15^th International Conference on Pharmaceutics and drug safety June 15-16, 2022 Amsterdam, Netherlands

Due to some changing resources it is necessary to full-fill the regulatory requirements. Regulatory Affairs department is continuously developed and growing, and the one which is minutely affected during the Acquisition, Merger and recession. The international  drug safety market and Business opportunity was valued at USD 2,408.0 million in 2013 and is predicted to increase at a CAGR of 12.6% at the time of  forecast period. And on the second position it was Phase III clinical trial market and was valued at over USD 750.0 million in 2013.

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  Drug safety software Development Companies


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  Business Opportunities for drug safety Software Developing Companies


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  Opportunities for drug safety Software Services companies


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  Career Growth in drug safety Consulting

Clinical data management (CDM) is a complicated process in the field of clinical research, which posses to generation that are of high-quality, reliable, and statistically sound data from clinical trials. The main aim of CDM is to give the sureity about the final data collected from the research.

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  Electronic health records


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  Administrative data 


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  Claims data


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  Disease registries 

Drug regulation is a process by which we can control the use of drug by international agreement and through some regulatory authorities like US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese Pharmaceutical and Medical Devices Agency (PMDA).

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  Role of drug regulation


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  Future of medicine regulation 

The Pharmaceutical science is an extortionate scope of logical controls of revelation and advancement of newly developed medications and treatments. Pharmaceutical sciences includes the basic fundamental standards of physical and compound science, designing, organic chemistry, and science to see how to upgrade transference of medications to the body and make an interpretation of this coordinated comprehension into as good as ever treatments against human ailment.

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  Drug Discovery and Design


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  Drug Delivery


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  Drug Action


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  Clinical Sciences

Every industry is developed more rapidly. Products and administrations are growing increasingly at commercial level. Evolution plays an important part in inquire about and improvement, showcasing and promoting, and deals and dispersion. Only pharmaceutical division has speculated the investigation and advancement over the past few years and also in other sections in a decade time.

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  Body sensors clinical trail 

The main purpose of this study is to evaluate the prevalence and explain the characteristics of PDDIs  in medical recommendation of hospitalized surgical patients. In this transverse study, we examine 370 medical prescriptions from the surgery unit of a Mexican public teaching hospital. The classification and identification of potential drug-drug interactions were performed with the Micromedex 2.0 electronic drug information database. Results were examined with illustrative statistics and we estimated OR (odds ratio) to determine associated risk factors.

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  Study of Medscape Drug Interaction Checker

In Pharmacoepidemiology we will examine the uses and effects of drugs on the population.  This is the branch of pharmacology and epidemiology Thus, Pharmacoepidemiology is the bridge between pharmacology and epidemiology. In pharmacology we will read about the effect of drugs while in clinical pharmacology we will read about the effect of drugs on clinical humans. Clinical pharmacology provides a risk benefit assessment by effects of drugs in Patients body.

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  Study about pharmacology


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  Study about epidemiology

Quality assurance is a process by which we can prevent the mistakes and defects in manufactured product. So that, when we are delivering the product customers does not face any problem.

The study plays crucial role in clinical research program which can be an unexpected association between disease disorders or symptoms like unexpected event occurring during diagnosis, treatment, pathogenesis or adverse effects of diseases. Notable Variation in anatomical structure, therapeutic approaches or salient features is core objective focused in care report.

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  Unique therapeutic approaches


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  Cancer case reports


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  Cardiovascular trials case report


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  Case studies on sexually transmitted diseases


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  Case studies on type 1 and type 2 diabetes


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  Individual case safety reports

Clinical trials allow drug testing for safety assessment in different population. Preclinical development referred as preclinical studies or nonclinical Studies, is a research stage carried at initial level of increasing accessibility and iterative testing and drug safety data are collected. Main goals of preclinical studies to determine the safe dose in first phase and evaluate the product safety profile. Product may include drugs, gene safety, and diagnostic tools.

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  Clinical trials on drugs used in respiratory disorders


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  Regulatory authorities and ethics committee


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  Multi centre trials and monitoring


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  Alternative trials design and models


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  Data collection and quality control


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  Bioassay and its types


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  Designing of trials: pre-clinical studies


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  Scientific Models for Pre-Clinical and Clinical Trials


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  Pre-Clinical Testing


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  Mechanism of adverse drug reactions


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  Recent clinical trials on AIDS


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  Classification of various adverse drug reactions

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  Expected and un-expected drug reactions and its reporting

Clinical trial industry is repeatedly growing with diversified clinical research technologies and new clinical studies are being launched at an ever-growing pace. Clinical trials have always been a crucial part of the medicine development process, they provide clinical data 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 diligence and being strategic possible in results. This diversity makes better understanding in the field of drug safety.

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  SAS Programing in Clinical Research and Pharmaceutical Industry

Its significance Increase the impact of drug safety on patient welfare. This track gives the brief discussion about drug safety and pharmacy in healthcare system. Drug safety protection gives an outlook on the rules and laws to follow in drug safety and pharmacy practice. The Role of Pharma industries works in the improvement of drug safety system crucial to maintain analyze safety assessment data, its Detection and Evaluation of signals manual and medical devices reporting.

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  Significance of drug safety


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  Drug safety and healthcare system


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  Role of pharma industries in the improvement of drug safety system


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  Detection and evaluation of drug safety signals through manual and medical devices reporting

Data quality management and analysis in drug safety depend on information collected from individuals. Quality management involves quality control, quality planning, quality assurance, and quality improvement. First step of data collecting cycle is collection of data in system, data entry. Second step is data storage, maintenance followed by data selection. In last data is analyzed. Finally process is concluded to analyze the data.

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   ·         Data Quality Control and Assurance


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   ·         Quality Planning and Improvement 


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              Data Safety Monitoring

It includes various chronic diseases like: AIDS, Benign and Malignant tumor, Diabetes, Clinical Trials of Monoclonal and Polyclonal antibodies, neurological, physiological and psycological disorder.

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  Emerging technology in clinical trials


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  Recent clinical trials on AIDS


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  Clinical trials on benign and malignant tumors


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  Clinical trials on cardiovascular diseases


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  Clinical trials on diabetes


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  Clinical trials of monoclonal and polyclonal antibodies


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  Clinical trials on drugs used in psychological disorders


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  Applications of biomarkers in clinical trials

In this track we will discuss about rational drug management of cancer, diabetes, cardiovascular disorder and management of psychiatric disorders and autoimmune disease. Bioavailability and bioequivalence study plays an important role. International market for biopharmaceutics in 2013 was $ 305.1 million and expected to reach $ 326.3 million in 2014.

Pharmacy practice develops the professional role of pharmacists. Include disease state management, pharmacy professional development pharmaceutical drug, clinical drug intervention, pharmaceutical compounding, health physiology drug incompatibility and community pharmacy.

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  Pharmacy practice and its guidelines


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  Challenges in compounding and dispensing practice


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  Dosage regimen, drug toxicity and drug safety measures


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  Pharmacoepidemiology of drug shortages


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  Drug labeling

Good Pharmacovigilance practice and pharmacoepidemiology in risk management to increase the possibility of beneficial effects of drug and adverse effects in population maintain reporting practice to avoiding the major problems in risk management. Also concentrate to examine information by collecting drug effects, caused by medicine. Pharmacovigilance and clinical trial services should have Pharmacovigilance certification.

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  Role of Pharmacovigilance and pharmacoepidemiology in risk management


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  Good reporting practices


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  Interpreting safety signals


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  Randomized clinical trials


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  Ethical and social aspects of drug use

Adverse drug reaction is a form of toxicity or increase drug effect which mainly occurs during efficient use. In US 3-7% hospitalization are due to ADRs. ADRs occur during 10-20% of hospitalizations, 10-20% of ADRs are severe. ADR’s showed no pharmacokinetic effects resulting in 0% death incidence till date. Suggested rate of 0.5 – 0.9% may be high because patient have some serious disorder. Severity and incidence vary through patients characteristic and through drug factors.

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  Acute and chronic adverse drug events


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  Classification of various adverse drug reactions


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  Mechanism of adverse drug reactions


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  Assessing and reporting adverse drug reactions


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  Post marketing reports on adverse effects