8th Annual Pharmacovigilance 2015 will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry.  The entire program will cover the detection, analysis and prevention of adverse drug reactions.  It will be studied with the help of case studies and industry experiences. This conference will help the drug safety representatives from the pharmaceutical industry and academic and quality research organisations who wish to understand how to avoid common deficiencies in inspections by learning from the experiences of others; to gain a greater understanding of new and existing pharmacovigilance requirements, and to improve their organisations’ compliance with pharmacovigilance requirements. Also it can help you control your product’s lifecycle, your patient’s trust, and your revenue. Hence, this conference will provide an important platform for pharmacovigilance stakeholders to discuss and share best practices in expediting pharmacovigilance development.

KEY THEMES

• Update yourself with respect to terms of legislation, policies, systems, technology, communication strategies and best practice in PV
• Developing Pharmacovigilance into high quality management system and its components
• Audit and Inspection: Realistic steps for a fruitful consequence
• EMA PSMF – Assuring compliance and provide standardization
• Discover approaches for collecting, integrating and analyzing all of the safety data generated from preclinical models
• Exploiting the pharmacy automations and technologies for enhancement of medication safety
• Developments in Pharmacovigilance, drug safety & risk management to ensure safer drugs to market
• Improving patient care and safety in relation to use of medicines and all medical and paramedical interventions
• Determining the steps and strategies for enhancing quality in healthcare
• Emerging signal detection data gathering successful tools to highlight emerging risks
• IT solutions for Pharmacovigilance – Learn & Explore
• Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients
• GVP Module V and XVI – explaining authority expectations and avoid speculation and differing interpretation of the current guidelines
• Review the use of (PSURs) post-authorisation for safety signals
• ICH-R3 standards – Determining where future challenges could arise
• The developing regulatory framework in advanced and developing markets
• Accelerating new medicine introduction in developing world & overcoming challenges
• Explaining how to use the data sources and observational research for effective safety analysis
• Be part of a major networking opportunity

WHO SHOULD ATTEND

• Pharmacovigilance
• Pharmacoepidemiology
• Pharmacogenomics
• Drug/Product Safety
• Drug Development
• Information and Clinical Data Management
• Clinical Pharmacology
• Clinical Safety
• Periodical safety update Reports
• Risk Management
• Research & Development
• Quality Assurance
• Patient Safety
• Signal Detection
• Safety Surveillance
• Outcomes Research
• Data Analysis
• Epidemiology
• Medical Affairs
• Regulatory Affairs and Compliance
• Information technology
• Sales and Marketing

http://www.virtueinsight.com/pharma/8th-Pharmacovigilance-2015/

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