2^nd European Conference on Pharmacovigilance and Drug Safety June 07-08, 2021 Prague, Czech Republic

The current challenges posed by the COVID-19 pandemic have also prompted regulatory agencies to reconsider their requirements and have emphasised the importance of electronic reporting to ensure data exchange for patient safety. A strong process for regulatory intelligence maintenance, a rapid change-implementation process and robust system to enter rule-based decisions can contribute to ensure compliance and quality.

Good pharmacovigilance practices are measures drawn up to facilitate the performance of pharmacovigilance in the European Union. Application of GVP to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities. They include medicines authorised centrally via the Agency as well as medicines authorised at higher level. Pharmacovigilance system defined as the system used by an organisation to fulfil its legal tasks and responsibilities in relation to pharmacovigilance and designed to monitor the safety of authorised medicinal products and detect change to their risk-benefit balance.

Risk management plan explains the knowledge about the safety and efficacy of a medicinal product. The RMP gives information on plans for studies and other activities to gain knowledge on the safety and efficacy of the medicine. It also describes measures to be undertaken to minimise risks associated with the use of product in patients. Marketing authorisation holders are required to have an RMP for any new medicinal product for human use that must be submitted at the time of application for marketing authorisation. For nationally authorised products RMPs must be submitted for review and approval.

Study of what the body does to the drug is known to be Pharmacokinetics, and Pharmacodynamics is the study of what the drug does to the body. Pharmacokinetics refers to the movement of any drug going into, through, and out of the body. Pharmacodynamics means is to think of the word ‘dynamo’. Dynamo typically refers to energy or power. In terms of pharmacodynamics, it includes how the drug works and how it exerts its power on the body. Whereas in pharmaceuticals, pharmacodynamics focuses on receptor binding and chemical interactions. The biotherapeutic is dosed and samples are collected to determine the pharmacokinetic properties of the drug.

The PV Operations include Case Management, Alliance and Vendor Management, and Quality and Document Management. Individual have to manage the operation infrastructure required to oversee all aspects of adverse event collection, processing, and reporting from clinical trials. Responsible for development and preparation of the safety sections of protocols, investigator brochures, clinical study reports, and other documents to ensure that the documents are appropriate, feasible, operational and accurately reflect the safety and/or risk-benefit profile.

Medication Safety is not new in the developed countries in the field of health. All drugs have side effects, but the extent of their impact and severity varies from mild to severe. Side effects are predictable and mentioned in the leaflets for each drug. Some of the drugs side effects are have not been noticed, and the real risk here is whether they would exert a severe deleterious impact on the patients who are using them. Few drugs may not cause adverse symptoms, such as some types of antibiotics; other medications may cause serious symptoms, such as certain cancer drugs, anti-diabetic medications, medications to control elevated blood lipids, and many others.

To determine that the marketing authorisation holder has personnel, systems and facilities in place to meet their pharmacovigilance obligations, to identify, record and address non-compliance which may pose a risk to public health, to use the inspection results as a basis for enforcement action, where considered necessary. The aim of a pharmacovigilance audit is to use objective evidence to assess the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system. The audit must be clearly documented and can only relyon verifiable evidence, such as written records and statements.

The evolution of technology has increased the access to and potential value of these programs. Many Patient Support Programs include disease information and resources, value-add tools and services, access to nurses or other healthcare professionals via phone or online chat, financial assistance, co-pay or savings programs devices such as blood glucose monitors, wireless health trackers, etc.

Medical Affairs, Market Research and Marketing must be sensible about the risks, obligations and PV costs results in such initiatives. Few companies charge back for PV activities, which makes sense as it should be in actual cost of running a survey or disease registry. It is very critical that PV involved at the earliest stages of the Patient Support Programs/Market Research Programs design and approval. This is a way to ensure that the safety data information from the initiatives will be collected and analyzed, and contributed to the signal detection activities, and will be reported to the authorities as needed. The cost for non-compliance is potentially very high.

An information that suggests a potential causal association between an intervention and an event, indicating the possibility of unintended outcomes. A signal might uncover rare but dangerous side effect in a marketed drug did not emerge in clinical trials. Generally, signal detection was a reactive process. If an adverse event, such as a heart attack, was reported by a patient or their physician, related to a specific treatment, the report would be studied and actions taken if the signal proved reliable and meaningful to the context of the treatment.      

The process of bringing a new drug molecule into clinical practice is explained as Drug Development. This encompasses all steps from the basic research process to support the commercial launch of the drug. Development refers to the clinical parts of this process, with discovery which is used to explain the nonclinical research components. Researchers identify a promising compound for development, they gather information to conduct experiments on how it is absorbed, distributed, metabolized, and excreted, its potential benefits and mechanisms of action and the best dosage.

Pharmaceutical toxicology lies on the margin of the toxicology and drug discovery, and includes all the research about harmful effects and safety of medicines in relation to the therapeutic benefits. In adding and determination of the direct effect of the potential drug on the functioning of cells, tissues and organisms. Toxicologists can use computer models and in vivo tests to understand whether metabolism body is likely to affect the toxicity of the drug.

Drug tolerance is revealing of drug use but is not necessarily associated with drug dependence or addiction. The process of tolerance development is reversible that can involve both physiological factors and psychological factors. Drug tolerance should not be disordered with drug tolerability, which refers to the grade to which over adverse effects of a drug can be tolerated by a patient.

Regulatory affairs experts play a significant role in communication between their company and different regulatory bodies such as the FDA, Singapore HSA, etc. We provide a wide range of regulatory affairs services, including assessing and repayment, to our client. There are several Regulatory Affairs departments depending upon the countries within ever growing pace of companies. Global Harmonization in standards has led to consistent approach in regulatory submissions and hence its review.

Adverse drug reactions can be considered a form of toxicity .toxicity is most commonly applied to effects of over absorption. For information on toxicity of specific drugs see the table Symptoms and Treatment of Specific Toxins. Adverse drug reactions are usually classified as mild, moderate, lethal (see table Classification of Adverse Drug Reactions [ADRs]. Severe or lethal ADRs may be specifically mentioned in black box notices in the physician prescribing information provided by the manufacturer.