행사/교육
World Drug Safety Congress Americas 2013
- 등록일2013-02-19
- 조회수4018
- 구분 국외
- 행사교육분류 행사
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주관기관
Health Network Communications Ltd
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행사장소
Revere Hotel - Boston Common - Boston
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행사기간
2013-04-24 ~ 2013-04-25
- 원문링크
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첨부파일
World Drug Safety Congress Americas 2013
conference programme
Day One - Wednesday 24th April 2013
Safety Signal Management Strategies
8.30am Opening Remarks from the Chair
8.45am How to achieve drug safety excellence in today’s challenging industry environment
GLOBAL SAFETY DRIVERS
9.15am USA drug safety regulatory update
• Review of the drug safety regulatory backdrop in the US and resulting impact on global operations
• FDA MeEdWatch: The FDA Safety Information and Adverse Event Reporting Program
• Investigational New Drug Safety Reporting Requirements
• Sentinel initiative › Dr José Vega, Vice President Global Safety, Amgen
USA drug safety regulatory update
9.45am PANEL DISCUSSION: Can the industry achieve global harmonisation in a local-level focussed regulatory system?
› David Balderson, Executive Director, Safety Operations, Amgen› Philip Miner, Director, Safety Alliance Management, Forest Laboratories Inc PANEL DISCUSSION: Can the industry achieve global harmonisation in a local-level focussed regulatory system?
10.15am Speed networking followed by refreshments
BENEFIT RISK MANAGEMENT
11am The benefit risk mindset & evolving management strategies
11.30am Assessing the effectiveness of Risk Management Plans and REMS
12pm Future of Pharmacovigilance: Five Imperatives that will Drive Improved Business
12.30pm Social Media, Digitized Healthcare Data, and The Future of Drug Safety
1pm Lunch
SAFETY SIGNAL MANAGEMENT STRATEGIES
2pm Signal detection strategies through the lifecycle: advancing the science, ensuring compliance, protecting patients
2.30pm An organizational approach to safety review teams and signal tracking for better benefit risk governance
3pm Analysis and evaluation of signals in practice
3.30pm Setting up a signal detection unit in an emerging market
4pm Afternoon Refreshments
4.30pm Inspection Preparedness
5pm Benefit risk communication strategies for key stakeholders
5.30pm Case study: Designing a pharmacovigilance and risk plan for therapeutic area specific drugs
6pm Networking Drinks Reception
Data Management Tools & Techniques
8.30am Opening Remarks from the Chair
8.45am How to achieve drug safety excellence in today’s challenging industry environment
GLOBAL SAFETY DRIVERS
9.15am USA drug safety regulatory update
• Review of the drug safety regulatory backdrop in the US and resulting impact on global operations
• FDA MeEdWatch: The FDA Safety Information and Adverse Event Reporting Program
• Investigational New Drug Safety Reporting Requirements
• Sentinel initiative
› Dr José Vega, Vice President Global Safety, Amgen USA drug safety regulatory update
9.45am PANEL DISCUSSION: Can the industry achieve global harmonisation in a local-level focussed regulatory system?
› David Balderson, Executive Director, Safety Operations, Amgen› Philip Miner, Director, Safety Alliance Management, Forest Laboratories Inc
PANEL DISCUSSION: Can the industry achieve global harmonisation in a local-level focussed regulatory system?
10.15am Speed networking followed by refreshments
BENEFIT RISK MANAGEMENT
11am The benefit risk mindset & evolving management strategies
11.30am Assessing the effectiveness of Risk Management Plans and REMS
12pm Future of Pharmacovigilance: Five Imperatives that will Drive Improved Business
12.30pm Social Media, Digitized Healthcare Data, and The Future of Drug Safety
1pm Lunch
DATA MANAGEMENT TOOLS & TECHNIQUES
2pm Determining the extent of safety data needed to satisfy regulatory and internal needs
2.30pm Safety Data Exchange Agreements for co-marketed/licensed products
3pm Application of data mining techniques to aid signal detection
3.30pm Safety data review tools and technologies
4pm Afternoon Refreshments
4.30pm Inspection Preparedness
5pm Benefit risk communication strategies for key stakeholders
5.30pm Case study: Designing a pharmacovigilance and risk plan for therapeutic area specific drugs
6pm Networking Drinks Reception
........(계속)
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