We solicit your gracious presence at the upcoming 11th Annual Congress On Pharmacovigilance & Clinical Trials scheduled to happen during 2018 in Orlando, USA focusing on the advancements in emerging research and technologies in pharmacovigilance, clinical trials and risk management.

Theme   Safer Drug Innovations & Critical Considerations in Clinical TrialsTrack 1: Pharmacovigilance and Drug Safety

Pharmacovigilance activities related to collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products and the safety surveillance and risk management. PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmers by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines. pharmacovigilance plays a critical role in minimizing the risk of any harm that may come to patients by safety surveillance, risk management and identifying the hazards associated with pharmaceutical products.

Track 2: Pre-Clinical and Clinical Trials

Pre-Clinical and Clinical Trials aim at testing the potentiality of medicinal therapeutic efficacy of pharmaceutical products on cells and animals. Clinical study design aims to ensure the scientific validity and reproducibility of the results. Clinical trials is the propagative studies conducted on patients using of patient data, disease mechanisms, therapeutic interventions and epidemiology, patient centric approach and benefit risk management. Pre-Clinical trials are essential before a company starts performing the clinical trials and helps in calculating toxicity, efficacy and collecting pharmacokinetic data. Pre-Clinical and Clinical Trials involve intervention of human subjects to study the cause-and-effect relationship between a medical intervention and a health outcome. The perfect outcome of clinical trials is minimizing risks; enhance benefits, and optimal use of an intervention of therapeutic drugs.

Track 3: Pharmacodynamics and Pharmacokinetics

Pharmacokinetic and pharmacodynamic parameters become important because of the association between host drug concentrations, microorganism eradication, and resistance. Since long scientific advances allowed scientists to come together with the study of physiological effects with biological effects. This scientific exchange enables scientists from academia, industry, and regulatory agencies to improve/develop better therapies while jointly advancing their professional development and respective disciplines. The Pharmaceutical industry's long successful strategy of placing big bets on a few molecules, promoting them heavily and turning them into blockbusters worked well for many years, but its R&D productivity has now plummeted and the environment’s changing.

Track 4: Clinical Data Management

Clinical data management is critical phases in clinical researches, which generates high-quality and statistically sound data from clinical trials. The ultimate goal of CDM is to assure that data support conclusions drawn from research. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). The ultimate goal is to assure that data support conclusions drawn from research, which protects public health and confidence in marketed therapeutics.

Track 5: Adverse Event Reporting

Pharmacovigilance activity is commonly associated with adverse event reporting which consumes a significant amount of resources for drug regulatory authorities in pharmaceutical industries. Adverse event reporting involves the data entering, case assessment, documentation, receipt and triage. This AE involves the spontaneous reports from the drug regulatory authorities.  AE plays a key role in assessing the risk-benefit profile of a given drug. Adverse event leads to spontaneous reporting, clinical reporting and periodic reporting.

Track 6: Clinical and Medical Case Reports

Clinical and medical case report is a method for conveying something new that has been learnt from clinical practice. It could be around a surprising or beforehand obscure condition, an uncommon presentation or difficulty of a known illness, or even another way to deal with dealing with a typical condition. A case report gives the point by point report of indications, signs, conclusion, treatment, and follow-up of an individual patient. Case reports may contain a statistic profile of the patient and assume significant part in the field of restorative clinical research and prove based pharmaceutical. Besides, case reports can serve as an early cautioning signal for the antagonistic impacts of new solutions, or the presentations of new and rising ailments.

Track 7: Pharmacovigilance Data Base Management

Pharmacovigilance data base management system (DBMS) is a computer software application that interacts with the user, other applications, and the database itself to capture and analyze data. A general-purpose DBMS is designed to allow the definition, creation, querying, update, and administration of databases. Well-known database management includes Argus, Aris G, Oracle AERS, Clintrace, PVNET, repClinical, Vigilanz Dynanic Monitoring System are often classified according to the database model that they support; the most popular database of Pharmacovigilance.

Track 8: Clinical Trial Regulatory Challenges

Clinical Trials investigation of medication endorsements amid the most recent three decades is made to figure out if a decrease in new medication improvement has for sure happened. The paper additionally looks at the issue of new medication improvement. Alternate issues that this paper examines incorporate rising rivalry from non-specific medications, FDA directions, troubles in concocting new particles by pharmaceutical organizations, and a developing pattern towards inclination for biologic medications.

Track 9: Data Quality Management and Analysis

Data quality management in pharmacovigilance can be relied only on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. The quality of a pharmacovigilance data system can be defined as a measure of excellence or a state of being free from defects, deficiencies and significant variations and the data quality management includes all the activities that organizations use to direct, control and coordinate the quality of data. The resulting data output is analysed and assessed. Finally, conclusions are drawn and decisions made. Several functioning, well documented and transparent quality management systems will assist in data collection management and output production and in addition will help the pharmacovigilance end users and patients.

Track 10: Design of Clinical Studies and Trials

Clinical review configuration is the definition of trials and tests, and in addition observational reviews in restorative, clinical and different sorts of research including people. Clinical research are normally led in four stages, every stage is considered as particular trial and, after finish of a stage, examiners are required to present their information for endorsement from the FDA before proceeding to the following stage. By partaking in clinical trials, members cannot just assume a more dynamic part in their own particular social insurance, yet they can likewise get to new medications and help other people by adding to therapeutic research. Sorts of Study Designs Meta-Analysis, Systematic Review, Randomized Controlled Trial, Cohort Study, Comparative Study, Case-control Study, Cross-sectional review, Case Reports and Series, Animal Research Studies, Test-tube Lab Research.

Track 11: Clinical Research

Clinical research provides the building block upon which other types of biomedical research. Pre-clinical Research involves the evaluation of therapeutic intervention in humans and animals. Candidates for entry into clinical trials can then be selected based on their effectiveness and safety. All drugs require data from various toxicological preclinical studies to support their potential safety in humans before clinical trials before trail begin.