (CAGR) of 9.2% during the forecast period (2014 to 2019).
- Track 12-1Emerging technology in clinical trials
- Track 12-2Recent clinical trials on AIDS
- Track 12-3Clinical trials on benign and malignant tumors
- Track 12-4Clinical trials on cardiovascular diseases
- Track 12-5Clinical trials on diabetes
- Track 12-6Clinical trials of monoclonal and polyclonal antibodies
- Track 12-7Clinical trials on drugs used in psychological disorders
- Track 12-8Applications of biomarkers in clinical trials
The global pharmacovigilance market valued USD 2,408.0 million in 2013 and is expected to grow at a CAGR of 12.6% in upcoming periods. ADR, a substantial burden on healthcare systems and is one of the prominent reasons of morbidity in developed countries. Approximately 5% of total hospitalizations in a year are due to ADR. With an upsurge in the drug production, regulatory authorities such as the U.S. FDA and EMEA (European Medicines Agency) have intensified drug safety regulations prior and post commercialization.
In Clinical Research and Statistics,clinical trials go for regulatory submissions based on ICH guidelines. Stastical analysis of past pharmacovigilance and adverse drug reactions reports also consider for the regulatory submission. The global liver diseases therapeutics market totaled nearly $24.5 billion in 2014 and is projected to approach $33.8 billion by 2019, registering a compound annual growth rate (CAGR) of 6.7% through 2019.
- Track 14-1ICH guidelines for clinical research and its statistics
- Track 14-2Data mining concepts and techniques
- Track 14-3Stastical analysis of past pharmacovigilance and adverse drug reactions reports
Case Report in Clinical Trials plays major role in clinical research. In this track we discussed about the several case reports like Cancer case reports, Cardiovascular trials case report, Case studies on sexually transmitted diseases, Case studies on type 1 and type 2 diabetes, Case reports on drugs used in pregnancy and lactation. New technologies and the outsourcing of clinical trials to lower-cost countries will slow the recent annual increases in expenditures in the U.S. to a 3.3% compound annual growth rate (CAGR) over the forecast period. Clinical trial spending in 2010 is an estimated $25 billion and is expected to reach $28.5 billion by 2014.
- Track 15-1Unique therapeutic approaches
- Track 15-2Cancer case reports
- Track 15-3Cardiovascular trials case report
- Track 15-4Case studies on sexually transmitted diseases
- Track 15-5Case studies on type 1 and type 2 diabetes
- Track 15-6Case reports on drugs used in pregnancy and lactation
In Clinical Pharmacology and Biopharmaceutics track we will be disussing about the Rational drug management of cancer, diabetes and cardiovascular disorders, and Management of psychiatric disorders and autoimmune disorders. Along with clinical trials Bioavailability and bioequivalence studies also plays major role in clinical research. The global pulmonary drug delivery technologies market which was $19.6 billion in 2010 is expected to be around $22.5 billion by 2011. This global market is further projected to reach nearly $44 billion by 2016 at a compound annual growth rate (CAGR) of 14.3%.
- Track 16-1Rational drug management of cancer, diabetes and cardiovascular disorders
- Track 16-2Management of psychiatric disorders and autoimmune disorders
- Track 16-3Bioavailaibility and bioequivalence
- Track 16-4Invivo-invitro correlation
There is advantage in centralising all safety data, clinical data, analysis and reporting with one provider. Pharmacovigilance Software tool provides comprehensive analysis of adverse events arising from the use of pharmaceutical products (Medicinal Product, Medical Device, Vaccines, Non-Drug Therapy and Veterinary Medicinal Product). The drug safety database allows the risk- benefit analysis of medicinal products taking into account new and emerging information, in the context of cumulative information. Pharmacovigilance since beginning has been a compliance driven activity, wherein your regulatory compliance determines company’s risk assessment scores. A drug safety database offers scheduling of alerts for expedited cases, follow-up cases and PSUR/PADER reports submission to meet regulatory timeline compliance. The global market for pediatric medicines reached $80.7 billion in 2013 and should reach $83.6 billion in 2014. This market is expected to reach about $100.7 billion by 2019, registering a compound annual growth rate (CAGR) of 3.8% from 2014 to 2019.
- Track 17-1Drug Monitoring Authorities
- Track 17-2WebVDME Pharmacovigilance Signal Detection and Signal Management Software
- Track 17-3Argus
- Track 17-4Aris G
- Track 17-5Clintrace
- Track 17-6PVNET
- Track 17-7Vigilanz Dynanic Monitoring System
- Track 17-8RepClinical
- Track 17-9Oracle AERS
Due to the changing resources necessary to fulfil the regulatory requirements, some companies also choose to outsource or out task regulatory affairs to external service providers. The global market for pediatric medicines reached $80.7 billion in 2013 and should reach $83.6 billion in 2014. This market is expected to reach about $100.7 billion by 2019, registering a compound annual growth rate (CAGR) of 3.8% from 2014 to 2019.
- Track 18-1Pharmacovigilance software Devlopment Companies
- Track 18-2Bussiness Opportunities for PV Software Devloping Companies
- Track 18-3Opportunities for PV Software Services companies
- Track 18-4Career Growth in PV Consulting
Regulatory affairs for clinical trials is the major part in the clinical trials approaches. Every clinical trial must be conduct according to the Regulatory affairs guidelines. There are several Regulatory affairs depending upon the countries. Regulatory Affairs departments are growing within companies. Global harmonization in standards has led to consistent approach in regulatory submissions and hence its review. The global biologics market totaled $200.6 billion in 2013 and is expected to grow to nearly $234 billion in 2014. The total market is expected to grow to $386.7 billion by the end of 2019 at compound annual growth rate (CAGR) of 10.6%.
- Track 19-1Regulatory Guidelines
- Track 19-2USFDA
- Track 19-3EU
- Track 19-4MHRA
- Track 19-5Medical writing Pharmacovigilance
Strategies for Growth in Pharma Environment track mainly focused in Strategic development towards FDA approval and Post market product surveillances. The updates and advances in pharmacovigilance regulation system are discussed in Advances in changing pharmacovigilance regulation system track. The global market for sequencing products was nearly $3 billion in 2011, and it is forecast to grow at a compound annual growth rate (CAGR) of 17.5% to reach $6.6 billion by 2016
- Track 20-1Strategic development towards FDA approval
- Track 20-2Post market product surveillances
- Track 20-3Advances in changing pharmacovigilance regulation system
In Pharmacy Practices and its Challenges track mainly focusses on Pharmacy practice and its guidelines and Challenges in compounding and dispensing practice. Dosage regimen, drug toxicity and drug safety measures place important position in clinical research. The global inpatient and outpatient pharmacy automation market was valued at $2.4 billion in 2011 and should reach $2.6 billion in 2012. Total market value is expected to reach nearly $3.9 billion in 2017 after increasing at a five-year compound annual growth rate (CAGR) of 8%.
- Track 21-1Pharmacy practice and its guidelines
- Track 21-2Challenges in compounding and dispensing practice
- Track 21-3Dosage regimen, drug toxicity and drug safety measures
- Track 21-4Pharmacoepidemiology of drug shortages
Getting startup capital can be easy if you have a good idea and know the right investor. If you’ve spent serious time thinking about becoming an entrepreneur or you’re already in the early stages of business development, you probably already have a good idea (and if you don’t, you’re in the process of improving it). The bigger problem, then, is meeting the right investor. The global inpatient and outpatient pharmacy automation market was valued at $2.4 billion in 2011 and should reach $2.6 billion in 2012. Total market value is expected to reach nearly $3.9 billion in 2017 after increasing at a five-year compound annual growth rate (CAGR) of 8%.