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12th Global
Pharmacovigilance & Clinical Trials Summit, will be organized around the theme “Comprehend Multiple Facets of Pharmacovigilance, Drug Safety and Clinical Trials”

Global Pharmacovigilance 2018 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 2018

Submit your abstract to any of the mentioned tracks.

Register now for the conference by choosing an appropriate package suitable to you.

The global pharmacovigilance (PV) market size was estimated at USD 3.40 billion in 2016 and is anticipated to witness a CAGR of 13.1% over the forecast period. Increasing incidence of Adverse Drug Reactions (ADRs) is expected to accelerate the demand for pharmacovigilance services 

The main aim of pharmacovigilance is to supply complete and clear info associated with drug safety and varied risks and advantages related to them. Pharmacovigilance will facilitate in providing info of unintended and severe adverse events that couldn't be provided by clinical trials involving in-vivo technique. It enhances the impact of pharmacovigilance on patient welfare and public health and to grasp what's pharmacovigilance. This track offers a short discussion on Pharmacovigilance role in health care system. Pharmacovigilance legislation offers associate degree outlook on the principles and laws to follow in Pharmacovigilance observe. The Role of pharmaceutical company industries within the improvement of pharmacovigilance system is extremely crucial to take care of the protection knowledge, Detection and analysis of drug safety signals through manual and medical devices reportage. Pharmacovigilance scope additionally deals as Ecopharmacovigilance (EPV), pharmacoenvironmentology and pharmacovigilance in flavourer medicines.

 

 

  • Track 1-1Significance of pharmacovigilance
  • Track 1-2Pharmacovigilance and healthcare system
  • Track 1-3Pharmacovigilance legislation
  • Track 1-4Role of pharma industries in the improvement of pharmacovigilance system
  • Track 1-5Detection and evaluation of drug safety signals through manual and medical devices reporting
  • Track 1-6Ecopharmacovigilance (EPV)
  • Track 1-7pharmacoenvironmentology
  • Track 1-8Pharmacovigilance in herbal medicines
  • Track 1-9Methods of pharmacovigilance
  • Track 1-10Post market product surveillance
  • Track 1-11Pharmacovigilance for Veterinary Medicinal Products
Good Pharmacovigilance Practices (GVP) begins with the acquisition of complete information from spontaneous adverse event reports. GVP characterizes the adverse event details, baseline patient characteristics, medical aid details, identification of the events and clinical course of the event. The role of excellent Pharmacovigilance observe and Pharmacoepidemology in Risk Management is principally to increase the chance of useful effects of a drug in a very population than the chance of adverse effects and to keep up the nice reportage Practices by avoiding the most important issues in risk management. conjointly it's vital to consider Signal investigation by gathering the knowledge on new or unknown drug effects that's doubtless caused by a medication which finally ought to result in making certain safety. The pharmacovigilance and clinical trials services providing corporations ought to have the Pharmacovigilance certification.
 
 
  • Track 2-1Role of pharmacovigilance and pharmacoepidemiology in risk management
  • Track 2-2Good reporting practices
  • Track 2-3Signal investigation via observational studies
  • Track 2-4Interpreting safety signals
  • Track 2-5Randomized clinical trials

Adverse Drug Reaction (ADR) is that the contrary reaction caused by taking a medicine. several Adverse Drug Reactions represent an awesome facet effects of the drug's therapeutic effects and ar thanks to administration of single dose or prolonged usage of drug. These reactions ar caused by one drug or combination of multiple medication. ADRs is native i.e, restricted to bound location or it is general i.e, unfold throughout whole circulation. Acoording to US FDA an adverse drug reaction is severe once it ends up in death of patient or causes permanent harm or important incapacity in patient’s body functions. Adverse Drug Reactions of medicine is studied by reportage the mechanism of adverse drug reactions and maintaining the drug safety systems. This track is concerning expected and un-expected drug reactions and its reportage makers, Professionals, and shoppers will report Post promoting reports on adverse effects.

  • Track 3-1Classification of various adverse drug reactions
  • Track 3-2Mechanism of adverse drug reactions
  • Track 3-3Assessing and reporting adverse drug reactions
  • Track 3-4Expected and un-expected drug reactions and its reporting
  • Track 3-5Post marketing reports on adverse effects
Drug Safety is that the pharmacologic science making certain safety and associated with the gathering, detection, assessment, monitoring, and hindrance of adverse facet effects with pharmacologic action of pharmaceutical product. in line with US Food and Drug Administration a drug is thought to be safe by staring at facet effects, its producing method and results of animal testing and clinical trials. during this track, we have a tendency to discuss Drug safety and its applications in varied fields like Softwares, coaching etc.
 
 
  • Track 4-1Drug Safety Updates
  • Track 4-2Drug Safety Solutions
  • Track 4-3Drug Safety Training
  • Track 4-4Drug Safety Surveilance
  • Track 4-5Drug Safety Services & Softwares
  • Track 4-6Drug Safety Reporting & Monitoring
  • Track 4-7Pharmacoepidemiology
Pharmacodynamics and pharmacokinetics are two key areas of pharmacological medicine. Pharmacodynamics is that the study of the molecular, organic chemistry, and physiological effects of medicine on cellular systems and their mechanisms of action. PK focuses rather on how the body affects the drug, in terms of its absorption, metabolism, distribution and elimination. Today, pharmacologists use a range of techniques, together with genetic science, biological science and chemistry, to elucidate and manipulate the pharmacologic action of drugs for health functions. BA and BE ofttimes accept pharmacokinetic measures such United Self-Defense Group of Colombia to assess extent of general exposure and Cmax and Tmax to assess rate of systemic absorption.
 
It has a broad scope, from the invention of latest target molecules, to the results of drug usage in whole populations. Clinical pharmacologists add a range of settings in academe, business and government. within the laboratory setting they study biomarkers, materia medica, drug metabolism and genetic science. Bioanalytical methodology techniques and validation plays a significant role within the analysis and interpretation of bioequivalence, materia medica, and toxicokinetic studies. Clinical and experimental pharmacological medicine deals with Clinical drug developments . Pharmacogenomics is that the study of however genetic variation influences responses to medicine. This includes however genetic variants have an effect on drug metabolism, effectivity and toxicity, with the goal of rising and personalizing drug medical care.
  • Track 5-1Advances in pharmacokinetic interactions
  • Track 5-2Advances in pharmacodynamic interactions
  • Track 5-3Drug and substance abuse
  • Track 5-4Data monitoring for trials with an adaptive design
  • Track 5-5Drug-drug interactions
  • Track 5-6Systems Pharmacology
  • Track 6-1Phases of clinical trials
  • Track 6-2Innovations in patient and community engagement in clinical trials
  • Track 6-3Heterogeneity of treatment effect in randomized clinical trials
  • Track 6-4Treating different ailments by clinical trials
  • Track 6-5Pre-clinical research leading to clinical trials

Pharmacovigilance is an important and integral part of clinical research and these days it is growing in many countries. Bioavailability and bioequivalence studies also plays major role in clinical research. Clinical trials are nothing but experiments done in clinical research. Clinical research system involves a complex network of pharmaceutical companies, sites and educational research institutions/ laboratories. Each clinical trial has a plan of action or a protocol for conducting trial. Clinical trials generate data on safety and efficacy.

 

  • Track 7-1Pre-clinical research/trail
  • Track 7-2Clinical Trial Management
  • Track 7-3Clinical research phase studies
  • Track 7-4In Vitro and In Vivo studies
  • Track 7-5Bioequivalence Protocol
  • Track 7-6Trial design: formulation development
  • Track 7-7Efficacy and Effectiveness of the trail
  • Track 7-8Role of Biomarkers

The main goals of Pre-Clinical and Clinical Trials are to determine the safe dose and start to assess product's safety profile. Concentrating on dosages forms in random clinical trials is very important. Although preclinical studies have revealed many possible mechanisms for these Adverse Events, the causes of some adverse events remain unknown.

Discussions are encouraged on Preclinical and clinical trial mechanisms and their significance, improvements, adversity.

 

  • Track 8-1Discovery and Preclinical Testing Phases
  • Track 8-2Pre-Clinical Testing
  • Track 8-3Clinical Study Designs
  • Track 8-4Bioassay and its types
  • Track 8-5Data collection and quality control
  • Track 8-6Alternative trials design and models
  • Track 8-7Multi center trials and monitoring
  • Track 8-8Regulatory authorities and ethics committee
  • Track 8-9Advanced Information technology in clinical trials and promoting companies
Clinical review configuration involves the quantity of study volunteers, their division seeable of differing variables, and their treatment during the clinical test handle. Examine configuration could be a key a part of clinical trials, and also the treatment of all patients specifically impacts the measurable legitimacy of data. reflect amass task has likewise been extensively increased as currently. Analysts have discovered several blessings to randomised task versus empiric task, in lightweight of qualities like sex, age, race, then forth. The randomised technique has been found to yield a lot of dependable outcomes than empiric review assignments.
 
As of late, the use of adjustive arrange techniques in clinical analysis has clad to be more and more documented as a result of its ability and effectiveness. Versatile plans supply probability the chance to decrease examine span and patient introduction whereas augmenting the likelihood of a fruitful result. Another development in clinical trials is that the Bucket arrange. Basin trials are supposed to use one specific medication and check that medication against numerous distinctive sicknesses. The advantage of this approach is that patients with numerous sicknesses may be "pooled" along below one larger trial instead of bunches of littler trials, consequently scotch time and plus in an exceedingly comparable approach, and there ar a lot of advancements in clinical trials.
  • Track 9-1Innovative approaches to patient recruitment
  • Track 9-2Innovative partnering in clinical research
  • Track 9-3Design for predictive bio marker validation
  • Track 9-4Randomized placebo- controlled trials

Clinical Trials for numerous ailments and clutters ar directed for assessing a minimum of one mediations (for instance, drugs, medicative gadgets, ways in which to traumatize surgery or radiation treatment) for treating an infection, disorder, or condition And what is more discovering approaches to stay the underlying improvement or repeat of an health problem or condition. These will incorporate solutions, antibodies, or approach of life changes, among totally different methodologies. many cases of the infections/issue that clinical trials leading to biological process framework, metabolic process framework sicknesses and alternative parasitic, viral, microorganism and contagious sicknesses. In short Clinical Trials on practices, mental, rest and dietary problems.

  • Track 10-1Stem Cell & Oncology
  • Track 10-2Diabetes & Gastroenterology¬†
  • Track 10-3Sexually Transmitted Diseases
  • Track 10-4Cardiovascular
  • Track 10-5Cancer
  • Track 10-6Vaccines
  • Track 10-7Zika Virus
  • Track 10-8Applications of biomarkers in clinical trials

Clinical data management is a support for drug development and a perquisite needs to get drugs to market the earlier so that the patients can access to drugs. The team of global clinical data management experts is committed to upholding a standardized, process-driven approach from Phase I through to post-marketing trials.

 

  • Track 11-1Data types and data processing techniques
  • Track 11-2Advanced products in data management
  • Track 11-3Bayesian data analysis
  • Track 11-4Sequential treatment factors for controlled trials
  • Track 11-5ICH guidelines for clinical research and its statistics
  • Track 11-6Data mining concepts and techniques
  • Track 11-7Stastical analysis of past pharmacovigilance and adverse drug reactions reports

Case Report forms a vital a part of Clinical analysis. A case report kind could be a document specifically employed in clinical trials. it's used as tool by the sponsor of the trial to collect data from every taking part web site. It includes of information of every and each patient taking part in clinical trials together with the adverse events. Case reports is also thought to be Associate in Nursing surprising association between diseases, disorders or symptoms. 

  • Track 12-1Case reports dealing with the use of novel technologies
  • Track 12-2Case reports in oncology, diabetes and cardiovascular diseases
  • Track 12-3Dermatology, gastroenterology, Nephrology, pulmonology and urology case reports
  • Track 12-4Case reports in neurology, ophthalmology, obstetrics and gynecology
  • Track 12-5Case reports on drugs used in psychological disorders
  • Track 12-6Case reports on drugs used in respiratory disorders
  • Track 12-7Case reports on drugs used in pregnancy and lactation

Drug safety and pharmacovigilance remains a dynamic clinical and scientific discipline. The regulatory framework for pharmacovigilance in the context of risk management planning, practical aspects of managing biopharmaceutical product risks and benefits in health care delivery system. Pharma Drug industry needs to stimulate companies in pharmacovigilance Practice and Softwares used in Pharmacovigilance and Clinical Trials.

Experts from different CRO’s, Pharmacovigilance Service Providers and Industrial delegates can share knowledge and discuss new updates under this track.

 

  • Track 13-1Information technology in pharmacovigilance and promoting companies
  • Track 13-2Review of softwares used in pharmacovigilance and clinical trials
  • Track 13-3Risk communication: Interface between pharmacovigilance, sales and marketing
  • Track 13-4Monitoring unlicensed, off labels and orphan drugs
  • Track 13-5Risk Management of Pre-Clinical and Clinical Research
  • Track 13-6Genetic Epidemiology in Risk Management
  • Track 13-7Pharmacovigilance in Risk Management
  • Track 13-8Pharmacoepidemiology in Clinical Research
  • Track 13-9Information technology in pharmacoepidemiology and clinical trials

Regulatory Affairs is involved in all the stages of development of a new medicine and its post-marketing activities with medicinal products authorities. This department heart of pharmaceutical industry. Internally it is a cluster of drug development, drug manufacturing, drug marketing and clinical research. Outward it is an interface between the company and regulatory authorities. In the Clinical trial approaches, major role is played by regulatory affairs for clinical trials. According to regulatory affairs guidelines clinical trials are to be conducted. Regulatory affairs are independent for specific country and their guidelines. International harmonization in principles has led to consistent approach in regulatory submissions and hence its review.

 

  • Track 14-1Regulatory Guidelines
  • Track 14-2USFDA
  • Track 14-3MHRA
  • Track 14-4Regulations in Pharmacovigilance
  • Track 14-5Medical writing Pharmacovigilance

In Pharmacy Practices and its Challenges track principally targeted on Pharmacy observe and its pointers and Challenges in change of integrity and dispensing observe. Indefinite quantity program, drug toxicity and drug safety measures place vital position in clinical analysis. Strategies for Growth in pharmaceutical company atmosphere are targeted in Strategic development towards bureau approval and Post market product Surveillances.

 

  • Track 15-1Quality Assurance
  • Track 15-2Quality Control
  • Track 15-3Challenges in compounding and dispensing practice
  • Track 15-4Dosage regimen, drug toxicity and drug safety measures
  • Track 15-5Industrial pharmaceutics
  • Track 15-6Supply chain management
  • Track 15-7Waste management
  • Track 15-8Product management

Pharmaceutical Toxicology describes the methodology and requirements of pre-clinical safety assessments of new medicines. With the effort on medicinal drugs, the most important safety issues of drugs are covered. This includes registration requirements of new drugs and pharmacovigilance.

  • Track 16-1Regulatory Toxicology
  • Track 16-2Analytical Toxicology
  • Track 16-3Toxicologic Pathology
  • Track 16-4Toxicokinetics
  • Track 16-5Drug Toxicology
  • Track 16-6Food Toxicology
  • Track 16-7Toxicity of Nanomaterials