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13th Global Pharmacovigilance & Clinical Trials Summit, will be organized around the theme “Explore the emerging tools for process automation in pharmacovigilance”
Pharmacovigilance-global 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-global 2019
Submit your abstract to any of the mentioned tracks.
Register now for the conference by choosing an appropriate package suitable to you.
Concept of drug safety is also known as Medication Safety in the field of health. It is associated with adverse effects of Pharmaceutical products involving many other scientific aspects, such as the side effects of drugs, the quality of medications, medication error in usage of drugs, lack of efficacy of drugs, and counterfeit drugs. Patient Safety, Drug Interaction (drug–drug and food–drug interaction) Drug Pharmacokinetic, and Adverse Drug Reactionare several terms involved with Drug Safety. Companies have to conduct a complete drug safety and pharmacovigilance audit to gauge their compliance with international standards of laws, regulations, and guidance.
In this track we will be focusing on Drug Safety Updates, Drug Safety Solutions, Training, Surveillance, Services & Software, Reporting & Monitoring.
These reactions are an open challenge for Healthcare professionals -to understand the problem and be conscious of how these reactions can be prevented and managed. However, adverse drug reactions can be minimized including the patient as one pillar of the therapeutic plan and providing more patient counseling, which will improve drug safety. Assessing and reporting adverse drug reactions are very important to maintain drug safety systems. PK-PD studies are the two principal focus areas of pharmacology. Pharmacodynamics is the study of the molecular, biochemical, and physiological effects of drugs on cellular systems and site of action. Pharmacokinetics focuses on how the body affects the drug, in ADME terms. Today, Clinical Pharmacology techniques and pharmacologists use different techniques to explain and manipulate the pharmacological action for safer use health concerns.
This track provides sound knowledge for drug product manufacturers, professionals, and consumers to report Post marketing reports on adverse effects and informative B2B meetings can be planned.
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.
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.
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.
Here in this track discussions are involved in types of diseases and theirs clinical trial output.
In Clinical Research, Case Report plays a prominent role. If an unexpected event in the course of observing, treating a patient, possibilities of pathogenesis of a disease or an adverse effect can drive into action as a Case report.
This track focus on several case reports of clinical trials involving Cancer, Cardiovascular, sexually transmitted diseases, Type 1 and type 2 diabetes, Case reports on drugs used in pregnancy and lactation, Applications of biomarkers in clinical trials.
GVP is abbreviated as Good pharmacovigilance practices which is to facilitate the measure and performance of Pharmacovigilance. The role of GVP and Pharmacoepidemiology in Risk Management is to increase the beneficial effects of a drug than its adverse effects. The clinical trials and pharmacovigilance services providing companies must be Certification. It is of high importance to focus on Signal investigation via observational studies to Interpret safety signals.
Medical device Pharmacovigilance is monitoring of safety profile of medical devices, from the processing to reporting of single adverse incidents including the removal of products from the market as fragment of a Field Safety Corrective Action. This to ensure that patient’s and healthcare professional’s safety is monitored and action taken as soon as a safety concern with a medical device arises.
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.
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.
Centralizing all safety data, clinical data, analysis and reporting with one provider is advantageous. Pharmacovigilance Software tool provides broad analysis of adverse events arising from the use of Pharmaceutical products (Medical Device, Medicinal Product, Veterinary Medicinal Product, Vaccines, Non-Drug Therapy. The drug safety database permits the risk- benefit analysis of medicinal and medical products taking into account, new and emerging information. Pharmacovigilance is a compliance driven activity, whereas regulatory compliance determines company’s risk assessment scores. A drug safety database provides follow-up cases, scheduling of alerts for expedited cases and PADER /PSUR reports submission to meet regulatory timeline compliance.
Owing to the changing resources which are necessary to fulfil the regulatory requirements, few companies choose to outsource or out task regulatory affairs to service providers externally. Regulatory Affairs department is constantly evolving and growing and hence it is one which is least impacted during the Acquisition and Merger, and also during recession. The stringent regulations on safety monitoring and their periodical revision have led to increased safety in data collection, analysis, regulatory surveillance including costs. Thus, Pharmacovigilance has become a critical phase in clinical development programs.
This is a main branch in Pharmaceutical Sciences which relates the physicochemical properties of the drugs - dosage form, pharmacology, toxicology / clinical response observed after its administration. Biopharmaceuticsuses the exact formulation to obtain the drug with new dosage form as related to the onset, duration, and intensity of drug action, including constituents and mode of manufacture.
Discussions under this track include rational drug management of cancer, diabetes and cardiovascular disorders, Management of psychiatric disorders and autoimmune disorders, Bioavailability and bioequivalence, drug disposition, Invivo-invitro correlation, Pharmacodynamics, Drug Interaction, Bio analytical method, Clinical Pharmacology, Clinical toxicology, Biomarkers, Recent Biomedical Innovation
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.
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.
A platform aimed to connect Entrepreneurs, Investors, and Proposers globally. It's intended to create and facilitate industrial delegates, research scientists, business delegate a viable meeting place for engaging people and it would be a good opportunity for Startup Company representatives in global business discussions, evaluation and execution of promising business ideas. For entrepreneurs, it would be an ideal place to find out suitable investors and partners to start and/or expand their business.