Conference on 5th Annual Pharmacovigilance(Conference and workshop) 

Venue: BSG House, London, UK

Location: London, United Kingdom

Event Date/Time: Mar 17, 2010 End Date/Time: Mar 19, 2010
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Description

Pharmacovigilance is becoming ever more critical for pharmaceutical companies as the public and legislative pressure to ensure drug safety increases every day. Effective implementation of pharmacovigilance can aid drug development, benefit rational communication and sound public understanding, taking emerging regulatory policies worldwide into account. The challenge to manage adverse events in an optimal and efficient way and, at the same time, adhere to regulatory requirements will demand a great emphasis on pharmacovigilance in the near future.
5th Annual Pharmacovigilance conference will underpin processes and developments on many different elements including the regulatory and legislative framework, risk management, PSUR, live licensing, in drug safety and surveillance. With succinct themes, interactive sessions by key opinion leaders, our conference will bring latest insights, integrated strategies and best practices in pharmacovigilance. 
Why Attend?
Gain knowledge on:
• Evaluation of risk mitigation activities: REMS and beyond from the pharmacoepidemiologist's perspective
• Regulatory focus on evaluation of risk mitigation strategies, contrasting the FDAAA, REMS and the EU-RMP
• Adverse drug reactions can be classification by mechanism (the EIDOS system) and by clinical presentation (the DoTS system)
• Pharmacovigilance in clinical trials of investigational medicinal products
• New Horizons: Proposals from the EU Commission "Pharma Package"
• Developing and implementing training programs for global pharmacovigilance systems, bridging geographies and requirements
• Pharmacovigilance in early phase oncology trials (Phase I & II)
• Implementing inspection readiness program as a guide to maximise readiness
• Drug safety investigation – Pre and Post Marketing 
Who will attend?
VP’s, Directors, Heads, Managers, Scientific Advisors, Consultants of: 
• Pharmacovigilance
• Pharmacoepidemiology
• Pharmacogenomics
• Drug/Product Safety
• Drug Development
• Information and Clinical Data Management
• Clinical Pharmacology
• Clinical Safety
• PSUR
• Risk Management
• Research & Development
• Quality Assurance
• QPPV
• Patient Safety/ Surveillance
• Signal Detection
• Outcomes Research
• Data Analysis
• Epidemiology 
• Toxicology 
• Medical Affairs
• Regulatory Affairs and Compliance 
• Sales & Marketing 
Key Topics:
During this one day workshop we will explore the Safety Data Exchange Agreements (SDEA) for licensed and unlicensed products and how these are scrutinised by competent authority inspectors. This workshop will be an interactive and collaborative forum and help you achieve a thorough understanding on the following themes:
• Safety Data Exchange Agreements (SDEA) for licensed and unlicensed products i.e. those provided on a named patent basis
- Strategies for clear SDEA to ensure that all parties know what their responsibilities are
• Impact of acquisition and divestment of products or companies on the pharmacovigilance system
- Careful management of acquisition of a company or product to ensure transition and merger into the current pharmacovigilance system
 - Implementation of divestment of products from the portfolio needs to ensure that all safety data is transferred from one MAH to another 
10:10 Evaluation of risk mitigation activities: REMS and beyond from the pharmacoepidemiologist's perspective
• Pharmacoepidemiologist’s role in risk management & pharmacovigilance
• Summarise the increased regulatory focus on evaluation of risk mitigation strategies, contrasting the EU & US legislation on risk mitigation evaluation (i.e. FDAAA, REMS and the EU-RMP)
• Case examples and current challenges to implementation

Venue

London, UK
London
United Kingdom
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