14^th International Conference on Pharmaceutics and drug safety October 21-22, 2020 Frankfurt, Germany

Drug safety relates to the potential for adverse effects related to the administration of drugs. Efforts to establish the safely profile of drugs begin early in their development, with in vitro and in vivo toxicity testing, and continue through clinical trials leading up to drug approval and following approval in specific post-marketing studies or general pharmacovigilance efforts. Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation). 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\r\n Signal Detection in Drug Safety

Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial  their approval does not mean that the therapy is safe or effective, only that the trial may be conducted.

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.

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.

In Clinical Pharmacology and Biopharmaceutics track we will discuss about the Rational drug management of cancer, diabetes and cardiovascular disorders, and Management of psychiatric disorders and autoimmune disorders. Along with clinical trials Bioavailability and bioequivalence studies also plays major role in clinical research. The global market for Bio pharmaceutics in 2013 was $305.1 million, which is expected to reach about $326.3 million by year-end 2014. The projected PAT instrumentation market is expected to be valued at around $450.6 million by 2019 at a compound annual growth rate (CAGR) of 6.7% for the period of 2014 to 2019.

Clinical Trials on various diseases include Clinical Trials in long chronic diseases like AIDS, Benign and Malignant Tumours, Cardiovascular diseases, Diabetes, Clinical Trials on Monoclonal and Polyclonal Antibodies, Neurological, Physiological and Psychological Disorders.

Good data quality management in pharmacovigilance can be relied only on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. Quality management consists of quality planning, quality control, quality assurance and quality improvements. The pharmacovigilance data processing cycle starts with data collection and, in computerised systems, data entry; the next step is data storage and maintenance; followed by data selection, retrieval and manipulation. The resulting data output is analysed and assessed. Finally, conclusions are drawn and decisions are made. The quality of a pharmacovigilance data system can be defined as a measure of excellence or a state of being free from defects, deficiencies and significant variations and the  data quality management includes all the activities that organizations use to direct, control and coordinate the quality of data.

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.

Drug manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs by pharmaceutical companies. The process of drug manufacturing can be broken down into a series of unit operations, such as milling, granulation, coating, tablet pressing, and others.

Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use. Many countries have legislated that manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation. All guideline follows a few basic principles.

Intellectual property (IP)  is a category of property that includes intangible creations of the human intellect.Intellectual property encompasses two types of rights: industrial property rights (trademarks, patents, designations of origin, industrial designs and models) and copyright.It was not until the 19th century that the term "intellectual property" began to be used, and not until the late 20th century that it became commonplace in the majority of the world

Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods).

Regulatory affairs (medical affairs) professionals (aka regulatory professionals) usually have responsibility for the following general areas;

Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business, i.e., working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission (banking).

Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance.

The Agreement provides norms and standards in respect of following areas of intellectual properties are Patents, Trademarks, copyrights, Geographical indications, Industrial designs.

Pharmaceutical formulation in pharmaceutics is the process in which various chemical substances including the vigorous drug are joined to produce a final medicinal product. Formulation studies involve developing a preparation of the drug which is both stable and acceptable to the patient. For orally taken drugs, this usually contains combining the drug into a tablet or a capsule. Formulations confirm that the drug is compatible with these other substances. In the pharmaceutical drug formulations, the different physical, chemical, and mechanical properties of a drug are considered so as to know what other ingredients should be used in the preparation. The various factors like polymorphism, particle size, pH, and solubility are all considered while formulating the drug, also considering the appearance of the tablet.

Pharmaceutical Technology is the regulation of pharmacy that assign with the process of turning an Active Pharmaceutical Ingredient (API) into a medication to be used by patients.  It is also a knowledge base to pharmacy, pharmacology and also pharmaceutical business. It describes designs, techniques, instrumentation in the preparation, manufacturing, compounding, packaging, dispensing, accumulating of narcotic and other preparations used in determinative and diagnostic e procedures in the treatment of patients. It is additionally associated with the science of dose type.

Pharmaceutical care is defined as the responsible provision of drug therapy for the purpose of achieving definite therapeutic outcomes that improves the patients quality of life. It involves the process through which a pharmacist cooperates with patients and other professionals in designing, implementing and monitoring a therapeutic plan will produce specific therapeutic outcomes for the patients.

Drug regulation is the control of drug use by international agreement and/or by regulatory authorities such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese Pharmaceutical and Medical Devices Agency (PMDA).

It covers the discipline and practice of Data Quality Management (DQM) in a multi-domain Master Data Management (MDM) framework. It discusses how to define and apply a DQM model consistently across a multi-domain environment, and how to expand the practice of DQM to an enterprise level. This chapter starts by presenting how DQM fits into a multi-domain MDM environment and how important it is to manage DQM strategies, decisions, and execution. It continues by introducing a DQM model that is critical to supporting and scaling the discipline beyond MDM. Finally, it covers a data-quality improvement life cycle, with the required steps and activities to analyze, plan, execute, and monitor data quality projects effectively and efficiently.

Quality assurance is a way of preventing mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers; which ISO 9000 defines as "part of quality management focused on providing confidence that quality requirements will be fulfilled.

The objective of this study is to estimate the prevalence and describe the characteristics of pDDIs in medical prescriptions of hospitalized surgical patients. In this cross-sectional study, we analyzed 370 medical prescriptions from the surgery unit of a Mexican public teaching hospital. The identification and classification of potential drug-drug interactions were performed with the Micromedex 2.0 electronic drug information database. Results were analyzed with descriptive statistics and we estimated OR (odds ratio) to determine associated risk factors.

Pharmacoepidemiology  is the study of the uses and effects of drugs in well-defined populations. To accomplish this study, pharmacoepidemiology borrows from both pharmacology and epidemiology. Thus, pharmacoepidemiology is the bridge between both pharmacology and epidemiology. Pharmacology is the study of the effect of drugs and clinical pharmacology is the study of effect of drugs on clinical humans. Part of the task of clinical pharmacology is to provide a risk benefit assessment by effects of drugs in patients:

•  doing the studies needed to provide an estimate of the probability of beneficial effects on populations,
• or assessing the probability of adverse effects on populations.

Every industry is changing at a more fast pace. Products and administrations are getting to be progressively commercialized. Innovation is playing a continuously greater part in inquire about and improvement, showcasing and promoting, and deals and dispersion. The pharmaceutical division is one that has felt this change in investigate and advancement over the past few years and will begin to feel it within the other divisions over the another decade. It's exceptionally likely that within the next decade, people will now not be pharmaceutical test subjects. Instead, cognitive computers will be utilized in biotechnology and genomic research. Instead of it taking months to see the impact of a specific drug on thousands of individuals, it'll take seconds to see the impact of thousands of drugs on billions of simulations of the human body's physiology. Body sensors are a new innovation that's right now still in clinical trials. These sensors can either be put on the body or interior of it. They degree different basic crucial signs. With the unused innovation and advancement, patients are picking up more control. They presently have the capacity to have more of a say when it comes to their body and their health. In this way, pharmaceutical companies will have to be starting taking patient needs, thoughts, and desires into consideration. Products will be more effective if patients are included in their creation and distribution. It's likely that over the coming a long time, numerous companies within the pharmaceutical industry will make persistent admonitory sheets. The pharmaceutical industry is changing at each an each level.