Pharmacovigilance and Risk Management Strategies Conference
In-Person Event
Jan 21 - 24, 2018
Washington, Dist Of Col, USASpeakers
OVERVIEW
Pharmacovigilance and Risk Management Strategies Conference is organized by Drug Information Association / Develop Innovate Advance (DIA) and will be held during Jan 21 - 24, 2018 at Omni Shoreham Hotel, Washington, District of Columbia, United States of America.
The target audience for this medical event is Drug Safety/Pharmacovigilance, Risk Management, including Risk Evaluation and Mitigation Strategies (REMS), Benefit-risk assessment and communication, Medical Product Safety Assessment, Regulatory Affairs, Pharmaceuticals, biologics, combination products, devices, Clinical Research and Clinical Research Organizations, Pharmacoepidemiology, Post-market studies and Real World Evidence generation, Customer Engagement Programs, including Patient Support Programs, Medical Information, Medical Communications, Health Outcomes, Academic Research Centers, Regulatory Agencies.
Conference Description :
This conference will give you the foundation for strong strategic planning and practical decision-making in your pharmacovigilance programs, rather than the cookbook approaches often presented elsewhere. In addition to new developments and updates on regional regulations and guidelines, regulators from the US, EU, and other global regions provide the context and thinking behind evolving requirements.
Preconference Short Courses on Sunday, January 21 :
• Pharmacovigilance and Risk Management Planning.
• PBRER.
• Pharmacovigilance Inspections Part 1: Readiness, Conducting, Findings, and Report-Outs.
• Pharmacovigilance Inspections Part 2: Response, Measurement, Resolution, and Tracking.
Conference Objectives are :
• Apply the current regulatory framework for pharmacovigilance in key markets, including the US and the changing EU.
• Examine the influence of recent regulatory developments and expectations in Japan, Canada, and Eurasia on safety and pharmacovigilance practice.
• Discuss changes in pharmacovigilance and risk management resulting from the emergence of new and advanced technologies and therapies such as CAR-T cells, monoclonal antibodies, and gene therapy.
• Describe pharmacovigilance and risk management considerations and approaches for combination products and rare disease therapies.
• Apply frameworks and learnings from recent government and industry initiatives to improve safety monitoring and reporting in clinical trials.
• Discuss challenges posed by the changing nature of safety data and the implications of new guidelines, such as the developing ICH E19 Guideline, and new approaches to pharmacovigilance and risk management, such as Artificial Intelligence/Machine Learning.
Additional details will be posted as soon as they are available.
The target audience for this medical event is Drug Safety/Pharmacovigilance, Risk Management, including Risk Evaluation and Mitigation Strategies (REMS), Benefit-risk assessment and communication, Medical Product Safety Assessment, Regulatory Affairs, Pharmaceuticals, biologics, combination products, devices, Clinical Research and Clinical Research Organizations, Pharmacoepidemiology, Post-market studies and Real World Evidence generation, Customer Engagement Programs, including Patient Support Programs, Medical Information, Medical Communications, Health Outcomes, Academic Research Centers, Regulatory Agencies.
Conference Description :
This conference will give you the foundation for strong strategic planning and practical decision-making in your pharmacovigilance programs, rather than the cookbook approaches often presented elsewhere. In addition to new developments and updates on regional regulations and guidelines, regulators from the US, EU, and other global regions provide the context and thinking behind evolving requirements.
Preconference Short Courses on Sunday, January 21 :
• Pharmacovigilance and Risk Management Planning.
• PBRER.
• Pharmacovigilance Inspections Part 1: Readiness, Conducting, Findings, and Report-Outs.
• Pharmacovigilance Inspections Part 2: Response, Measurement, Resolution, and Tracking.
Conference Objectives are :
• Apply the current regulatory framework for pharmacovigilance in key markets, including the US and the changing EU.
• Examine the influence of recent regulatory developments and expectations in Japan, Canada, and Eurasia on safety and pharmacovigilance practice.
• Discuss changes in pharmacovigilance and risk management resulting from the emergence of new and advanced technologies and therapies such as CAR-T cells, monoclonal antibodies, and gene therapy.
• Describe pharmacovigilance and risk management considerations and approaches for combination products and rare disease therapies.
• Apply frameworks and learnings from recent government and industry initiatives to improve safety monitoring and reporting in clinical trials.
• Discuss challenges posed by the changing nature of safety data and the implications of new guidelines, such as the developing ICH E19 Guideline, and new approaches to pharmacovigilance and risk management, such as Artificial Intelligence/Machine Learning.
Additional details will be posted as soon as they are available.
KEY DATES
21 Jan, 2018
Event Start Date
24 Jan, 2018
Event End Date
SPECIALITIES
Pharmacy and MedicineSUGGESTED HOTELS
CONFERENCE VENUE
Omni Shoreham HotelRELATED CONFERENCES & LIVE WEBINARS
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