Call for Abstract
10th Pharmacovigilance Congress, will be organized around the theme “Impact of advanced therapies and technologies on pharmacovigilance practice and risk management in compliance with latest regulatory framework”
Pharmacovigilance Congress 2017 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in Pharmacovigilance Congress 2017
Submit your abstract to any of the mentioned tracks.
Register now for the conference by choosing an appropriate package suitable to you.
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.
- Track 1-1Drug Safety Reporting & Monitoring
- Track 1-2Drug Safety Updates
- Track 1-3Pharmacovigilance Planning
- Track 1-4Development Safety Update Reports
- Track 1-5Clinical Safety Data Management
- Track 1-6Drug Safety Services & Softwares
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
- Track 2-1Classification of Various Adverse Drug Reactions
- Track 2-2Overdose Toxicity
- Track 2-3Expected and Un-expected Drug Reactions and its Reporting
- Track 2-4Pharmacogenomics
- Track 2-5Post marketing reports on Adverse Effects
- Track 2-6Reduction of Adverse Drug Reaction by Nanotechnology
- Track 2-7Chemical Structures on Biological Action
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.
- Track 3-1Identify or characterise safety profile
- Track 3-2Measures to prevent or minimise risks
- Track 3-3For each of the safety concerns the planned pharmacovigilance activities should be provided
- Track 3-4Protocols of the studies
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.
- Track 4-1Periodic safety update reports
- Track 4-2clinical trials on various disorders
- Track 4-3All AE/SAE handling and databasing
- Track 4-4protocol and CRF design
- Track 4-5Ongoing monitoring of events
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.
- Track 5-1MHRA inspections- marketing authorisation holders and their contractors
- Track 5-2Modules covering major pharmacovigilance processes
- Track 5-3Types of inspection
- Track 5-4GPvP inspection
- Track 5-5Signal management
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.
- Track 6-1Standard operating procedures
- Track 6-2Case report form design
- Track 6-3Database design and build
- Track 6-4Computer system validation (CSV)
- Track 6-5Data validation
- Track 6-6Serious Adverse Event Reconciliation
- Track 6-7Patient recorded data
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.
- Track 7-1PK and PD in New Drug Development
- Track 7-2Routes of Drug Administration
- Track 7-3Drug-Drug Interaction
- Track 7-4Reactions of Drug Metabolism
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.
- Track 8-1Human Clinical Trial Phases
- Track 8-2Participating in a Clinical Trial
- Track 8-3Patient Education Resources
- Track 8-4Efficacy vs Effectiveness
- Track 8-5Multi Center Trials and Monitoring
- Track 8-6Regulatory Authorities and Ethics Committee
- Track 8-7Advanced Information Technology in Clinical Trials and Promoting Companies
- Track 8-8Postmarketing Clinical Trials
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.
- Track 9-1Emerging Technology in Clinical Trials
- Track 9-2Recent Clinical Trials on AIDS
- Track 9-3Clinical Trials on Benign and Malignant Tumors
- Track 9-4Clinical Trials on Cardiovascular Diseases
- Track 9-5Clinical Trials on Diabetes
- Track 9-6Clinical Trials of Monoclonal and Polyclonal Antibodies
- Track 9-7Clinical Trials on Drugs used in Psychological Disorders
- Track 9-8Applications of Biomarkers in Clinical Trials
- Track 9-9Clinical Pharmacology and Diagnosis of various disorders
Case Report in Clinical Trials plays major role in clinical research. In this track we will aim 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.
- Track 10-1Case Studies on Sexually Transmitted Diseases
- Track 10-2Case Studies on Type 1 and Type 2 Diabetes
- Track 10-3Case Reports on Drugs used in Pregnancy and Lactation
- Track 10-4Unique Therapeutic Approaches
- Track 10-5Cancer Case Reports
- Track 10-6Cardiovascular Trials Case Report
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.
- Track 11-1Rational Drug Management of Cancer, Diabetes and Cardiovascular Disorders
- Track 11-2Management of Psychiatric Disorders and Autoimmune Disorders
- Track 11-3Bioavailaibility and Bioequivalence
- Track 11-4Invivo-Invitro Correlation
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).
- Track 12-1Drug Monitoring Authorities
- Track 12-2WebVDME Pharmacovigilance Signal Detection and Signal Management Software
- Track 12-3Argus
- Track 12-4Aris G
- Track 12-5Clintrace
- Track 12-6PVNET
- Track 12-7Vigilanz Dynanic Monitoring System
- Track 12-8RepClinical
- Track 12-9Oracle AERS
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.
- Track 13-1Pharmacovigilance Software Devlopment Companies
- Track 13-2Bussiness Opportunities for PV Software Devloping Companies
- Track 13-3Opportunities for PV Software Services Companies
- Track 13-4Career Growth in PV Consulting
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.
- Track 14-1Regulatory Guidelines
- Track 14-2USFDA
- Track 14-3EU
- Track 14-4MHRA
Strategies for Growth in Pharma Environment track mainly focused in Strategic development towards FDA approval and Post market product surveillances.
- Track 15-1Strategic Development towards FDA Approval
- Track 15-2Post Market Product Surveillances
- Track 15-3Advances in Changing Pharmacovigilance Regulation System
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%.
- Track 16-1Pharmacy Practice and its Guidelines
- Track 16-2Challenges in Compounding and Dispensing Practice
- Track 16-3Dosage Regimen, Drug Toxicity and Drug Safety Measures
- Track 16-4Pharmacoepidemiology of Drug Shortages
Pharmacovigilance congress 2016 is a Symposium focusing on collaboration and communication among the Pharma Professionals, Scientific Researchers and Pharma Industrial Persons and Directors. Agendas in making their annual business meetings. some of the world's Officials participate in this Conference and share their ideas.