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17th International Conference and Exhibition on Pharmacovigilance & Drug Safety, will be organized around the theme “”
PHARMACOVIGILANCE 2024 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in PHARMACOVIGILANCE 2024
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 2019 and is projected to reach around USD 22 billion by the year 2023, and the annual growth rate of (7.5%). There are additionally numerous clinical trials started by scholarly clinical scientists.
- Track 1-1Clinical trials on drugs used in respiratory disorders
- Track 1-2Recent clinical trials on AIDS
- Track 1-3Pre-Clinical Testing
- Track 1-4Designing of trials: pre-clinical studies
Adverse drug reactions can be considered a form of toxicity or enhanced drug effects that occur during appropriate use (e.g., 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.
- Track 2-1Acute and chronic adverse drug events
- Track 2-2Post marketing reports on adverse effects
- Track 2-3Assessing and reporting adverse drug reactions
- Track 2-4Mechanism of adverse drug reactions
Pharmacovigilance and Risk Management comprises set of Pharmacovigilance activities and interventions designed to identify, characterize, prevent or minimize 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 software’s used in pharmacovigilance and clinical trials.
- Track 3-1Risk communication: Interface between pharmacovigilance, sales and marketing
- Track 3-2Implementation of Risk Minimization Plans
- Track 3-3Information technology in pharmacovigilance and promoting companies
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.
- Track 4-1Ethical and social aspects of drug use
- Track 4-2Randomized clinical trials
- Track 4-3Interpreting safety signals
- Track 4-4Role of pharmacovigilance and pharmacoepidemiology in risk management
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 minimization of adverse events and drug incompatibility and community pharmacy.
- Track 5-1Challenges in compounding and dispensing practice
- Track 5-2Dosage regimen, drug toxicity and drug safety measures
- Track 5-3Pharmacoepidemiology of drug shortages
- Track 5-4Pharmacy practice and its guidelines
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 Bio pharmaceutics in 2013 was $305.1 million, which is expected to reach about $326.3 million by year-end 2014.
- Track 6-1Biotechnology
- Track 6-2Drug Discovery
- Track 6-3Pharmacology
- Track 6-4Regulatory Affairs
Clinical Trials on various diseases include Clinical Trials in long chronic diseases like AIDS, Benign and Malignant Tumors, Cardiovascular diseases, Diabetes, Clinical Trials on Monoclonal and Polyclonal Antibodies, Neurological, Physiological and Psychological Disorders
- Track 7-1Clinical trials on benign and malignant tumors
- Track 7-2Clinical trials on cardiovascular diseases
- Track 7-3Clinical trials of monoclonal and polyclonal antibodies
- Track 7-4Clinical trials on drugs used in psychological disorders
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 computerized systems, data entry; the next step is data storage and maintenance; followed by data selection, retrieval and manipulation.
- Track 8-1Managing reference data (e.g., drug names, patient IDs)
- Track 8-2Data Quality Control and Assurance
- Track 8-3Quality Planning and Improvement
- Track 8-4Data 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.
- 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
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.
- Track 10-1Socioeconomic Diversity
- Track 10-2Racial and Ethnic Diversity
- Track 10-3Gender Diversity
- Track 10-4Age Diversity
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 11-1Study Design
- Track 11-2Biostatistics
- Track 11-3Data Collection and Management
- Track 11-4Ethical and Regulatory Considerations
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 12-1Cancer case reports
- Track 12-2Cardiovascular trials case report
- Track 12-3Case studies on sexually transmitted diseases
- Track 12-4Case studies on type 1 and type 2 diabetes
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.
- Track 13-1Drug Safety Reporting & Monitoring
- Track 13-2Drug Safety Services & Softwares
- Track 13-3Drug Safety Surveillance
- Track 13-4Drug Safety Training
There is an advantage in centralizing 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.
- Track 14-1Data Collection and Entry
- Track 14-2Database Design and Structure
- Track 14-3Clinical Decision Support
- Track 14-4Data Retrieval and Reporting
Due to the changing resources necessary to fulfill 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.
- Track 15-1Pharmacovigilance software Development Companies
- Track 15-2Business Opportunities for PV Software Developing Companies
- Track 15-3Opportunities for PV Software Services companies
- Track 15-4Career Growth in PV Consulting
Regulatory Affairs for clinical trials is the major part in the clinical trials approaches. Every clinical trial must be analyzed 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 16-1Regulatory Guidelines
- Track 16-2Regulations in Pharmacovigilance
- Track 16-3Quality Assurance and Control
- Track 16-4Regulatory Compliance
Forensic toxicology is the use of toxicology and disciplines such as analytical chemistry, pharmacology and clinical chemistry to aid medical or legal investigation of death, poisoning, and drug use.
- Track 17-1Forensic Pathology
- Track 17-2Forensic DNA Analysis
- Track 17-3Forensic Chemistry
- Track 17-4Forensic Toxicology