Call for Abstract
16th International Conference and Exhibition on Pharmacovigilance & Drug Safety, will be organized around the theme “Employing therapeutic drug monitoring practices for ensuring enhanced drug safety”
PHARMACOVIGILANCE 2023 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in PHARMACOVIGILANCE 2023
Submit your abstract to any of the mentioned tracks.
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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 1-1Expected and un-expected drug reactions and its reporting
- Track 1-2Drug Labelling
During the COVID-19 pandemic, mandatory social distancing and the lack of effective treatments has made telemedicine the safest interactive system between patients, both infected and uninfected, and clinicians. A few potential evidence-based scenarios for the application of telemedicine have been hypothesized.
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 3-1Drug Safety Updates
- Track 3-2Drug Safety Solutions
- Track 3-3Drug Safety Training
- Track 3-4Drug Safety Surveilance
- Track 3-5Drug Safety Services & Softwares
- Track 3-6Drug Safety Reporting & Monitoring
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 2022, 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 4-1Clinical trials on drugs used in respiratory disorders
- Track 4-2Classification of various adverse drug reactions
- Track 4-3Risk communication: Interface between pharmacovigilance, sales and marketing
- Track 4-4Recent clinical trials on AIDS
- Track 4-5Mechanism of adverse drug reactions
- Track 4-6Pre-Clinical Testing
- Track 4-7Scientific Models for Pre-Clinical and Clinical Trials
- Track 4-8Designing of trials: pre-clinical studies
- Track 4-9Bioassay and its types
- Track 4-10Data collection and quality control
- Track 4-11Alternative trials design and models
- Track 4-12Multi center trials and monitoring
- Track 4-13Regulatory authorities and ethics committee
- Track 4-14Advanced Information technology in clinical trials
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 5-1Acute and chronic adverse drug events
- Track 5-2Post marketing reports on adverse effects
- Track 5-3Assessing and reporting adverse drug reactions
- Track 5-4Mechanism of adverse drug reactions
- Track 5-5Classification of various adverse drug reactions
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 6-1Risk communication: Interface between pharmacovigilance, sales and marketing
- Track 6-2Implementation of Risk Minimization Plans
- Track 6-3Review of softwares used in pharmacovigilance and clinical trials
- Track 6-4Information technology in pharmacovigilance and promoting companies
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 7-1Pharmacy practice and its guidelines
- Track 7-2Challenges in compounding and dispensing practice
- Track 7-3Dosage regimen, drug toxicity and drug safety measures
- Track 7-4Pharmacoepidemiology of drug shortages
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. 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 9-1Emerging technology in clinical trials
- Track 9-2Recent clinical trials on AIDS
- Track 9-3Clinical trials on benign and malignant tumors
- Track 9-4Clinical trials on cardiovascular diseases
- Track 9-5Clinical trials on diabetes
- Track 9-6Clinical trials of monoclonal and polyclonal antibodies
- Track 9-7Clinical trials on drugs used in psychological disorders
- Track 9-8Applications 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 10-1Data Quality Control and Assurance
- Track 10-2Quality Planning and Improvement
- Track 10-3Data 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 11-1Significance of pharmacovigilance
- Track 11-2Pharmacovigilance and healthcare system
- Track 11-3Pharmacovigilance legislation
- Track 11-4 Role of pharma industries in the improvement of pharmacovigilance system
- Track 11-5 Detection 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.
- Track 12-1SAS Programing in Clinical Research and Pharmacutical Industry
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 reaction reports can also be considered for the regulatory submission.
- Track 13-1 SAS Programing in Clinical Research and Pharmacutical Industry
- Track 13-2ICH guidelines for clinical research and its statistics
- Track 13-3Case 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 14-1Unique therapeutic approaches
- Track 14-2Cancer case reports
- Track 14-3Cardiovascular trials case report
- Track 14-4Case studies on sexually transmitted diseases
- Track 14-5Case studies on type 1 and type 2 diabetes
- Track 14-6Individual case safety reports
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 15-1 WebVDME Pharmacovigilance Signal Detection and Signal Management Software
- Track 15-2Argus
- Track 15-3Aris G
- Track 15-4Clintrace
- Track 15-5PVNET
- Track 15-6RepClinical
- Track 15-7Oracle AERS
- Track 15-8Periodic safety update reports
- Track 15-9Post 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 16-1Regulatory Guidelines
- Track 16-2USFDA
- Track 16-3MHRA
- Track 16-4Regulations 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 17-1Pharmacovigilance software Devlopment Companies
- Track 17-2Bussiness Opportunities for PV Software Devloping Companies
- Track 17-3Opportunities for PV Software Services companies
- Track 17-4Career Growth in PV Consulting
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 18-1Ethical and social aspects of drug use
- Track 18-2Randomized clinical trials
- Track 18-3Interpreting safety signals
- Track 18-4Good reporting practices
- Track 18-5Role of pharmacovigilance and pharmacoepidemiology in risk management