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12th International Conference and Exhibition on Pharmacovigilance & Drug Safety , will be organized around the theme “Exploring Latest Trends in Pharmacovigilance and Clinical Trials”
Pharmacovigilance 2019 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in Pharmacovigilance 2019
Submit your abstract to any of the mentioned tracks.
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Clinical trials allow the drug to be tested for safety by different ethnic population. Due to the higher medical needs and increasing disease prevalence, developing countries are becoming a hub for clinical trial execution. The clinical trials market has been estimated to reach USD 14.2 billion in 2016 and is projected to reach around USD 22 billion by the year 2021, and the annual growth rate of (7.5%). There are additionally numerous clinical trials started by scholarly clinical scientists. Whether started by industry or by scholastic clinical examiners and research is frequently performed in national, European and overall consortia, which can be expansive ones. Clinical research brings up moral and security issues. Clinical research is exceedingly controlled. To encourage and coordinated efforts crosswise over fringes.
- Track 1-1Pre-Clinical Testing
- Track 1-2Risk communication: Interface between pharmacovigilance, sales and marketing
- Track 1-3Classification of various adverse drug reactions
- Track 1-4Clinical trials on drugs used in respiratory disorders
- Track 1-5Advanced Information technology in clinical trials
- Track 1-6Regulatory authorities and ethics committee
- Track 1-7Multi center trials and monitoring
- Track 1-8Alternative trials design and models
- Track 1-9Data collection and quality control
- Track 1-10Bioassay and its types
- Track 1-11Designing of trials: pre-clinical studies
- Track 1-12Scientific Models for Pre-Clinical and Clinical Trials
- Track 1-13Recent clinical trials on AIDS
Adverse drug reactions can be considered a form of toxicity or enhanced drug effects that occur during appropriate use (eg, when drug metabolism is temporarily inhibited by a disorder or another drug). In the US, 3 to 7% of all hospitalizations are due to adverse drug reactions. ADRs occur during 10 to 20% of hospitalizations; about 10 to 20% of these ADRs are severe. Incidence of death due to ADRs is unknown; suggested rates of 0.5 to 0.9% may be falsely high because many of the patients included had serious and complex disorders. Incidence and severity of adverse drug reactions vary by patient characteristics (eg, age, sex, ethnicity, coexisting disorders, genetic or geographic factors) and by drug factors (eg, type of drug, administration route, treatment duration, dosage, and bioavailability. Incidence is higher with advanced age and polypharmacy
- Track 2-1Acute and chronic adverse drug events
- Track 2-2Classification of various adverse drug reactions
- Track 2-3Mechanism of adverse drug reactions
- Track 2-4Assessing and reporting adverse drug reactions
- Track 2-5Expected and un-expected drug reactions and its reporting
- Track 2-6Post marketing reports on adverse effects
Pharmacovigilance and Risk Management comprises set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal and therapeutic products including the assessment of the effectiveness of their clinical interventions and combination therapies. Drug industry need to promote companies in pharmacovigilance practice to use information technology and to review softwares used in pharmacovigilance and clinical trials. Monitoring unlicensed, off labels and orphan drugs is major task in risk management. Many experts from different pharmacovigilance CRO’s pharmacovigilance service providers and industrial delegates are participating in this conference to share their knowledge and discuss about the new updates.
- Track 3-1Information technology in pharmacovigilance and promoting companies
- Track 3-2Review of softwares used in pharmacovigilance and clinical trials
- Track 3-3Implementation of Risk Minimization Plans
- Track 3-4Risk communication: Interface between pharmacovigilance, sales and marketing
The role of Good Pharmacovigilance Practice and Pharmacoepidemiology in Risk Management is mainly to increase the probability of beneficial effects of a drug in a population than the probability of adverse effects and to maintain the Good Reporting Practices by avoiding the major problems in risk management. Also it is important to concentrate on Signal investigation by gathering the information on new or unknown drug effects that is potentially caused by a medicine and that finally should lead to ensuring safety. The pharmacovigilance and clinical trials services providing companies should have the Pharmacovigilance certification.
- Track 4-1Role of pharmacovigilance and pharmacoepidemiology in risk management
- Track 4-2Good reporting practices
- Track 4-3Interpreting safety signals
- Track 4-4Randomized clinical trials
- Track 4-5Ethical and social aspects of drug use
Pharmacy practice is the field of pharmacy which involves developing the professional roles of pharmacists. It includes Disease-state management, Clinical drug interventions, Pharmacy professional development and pharmaceutical care, pharmaceutical compounding and health psychology, patient care, drug abuse prevention, prevention of drug interactions or minimisation of adverse events and drug incompatibility and community pharmacy.
- Track 5-1Pharmacy practice and its guidelines
- Track 5-2Challenges in compounding and dispensing practice
- Track 5-3Dosage regimen, drug toxicity and drug safety measures
- Track 5-4Pharmacoepidemiology of drug shortages
- Track 5-5Drug Labelling
In Clinical Pharmacology and Biopharmaceutics track we will discuss 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 market for Biopharmaceutics in 2013 was $305.1 million, which is expected to reach about $326.3 million by year-end 2014. The projected PAT instrumentation market is expected to be valued at around $450.6 million by 2019 at a compound annual growth rate (CAGR) of 6.7% for the period of 2014 to 2019.
Clinical Trials on various diseases include Clinical Trials in long chronic diseases like AIDS, Benign and Malignant Tumours, Cardiovascular diseases, Diabetes, Clinical Trials on Monoclonal and Polyclonal Antibodies, Neurological, Physiological and Psychological Disorders.
- Track 7-1Emerging technology in clinical trials
- Track 7-2Recent clinical trials on AIDS
- Track 7-3Clinical trials on benign and malignant tumors
- Track 7-4Clinical trials on cardiovascular diseases
- Track 7-5Clinical trials on diabetes
- Track 7-6Clinical trials of monoclonal and polyclonal antibodies
- Track 7-7Clinical trials on drugs used in psychological disorders
- Track 7-8Applications of biomarkers in clinical trials
Good data quality management in pharmacovigilance can be relied only on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. Quality management consists of quality planning, quality control, quality assurance and quality improvements. The pharmacovigilance data processing cycle starts with data collection and, in computerised systems, data entry; the next step is data storage and maintenance; followed by data selection, retrieval and manipulation. The resulting data output is analysed and assessed. Finally, conclusions are drawn and decisions are made. 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
- Track 8-1Data Quality Control and Assurance
- Track 8-2Quality Planning and Improvement
- Track 8-3Data Safety Monitoring
Concept of Pharmacovigilance and its Significance enhances the impact of pharmacovigilance on patient welfare and public health and to know what is pharmacovigilance. This track gives a brief discussion on Pharmacovigilance role in healthcare system. Pharmacovigilance legislation gives an outlook on the rules and laws to follow in Pharmacovigilance practice. The Role of Pharma industries in the improvement of pharmacovigilance system is very crucial to maintain the safety data, Detection and Evaluation of drug safety signals through manual and medical devices reporting. Pharmacovigilance scope also deals as Ecopharmacovigilance (EPV), pharmacoenvironmentology and pharmacovigilance in herbal medicines.
- Track 9-1Significance of pharmacovigilance
- Track 9-2Pharmacovigilance and healthcare system
- Track 9-3Pharmacovigilance legislation
- Track 9-4Role of pharma industries in the improvement of pharmacovigilance system
- Track 9-5Detection and evaluation of drug safety signals through manual and medical devices reporting
The clinical trial industry is constantly evolving with diversified clinical research technologies and new clinical studies are being launched at an ever-growing pace. Clinical trials have always been a vital part of the medicine development process, as they provide clinical data on the best ways for treating pathological disorders and diseases. The importance of diversity in industrial clinical trials and clinical research is to ensure that industrial clinical trials are doing due diligence and being as strategic as possible in their results. This diversity makes us to better understand the unmet medical needs of patients.
In Clinical Research, Statistics plays a prominent role in regulatory submissions. Statistical analysis of Pharmacovigilance can be achieved by several guidelines mainly ICH guidelines. Adverse Drug Reactions reports can also be considered for the regulatory submission
- Track 11-1SAS Programing in Clinical Research and Pharmacutical Industry
- Track 11-2ICH guidelines for clinical research and its statistics
- Track 11-3Case reports on drugs used in pregnancy and lactation
Case Report in Clinical Trials plays a key role in Clinical Research. Case reports may be on unexpected association between diseases, disorders or symptoms. An unexpected event in the course of observing, treating a patient, possibilities of pathogenesis of a disease or an adverse effect. Unique or rare salient features of a disease or therapeutic approaches or a notable variation of the anatomical structures.
- Track 12-1Unique therapeutic approaches
- Track 12-2Cancer case reports
- Track 12-3Cardiovascular trials case report
- Track 12-4Case studies on sexually transmitted diseases
- Track 12-5Case studies on type 1 and type 2 diabetes
- Track 12-6Individual case safety reports
Drug Safety heavily focuses on adverse drug reactions which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction. Information received from patients and healthcare providers via pharmacovigilance agreements (PVAs), as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place. Ultimately, drug safety is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with worldwide laws, regulations, and guidance.
- Track 13-1Drug Safety Updates
- Track 13-2Drug Safety Solutions
- Track 13-3Drug Safety Training
- Track 13-4Drug Safety Surveilance
- Track 13-5Drug Safety Services & Softwares
- Track 13-6Drug Safety Reporting & Monitoring
There is an 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.
- Track 14-1WebVDME Pharmacovigilance Signal Detection and Signal Management Software
- Track 14-2Argus
- Track 14-3Aris G
- Track 14-4Clintrace
- Track 14-5PVNET
- Track 14-6RepClinical
- Track 14-7Oracle AERS
- Track 14-8Periodic safety update reports
- Track 14-9Post authorisation safety and efficacy studies
Regulatory Affairs for clinical trials is the major part in the clinical trials approaches. Every clinical trial must be analysed according to the Regulatory Affairs Guidelines. There are several Regulatory Affairs departments depending upon the countries within ever growing pace of companies. Global Harmonization in standards has led to consistent approach in regulatory submissions and hence its review.
- Track 15-1Regulatory Guidelines
- Track 15-2USFDA
- Track 15-3MHRA
- Track 15-4Regulations in Pharmacovigilance
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. Regulatory Affairs department is constantly evolving and growing and is the one which is least impacted during the Acquisition and Merger, and also during recession. The global pharmacovigilance market and Business opportunity was valued at USD 2,408.0 million in 2013 and is expected to grow at a CAGR of 12.6% during the forecast period. Phase III clinical trials market was the second largest and was valued at over USD 750.0 million in 2013.
- Track 16-1Pharmacovigilance software Devlopment Companies
- Track 16-2Bussiness Opportunities for PV Software Devloping Companies
- Track 16-3Opportunities for PV Software Services companies
- Track 16-4Career Growth in PV Consulting
Initial investment, capital requirements, business financing, current trends and the amount of time will take to get your business up and running. Pharmacovigilance 2019 focus in collaboration and communication among the Pharma Professionals, Business Entrepreneurs, CEO’s and Pharma Industrial Persons