Renowned Speakers

Sheraz Ali

King Saud Medical City, Ministry of Health Saudi Arabia

Silvia Cacho-Elizondo

IPADE Business School USA

Nicole Powell,

Statistics and Data Corporation USA

Thomas E Serena

Serena Group USA

David A Pearce

Sanford Research USA

Nazila Bazrafshan

Yazd University Iraq

Ramandeep Kaur Brar

Baba Farid University of Health Sciences India

Magd Zakaria

Ain Shams University Egypt

Recommended Global Pharmaceutical Sciences Webinars & Conferences

Europe & UK

Asia Pacific & Middle East

Canada

Clinical Trials 2020

About Conference

27th World Congress on Pharmacovigilance and Clinical Trials which is going to be held October 21-22, 2020 at Frankfurt, Germany. This Pharmacovigilance and Clinical Research is committed to advancing propels that address key clinical, administrative, methodological and strategy challenges in the congress we will be discussing and scrutinizing with the theme of Science, Technology and Regulations bringing together in Health Care This work is practiced through organization with people there is an increasing interest and awareness in exploring clinical development for rare disease therapies, significant challenges remain in ensuring successful and sustainable clinical trials key topics addressed will include patient identification, recruitment and retention, novel study design and approaches, patient preference studies, preclinical collaborations and evolving technologies to enable adaptive trials. Patient-driven progress will also be highlighted through discussions of changes in the drug development paradigm.ConferenceSeries Organizes 3000+ Global Events Every Year across USA, Europe & Asia with support from 1000 more scientific societies and Publishes 700+ Open access journals which contains over 100000 eminent personalities, reputed scientists as editorial board and organizing committee members. The conference series website will provide you list and details about the conferences organize worldwide.

Why to attend

27th World Congress on Pharmacovigilance and Clinical Trials Conference is a multidisciplinary program with broad participation with members from around the globe focused on learning about Pharma Clinical Research and its advances. This is your best opportunity to reach the largest assemblage of participants from Clinical Trials there will be many opportunities to network and meet new colleagues from industry and patient’s Clinical organizations,, clinical research entities, medical groups, related associations, societies and also from government agencies, pharmaceutical, biomedical and medical device industries.

Clinical Trial 2020 will discuss various disciplines involved in the pre-clinical research, conduct of clinical trials; it will educate health care researchers about design, operation, organizing, research computing, regulatory aspects and reporting of clinical trials. It promotes better understanding by the general public about the importance of clinical trials in prevention, diagnosis and treatment of disease.

Conduct presentations, distribute information, meet with current and potential scientists, make a splash with new clinical research developments, and receive name recognition at this 2-days event. World renowned speakers and the most recent techniques, developments, the newest updates in Clinical Research and encouraging world toward conducting Clinical Research and Clinical Trials are hallmarks of this conference.

Who should attend and Who You’ll Meet:

Directors/Senior Directors/Executive Directors and Vice Presidents/Senior Vice Presidents/Executive Vice Presidents and Heads/Leaders/Partners of

Pharma R&D
CROs and CMOs
Clinical Research Sites
Pharma/Biotech and Medical Device industries
Hospitals, Associations

Medical Directors, Principal Investigators, Methodologists, and other clinical research professionals along with Academicians: University Faculties like Directors, Senior Professors/Assistant Professors/ Associate Professor, Research Scholars, scientists who are related to clinical and medical research. Students also participate at this event as student delegates and young research forum (YRF).

Sessions/Tracks

Tracks 1: Pharmacovigilance and Clinical Trials

Pharmacovigilance and Clinical Trials will have the rapid development of new drug and innovative therapeutics, new Pharmacovigilance procedures and methods have to be implemented for reassurance and Patient Benefit Safety Management in Pharma, Biotech and Health Care. Clinical Trails comprise the best quality level to assess the viability and wellbeing of new medications. However, in light of the fact that they are led in homogeneous conditions a long way from this present reality of solution and use, errors in patient choice or treatment conditions may change both the viability and dangers.

Related Conferences:

6th Congress on Drug Discovery & Toxicology, April 22-23, 2019 Abu Dhabi, UAE; Top clinical Research USA, 18th Congress on Pharmaceutics & Drug Delivery Systems, June 27-29, 2019 Amsterdam, Netherlands; 20th Conference on Pharmaceutics & Novel Drug Delivery Systems, March 18-20, 2019 Edinburgh, Scotland; Clinical Research Meetings, 21st European Pharma Congress, May 20-21, 2019 Zurich, Switzerland; 6th Congress and Exhibition on Antibiotics and Antibiotic Resistance, June 03-04, 2019 London, UK; 12th Conference and Exhibition on Pharmacovigilance & Drug Safety, July 04-05, 2019 Valencia, Spain; 12th European Biosimilars Congress, April 15-16, 2019 Berlin, Germany; 18th Conference on Pharmaceutics & Novel Drug Delivery Systems, April 25-26, 2019 Istanbul, Turkey; Clinical Trials Regulations Conference

Tracks 2: Pharmacovigilance Practice

The piece of Good Pharmacovigilance Practice and Pharmaco-epidemiology in Risk Management is widely to manufacture the probability of productive effects of a drug in a people than the probability of hostile effects and to keep up the Good Reporting Practices by avoiding the important issues in peril organization. Moreover, it is basic to center around Signal examination by party the facts on new or cloud solution impacts that is possibly caused by a medicine and that finally should provoke ensuring prosperity. The pharmacovigilance and clinical preliminaries organizations giving associations should have the Pharmacovigilance validation.

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Tracks3:Clinical Trials Pharmacovigilance

A clinical preliminary incorporates the testing of another medication (or other treatment) to gauge whether it is powerful and safe. Clinical preliminaries of medications can be partitioned into those surveying the treatment of the sickness (for example asthma) or those evaluating medications to counteract the event of huge medicinal services measures later on (for example stroke). Clinical preliminaries convey the quantitative data about the advantages, antagonistic impacts and potential employments of new medicates that enables prescribers and patients to settle on sound choices with respect to tranquilize treatment.

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Tracks 4:Adverse Drug Reactions

We outline associate adverse drug reaction as “an appreciably harmful or unpleasant reaction, ensuing from associate intervention associated with the employment of a healthful product that predicts hazard from future administration and warrants bar or specific treatment or alteration of the dose plan, or withdrawal of the merchandise.” Such reactions are presently reportable by use of WHO's Adverse Reaction nomenclature, which is able to eventually become a set of the International Classification of Diseases.

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Tracks 5:Causality Assessment

Causality assessment of ADRs may be a technique used for estimating the strength of relationship between drug(s) exposure and incidence of adverse reaction(s). Relation assessment of ADRs is also undertaken by clinicians, academics, the pharmaceutical trade and regulators, and in numerous settings, as well as clinical trials. At a private level, health-care suppliers assess relation informally once managing ADRs in patients to create choices concerning future medical aid. Several regulative authorities assess spontaneous ADR reports, wherever relation assessment will facilitate in detection and risk–benefit choices concerning medicines, exploitation formal CATs to help during this method

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Tracks 6:Drug Safety

The drug safety thought has attained plenty of attention throughout the past decade thanks to the very fact it plays a significant role in patients’ health. Recent laws stress this idea ought to be enclosed within the method of latest medications’ approval and continued conduct of post-marketing drug evaluations. Benefit–risk assessment ought to be thought of by all health care professionals once they ought to offer specific medicine to specific teams of patients. Therefore, additional care ought to incline to some patients, like pregnant girls, youngsters and therefore the aged, since they're thought of vulnerable populations.

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Tracks 7: Clinical Trial Protocols

All irregular clinical trials (RCTs) need a protocol; but, various studies have highlighted protocol deficiencies. Reportage pointers might improve the content of analysis reports and, if developed mistreatment sturdy ways, might increase the utility of reports to stakeholders. The target of this study was to consistently establish and review RCT protocol pointers, to assess their characteristics and ways of development, and to check recommendations

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Tracks 8: Clinical Research and Statistics

Clinical analysis contains exploring planned medical treatments, evaluating the relative advantages of competitive therapies, and launching optimum treatment combos. Clinical analysis makes an attempt to answer queries like “should a person with glandular carcinoma endure radical ablation or radiation or wait and see?” Statistics play a awfully important role in any run from style, conduct, analysis, and reportage in terms of dominant for and minimizing biases, contradictory factors, and mensuration irregular errors. A grasp of applied math strategies is crucial to understanding randomized trial strategies and results.

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Tracks 09:Global Clinical Trials

Clinical research by academic institutions and pharmaceutical companies has followed the overall trend of globalization and has moved inexorably towards low- and middle-income countries. This trend has raised various concerns, including whether the research being conducted is useful to public health in these countries or whether economically disadvantaged populations are being exploited for the advantage of patients in rich countries. Nevertheless, clinical trials and therefore the research and health care that accompany them can directly benefit patients, especially those that would otherwise haven't any or only little access to health care services. Clinical trials are a necessary step in drug development and are conducted throughout the planet, both in developed and in developing countries. Trials themselves are thus not intrinsically immoral, and there are a spread of reasons to conduct responsible clinical trials. Doing so, for instance, is usually the sole thanks to test drugs and vaccines for diseases that predominantly afflict people.

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Tracks 10: Clinical Database Management

The field of clinical knowledge management (CDM) has manifested itself thanks to demands from each the pharmaceutical business and therefore the restrictive authorities. Because the drive to “fast-track” the event of pharmaceutical product continues to accelerate, restrictive entities have responded by requiring quality-assurance standards be met in assembling the info employed in the drug analysis method. Clinical knowledge management systems (CDMS) area unit particularly important in trials conducted across medical centres during which a colossal quantity of information is made.

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Tracks 11 :Drug Safety and Pharmacovigilance

Drug safety relates to the potential for adverse effects related to the administration of drugs. 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. Pharmacovigilance (PV or PhV), also known as drug safety,is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation). 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 Signal Detection in Drug Safety

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Tracks 12:Recent trends in Pharma and Technology

Every industry is changing at a more fast pace. Products and administrations are getting to be progressively commercialized. Innovation is playing a continuously greater part in inquire about and improvement, showcasing and promoting, and deals and dispersion. The pharmaceutical division is one that has felt this change in investigate and advancement over the past few years and will begin to feel it within the other divisions over the another decade. It's exceptionally likely that within the next decade, people will now not be pharmaceutical test subjects. Instead, cognitive computers will be utilized in biotechnology and genomic research. Instead of it taking months to see the impact of a specific drug on thousands of individuals, it'll take seconds to see the impact of thousands of drugs on billions of simulations of the human body's physiology. Body sensors are a new innovation that's right now still in clinical trials. These sensors can either be put on the body or interior of it. They degree different basic crucial signs. With the unused innovation and advancement, patients are picking up more control. They presently have the capacity to have more of a say when it comes to their body and their health. In this way, pharmaceutical companies will have to be starting taking patient needs, thoughts, and desires into consideration. Products will be more effective if patients are included in their creation and distribution. It's likely that over the coming a long time, numerous companies within the pharmaceutical industry will make persistent admonitory sheets. The pharmaceutical industry is changing at each an each level.

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Tracks 13:Pharmacovigilance and Risk Management

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.

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Tracks 14: Prevalence of Potential Drug- Drug Interaction

The objective of this study is to estimate the prevalence and describe the characteristics of pDDIs in medical prescriptions of hospitalized surgical patients. In this cross-sectional study, we analyzed 370 medical prescriptions from the surgery unit of a Mexican public teaching hospital. The identification and classification of potential drug-drug interactions were performed with the Micromedex 2.0 electronic drug information database. Results were analyzed with descriptive statistics and we estimated OR (odds ratio) to determine associated risk factors.

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Tracks 15:Pharmacovigilance Significance and Scope

Pharmacovigilance main aim is to convey clear info regarding drug safety and its Risk or advantages of medicine to the patients. Patients are main finish users of medication. Patient info leaflet with reference to medication to be provided to the patient to extend the benefits of the medication and to scale back the chance related to them. It's essential for Risk decrease by creating associate early detection and preventing the progression of the adverse effects. Complete info of unintended and severe adverse events may well be finding through the Pharmacovigilance. It couldn't be done through clinical trials that are conducted in associate in vivo methodology.

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Tracks 16: Drug repurposing to treat Viruses: COVID-19

Drug repurposing is a methodology for making more value from an existing drug by targeting diseases by focusing on infections other than that for which it was initially proposed, For instance, teicoplanin, oritavancin, dalbavancin and monensin are affirmed antibiotics that have been appeared to inhibit corona- and other viruses in the research facility. The researchers reviewed information on the discovery and development of wide-spectrum antiviral agents (BSAAs), which are drugs that target viruses from two or more different viral families. They condensed what they found for 120 drugs that had just been demonstrated to be ok for people use and made a database, which is uninhibitedly available Thirty-one of these were found by the researchers to be possible candidates for prophylaxis and treatment of the COVID-19 infections. The researchers also found that clinical investigations have recently begun of five possible drug candidates to treat the virus that causes COVID-19.

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Tracks 17:Medical Devices for Drug Delivery

Medical devices layout for drug delivery through the pulmonary and nasal routes. These routes are of interest for local delivery, as in asthma, but also for rapid delivery of drugs to the system circulation and direct delivery to the central nervous system. Devices that report for particular anatomical and physiological features of the intranasal and pulmonary routes will be characterized. Drug delivery devices are specialized tools for the delivery of a drug or therapeutic agent via a particular route of administration. Such devices are used as bit of one or more medical treatments. Many in the industry have lengthy felt overly laden by what they acknowledge to be an unessential complicated approval process. Critics declare it impedes innovation and detain the opportunity of better health care. In order to help innovators import health care to the public.

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Tracks 18:Pharmacovigilance and Cosmetovigilance

Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical product. The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation). 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.

Cosmetovigilance is the ongoing and systematic monitoring of the safety of cosmetics in terms of human health. The aim is to detect adverse effects of cosmetic products, and to prevent adverse effects by taking appropriate measures. Regulations for cosmetic products primarily address the safety of products that may be used by large populations of healthy consumers. The identification and analysis of adverse effects related to cosmetic products is a process that is currently still, to a large extent, industry driven. It is the responsibility of manufacturers to determine that products and ingredients are safe before they are marketed, and then to collect reports of adverse reactions.

Tracks 19:Pharmacokinetics and Pharmacodynamics in Drugs

Pharmacokinetics is currently defined as the study of the time course of drug absorption, distribution, metabolism, and excretion. Clinical pharmacokinetics is the application of pharmacokinetic principles to the safe and effective therapeutic management of drugs in an individual patient. Primary goals of clinical pharmacokinetics include enhancing efficacy and decreasing toxicity of a patient’s drug therapy. The development of strong correlations between drug concentrations and their pharmacologic responses has enabled clinicians to apply pharmacokinetic principles to actual patient situations.

Pharmacodynamics refers to the relationship between drug concentration at the site of action and the resulting effect, including the time course and intensity of therapeutic and adverse effects. The effect of a drug present at the site of action is determined by that drug’s binding with a receptor.

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Tracks 20: Pharmaceutical Research and Development

For developing a new medicine it will take nearly 10-15 years and on average and costs an average of $2.6 billion. In discovery procedure comprises the initial stages of research, which are intended to recognize an investigational drug and perform primary tests in the lab. This first stage of the process takes three to six years. By the end, investigators hope to identify a capable drug aspirant to further study in the lab and in animal models, and then in people. These developments offer great ability, but also add complexity to the R&D process. In order to ensure the safety and efficacy of personalized therapies that are used along with diagnostics, clinical trial protocols must be improved and increased.

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Tracks 21:Pharma Market Research

Two powerful megatrends — dramatic deceleration in U.S. market growth and significant restructuring of the healthcare system — are at play in the U.S. pharmaceuticals industry. The U.S. pharmaceutical market is the world’s most important national market. Together with Canada and Mexico, it represents the largest continental pharma market worldwide. The United States alone holds over 45 percent of the global pharmaceutical market. In 2016, this share was valued around 446 billion U.S. dollars. The biopharmaceutical companies in the United States exported goods in the amount of some 31 billion U.S. dollars during 2016. In the United States, there are an estimated 100,000 OTC drug products marketed and sold in a variety of outlets, such as pharmacies and convenience stores. TH revenue for the OTC drugs also add to the pharma market growth. Top markets for pharmaceutical products continue to be developed countries in Western Europe, East Asia, and North America with high per capita spending on healthcare, growing elderly populations, and advanced regulatory systems. Though ranked lower, there are growing opportunities in developing countries like China as incomes and healthcare spending increases. The pharmaceutical sector has consistently been one of the most R&D intensive industries in the United States. The research-based industry generally allocates around 15 to 20 percent of revenues to R&D activities and invests over $50 billion on R&D annually.

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Tracks 22:Regulatory Authority Compliance

With more stringent compliance parameters set by the USFDA the quality assurance of pharmaceutical products is ensured. In addition to cGMP, GLP and GCP practices as per the US Federal law pharma products should comply with 21CFR regulations. Also on a regular basis the FDA organizes compliance programs for the pharma industries in program areas like Biologics (CBER), Bioresearch Monitoring (BIMO), Devices/Radiological Health (CDRH), Drugs (CDER), Food and Cosmetics (CFSAN), Veterinary Medicine (CVM). The results of regulatory audits NAI – No Action Indication, VAI – Voluntary Actions Indicated, OAI – Official FDA Action Indicated are also critical to decide by auditors in regards to compliance matters and call for several challenges to overcome by the manufacturers.

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Tracks 23:Importance of Audit in Pharmaceutical Industry

International Organization for Standardization (ISO) 9000 requirements do not have the same status of “the law” in the U.S. as do requirements listed in the Code of Federal Regulations (CFR). Because 21 CFR 210 and 211 have legal status, the U.S. Justice Department has extensive powers to ensure compliance. For example, product in the marketplace can be seized, fines can be levied, and personal liability can be assigned. So, management must understand that auditing must be taken seriously, and the requirements listed are just that – requirements. While audits are the common place in the pharmaceutical industry, the preparedness for those events varies. The companies that develop a risk-based approach to audits are able to remain competitive while meeting quality and government compliance standards on a regular basis. Conversely, the companies that have not implemented strong processes are putting themselves at risk for non-compliance. According to the Federal Food, Drug and Cosmetic Act, “Registered domestic drug establishments shall be inspected by the FDA at least once every two years.” Under some conditions the inspections may be even more frequent, As regulations become more stringent, regulatory authorities are likely to step up audits which is even more reason for companies to be prepared

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Tracks 24:Pharmaceutical Auditing for OTC Drugs

Non-prescription medicines, commonly known as over the counter or OTC medicines, are used for treatment. Sales of over the counter medicines in pharmacy and grocery outlets reached £1268 5 million in 1994 about a third of the NHS drugs bill of C3 6 billion. In the late 1980s the government fuelled the over the counter market by making it easier to reclassify certain medicines from prescription only status to allow over the counter sale in pharmacies. Although all non-prescription medicines are required to hold a product licence, few have been evaluated in formal clinical trials in the setting in which they will be used. As a result many non-prescription products sold by pharmacists have been criticised for their lack of effectiveness. There are three legal categories of medicines prescription only medicine (POM), pharmacy medicine (P), and general sales list medicine (GSL); the last can be sold from outlets including supermarkets and drugstores. The principle of a class of medicines whose sale requires the supervision of a pharmacist is not unique to the United Kingdom.

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Tracks 25:Use of Nanoparticles in DDS and Newer Methodologies

A particle with at least one dimension less than 100nm is a nanoparticle. They are composed of synthetic or semisynthetic polymers carrying drugs or proteinaceous substances. Nanoparticles have developed as capable vehicles to deliver drugs in the body. Nanoparticles comprising encapsulated, dispersed, absorbed or conjugated drugs have exceptional characteristics that can lead to higher performance in a variety of dosage forms. Nanoparticles are one of the novel drug delivery systems which can be of potential use in controlling and targeting drug delivery as well as in cosmetic textiles and paints. There are recent developments in the use of nanoparticles as drug delivery systems to treat a wide variety of diseases.

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Tracks 26:Pharmaceutical Nanotechnology: Challenges and Opportunities

Pharmaceutical nanotechnology is most innovative field in the pharmaceutical industry. Nano technology is dealing with new emerging technologies. Application of nanotechnology in imaging, diagnostics and therapeutics is considered as an important factor. The drug delivery system positively impacts the rate of absorption, distribution, metabolism, and excretion of the drug or other related chemical substances in the body. Within regulatory boundaries thermodynamics and nanotechnology are considered to be evolving tools to provide new and integrated knowledge for the production of new medicines.

Nanotechnology speaks to a stage for creating progressive changes and enhancements to a wide range of parts of pharmaceutical assembling. Pharmaceutical nanotechnology has provided fine-tuned diagnosis and focused treatment of disease at a molecular level. Nano technology is having an utmost importance in Gene therapy.

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Tracks 27:Drug Delivery Technologies & Drug Designing and Development

The global drug delivery technology market is projected to reach USD 1,669.40 Billion by 2021 from USD 1,179.20 Billion in 2016, at a CAGR of 7.2% during the forecast period. The North American drug delivery technologies market is projected to reach USD 758.7 Billion by 2021 from USD 520.0 Billion in 2016, at a CAGR of 6.5% during the forecast period. Bringing one new drug to the public typically costs a pharmaceutical or biotechnology company on average more than $1 billion and takes an average of 10 to 15 years. Each drug undergoes a stringent process of discovery, development, approval and finally, public use.

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Tracks 28:Pharmacoeconomics

Health economics is a tool to help us prioritise different and sometimes competing health care interventions for these fixed resources and, in doing so, health care is treated as a commodity like any other. Knowledge of health economics coupled with political insight is essential to understand resource allocation and expenditure in a modern health care system. Pharmacists, with their unique knowledge of medicine, are crucial in using pharmacoeconomic analysis to influence expenditure and distribution of resources on medicines. Design and management of pharmacoeconomic studies

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TrackS 29 :QC & QA: Quality control and Quality assurance

With greater attention to the following elements this session will discuss the all the key lookouts essential for the development of a QA/QC system in pharmaceutical manufacturing process and requires implementation in tracking inventory compilation:

An inventory agency responsible for coordinating QA/QC activities;
A QA/QC plan;
General QC procedures
Source category-specific QC procedure
QA review procedures;
Reporting, documentation, and archiving procedures.
Market research analysts predict that the global automated industrial quality control (QC) market will grow steadily at a CAGR of around 8% by 2021.

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Track 30:Quality by design(QbD) approach

“The Quality cannot be tested into the product, but it should be built into it.” QbD can be attributed as a Scientific, risk-based, holistic and proactive approach to the development of a pharmaceutical product. It is more of a deliberate design effort from product conception through commercialization requiring full understanding of how product attributes and process would relate to product performance. In FDA’s Office of New Drug Quality Assessment (ONDQA), a new risk-based pharmaceutical quality assessment system (PQAS) was established based on the application of product and process understanding. The difference between QbD for NDA and ANDA products is most apparent at the first step of the process. For an NDA, the target product profile is under development while for the ANDA product the target product profile is well established by the labeling and clinical studies conducted to support the approval of the reference product.

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Track 31:Drug discovery and NCEs

In 2018 FDA has approved 34 new drugs which are presently in the market. Each year, CDER approves series of new drugs and biological products. Some of these products are often innovative new products that never before have been used in clinical practice. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act. According to Medscape the ratio of researched drugs to eventually approved therapies at between 5,000-to-1 and 10,000-to-1. Nonetheless, if a drug manages to gain FDA approval, the cumulative direct and indirect expenses are huge. As per estimated study performed by a well-known university, the true cost to bring a drug to market was US$2.56 billion. This figure is inclusive of just shy of $1.4 billion in average out-of-pocket costs to the drug developer, as well as $1.16 billion in time costs, which are essentially the expected returns that investors forgo while a drug is in development.

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Track 32:Pharmaceutical Manufacturing, Scale Up and Tech transfer

Recently, process engineers have shown inclination to single-use, modular and continuous manufacturing technologies to improve efficiency and minimize scale-up and technology transfer challenges in the pharmaceutical industry. Lot of these innovations are driven by updates instigated by the FDA. The changes are inevitable; especially in the already aging biopharmaceutical sector of the industry, where original processes are often overly complex, and are characterized by inefficiency, and occasionally, inherent unpredictability.

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Track 33:Analytical strategies for pharmaceutical products

Chromatography and MS are extensively used in the formulation development stage of generic drug products. The ICH Q3B guidelines address the reporting threshold, identification threshold, and qualification threshold for impurities in the drug product. Chromatography (LC) and Gas Chromatography (GC) are extensively used to analyze stable compounds. However, for labile compounds require derivatization prior to LC or GC analysis. For certain selected analyses, Liquid Chromatography- Ultraviolet Detection (LC-UVD) and Gas Chromatography-Flame Ionization Detection (GC-FID) techniques may be deemed suitable. However, Liquid Chromatography-Mass Spectrometry (LC-MS) and Gas Chromatography-Mass Spectrometry (GC-MS) are usually the techniques of choice when higher specificity and sensitivity are required. Gas Chromatography-Electron Capture Detection (GC-ECD) techniques are commonly used for halogenated PGIs/GIs to enhance sensitivity and selectivity. Occasionally, some spectroscopic techniques like Nuclear Magnetic Resonance (NMR), light scattering, and Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) are used in analyzing PGIs/GIs.

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Track: 34 Clinical Data Management

The Clinical Data Management is the system of the dealing with data from the clinical primers. The regular goal of any clinical data the board is the system is to convey and to keep up quality data. Likewise, this office is unnecessarily drawn in with the general social event and in treatment of the clinical starter data. Also, the Data Management bunches that make gadgets for collection of data at the clinical primer regions, and quality check the assembled data for missteps and raise hails if there ought to emerge an event of any mistake is perceived. They develop the instruments for the check, endorsement and the quality control of the data collected during the clinical primer. Clinical data executives to ensure the trustworthiness and the mystery of accumulated data are too much kept up at all the events.

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6th Congress on Drug Discovery & Toxicology, April 22-23, 2019 Abu Dhabi, UAE; Top Clinical Research USA, 18th Congress on Pharmaceutics & Drug Delivery Systems; June 27-29, 2019 Amsterdam, Netherlands; 20th Conference on Pharmaceutics & Novel Drug Delivery Systems, March 18-20, 2019 Edinburgh, Scotland; Clinical Research Meetings, 21st European Pharma Congress, May 20-21, 2019 Zurich, Switzerland; 6th Congress and Exhibition on Antibiotics and Antibiotic Resistance, June 03-04, 2019 London, UK; 12th Conference and Exhibition on Pharmacovigilance & Drug Safety, July 04-05, 2019 Valencia, Spain; 12th European Biosimilars Congress, April 15-16, 2019 Berlin, Germany; 18th Conference on Pharmaceutics & Novel Drug Delivery Systems, April 25-26, 2019 Istanbul, Turkey; Clinical Trials Regulations Conference

Track: 35 Patient Recruiting & Retention

Enlisting and selecting patients for clinical trials can frequently be a long and troublesome process. It's not shocking at that point, that finding the objective statistic, qualifying and selecting patients can expend significant time and cash. Hence, it is basic that the way toward enrolling is all around arranged and fits inside the convention spending plan and timetable. When patients are enlisted in an examination, it can be similarly as difficult to hold them. An assortment of startling variables can lead patients to pull back from the examination, bringing about insufficient information and conceivably, a costlier trial. Before you set out on a patient enlistment crusade, it is vital to have an arrangement. Taking a gander at your accessible assets, doing your examination, and defining objectives can enable spare to time and cash over the long haul. The best and minimum costly patient to select into an examination originates from the site's own particular database or practice. These clinical research patients as of now have an association with the site, know about their examination, and have been most agreeable while taking an interest in investigate. Consequently, setting the site up for viable inside enlistment through enrolment arranging is imperative to the accomplishment of any investigation.

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21st European Pharma Congress, May 20-21, 2019 Zurich, Switzerland; 6th Congress and Exhibition on Antibiotics and Antibiotic Resistance, June 03-04, 2019 London, UK; Top clinical Research Europe, 12th Conference and Exhibition on Pharmacovigilance & Drug Safety, July 04-05, 2019 Valencia, Spain; 20th Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems, March 18-20, 2019 Edinburgh, Scotland; Clinical Research Event, 12th European Biosimilars Congress, April 15-16, 2019 Berlin, Germany; 18th Conference on Pharmaceutics & Novel Drug Delivery Systems, April 25-26, 2019 Istanbul, Turkey; 6th Congress on Drug Discovery & Toxicology, April 22-23, 2019 Abu Dhabi, UAE; 18th Congress on Pharmaceutics & Drug Delivery Systems, June 27-29, 2019 Amsterdam, Netherlands; Top clinical Research Asia

Track:36 Risk assessment and management in clinical trials

With the expanded in clinical R&D and fund needs within the complexities of a clinical improvement, a hazard the board has become a elementary and indispensable piece to a clinical preliminary administration to ensure the nice profit for the speculation. The middle of a hazard the executives is distinctive proof and analysis of dangers 1st and foremost and it's likewise persistent reason for hazard bearing exercises in clinical preliminary. Once issuing of direction on a Risk-Based observation by FDA, the patrons/CROs have shown a definite fascination for receiving a particular thanks to alter a hazard appraisal in clinical preliminaries. Hazard appraisal is associate economical procedure for distinctive and assessing occasions that would be influence the accomplishment of the clinical examination targets.

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18th Congress on Pharmaceutics & Drug Delivery Systems, June 27-29, 2019 Amsterdam, Netherlands; 20th Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems, March 18-20, 2019 Edinburgh, Scotland; Clinical Research Organization, 21st European Pharma Congress, May 20-21, 2019 Zurich, Switzerland; 6th Congress and Exhibition on Antibiotics and Antibiotic Resistance, June 03-04, 2019 London, UK; Clinical Research 2019 Conferences , 12th Conference and Exhibition on Pharmacovigilance & Drug Safety, July 04-05, 2019 Valencia, Spain; 12th European Biosimilars Congress, April 15-16, 2019 Berlin, Germany; 18th Conference on Pharmaceutics & Novel Drug Delivery Systems, April 25-26, 2019 Istanbul, Turkey; 6th Congress on Drug Discovery & Toxicology, April 22-23, 2019 Abu Dhabi, UAE; CRO/Sponsorship Clinical Trials

Track: 37 Pharmacognosy

Pharmacognosy is the study of medicinal drugs derived from plants or other natural sources. The American Society of Pharmacognosy defines Pharmacognosy as "the study of the physical, chemical, biochemical and biological properties of drugs, drug substances or potential drugs or drug substances of natural origin as well as the search for new drugs from natural sources”. It is also defined as the study of crude drugs. Zoopharmacognosy is the process by which animals self-medicate, by selecting and using plants, soils, and insects to treat and prevent disease. Medical Ethnobotany is the study of the traditional use of plants for medicinal purposes.

For thousands of year’s Pharmacognosy and natural products have played a very important role in health care and prevention of diseases. It is estimated that about 70% of the supply of herbal raw material for Ayurveda and other homeopathic medicines in India comes from the wild. The global market for botanical and plant-derived drugs was valued at $23.2 billion in 2013 and $24.4 billion in 2014. This total market is expected to reach $25.6 billion in 2015 and nearly $35.4 billion in 2020, with a compound annual growth rate (CAGR) of 6.6% from 2015 to 2020.

Marine pharmacognosy
Phytotherapy
Traditional medicine inspired drug discovery.

Related Conferences:

20th Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems, March 18-20, 2019 Edinburgh, Scotland; 21st European Pharma Congress, May 20-21, 2019 Zurich, Switzerland; Clinical Research Event, 6th Congress and Exhibition on Antibiotics and Antibiotic Resistance, June 03-04, 2019 London, UK; 12th Conference and Exhibition on Pharmacovigilance & Drug Safety, July 04-05, 2019 Valencia, Spain; 12th European Biosimilars Congress, April 15-16, 2019 Berlin, Germany; 18th Conference on Pharmaceutics & Novel Drug Delivery Systems, April 25-26, 2019 Istanbul, Turkey; 6th Congress on Drug Discovery & Toxicology, April 22-23, 2019 Abu Dhabi, UAE; Top clinical Research Europe, 18th Congress on Pharmaceutics & Drug Delivery Systems, June 27-29, 2019 Amsterdam, Netherlands, Clinical Trial Conferences

Track:38 Pharmaceutical Analyses

Pharmaceutical analysis is a practical chemistry that involve a series of steps like process of identification, determination, quantification and purification of a chemical components, separation of the components of a solution, or study of structure of chemical compounds

Regulatory Affairs has a very specific and particular meaning within the healthcare industries. The regulations are for manufacturing and marketing of safe, efficacious and qualitative drugs. Improving new regulations and adapting to the technology regulatory affairs set new goals and challenges to the pharmaceutical formulation.

Novel approaches to analytical and bio analytical methods
Bio analytical techniques
Chromatography and techniques
Spectroscopic techniques
Nuclear magnetic resonance
Mass spectroscopy
Regulatory issues and biosafety challenges in bioanalysis
Applications of analytical and bioanalytical methods

Related Conferences:

Track: 39 Oncology Clinical Research

Oncology is a branch of prescription that arrangements with tumours. A therapeutic expert who hones oncology is an oncologist. Integrative oncology deals with the brain, body, and soul. Modalities of development, touch, nourishment, and care are utilized inside routine disease care to address and enhance indications and personal satisfaction. That is the reason numerous experts, including medicinal specialists, have grasped the quickly extending field of integrative oncology, which melds the best of customary and option medications. Immuno-oncology treatments enact our invulnerable framework, making it ready to perceive growth cells and annihilate them. Since tumor cells are altogether different from ordinary cells in the body, the resistant framework assaults them when it can remember them. Neuro-oncology assesses and treats individuals with essential and optional tumors of the cerebrum, spinal line, and the layers encompassing the mind and spinal rope (meninges). Oncologic Emergencies, as the term infers, are difficulties coming about because of a growth itself, a Para neoplastic disorder, or from treatment of malignancy that require prompt consideration and inversion, if conceivable. Inpatient treatment is an absolute necessity and frequently these conditions require intercession in an escalated mind setting.

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Track: 40 Clinical Research Nursing

The term nursing research is characterized as the deliberate, target procedure of investigating marvels of significance to nursing. Utilizing this definition, nursing research incorporates all reviews concerning nursing work on, nursing instruction, and nursing organization. Additionally, thinks about concerning medical attendants themselves are incorporated into the general class of nursing examination. The term clinical nursing research exploration is utilized here to show nursing research including customers or studies that have the potential for influencing the care of customers, for example, considers with creatures or with alleged typical subjects. It likewise has an extensive concentrate on counteractive action and wellbeing advancement instead of the medicinal model.

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Scope & Importance

Scope & Importance

Concept of Pharmacovigilance and its Significance enhances the impact of Pharmacovigilance on patient welfare and public health and to understand what's Pharmacovigilance. This track offers a quick discussion on Pharmacovigilance role in healthcare system. Pharmacovigilance legislation offers associate degree outlook on the principles and laws to follow in Pharmacovigilance practice. The Role of company industries within the improvement of Pharmacovigilance system is extremely crucial to keep up the security information, Detection and analysis of drug safety signals through manual and medical devices coverage. Pharmacovigilance scope additionally deals as Ecopharmacovigilance (EPV), pharmacoenvironmentology and Pharmacovigilance in seasoning medicines.

Market Analysis

Market Analysis

The global clinical trial supply and logistics market was valued at US$11.437 billion in 2017 and is projected to expand at a CAGR of 8.02% over the forecast period to reach US$18.164 billion by 2023. Clinical trial supply and logistics play an important role in the efficient conduction and management of clinical trials. In order to make sure that the required study drug is available on time there must be a strategic planning followed by an effective team effort and coordination. The sponsors need to have the right personnel, procedures, facilities, and technology.

Global Clinical Trial Supply and Logistics Market by Geography:

By geography, the clinical trial supply and logistics market is segmented as North America, South America, Europe, Middle East and Africa, and Asia Pacific. Furthermore, country level analysis is provided within the regions. North America is anticipated to grow significantly on account of growing pharmaceutical companies’ research and development budget. Moreover, growing complexity of conducting a clinical trial is likely to support the growth of the market in Europe while the favourable regulatory changes supporting the conduct trial will drive the Asia Pacific clinical trial supply and logistics market during the forecast period.

Global Clinical Trial Supply and Logistics Market by Component:

By component, the global clinical trial supply and logistics market has been segmented as manufacturing, packaging and labelling, and distribution. Distribution held a significant market share in 2017 on account of increasing research and development expenditure incurred by several companies so as to develop new and improved drugs.

Target Audience

CRO’s, Pharmacy professionals, Association chiefs and Pharma Business people. Professors, Students and to provide an international forum for the spread of original research results, new ideas and practical development experiences which concentrate on both theory and practices, CEO's and Scientists, R & D Professionals.

Industry 50%

Researchers 20%

Academia 20%

Others 10%

Target Audience Analysis

Past Conference Report

Past Conference Report

Global Pharmacovigilance-2020

Global Pharmacovigilance 2019 Report:

We gratefully thank all our wonderful Keynote and Plenary Speakers, Conference Attendees, Students, Media Partners and Associations for making Pharmacovigilance and Clinical Trials 2019 grand success.

27th World Congress on Pharmacovigilance and Clinical Trials hosted by the Conference series was held during October 21-22, 2020 Frankfurt, Germany based on the theme “Developments and Discoveries for Global Clinical Trials Of The Future". Benevolent response and active participation was received from the Organizing Committee Members along with Scientists, Researchers, Students and leaders from the area of Pharmacovigilance, Drug Safety and, Clinical Trials who made this event a grand success.

Conference series expresses its feeling to the conference Moderator, specifically Eliana silva de Moraes, Food and Drug Law, From Brazil, for seizing the responsibility to coordinate throughout the sessions. We have a tendency to area unit indebted to your support.

Conference series would like to convey a warm gratitude to all the Honourable guests and Keynote Speakers of Global Pharmacovigilance 2019:

Essam Ghanem, Celyad Biopharmaceutical, Belgium
Maria Amparo Lopez Ruiz, Cardenal Herrera University, Spain
Aaron Damien Barzey, ADB Medical, UK
Subodh Bhardwaj, New York & Inventprise, USA
Eliana Silva de Moraes, Food and Drug Law, Brazil
Cristina Scavone, University of Campania Luigi Vanvitelli, Italy
Kety Mirkovic Kos, PharmaKos d.o.o., Croatia
Meital Simhi, Ben Gurion University of the Negev, Israel
Mervat Alsous, Applied Science Private University, Jordan
Jyoti B Sharma, Tata Memorial Centre, India
Raymond R Mattingly, Wayne State University School of Medicine, USA

Conference series offers its heartfelt appreciation to organizations such as our esteemed Media Partners, Exhibitors, and other eminent personalities who supported the conference by promoting in various modes online and offline which helped the conference reach every nook and corner of the globe. It also took privilege to felicitate the Keynote Speakers, Organizing Committee Members, Chairs and Co-chairs who supported this event.

With the grand success of Global Pharmacovigilance 2019, Conference series is proud to announce the 27th World Congress on Pharmacovigilance and Clinical Trials October 21-22, 2020 Frankfurt, Germany

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Conference Date October 21-22, 2020

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All accepted abstracts will be published in respective Conference Series International Journals.

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Renowned Speakers

Sheraz Ali

Silvia Cacho-Elizondo

Nicole Powell,

Thomas E Serena

David A Pearce

Nazila Bazrafshan

Ramandeep Kaur Brar

Magd Zakaria

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Clinical Trials 2020

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