Clinical Trials & Pharmacovigilance is on Sep 23 2019 at Prague

Scientific Program

Clinical Trials & Pharmacovigilance will be organized around the theme Futuristic approach towards the enhancement of clinical trials & research

clinical-trials-2019 is compromised of 24 tracks and 32 sessions designed to offer comprehensive sessions that address current issues in clinical-trials-2019

Preclinical Studies

Concluding whether the drug molecule is ready for Clinical trials starts from the preclinical studies Drug testing in Invitro and In vivo animal studies are done to ensure the safety and efficacy of the drug. MSRD will be evaluated in the preclinical studies, the species of the selected animals are identified, and testing is carried out with the proper approval from the government bodies. Most of animal specimens used are Mice, rats, Guinea pigs. Pharmacokinetic and pharmacodynamic studies are checked in animal studies

Invitro & Invivo Studies

Animal Testing

Phyto Chemical Studies

Clinical Trials

The target of Clinical trials is to determine the safety of drug and dosage in the participant. Exploring ways for a comfortable life for people with chronic illness. Clinical Trials are conducted by a team of researcher which includes a doctor, social workers, and other healthcare professionals. Clinical Trials done in the United States must be approved and monitored by the Institutional Review Board.

Drug Design and Drug Metabolism

IInterventional Clinical Trials

Observational Clinical Trials

Clinical Pharmacology

Clinical pharmacology encompasses all aspects of the connection between medication and humans. It's the only medical specialty within the NHS that specialize in the safe, effective and economic use of medicines. It's a various discipline that each sustains and advances best health care Understanding drugs and the interactions of chemical substances with living beings, including the interactions between drug molecules drug receptors and how these interactions induce an effect.
They play a major role from assessment of literature, to application of information of drugs, to clinical practice; moving on to clinical and basic analysis, to drug development method, to policy making.

Applied Biopharmaceutics

Clinical Drug Trials

Biopharmaceutics and Drug Disposition

Biopharmaceuticals Process Validation

Pharmacoeconomics

Pharmacology Drug Classes

Psychopharmacology

Clinical Pharmacy

History of Pharmacology

Bio Pharmaceutics & Drug Targeting

Clinical Toxicology

The study of poisons and toxins in the given drug molecules which leads to adverse and serious adverse reactions. Toxicology studies play the key role in Clinical Trials testing. Significant to investigate, interpret and communicate the toxic reactions Every Pharmacokinetic and Pharmacodynamic analysis are carried out in the clinical toxicology studies Includes the chemistry, Biology, biochemistry and the forensic sciences

Computational Toxicology

Cutaneous Toxicology

Drug Dosage Estimation

Bio availability & Bio Equivalence

The amount of administered therapeutic medicine that is absorbed in site of drug action Blood concentrations of the active ingredients and their active metabolites will provide a marker for the concentration at the site of action with a valid measure of bioavailability Two drugs comprising identical active ingredients, otherwise two different dosage forms of the same investigational product possess similar bioavailability and produce the same effect at the site of action of Bio equivalence

Pharmacokinetics

Pharmacodynamics

Pharmacometrics

Phases of Clinical Trials

Clinical trials are conducted to gather knowledge relating to the security and effectuality of recent drug and device development. There are many steps and stages of approval within the clinical trials method before a drug or device may be sold within the client market Phase I studies assess the security of a drug or device. Phase II studies check the effectuality of a drug or device. Phase III studies involve randomised and blind testing in many hundred to many thousand patients. Phase IV studies, usually known as Post marketing Trials, are conducted once a drug or device has been approved for client sale.

Analysis of Phase 1 Trials

Analysis of Phase 2 Trials

Analysis of Phase 3 Trials

Phase 4 Trials and Post marketing Strategies

Patient Centric Clinical Trials

Clinical trials struggle with both registration and patient retention. Scheming and running a study while keeping the patient viewpoint in mind can help at every stage of a clinical trial. There are several ways to put the patient first during each stage of a clinical trial, from staffing to retention to study follow-ups. By Working with patient advocacy organizations. By Using real-world data Calculating the health literacy of the patient Site Accessibility

Calibrating the patients needs in Clinical research

Patient Advocates and Patient Centricity

Adaptive Clinical Trials

A Clinical Study protocol that agrees alterations to the trial and/or statistical measures of the trial after its initiation without undermining its legitimacy and integrity. The purpose is to make clinical trials more flexible, efficient and fast. Due to the level of flexibility involved, these trial designs are also termed as “flexible designs”.

: Adaptive randomization design

Group sequential design

Sample size re-estimation design

Biomarker-adaptive design

Medical Device Research

Medical device research comprises a part of overall pharmaceutical research and comprises a major sector of the medical industry representing more than $100 billion industry in the U.S in 2008.The clinical trials in the medical device are mainly in the prototype development.

Diagnostic Devices

In Vitro Devices and Biomarkers

Genetic Tests

Clinical Trials in Dermatology

Clinical trials are the backbone of contemporary day medication. Randomized, double blinded, placebo controlled studies are essential for advancement in medication and medicine. Skin conditions like psoriasis and dermatitis are among the foremost common health issues within the US and Most parts of the world. Clinical trials will give treatments that not solely supply objective enhancements in clinical disease status however also subjective improvements within the quality of lifetime of patients who square measure afflicted with the disease.Significance towards the dermatology trials are gaining rapid attention, these trials tend to build confidence to the people who are affected with skin diseases and syndromes

HIV Clinical Trials

Research and Trials towards the HIV medicine has been highly increased. Clinical Trials comprising study medicines to prevent HIV, Interventional trials that treat as well as prevent HIV and cohort studies that is based on the infections that is related to the HIV clinical Trials Many governmental bodies and NGO organizations works on underdeveloped and developing countries patients to participate in the Clinical Trials studies

Patient Recruitment and Complications

Clinical research & HIV research in underdeveloped countries

STD Study design

Clinical Trials in Cardiology

Clinical trials in cardiovascular drugs have big in size, scope, and complexity. As therapeutic approaches in cardiovascular drugs became simpler, the amount of proof needed to support progressive new advances has enhanced considerably. This fact, in conjunction with real and perceived will increase in regulative needs, and therefore the mandate for higher estimation of cardiovascular safety for non-cardiovascular therapies, have resulted in tumescent and prohibitively costly trials. Thus, despite the success of clinical trials in vessel drugs over the past twenty-five years, the power to bring new cardiovascular therapies to patients would require new approaches to curtail value and maintain quality of future trials.

Clinical Trials in Neurology

Neurology is a vast space encompassing various disease states, as well as multiple sclerosis, epilepsy, stroke and headache. These conditions influence people across the age spectrum and may be encountered all told apply settings. whereas neurology was once considered a subspecialty with few treatment choices, nowadays several therapies area unit obtainable which will considerably improve physical function and quality of life With a rise in old population can come back a bigger prevalence of diseases of the aging brain, requiring clinicians to respond to the increasing demand for medicine care.1 annually, new studies area unit added to the prevailing literature pool all told of those numerous sub specialties, making a challenge for busy clinicians to stay up with best apply for his or her patients.

Clinical Trials in Oncology

Oncology trials have given life and strength to the cancer survivors, over lakhs of people are benefitted from oncology trials the death rate has been slightly decreased and giving a promising future to the oncology studies Clinical Trials 2019 takes a strong stand in invites the researchers to platform their research in oncology trials

Clinical research and Case Reports

The persistence and growth of case reports within the era of clinical trials counsel that case reports have worth. subtle knowledge analysis exploitation language process and massive knowledge permits analysis of information from the purpose of care and case reports in a very means that wasn't doable thirty years ago—uncovering proof hidden in what accustomed be thought to be anecdotes. Anticipating a future role for case reports in clinical analysis and in guiding clinical follow

Pharmacovigilance

Pharmacovigilance The pharmacological science relating to the detection, assessment, monitoring the safety of the pharmaceutical drug or medical device, and prevention of adverse effects with other pharmaceutical products after being released from the market is an important part of pharmacovigilance. Monitoring the adverse reactions and trials related events plays a vital role in the Pharmacovigilance practices. Data obtained from the patients and healthcare providers through the pharmacovigilance agreements (PVAs), medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place

Good Pharmacovigilance practices

After the thalidomide tragedy, many union bodies put forth the set of regulations to abide the Ethical and social aspects of drug use. Good pharmacovigilance practices (GVP) are a set of events which are established to facilitate the performance of pharmacovigilance in the EU. Encourage a safe, rational and effective use of medicines. These practices provided the enhancement of patient safety and care while using medicines, drugs or any medical interventions.

Drug Safety

Randomized controlled trials are the principal suggests that of creating the efficaciousness of drugs. However, pre-marketing trials are restricted in size and length and exclude risky populations. They have restricted applied math power to discover rare however doubtless serious adverse events in real-world patients. We summarize the principal method challenges within the coverage, analysis and interpretation of safety information in clinical trials exploitation recent examples from systematic reviews. These challenges embrace the shortage of an evidentiary gold normal, the restricted applied math power of irregular controlled trials and ensuing sort a pair of error, the shortage of adequate ascertainment of adverse events and restricted generalizability of trials that exclude high risk patients.

Clinical Trials Auditing

A methodical check-up, by people not directly involved in the trial, to estimate whether the implementation, data recording and analysis of the trial are in accordance with the trial proposal, standard operation regulations and other guidelines linked to drug clinical trials. Drug supervision and management authorities will official evaluate the documents, implement, record and other aspects of a clinical trial. Inspection can take place in the trial institute, location of the sponsor, or venue of the contract research organization (CRO)

Clinical Trials and Statisticians

Biostatistics in Clinical Trials offers each teachers and practitioners from varied disciplines and settings, like universities, the pharmaceutical business and clinical analysis organisations, up-to-date info in addition as references to help professionals concerned within the style and conduct of clinical trials. It provides the elemental applied math problems in planning clinical analysis studies. Its primary stress is on understanding the planning and analytic strategies of clinical research from an applied math perspective. Bio statistics can specialise in Data information analysis, basic ideas of applied math analysis, construction of hypothesis tests and confidence intervals, the event of applied math strategies for analyzing information, development of mathematical models accustomed relate a response variable to informative or descriptive variables, and an introduction to Data analysis of micro-array and genomic studies

Biomedical Clinical Trials

Clinical trials are prospective biomedical or activity analysis studies of human subjects that area unit designed to answer specific questions about medicine or behavioural interventions (drugs, treatments, devices, or new ways in which in which of using known drugs, treatments, or devices). Clinical trials are accustomed confirm whether new biomedical or behavioural interventions are safe, efficacious, and effective. Biomedical clinical trials of an experimental drug, treatment, device, or behavioural intervention might proceed through Tests a replacement biomedical intervention during a little cluster of individuals, Study the biomedical or behavioural intervention during a larger cluster of individuals, Study to see effectualness of the medicine or activity intervention in giant teams of individuals, Studies conducted when the intervention has been marketed. These studies are designed to observe the effectiveness of the approved intervention among the ultimate population and to gather info about any adverse effects related to widespread use.

Ethical Committee and Regulatory Board

Institutional Review Board (IRB) whose primary mandate is to shield the rights and safeguard the welfare of the topics. In their deliberations, IRBs square measure expected to require into consideration the character, content, and style of the analysis and make sure that they're compliant with the moral principles of the dirt track Report, Declaration of national capital, moral Principles of medical specialty analysis (Indian council of medical analysis (ICMR), 2006)[1] and, once applicable and applicable, the regulative needs of Country. ECs reassure the general public that the rights and welfare of human subject’s square measure seriously thought of by folks that don't have an unconditional interest within the outcome of the analysis.

Artificial Intelligence in Clinical Trials

Man-made brainpower (AI) innovations have made huge advances and a stream of companies are focusing, applying these advances to business challenges and, all the while, pioneering new trails. While numerous individuals might consider computerized reasoning as something recondite and in the domain of sci-fi, there are genuine applications that can offer organizations some assistance with solving complex issues, for example, understanding enormous information, increasing human choice making, or furnishing clients with master guidance.AI advancements are accessible for different markets and parts, and offer five consumable business abilities. A third region is an instinctive correspondence, going past basic voice acknowledgment and characteristic dialect handling, looking to permit the catch of the genuine importance at the semantics of content and discourse, by mapping outward appearances and signals to enthusiastic state and mapping voice inflection to passionate state

Future in Clinical Trials

2018 has been a remarkable year for the clinical industry in many ways, driven by many methods, regulations, and technology.There are advancements made by the FDA by laying out the foundation for digital health, patient centricity is evolving to include Quality management systems are starting to leverage predictive modeling and adaptive governance and oversight models.In 2018 we are likely to see growth in virtual trials and site-centric approaches towards clinical trials execution and other new concepts involving patients as drivers for study design. The Digital Patient Remote Trials In Silico Trials Organ on Chips

Smartphone Application in Clinical Trials

CPD Accredited 2nd International Conference on Clinical Trials & Pharmacovigilance

Panorama Hotel Prague | Prague, Czech Republic

September 23-24, 2019