Thursday, 16. May 2019, Boston, Pharmacovigilance USA 2019

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 Pharmacovigilance USA 2019
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Speaker Proposals are Invited.
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The conference will bring together industry experts and regulators to discuss the new updates in legislation, operational challenges of implication of these changes, experience of implementing global risk management plans, the best and effective way forward, impact of IT and social media on PV and harmonization of different regulatory bodies.
Key Themes

Explore the impact of PV legislation changes and updates on industries and the best practices
Assuring Compliance and its monitoring
Preparing for PV audit and inspections and the role of QPPV
Risk management plans, strategies and new risk- benefit analysis tools to improve REMS reporting
Implementing risk management and safety surveillance methodologies for medical devices
New approaches for risk minimization and communication
Determining steps and strategies for more transparency and involvement of patients
Discussing the how IT and Social media effect Pharmacovigilance and Adverse events reporting
Discuss and review the use of databases and emerging tools for generation and detection of safety signals
Importance of outsourcing and its effectiveness
Harmonization of regulatory framework- developed and emerging markets

Why Should You Attend
Pharma/BioTech companies are always faced with the challenge to improve quality of the safety data with the ever-increasing quantity of the data. The companies are also left with the challenge to manage the dynamic regulatory requirements. There are still many complexities that the industries and the regulatory authorities have to tackle. With more communication and networking you can expand your knowledge on the key complications currently experienced by various industries and departments and design new strategies to overcome the same.
Who Should Attend
VPs, Directors, Heads, Managers, Scientific Advisors, Consultants, Research Scholars and professionals with intermediate to advance knowledge and experience in the following

Risk management
Drug safety
Drug Research & Development
Clinical Pharmacology
Clinical Safety
Information and Clinical Data Management
Medical product safety assessment
Clinical research & safety
Data analysis
Information technology
Medical information
Health outcomes
Sales and Marketing
Contract Manufacturing

*Graviton International Terms and Conditions (T&C) applicable.

Pharmacovigilance USA 2019

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