14^th Global Pharmacovigilance & clinical Trials Summit

Pharmacovigilance (PV) is the process of detecting and monitoring adverse drug reactions (ADR), adverse events (ADE), detecting potential 'signals' throughout the drug/medical device lifecycle, and also tracking trends in consumers' sentiments regarding a particular product (drug/medical device) over time.

There are four important methods in Pharmacovigilance such as,

Passive surveillance.

Active surveillance.

Cohort event monitoring.

Targeted Clinical Investigations.

The purpose of pharmacovigilance is to enhance patient care and patient safety in relation to the use of medicines according to the life cycle of a health product. During clinical trials, the investigator collects and analyzes data on serious adverse events (SAEs), determining whether the drug in question caused the SAEs. If they conclude that the negative side effects were causal, they are categorized as adverse drug reactions (ADRs).

The definition has included reactions occurring as a result of error, misuse or abuse, and to suspected reactions to medicines that are unlicensed or being used off-label in addition to the authorised use of a medicinal product in normal doses.2 While this change potentially alters the reporting and surveillance carried out by manufactures and medicines regulators, in clinical practice it should not affect our approach to managing ADRs.

Causality assessment is the assessment of relationship between a treatment drug and the occurrence of an adverse event. Causality assessment of ADRs is a method used for estimating the strength of relationship between drug(s) exposure and occurrence of adverse reaction(s). Causality terms include certain, probable/likely, possible, unlikely, conditional, and unassessable. Naranjo algorithm,[6] was developed in 1991 by Naranjo et al., from the University of Toronto and is often referred to as the Naranjo Scale.

A clinical protocol is required for any experiments in which a drug is administered to, dispensed to, or used in one or more human subjects. The protocol is a written plan for how the drug or biologic is to be studied and the procedure to be followed by each investigator. A protocol is a written document that serves many purposes: It instructs the physician (primary investigator) and staff (study coordinators) how to execute the trial. It describes how a trial is conducted, ensures the safety of study participants and ensures the integrity of the data collected throughout the trial.

Clinical data management (CDM) is the process of collecting and managing research data in accordance with regulatory standards to obtain quality information that is complete and error-free. The goal is to gather as much of such data for analysis as possible that adheres to federal, state, and local regulations. Clinical databases consist of observational data collected on patients who meet specific criteria. The uses of these databases depend on whether the observations are drawn from a single institution, multiple clinical centers, or are population-based.

Data management is the practice of collecting, organizing, protecting, and storing an organization's data so it can be analyzed for business decisions. As organizations create and consume data at unprecedented rates, data management solutions become essential for making sense of the vast quantities of data. Quality management includes the determination of a quality policy, creating and implementing quality planning and assurance, and quality control and quality improvement. TQM requires that all stakeholders in a business work together to improve processes, products, services and the culture of the company itself.

Regulatory affairs is vital to the proper functioning of societies and economies. Robust regulation protects the rights, safety and health of citizens and ensures the safe and effective delivery of public goods and services. Without it, companies could potentially exploit the welfare of vulnerable workers and consumers.

The FDA has authority to grant orphan-drug designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition. Orphan drug designation qualifies sponsors for incentives including: Tax credits for qualified clinical trials. What is the Orphan Drug Act? The Orphan Drug Act is a law passed by Congress in 1983 that incentivizes the development of drugs to treat rare diseases. Companies and other drug developers can request orphan drug designation and FDA will grant such designation if the drug meets specific criteria.

Pharmaceutical Chemistry is a branch of chemistry which deals with the study of organic chemistry (molecules and compounds) in combination with structural & chemical biology and pharmacology for producing pharmaceutical drugs and medicines. Medicinal chemistry provides pharmacy students with a thorough understanding of drug mechanisms of action, structure-activity relationships (SAR), acid-base and physicochemical properties, and absorption, distribution, metabolism, excretion, and toxicity (ADMET) profiles.

Pharmacokinetics is the aspect of pharmacology dealing with how drugs reach their site of actionand are removed from the body. The following processes govern the rate of accumulation and removal of drug from an organism–absorption, distribution, metabolism, and excretion. The main difference between pharmacokinetics and pharmacodynamics is that pharmacokinetics (PK) is defined as the movement of drugs through the body, whereas pharmacodynamics (PD) is defined as the body's biological response to drugs.

Nanotechnology in Medicine Application: Drug Delivery

Particles are engineered so that they are attracted to diseased cells, which allows direct treatment of those cells. This technique reduces damage to healthy cells in the body and allows for earlier detection of disease. Encompassing nanoscale science, engineering, and technology, nanotechnology involves imaging, measuring, modelling, and manipulating matter at this length scale. Nanomedicine is the application of nanotechnology to medicine (National Science and Technology Council 2014).

Biopharmaceutics can be defined as the study of the physical and chemical properties of drugs and their proper dosage as related to the onset, duration, and intensity of drug action, or it can be defined as the study of the effects of physicochemical properties of the drug and the drug product, in vitro, on the bioavailability of the drug, in vivo, to produce a desired therapeutic effect. Both definitions imply the relationship between the physicochemical properties of the drug, the drug's biological fate in the body after its administration, and the resulting pharmacological action of the drug.

Clinical Trial means a systematic study of any new drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic), and/or adverse effects with the objective of determining safety and/or efficacy of the new drug.