Joint International Conference and expo on Industrial Pharmacy & 5^th Global Pharmacovigilance Summit April 28-29, 2016 Dubai, UAE

An Adverse Drug Reaction (ADR) is an injury caused by taking a medication. Many adverse drug reactions represent an over effectivness of the drug's therapeutic effects. In Classification of various adverse drug reactions we know about the different types of Adverse Drug Reactions and its effect. For understanding Adverse Drug Reactions, we need to know about the mechanism of  drug reactions. Assessing and reporting adverse drug reactions are very important to maintain drug safety systems. hospitalized patient populations have placed much higher estimates on the overall incidence of serious ADRs. The studies estimate that around  6.7% of hospitalized patients are suffering fromserious adverse drug reaction with a fatality rate of 0.32%.  If these estimates are true, then there are more than 2,216,000 serious ADRs in hospitalized patients, causing over 106,000 deaths annually. Examinig all these facts, ADRs are the 4th leading death causing —ahead of other diseases like AIDS, diabetes and automobile deaths.

Concept of Pharmacovigilance and its Significance and Scope to present the case for the importance of pharmacovigilance, to record its growth and potential as a significant discipline within medical science, and to describe its impact on patient welfare and public health and to know what is pharmacovigilance. In this Track we discussed about the Significance of pharmacovigilance. The global market for alzheimer’s disease reached $10.2 billion in 2012. The market is expected to decrease to $9.5 billion in 2017 for a CAGR of -1.5%.

Continental Pharmacovigilance helps to ensure compliance with local and international requirements. To operate more effectively across multiple regions and health authorities. The global liver diseases therapeutics market totaled nearly $24.5 billion in 2014 and is projected to approach $33.8 billion by 2019, registering a compound annual growth rate (CAGR) of 6.7% through 2019.

Good Pharmacovigilance Practice means to  maintain the Good reporting practices to avoid major problems in risk management. Also it is important to concentrate on Signal investigation via observational studies and Interpreting safety signals.

The new turn in Drug industry is to use Information technology in pharmacovigilance companies. Drug industry need to promoting companies in pharmacovigilance practice and the Review of softwares used in pharmacovigilance and clinical trials. The U.S. market for food-safety testing was valued at $3.3 billion in 2011 and is projected to increase slightly in 2012. In 2017, the market should reach nearly $4.4 billion after increasing at a five-year compound annual growth rate (CAGR) of 5.6%.

Medical device Pharmacovigilance is the monitoring of  safety profile of medical devices, from the processing and reporting of single adverse incidents through to the removal of products from the market as part of a Field Safety Corrective Action. This to ensure that patient’s and healthcare professional’s safety is monitored and action taken as soon as a safety concern with a medical device arises.
 

Drugs undergo, Pharmacokinetics and Pharmacodynamics and toxicity testing through animal testing. This data helps researchers to allometrically estimate a safe starting dose of the drug for clinical trials in humans. In this track mainly we will focuss on Advances in pharmacodynamic interactions, Drug and substance abuse, Drug-drug interactions. The global market for needle free technologies reached $963.6 million in 2013. This market is expected to grow to $1.1 billion in 2014 and $2.1 billion in 2019, with a compound annual growth rate (CAGR) of 14.3%.

Veterinary medicinal products only receive marketing authorisation if the assessment of the data concerning their quality, safety and efficacy shows that the benefits linked to their use are greater than the risks incurred.Pharmacovigilance thus aims to detect any emerging signs as quickly as possible, both unexpected adverse effects and known adverse effects with an unexpected frequency or severity. This post-MA monitoring sometimes results in adjusting risk management measures, which may include providing additional precautions for use on the package leaflet, or in certain cases withdrawal of the MA.

The main goals of Pre-Clinical and Clinical Trials are to determine the safe dose and start to assess product's safety profile. In Designing of trials there are pre-clinical studies and different phases of clinical trials. In this trails they estimate the Bioassay and its types. New technologies and the outsourcing of clinical trials to lower-cost countries will slow the recent annual increases in expenditures in the U.S. to a 3.3% compound annual growth rate (CAGR) over the forecast period. Clinical trial spending in 2010 is an estimated $25 billion and is expected to reach $28.5 billion by 2014.

With the rapid spread of information across the globe, increased communication across borders, easy access to variety of medicinal products and increasing public expectation of safety, there is a need for careful strategic planning adopting a holistic approach to meet the additional challenges. We need continuing and dynamic progress of all aspects of pharmacovigilance to improve public health and safety. There is a need for new global network to share information and intelligence about benefit and risk of medicinal products

The global pharmacovigilance market valued  USD 2,408.0 million in 2013 and is expected to grow at a CAGR of 12.6%  in upcoming periods. ADR, a substantial burden on healthcare systems and is one of the prominent reasons of morbidity in developed countries. Approximately 5% of total hospitalizations in a year are due to ADR. With an upsurge in the drug production, regulatory authorities such as the U.S. FDA and EMEA (European Medicines Agency) have intensified drug safety regulations prior and post commercialization.

In This track we will discuss about the Recent clinical trials on AIDS, Clinical trials on benign and malignant tumors, Clinical trials on cardiovascular diseases, Clinical trials on diabetes, Clinical trials of monoclonal and polyclonal antibodies, Clinical trials on drugs used in psychological disorders The current research mainly focus on Applications of biomarkers in clinical trials. The global orphan drug market totaled nearly $123 billion in 2014 and will continue to grow to reach nearly $191 billion by 2019, demonstrating a compound annual growth rate (CAGR) of 9.2% during the forecast period (2014 to 2019).

In Clinical Research and Statistics,clinical trials go for regulatory submissions based on ICH guidelines. Stastical analysis of past pharmacovigilance and adverse drug reactions reports also consider for the regulatory submission. The global liver diseases therapeutics market totaled nearly $24.5 billion in 2014 and is projected to approach $33.8 billion by 2019, registering a compound annual growth rate (CAGR) of 6.7% through 2019.

Case Report in Clinical Trials plays major role in clinical research. In this track we discussed about the several case reports like Cancer case reports, Cardiovascular trials case report, Case studies on sexually transmitted diseases, Case studies on type 1 and type 2 diabetes, Case reports on drugs used in pregnancy and lactation. New technologies and the outsourcing of clinical trials to lower-cost countries will slow the recent annual increases in expenditures in the U.S. to a 3.3% compound annual growth rate (CAGR) over the forecast period. Clinical trial spending in 2010 is an estimated $25 billion and is expected to reach $28.5 billion by 2014.

In Clinical Pharmacology and Biopharmaceutics track we will be disussing 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 pulmonary drug delivery technologies market which was $19.6 billion in 2010 is expected to be around $22.5 billion by 2011. This global market is further projected to reach nearly $44 billion by 2016 at a compound annual growth rate (CAGR) of 14.3%.

There is 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. The global market for pediatric medicines reached $80.7 billion in 2013 and should reach $83.6 billion in 2014. This market is expected to reach about $100.7 billion by 2019, registering a compound annual growth rate (CAGR) of 3.8% from 2014 to 2019.

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. The global market for pediatric medicines reached $80.7 billion in 2013 and should reach $83.6 billion in 2014. This market is expected to reach about $100.7 billion by 2019, registering a compound annual growth rate (CAGR) of 3.8% from 2014 to 2019.

Regulatory affairs for clinical trials is the major part in the clinical trials approaches. Every clinical trial must be conduct according to the Regulatory affairs guidelines. There are several Regulatory affairs depending upon the countries. Regulatory Affairs departments are growing within companies. Global harmonization in standards has led to consistent approach in regulatory submissions and hence its review. The global biologics market totaled $200.6 billion in 2013 and is expected to grow to nearly $234 billion in 2014. The total market is expected to grow to $386.7 billion by the end of 2019 at compound annual growth rate (CAGR) of 10.6%.

Strategies for Growth in Pharma Environment track mainly focused in Strategic development towards FDA approval and Post market product surveillances. The updates and advances in pharmacovigilance regulation system are discussed in Advances in changing pharmacovigilance regulation system track. The global market for sequencing products was nearly $3 billion in 2011, and it is forecast to grow at a compound annual growth rate (CAGR) of 17.5% to reach $6.6 billion by 2016.

In Pharmacy Practices and its Challenges track mainly focusses on Pharmacy practice and its guidelines and Challenges in compounding and dispensing practice. Dosage regimen, drug toxicity and drug safety measures place important position in clinical research. The global inpatient and outpatient pharmacy automation market was valued at $2.4 billion in 2011 and should reach $2.6 billion in 2012. Total market value is expected to reach nearly $3.9 billion in 2017 after increasing at a five-year compound annual growth rate (CAGR) of 8%.

Getting startup capital can be easy if you have a good idea and know the right investor. If you’ve spent serious time thinking about becoming an entrepreneur or you’re already in the early stages of business development, you probably already have a good idea (and if you don’t, you’re in the process of improving it). The bigger problem, then, is meeting the right investor. The global inpatient and outpatient pharmacy automation market was valued at $2.4 billion in 2011 and should reach $2.6 billion in 2012. Total market value is expected to reach nearly $3.9 billion in 2017 after increasing at a five-year compound annual growth rate (CAGR) of 8%.