With the grand success of Pharmacovigilance Series of Conferences in UK, USA in consecutive years over the last several years which met with great achievement in Business Conferencing. It’s glad to announce 12^th Global Pharmacovigilance & Drug Safety Summit during July 16-17, 2018 Sydney, Australia with the theme “Comprehend Multiple Facets of Pharmacovigilance, Drug Safety and Clinical Trials”. This is a 2 day Mega Event offering Exhibition, at venue to showcase the new and emerging technologies with Keynote presentation, Oral, YRF (Student Presentation), poster, e-poster Presentations. 

Track 1: Drug Safety

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 Reaction are 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.

Related Societies and Associations:

International Society for Pharmacoepidemiology, Center for Drug Safety and Effectiveness,  , International Pharmaceutical Federation, International Society of Pharmacovigilance , Society for Clinical Trials, Association of Clinical Research, The Society of Clinical Research Associates, Clinical Research Society, American Association of Pharmaceutical Scientists, Association of British Pharmaceutical Industry ,  Indian Society for Clinical Organization Research (ISCR), Pharmaceutical Information and Pharmacovigilance Association ( PIPA),International Society of Pharmacovigilance (ISOP),  Drug Information Association, The Australian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT), European Association for Clinical Pharmacology and Therapeutics (EACPT), European Drug Utilization Research Group (EURODURG

Track 2: Adverse Drug Reactions

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.

Related Societies and Associations:

Drug Information Association, International Pharmaceutical Federation, European Drug Utilization Research Group(EURODURG), International Society of Pharmacovigilance , Society for Clinical Trials, Association of Clinical Research, The Society of Clinical Research Associates, Clinical Research Society, American Association of Pharmaceutical Scientists, Association of British Pharmaceutical Industry,  Pharmaceutical Information and Pharmacovigilance Association ( PIPA), International Society of Pharmacovigilance (ISOP),  The Australian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT), European Association for Clinical Pharmacology and Therapeutics (EACPT), International Epidemiology Association, European Association of Employed Community Pharmacists in Europe (EPhEU), Association of Pharmacy Professionals (APP)

 

Track 3: Clinical Research and Statistics

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.

Related Societies and Associations:

International Society of Pharmacovigilance , Society for Clinical Trials, Association of Clinical Research, The Society of Clinical Research Associates, Clinical Research Society, American Association of Pharmaceutical Scientists, Association of British Pharmaceutical Industry ,  Indian Society for Clinical Organization Research(ISCR), Pharmaceutical Information and Pharmacovigilance Association ( PIPA), International Society of Pharmacovigilance (ISOP),  Drug Information Association, The Australian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT), European Association for Clinical Pharmacology and Therapeutics(EACPT), European Drug Utilization Research Group (EURODURG) International Epidemiology Association, European Association of Employed Community Pharmacists in Europe (EPhEU)

Track 4: Pre-Clinical and Clinical Trials

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.

Related Societies and Associations:

Society for Clinical Trials, Association of Clinical Research, The Society of Clinical Research Associates, Clinical Research Society, American Association of Pharmaceutical Scientists, Association of British Pharmaceutical Industry ,  Indian Society for Clinical Organization Research (ISCR), Pharmaceutical Information and Pharmacovigilance Association ( PIPA), Pharmaceutical Society Of New Zealand (PSNZ), Pharmaceutical Association of Mauritius(PAM),  International Society of Pharmacovigilance (ISOP),  Drug Information Association, The Australian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT), European Association for Clinical Pharmacology and Therapeutics (EACPT)

Track 5: Clinical Trials on Various Disorders

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.

Related Societies and Associations:

The Australian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT), European Association for Clinical Pharmacology and Therapeutics (EACPT), International Pharmaceutical Federation, International Society of Pharmacovigilance , Society for Clinical Trials, Association of Clinical Research, The Society of Clinical Research Associates, Clinical Research Society, American Association of Pharmaceutical Scientists, Association of British Pharmaceutical Industry ,  Indian Society for Clinical Organization Research(ISCR), Pharmaceutical Information and Pharmacovigilance Association ( PIPA), International Society of Pharmacovigilance (ISOP)

Track 6: Case Reports in Clinical Trials

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.

Related Societies and Associations:

International Society for Pharmacoepidemiology, Center for Drug Safety and Effectiveness,  Center for Public Health and Human Rights, Center  for Health Services  and Outcomes Research, International Pharmaceutical Federation, International Society of Pharmacovigilance , Society for Clinical Trials, Association of Clinical Research, The Society of Clinical Research Associates, Clinical Research Society, American Association of Pharmaceutical Scientists, Association of British Pharmaceutical Industry ,  Indian Society for Clinical Organization Research (ISCR), Pharmaceutical Information and Pharmacovigilance Association ( PIPA)

Track 7: Good Pharmacovigilance Practice

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.

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

Related Societies and Associations:

International Society of Pharmacovigilance (ISOP),  Drug Information Association, The Australian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT), European Association for Clinical Pharmacology and Therapeutics (EACPT), European Drug Utilization Research Group (EURODURG) International Epidemiology Association, European Association of Employed Community Pharmacists in Europe(EPhEU), Association of Pharmacy Professionals (APP), Pharmaceutical Society Of New Zealand (PSNZ), Pharmaceutical Association of Mauritius(PAM)

Track 8: Pharmacovigilance Significance & Scope

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.

Related Societies and Associations:

International Society for Pharmacoepidemiology, Center for Drug Safety and Effectiveness,  Center for Public Health and Human Rights, Center  for Health Services  and Outcomes Research, International Pharmaceutical Federation, International Society of Pharmacovigilance , Society for Clinical Trials, Association of Clinical Research, The Society of Clinical Research Associates, Clinical Research Society, American Association of Pharmaceutical Scientists, Association of British Pharmaceutical Industry ,  Indian Society for Clinical Organization Research (ISCR), Pharmaceutical Information and Pharmacovigilance Association ( PIPA)

Track 9: Pharmacovigilance and Risk Management

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.

Related Societies and Associations:

International Society of Pharmacovigilance , Society for Clinical Trials, Association of Clinical Research, The Society of Clinical Research Associates, Clinical Research Society, American Association of Pharmaceutical Scientists, Association of British Pharmaceutical Industry ,  Indian Society for Clinical Organization Research(ISCR), Pharmaceutical Information and Pharmacovigilance Association ( PIPA), International Society of Pharmacovigilance (ISOP),  Drug Information Association, The Australian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT), European Association for Clinical Pharmacology and Therapeutics(EACPT), European Drug Utilization Research Group (EURODURG) International Epidemiology Association, European Association of Employed Community Pharmacists in Europe (EPhEU)

Track 10: Clinical Data Base Management

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.

Related Societies and Associations:

Society for Clinical Data Management, International Pharmaceutical Federation, International Society of Pharmacovigilance , Society for Clinical Trials, Association of Clinical Research, The Society of Clinical Research Associates, Clinical Research Society, American Association of Pharmaceutical Scientists, Association of British Pharmaceutical Industry ,  Indian Society for Clinical Organization Research (ISCR), Pharmaceutical Information and Pharmacovigilance Association ( PIPA), International Society of Pharmacovigilance (ISOP),  Drug Information Association, The Australian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT), European Association for Clinical Pharmacology and Therapeutics (EACPT), International Epidemiology Association, European Association of Employed Community Pharmacists in Europe (EPhEU)

Track 11: Analysis of Data quality and Management

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.

Related Societies and Associations:

International Society for Pharmacoepidemiology, Center for Drug Safety and Effectiveness,  Center for Public Health and Human Rights, Center  for Health Services  and Outcomes Research, International Pharmaceutical Federation, International Society of Pharmacovigilance , Society for Clinical Trials, Association of Clinical Research, The Society of Clinical Research Associates, Clinical Research Society, American Association of Pharmaceutical Scientists, Association of British Pharmaceutical Industry ,  Indian Society for Clinical Organization Research (ISCR), Pharmaceutical Information and Pharmacovigilance Association ( PIPA)

Track 12: PV Consultings And Business opportunity

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.

Related Societies and Associations:

International Society for Pharmacoepidemiology, Center for Drug Safety and Effectiveness,  Center for Public Health and Human Rights, Center  for Health Services  and Outcomes Research, International Pharmaceutical Federation, International Society of Pharmacovigilance , Society for Clinical Trials, Association of Clinical Research, The Society of Clinical Research Associates, Clinical Research Society, American Association of Pharmaceutical Scientists, Association of British Pharmaceutical Industry ,  Indian Society for Clinical Organization Research (ISCR), Pharmaceutical Information and Pharmacovigilance Association ( PIPA)

Track 13: Biopharmaceutics

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

Related Societies and Associations:

International Society of Pharmacovigilance (ISOP),  Drug Information Association, The Australian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT), European Association for Clinical Pharmacology and Therapeutics (EACPT), European Drug Utilization Research Group (EURODURG) International Epidemiology Association, European Association of Employed Community Pharmacists in Europe(EPhEU), Association of Pharmacy Professionals (APP), Pharmaceutical Society Of New Zealand (PSNZ), Pharmaceutical Association of Mauritius(PAM)

Track 14: Regulatory Affairs

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.

Related Societies and Associations:

International Society for Pharmacoepidemiology, Center for Drug Safety and Effectiveness,  Center for Public Health and Human Rights, Center  for Health Services  and Outcomes Research, International Pharmaceutical Federation, International Society of Pharmacovigilance , Society for Clinical Trials, Association of Clinical Research, The Society of Clinical Research Associates, Clinical Research Society, American Association of Pharmaceutical Scientists, Association of British Pharmaceutical Industry ,  Indian Society for Clinical Organization Research (ISCR), Pharmaceutical Information and Pharmacovigilance Association ( PIPA),

 International Society of Pharmacovigilance (ISOP),  Drug Information Association, The Australian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT), European Association for Clinical Pharmacology and Therapeutics (EACPT), European Drug Utilization Research Group (EURODURG) International Epidemiology Association, European Association of Employed Community Pharmacists in Europe(EPhEU), Association of Pharmacy Professionals (APP), Pharmaceutical Society Of New Zealand (PSNZ), Pharmaceutical Association of Mauritius(PAM)

Track 15: Pharmacy Practices and its Challenges

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.

Related Societies and Associations:

European Association of Employed Community Pharmacists in Europe (EPhEU), Association of Pharmacy Professionals (APP), Pharmaceutical Society Of New Zealand (PSNZ), Pharmaceutical Association of Mauritius(PAM), Pharmaceutical Information and Pharmacovigilance Association ( PIPA), Drug Information Association, The Australian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT), European Association for Clinical Pharmacology and Therapeutics (EACPT), European Drug Utilization Research Group (EURODURG) International Epidemiology Association

Track 16: Entrepreneurs Investment Meet

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.