Clinical Trials & Pharmacovigilance is on Feb 28 2019 at Paris

Scientific Program

Clinical Trials & Pharmacovigilance will be organized around the theme Exploring Latest Trends in Clinical Trials and Research

clinical-trials-2019 is compromised of 17 tracks and 56 sessions designed to offer comprehensive sessions that address current issues in clinical-trials-2019

Submit your abstract to any of the mentioned tracks. All related abstracts are accepted.

Pre-Clinical Assessment

This phase of research starts before the clinical trials was medication security, other tests information is gathered.Pre-clinical research involves in the evaluation of potential therapeutics in cells and animals.Also, pre-clinical research increases knowledge about the functioning processes in living organisms.

Pharmacokinetics

Pharmacodynamics

Result of Animal models to clinical trials

Reasons for failure of animal models to predict a clinical result

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.

Trials of Drugs

Trials of devices

Trials of Procedures

Drug interventions

Phases of Clinical Trial Research

Phase 1 Trial

Phase 2 Trials

Phase 3 Trials

Phase 4 Trials

Interventional Clinical Trials:

Researchers assign two or more interventions to the participants so as to evaluate the effect of the intervention on biomedical or health-related outcome.According to studies, the strongest interventional study design is randomized control trials and quasi-experiments.

Randomization

Blinding

Patient Identification

One of the prevalent struggles for Clinical trials research is identifying and enrolling qualified trial participants.Thus when the enrollment goals are not met, Delay ensue and other resources must be invested additionally.Studies show that nearly 70% of clinical trials experience delays due to enrollment issues.Participants are more likely to participate only when they learn about them by their doctors.Not surprisingly a recent study says around 72% of patients would participate in trials if recommended by their doctor.

Putting Patient First

Importance of Patient Protection

Informed Consent

Patient Retention

Quality of Life in Clinical Trials

The concept of Quality of Life in Clinical trials includes health constructs, but not education and economics.It also includes assessments of sexual functioning, family, and marital relationship, sleep, general life satisfaction, Symptoms such as nausea and fatigue as disease and it’s treatment will not only affect the patient’s physical health but also emotional and social functioning.

Clinical data management

The Clinical Data management team helps in reducing the time from clinical research to marketing of the drug.CDM process is designed to provide an error-free, valid and a sound database.CDM process starts even before finalization of the study protocol in clinical trials.

Coding of Data

Data management plan

Database design considerations

Identifying and Managing Discrepancies

Inhuman Clinical Trials

Human Clinical Trials of new molecular entities in adult healthy volunteer which recommends a standardized procedure by which the MSRD can be selected.The purpose of this process is to ensure the safety of the human volunteers and also to establish a consistent terminology for discussing the starting dose, provide common conversion factors for deriving a human equivalent dose (HED), and delineate a strategy for selecting the MRSD for adult healthy volunteers, regardless of the projected clinical use.

Veterinary Clinical Trials

The importance of comparative medicine and the similarities between diseases in humans and animals are concepts fairly easily understood and accepted by all.The safety and effectiveness of any new drug are tested on animal models before conducting a clinical trial.These trials are supported as it is beneficial, no alternative exists and no unnecessary pain occurs.The assessments in the Clinical trials include historical analyses, critiques of animal models, surveys of clinicians, and citation analyses.

Drug design and Safety

Drug designing is a process of medication based on the biological target.It is done to reach a significant therapeutic response.Drug design is a complicated as well as an expensive process with strategies such as screening natural products, Mimicking Biological Substrate and use of fragment,structure-based drug design.

Drug Safety Solutions and Updates

Drug Interaction

Reporting and Monitoring

Clinical Trials in Various Disease

The clinical trial is experiment done in clinical research.Each clinical trials have a protocol for conducting trials.Clinical trial tells about the safety and efficacy of the drug or any medical device.This sessions discussions are involved in different types of diseases and its clinical trial output.

Cardio vascular trials

Clinical Trials on Infectious Diseases

Autism Trials

Melanoma Trials

Alzheimer Trials

Leukemia Trials

Psychology & Depression Trials

Neurology Trials

Ophthalmology Trials

Pediatric Trials

Clinical trials in Oncology

Cancer rate increases as the population ages.In an analysis of 23 oncology studies and 6000 patients, some of the barriers to participating in clinical trials were fear of reduced quality life, also a concern that experimental drug may not be the correct option.An ongoing diagnostic study is evaluating the accuracy of 3D ultrasounds in comparison with MRI and final histology to detect myometrial invasion in endometrial cancer.

Breast Cancer Trials

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

Pharmacovigilance

Pharmacovigilance is the branch of science associated with the detection, estimation, analyses, prevention of serious adverse events and adverse events or any other drug related issues. The advancement of pharmacovigilance has a rapid growth in recent years as a scientific arena to effective clinical studies and practice and to the public health sciences. Pharmacovigilance plays a substantial influence on drug regulatory authorities since drug safety affairs on the public health. Pharmacovigilance is a clinical discipline in its own right – one that affords to an ethics of safety and serves as an indicator of the standards of clinical care practised within a country.

Pharmacovigilance measures contributes a crucial role in starting phase of the Investigational Products. For the Drug developers its essential to consider their pharmacovigilance method prior to Phase 1 and throughout the duration of product development till post marketing product life cycle.

Polypharmacy

Adverse reactions and Side effects

Seriousness determination

Components of a Good Postmarketing Report

Risk management

Improving methods

Identifying the Ethical Challenges

Any new medical strategy or treatment need not be better than the current standard care.It may have side effects or sometimes include risks that even the doctors aren’t aware.Also, recruitment of participants is a major issue faced in conducting a clinical trial.This session discussion is about the various problems faced while conducting a clinical trial.

Trial Design

Regulations

Patient Access

Ethics in Clinical Trials

Adherence to principles of good clinical practices including adequate human subject protection is considered to be one of the major requirement for clinical research.There is an independent Ethics Committee which reviews the protocol and also ensures the safety, dignity and well being of the potential participants.they also must take into considerations about the risk-benefit ratio, plans to maintain confidentiality, informed consent process.

Principle of Non-Exploitation

Principle of Privacy and Confidentiality

Principle of Accountability and Transparency

Informed Consent Process

Future in Clinical Trials

2017 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

International Conference on Clinical Trials & Pharmacovigilance

Paris, France

February 28 - March 01, 2019