12th Global Pharmacovigilance & Clinical Trials Summit Follow Verify

12th Global Pharmacovigilance & Clinical Trials Summit
Date	2018-07-16
Place	Sydney, Australia

The world to “12th Global Pharmacovigilance & Clinical Trail Summit”, will provide a forum for interaction among attendees with discussion involving discovery of a new drug, Challenges in drug development, Pre-Clinical and Clinical trial reports, Case Studies, Pharmacovigilance, Biosimilar and Biologistics and its eye on new drug regulatory approvals. Session discussions will focus on discussions about approaches and innovations for Patient Benefit Risk Management in Pharma, Biotech and Healthcare Industry.

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Drug Safety

Concept of drug safety is also known as Medication Safety in the field of health. It relates to the potential for adverse effects related to the administration of drugs 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 Reaction are several terms involved with Drug Safety.

Efforts to establish the safely profile of drugs begin early in their development, with in vitro and in vivo toxicity testing, and continue through clinical trials leading up to drug approval and following approval in specific post-marketing studies or general pharmacovigilance efforts. 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 the Forum will be focusing on Drug Safety Updates, Drug Safety Solutions, Training, Surveillance, Services & Software, Reporting & Monitoring.

Conference Series LLC warmly invites all the participants across the world to “12th Global Pharmacovigilance & Clinical Trail Summit” scheduled on July 16-17, 2018 in Sydney, Australia. This conference provides a forum for interaction among attendees with discussion involving discovery of a new drug, Challenges in drug development, Pre-Clinical and Clinical trial reports, Case Studies, Pharmacovigilance, Biosimilar and Biologistics and its eye on new drug regulatory approvals. Session discussions focus on discussions about approaches and innovations for Patient Benefit Risk Management in Pharma, Biotech and Health care Industry.</ref>https://globalpharmacovigilance.pharmaceuticalconferences.com/</ref>

Adverse Drug Reactions

"An Adverse Drug Reaction (ADR) is a response to a medicinal product which is noxious and unintended and implies at least a reasonable possibility of a causal relationship between a suspected medicinal product and an adverse event." 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 will provide sound knowledge for drug product manufacturers, professionals, and consumers to report Post marketing reports on adverse effects and informative B2B meetings can be planned.

Clinical Research and Statistics

Clinical trials are nothing but experiments done in clinical research. Clinical trial safety is an important component of pharmacovigilance. Every medicinal product must have satisfactorily completed a clinical trial programme establishing acceptable evidence of safety and efficacy before being placed onto the market. 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 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.

Pre-Clinical and Clinical Trials

The entire process of moving a drug from design to clinical trials takes 10 to 12 years on average. Deciding whether a drug is ready for clinical trials (the so-called move from bench to bedside) involves extensive preclinical studies that yield preliminary efficacy, toxicity, pharmacokinetic and safety information. Wide doses of the drug are tested using in vitro (test tube or cell culture) and in vivo (animal) experiments, and it is also possible to perform in silico profiling using computer models of the drug–target interactions. 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 on Various Disorders

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. Clinical trials generally include interference such as medication, psychotherapy, new equipments and new approaches to surgery or radiation therapy. Clinical trials helps in inventing new ways to treat a particular disorder or condition and provide best possible ways to detect the presence of certain disorder or condition. 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.

Here in this track discussions are involved in types of diseases and theirs clinical trial output.

Case Reports in Clinical Trials

Case reports are still common but have come to be viewed more often than not as anecdotes rather than evidence. 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 will 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.

Good Pharmacovigilance Practice

Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the 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.

This track will focus on role of pharmacovigilance in risk Management, Pharmacoepidemiology, Good reporting practices, safety signals Interpretation and many more.

Pharmacovigilance Significance & Scope

"Pharmacovigilance of medical devices 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. The main aim of pharmacovigilance is to provide complete and clear information related to drug safety  and various risks and benefits  associated with them. Pharmacovigilance can help in providing information of unintended and severe adverse events  which could not be provided by clinical trials involving in-vivo method. It 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."

• Significance of pharmacovigilance
• Pharmacovigilance and healthcare system
• Pharmacovigilance legislation
• Role of pharma industries in the improvement of pharmacovigilance system
• Detection and evaluation of drug safety signals through manual and medical devices reporting
• Methods of pharmacovigilance

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• Armando Quintana
• Bonala Sumaya Sulthana
• Anamika Varghese
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