14^th International Conference and Exhibition on Pharmacovigilance & Drug Safety September 15-16, 2021 Rome, Italy

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

Market Analysis: Geographically, North America held the largest market share of the global market, owing to large production of new drugs development, along with increasing number of clinical trials has led to further need pharmacovigilance of drugs, resulting in higher demand in this region. Moreover, ADRs, contribute to more than 100,000 deaths in the United States annually and most top 10 leading causes of death. Regulator bodies are developing active surveillance approaches to assess the risk of medicine in the post-market phase of the novel products. The growth of pharmacovigilance market in Europe is also attributed to growing number of adverse drug reactions, and growing demand in end-use industry.

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.

Market Analysis: The global Pharmacovigilance Market is expected to reach USD 10.27 billion by 2025, according to a new report by Grand View Research, Inc. The market is expected to witness growth at 13.1% CAGR owing to Increasing incidence of ADR is key driver for the growth of pharmacovigilance market. As of 2015, the U.S. FDA received approximately 253,017 serious adverse events and 44,693 deaths associated with adverse drug reactions (ADRs). This shows the potential demand for implementing safety and pharmacovigilance services over the forecast period

The role of Good Pharmacovigilance Practice and Pharmacoepidemiology 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.

Market Analysis: The global Pharmacovigilance Market is expected to reach USD 10.27 billion by 2025, according to a new report by Grand View Research, Inc. The market is expected to witness growth at 13.1% CAGR owing to Increasing incidence of ADR is key driver for the growth of pharmacovigilance market. As of 2015, the U.S. FDA received approximately 253,017 serious adverse events and 44,693 deaths associated with adverse drug reactions (ADRs). This shows the potential demand for implementing safety and pharmacovigilance services over the forecast period

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.

Market Analysis: The Growing Pharmaceuticals Market: Expert Forecasts and Analysis. The global pharmaceuticals market was worth $934.8 billion in 2017 and will reach $1170 billion in 2021, growing at 5.8%, according to a recent pharma market research report by The Business Research Company.

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 Biopharmaceutics 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.

Market Analysysi:

The global biopharmaceuticals market is estimated to reach USD 341.16 billion in 2023. The market is expected to register a CAGR of 8.5% during the forecast period (2018 – 2023). North America dominates the market due to rapid technological advancements. Opportunities in biopharmaceuticals have been increasing over the past decade. The efficacy and the safety of the drugs are some of the key product features that drive the market’s growth. There have been biopharmaceutical products that are improving the quality of life and reducing the death rates in patients with HIV/AIDs, cancer, cystic fibrosis, rheumatoid arthritis.

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.

Market Analysyis : The global clinical trials market size was valued at USD 40.0 billion in 2016 and is expected to grow at a CAGR of 5.7% over the forecast period. Key drivers impacting the market growth are globalization of clinical trials, development of new treatments such as personalized medicine, augmenting evolution in technology, and boosting demand for CROs to conduct clinical trials. CROs diversified expertise as compared to pharmaceuticalcompanies with respect to performing clinical trials in wide array In January 2015, Hospira submitted one of the biosimilar versions of Epogen (Epoetin Alfa) and the result of the review in the U.S. is anticipated from the FDA within a year.

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.

Market Analysis:

The global pharmacovigilance (PV) market size was estimated at USD 3.40 billion in 2016 and is anticipated to witness a CAGR of 13.1% over the forecast period. Increasing incidence of Adverse Drug Reactions (ADRs) is expected to accelerate the demand for pharmacovigilance services over the forecast period. Growing prevalence of chronic diseases is another major contributor for the PV growth. Treatment of these chronic diseases require uptake of combination of drugs resulting in ADR. To curb this problem, PV services are used. According to statistics published in Journal of American Medical Association (JAMA), in 2014, ADR is one of the leading causes of mortality in the U.S. resulting in more than 100,000 deaths every year

Concept of Pharmacovigilance and its Significance 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.

Market Analysis: The global Pharmacovigilance Market is expected to reach USD 10.27 billion by 2025, according to a new report by Grand View Research, Inc. The market is expected to witness growth at 13.1% CAGR owing to Increasing incidence of ADR is key driver for the growth of pharmacovigilance market. As of 2015, the U.S. FDA received approximately 253,017 serious adverse events and 44,693 deaths associated with adverse drug reactions (ADRs). This shows the potential demand for implementing safety and pharmacovigilance services over the forecast period

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. This diversity makes us to better understand the unmet medical needs of patients.

Market Analysis:

The global clinical trials market size was valued at USD 40.0 billion in 2016 and is expected to grow at a CAGR of 5.7% over the forecast period. According to BioOutsource, the demand for Biosimilars testing is expected to increase in the U.S. This is attributed to the fact that the FDA finally started addressing the lack of clear guidance with regards to biosimilars, specifically how the developers should prove that their drugs are similar to that of the originator product. In January 2015, Hospira submitted one of the biosimilar versions of Epogen (Epoetin Alfa) and the result of the review in the U.S. is anticipated from the FDA within a year.

In Clinical Research, Statistics plays a prominent role in regulatory submissions. 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.

Market Analysis:

The global clinical trials market size was valued at USD 40.0 billion in 2016 and is expected to grow at a CAGR of 5.7% over the forecast period. According to BioOutsource, the demand for Biosimilars testing is expected to increase in the U.S. This is attributed to the fact that the FDA finally started addressing the lack of clear guidance with regards to biosimilars, specifically how the developers should prove that their drugs are similar to that of the originator product. In January 2015, Hospira submitted one of the biosimilar versions of Epogen (Epoetin Alfa) and the result of the review in the U.S. is anticipated from the FDA within a year.

Case Report in Clinical Trials plays a key role in Clinical Research. Case reports may be on 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.

Market Analysis:

Clinical trials are research studies which are performed to explore new medical treatments to implement them in people. There are 4-Phases in clinical trials. The final phase includes a documentation process which is called as a CASE REPORT. A case report is a detailed report of signs, symptoms, diagnosis, treatment & adverse/side effects (if any) in the form of a document. Among which Indonesia tops the list in spending less towards health care it rarely spent about 3.3% of GDP in 2013 whereas other Asian countries like Malaysia spent about 4.4% of GDP in 2013 likewise Philippines with about 4.6% of GDP in 2013 and Singapore around 3.9% of GDP. It’s expected to rise around 8.9% in Singapore by 2018, 4.5% in Malaysia by 2018, 4.5% in Philippines by 2018 whereas in Indonesia it is expected to reduce to 2.8% by 2018.

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.

Market Analysis:

The global pharmacovigilance and drug safety software market is poised to grow at a CAGR of 6.5% during 2014-2019, and is expected to reach a value of $154.1 Million in 2019. As of 2014, North America holds the largest share of the global pharmacovigilance and drug safety software market, followed by Europe. However, Asian and Latin American countries represent high growth markets, owing to a rise in research outsourcing by pharmaceutical giants and growing public and private investments in pharmaceutical R&D in these emerging nations

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.

Market Analysis:

The global clinical trial IT market is expected to grow from $2.63 billion in 2016 to $4.29 billion in 2020 at a compound annual growth rate (CAGR) of more than 13.0%. North America will continue to hold the largest market share (by revenue) in 2017, followed by Europe. Increasing clinical trial activities in the emerging Asia-Pacific markets and recent favourable regulatory reforms (China to accept overseas trial data; Indian government allowing? academic institutions to take Drug Controller General of India (DCGI) permission) are expected to drive the demand for clinical trial IT solutions from 2017 to 2020. Clinical trial data management (CTDM) and emerging clinical solutions comprising electronic.

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.

Market Analysis:

The global regulatory affairs outsourcing market is expected to reach USD 12.4 billion by 2025, according to a new report by Grand View Research, Inc. Outsourcing of regulatory affairs functions to CROs or other individual service providers offers life science companies the benefit to achieve cost efficiency and reduce the overall approval process time by eliminating delays associated with regulatory submission requirements. These benefits are primarily driving the outsourcing trend and hence impacting the market over the forecast period.

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 was 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.