6^th Pharmacovigilance Congress September 28-30, 2016 Toronto, Ontario, Canada

Drug Safety also known as Pharmacovigilance (Pv or Phv), is the pharmacological science relating to the collection, detection, assessment, monitoring and prevention of adverse effects of individual drugs and drug classes. Drug Safety Reviews on Clinical features, Epidemology. In this tract discussion will be about the drug safety and its applications in various fields such as software’s, training etc.

Adverse drug reaction is an harmful or obnoxious reaction from an intervention related to the use of medicinal product. Adverse drug reaction may occur due to due to dose related, non-dose related, or by failure of therapy. Timing, the pattern of illness, the results of investigations, and rechallenge can help attribute causality to a suspected adverse drug reaction. Suspected adverse drug reactions should be reported

Clinical data management is a critical phase in clinical research, which generates high-quality and statistically sound data from clinical trials. Clinical data management assures collectionand availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). The ultimate goal is to assure that data support conclusions drawn from research, which protects public health and confidence in marketed therapeutics.

Case study is to maintain a prospective representative database of the treated population during normal clinical practice, aimed to provide data on clinical safety, and closely monitor the usage of the product and monitor the use of the product in clinical practice. Collection of case report form(CRF) via hybrid solution.

Good pharmacovigilance practice (GPvP)-minimum standard for monitoring the safety of medicines on sale to the public in the EU. It is a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, European Medicines Agency and medicines regulatory authorities in EU Member States. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level.

The comparative evaluation or weighing of benefits (positive effects) and risks (potential harm) of various medical options for treatment, prophylaxis, prevention or diagnosis. Risk management is a global activity. However, because of differences in indication and healthcare systems, target populations may be different across the world and risk minimisation activities will need to be tailored to the system in place in a particular country or global region.

Drugs may undergo, Pharmacokinetics and Pharmacodynamics and toxicity testing through animal testing. This data allows researchers to allometrically estimate a safe starting dose of the drug for clinical trials in humans. In this track mainly focus will be  on Advances in pharmacodynamic interactions, Drug and substance abuse, Drug-drug interactions. 

Clinical trials are conducted to collect data regarding the safety and efficacy of new drug and device development. There are several steps and stages of approval in the clinical trials process before a drug or device can be sold in the consumer market, if ever. Postmarketing study commitments are studies required of or agreed to by a sponsor that are conducted after FDA has approved a product for marketing. FDA uses postmarketing study commitments to gather additional information about a product's safety, efficacy, or optimal use. 

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.

Biological activity or pharmacological activity describes the beneficial or adverse effects of a drug on living matter.pharmacological/biological activity plays a crucial role since it suggests uses of the compounds in the medical applications. However, chemical compounds may show some adverse and toxic effects which may prevent their use in medical practice.

In Clinical Pharmacology and Biopharmaceutics track discussion will be 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. With many major drugs set to see their patents expire before 2020, the biosimilars market is likely to expand in the EU. 

There is advantage in centralizing 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). 

Due to the changing resources necessary to fulfill 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. 

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.

Strategies for Growth in Pharma Environment track mainly focused in Strategic development towards FDA approval and Post market product surveillances.

In Pharmacy Practices and its Challenges track mainly focused 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%.