15^th International Conference and Exhibition on Pharmacovigilance & Drug Safety September 26-27, 2022 Paris, France

During the COVID-19 pandemic, mandatory social distancing and the lack of effective treatments has made telemedicine the safest interactive system between patients, both infected and uninfected, and clinicians. A few potential evidence-based scenarios for the application of telemedicine have been hypothesized.

Forensic toxicology is the use of toxicology and disciplines such as analytical chemistry, pharmacology and clinical chemistry to aid medical or legal investigation of death, poisoning, and drug use.

pharmaceutical quality: A product that is fit for use can be defined as one. that meets its established quality attributes and standards and has been. manufactured in accordance with CGMP regulations.

Pharmacotherapeutics (PT) is the application of pharmacological information together with the knowledge of the disease for its prevention, mitigation or cure.

Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance.

Medical affairs is the department within a pharmaceutical or medical device company that communicates accurate information to healthcare providers. Medical affairs also manages relationships with key thought leaders and stakeholders.

MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry. The terminology is used through the entire regulatory process, from pre- marketing to post-marketing, and for data entry, retrieval, evaluation, and presentation.

Pharmacology is a branch of science that deals with the study of drugs and their actions on living systems - that is, the study of how drugs work in the body (sometimes referred to as 'drug actions').

Clinical research is the study of health and illness in people. It is the way we learn how to prevent, diagnose and treat illness. Simply put, it involves human participants and helps translate basic research (done in labs) into new treatments and information to benefit patients.

Patient-centeredness is defined as “health care that establishes a partnership among practitioners, patients, and their families (when appropriate) to ensure that decisions respect patients' wants, needs, and preferences, and that patients have the education and support they need to make decisions and participate in their own care”.

Pharmacoepidemiology is the study of the utilization and effects of drugs in large numbers of people; it provides an estimate of the probability of beneficial effects of a drug in a population and the probability of adverse effects. It can be called a bridge science spanning both clinical pharmacology and epidemiology.

Covid has provided various challenges as well as opportunities for Pharmacovigilance service providers. During Coronavirus lockdowns there was a decline in ongoing clinical trials due to the restricted availability of clinical resources and research staff. The restriction of patients also brought changed work practices, routine audits and safety inspections. Additionally, an increase in the use of drugs (either approved for Covid or off label use) have driven the healthcare industry to work round the clock for safety profiling of the products. To be able to leverage such growth opportunities, the Pharmacovigilance industry is increasingly adapting to new trends attributed to better and more effective data collection and analysis.

AI will decrease the cost of processing each case and free up valuable resources to work on more complex and value-added tasks. Big data analytics using AI can also help discover drug-event associations for certain groups of people, improving the detection of potential events while improving risk-benefit assessments.

Ecopharmacovigilance (EPV) as a kind of pharmacovigilance for the environment is recognized worldwide as crucial to minimize the environmental risk of pharmaceutical pollutants.

There is an advantage in centralising all safety data, clinical data, analysis and reporting with one provider. Pharmacovigilance Software tool provides comprehensive analysis of adverse events arising from the use of Pharmaceutical products (Medicinal Product, Medical Device, Vaccines, Non-Drug Therapy and Veterinary Medicinal Product). The drug safety database allows the risk- benefit analysis of medicinal products taking into account new and emerging information, in the context of cumulative information. Pharmacovigilance since beginning has been a compliance driven activity, wherein your regulatory compliance determines company’s risk assessment scores. A drug safety database offers scheduling of alerts for expedited cases, follow-up cases and PSUR/PADER reports submission to meet regulatory timeline compliance.

Regulatory Affairs for clinical trials is the major part in the clinical trials approaches. Every clinical trial must be analysed according to the Regulatory Affairs Guidelines. 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.

Drug Safety heavily focuses on adverse drug reactions which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. 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. Information received from patients and healthcare providers via pharmacovigilance agreements (PVAs), as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place. Ultimately, drug safety is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with worldwide laws, regulations, and guidance.

Owing to the changing resources which are necessary to fulfil the regulatory requirements, few companies choose to outsource or out task regulatory affairs to service providers externally. Regulatory Affairs department is constantly evolving and growing and hence it is one which is least impacted during the Acquisition and Merger, and also during recession. The stringent regulations on safety monitoring and their periodical revision have led to increased safety in data collection, analysis, regulatory surveillance including costs. Thus, Pharmacovigilance has become a critical phase in clinical development programs.

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.

Adverse drug reactions can be considered a form of toxicity or enhanced drug effects that occur during appropriate use (eg, when drug metabolism is temporarily inhibited by a disorder or another drug). In the US, 3 to 7% of all hospitalizations are due to adverse drug reactions. ADRs occur during 10 to 20% of hospitalizations; about 10 to 20% of these ADRs are severe. Incidence of death due to ADRs is unknown; suggested rates of 0.5 to 0.9% may be falsely high because many of the patients included had serious and complex disorders. Incidence and severity of adverse drug reactions vary by patient characteristics (eg, age, sex, ethnicity, coexisting disorders, genetic or geographic factors) and by drug factors (eg, type of drug, administration route, treatment duration, dosage, and bioavailability. Incidence is higher with advanced age and polypharmacy.

Clinical trials allow the drug to be tested for safety by different ethnic population. In drug development, preclinical development, also named preclinical studies and nonclinical studies, is a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing and drug safety data are collected. The main goals of pre-clinical studies are to determine the safe dose for first-in-man study and assess a product's safety profile. Products may include new medical devices, drugs, gene therapy solutions and diagnostic tools.