12^th International Conference and Exhibition on Pharmacovigilance & Drug Safety June 21-22, 2018 Rome, Italy

Adverse Drug Reaction (ADR) is the contrary reaction caused by taking a medication. Many Adverse Drug Reactions represent an overwhelming  side effects of the drug's therapeutic effects and are due to administration of single dose or prolonged usage of drug. These reactions are caused by a single drug or combination of multiple drugs.  ADRs can be local i.e, limited to certain location or it can be systemic i.e, spread throughout whole systemic circulation. According to US FDA an adverse drug reaction is severe when  it leads to death of patient or causes permanent damage or significant disability in patient’s body functions. Adverse Drug Reactions of Drugs can be studied by reporting the mechanism of adverse drug reactions and maintaining the drug safety systems. This track is about expected and un-expected drug reactions and its reporting. Manufacturers, Professionals, and Consumers can report Post marketing reports on adverse effects.

Good Pharmacovigilance Practices (GVP) begins with the acquisition of complete data from spontaneous adverse event reports. GVP characterizes the adverse event details, baseline patient characteristics, therapy details, diagnosis of the events and clinical course of the event. The role of Good Pharmacovigilance Practice and Pharmacoepidemology in Risk Management is mainly to  increase the probability of beneficial effects of a drug in a population than the probability of adverse effects and to maintain the Good Reporting Practices by avoiding the major problems in risk management. Also it is important to concentrate on Signal investigation by gathering the information on new or unknown drug effects that is potentially caused by a medicine and that finally should lead to ensuring safety. The pharmacovigilance and clinical trials services providing companies should have the Pharmacovigilance certification .

Good Pharmacovigilance Practices (GVP) begins with the acquisition of complete data from spontaneous adverse event reports. GVP characterizes the adverse event details, baseline patient characteristics, therapy details, diagnosis of the events and clinical course of the event. The role of Good Pharmacovigilance Practice and Pharmacoepidemology in Risk Management is mainly to  increase the probability of beneficial effects of a drug in a population than the probability of adverse effects and to maintain the Good Reporting Practices by avoiding the major problems in risk management. Also it is important to concentrate on Signal investigation by gathering the information on new or unknown drug effects that is potentially caused by a medicine and that finally should lead to ensuring safety. The pharmacovigilance and clinical trials services providing companies should have the Pharmacovigilance certification .

Pharmacy practice is the field of pharmacy which involves developing the professional roles of pharmacists. It includes Disease-state management, Clinical drug interventions, Pharmacy professional development and pharmaceutical care, pharmaceutical compounding and health psychology, patient care, drug abuse prevention, prevention of drug interactions or minimisation of adverse events and drug incompatibility and community pharmacy. There are several challenges to pharmacy  practices. Antimicrobial drug resistance is becoming  a major public health threat to the effectiveness of the existing antimicrobial drugs.

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 Biopharmaceuticsin 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 generally include interference such as medication, psychotherapy, new equipments and new approaches to surgery or radiation therapy. Clinical trials helps in inventing new ways to treat a particular disorder or condition and provide best possible ways to detect the presence of certain disorder or condition. 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 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. Several functioning, well documented and transparent quality management systems will assist in data collection management and output production and in addition will help the pharmacovigilance end users and patients.

The main aim of pharmacovigilance is to provide complete and clear information related to drug safety  and various risks and benefits  associated with them. Pharmacovigilance can help in providing information of unintended and severe adverse events  which could not be provided by clinical trials involving in-vivo method. It enhances the impact of pharmacovigilance on patient welfare and public health and to know what is pharmacovigilance. This track gives a brief discussion on Pharmacovigilance role in healthcare system. Pharmacovigilance legislation gives an outlook on the rules and laws to follow in Pharmacovigilance practice. The Role of pharma industries in the improvement of pharmacovigilance system is very crucial to maintain the safety data, Detection and Evaluation of drug safety signals through manual and medical devices reporting. Pharmacovigilance scope also deals as Ecopharmacovigilance (EPV), pharmacoenvironmentology and pharmacovigilance in herbal medicines. 

The clinical trial industry is constantly evolving with diversified clinical research technologies and new clinical studies are being launched at an ever-growing pace. Clinical trials have always been a vital part of the medicine development process, as they provide clinical data on the best ways for treating pathological disorders and diseases. The importance of diversity in industrial clinical trials and clinical research is to ensure that industrial clinical trials are doing due diligence and being as strategic as possible in their results. Diverse populations in clinical trials and clinical research also help in determining  the level of safety and effectiveness of the medicinal products. FDA makes sure that people of different ages, races, ethnic groups and genders are included in clinical trials. This diversity makes us to better understand the unmet medical needs of patients. There are many obstacles to increasing participation in clinical trials but the main barrier is lack of awareness and misunderstanding the clinical trials.

In Clinical Research, Statistics plays a prominent role in regulatory submissions. Statistics applied to clinical research provide formal accounting for sources of variability in patient’s responses to treatment.  The researchers make use of statistics to form reasonable and accurate inferences from collected data and to make accurate decisions in the presence of uncertainity.  Statistical analysis of  Pharmacovigilance can be achieved by several guidelines mainly ICH guidelines. Adverse Drug Reactions reports can also be considered for the regulatory submission.

Case Report forms an important part of Clinical Research. A case report form is a document specifically used in clinical trials. It is used as tool by the sponsor of the clinical trial to gather  information from each participating site. It comprises of data of each and every patient participating in clinical trials including the adverse events. Case reports may be regarded as an unexpected association between diseases, disorders or symptoms. An unexpected event in the course of observing, treating a patient, possibilities of  pathogenesis of a disease or an adverse effect. Unique or rare salient features of a disease or therapeutic approaches or a notable variation of the anatomical structures.

Drug Safety is the pharmacological science ensuring safety and related to the collection, detection, assessment, monitoring, and prevention of adverse side effects with pharmacological action of pharmaceutical products. According to US FDA a drug is regarded as safe by looking at side effects, its manufacturing process and results of animal testing and clinical trials. In this track, we discuss Drug safety and its applications in various fields such as Softwares, Training etc.

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.

Due to the changing resources necessary to fulfil the regulatory requirements, some companies also choose to outsource or out task regulatory affairs to external service providers. Regulatory Affairs department is constantly evolving and growing and is the one which is least impacted during the Acquisition and Merger, and also during recession. The global pharmacovigilance market and Business opportunity bwas valued at USD 2,408.0 million in 2013 and is expected to grow at a CAGR of 12.6% during the forecast period. Phase III clinical trials market was the second largest and was valued at over USD 750.0 million in 2013.

Regulatory Affairs for clinical trials is the major part in the clinical trials approaches. Regulatory affairs helps the healthcare industries to make safe and effective healthcare products available worldwide.  Every clinical trial must be analysed according to the Regulatory Affairs Guidelines. There are several Regulatory Affairs departments depending upon the countries within evergrowing pace of companies. Global Harmonization in standards has led to consistent approach in regulatory submissions and hence its review.

Initial investment, capital requirements, business financing, current trends and the amount of time will take to get your business up and running. Pharmacovigilance 2017 focus in collaboration and communication among the Pharma Professionals, Business Entrepreneurs, CEO’s and  Pharma Industrial Persons.