Post-Approval Drug Safety Strategies - Dear Colleague

Dear Colleague:

I am pleased to announce the production of the Pharmaceutical Strategy Series' Third annual executive forum "Post-Approval Drug Safety Strategies: Best Practices to Assess and Mitigate Risks throughout the Product's Life Cycle" being held November 12-14, 2008 at The Ritz-Carlton, Pentagon City in Arlington, VA.

Improving products' effective clinical safety will increase the industry's fundamental value proposition to patients, healthcare providers, payors and regulators. The program will focus on pharmacovigilance program implementation and specific strategies and approaches to creating true value from a peri- and post-approval drug safety program. Drug safety programs and monitoring and the approach of this conference are not to look at safety in the silos of early-phase safety or post-approval safety but to view safety holistically, across the lifecycle, especially at the transition from approval to broader use in the marketplace.

The special, three-day executive forum entitled "Post-Approval Drug Safety Strategies: Best Practices to Assess and Mitigate Risks throughout the Product's Life Cycle" will tackle many of the pressing issues that executives are facing today.

Topics Include:

Implementing programs that increase the probability of timely approval and mitigate safety risks
Aligning resources to design and execute a proactive risk management plan
Integrating drug safety knowledge longitudinally across a compound's lifecycle
Optimizing the allocation of an organization's drug safety assessment resources
Understanding regulatory authorities' evolving drug safety risk management expectations
Utilizing quantitative approaches for surveillance and signal detection in pharmacovigilance
Driving your business for the best benefit-risk ratio
Active surveillance and the Sentinel System
Effectively working with Data and Safety Monitoring Boards (DSMBs) to ensure patient safety and study integrity
Opening Workshop: Developing and Implementing a Risk Management Plan

The Pharmaceutical Strategy Series' ( PSS ) mission is to assist in improving the overall health of the pharmaceutical industry by producing high-level meetings that bring together R&D leaders to discuss and debate potential solutions to overcoming the most pressing challenges facing their organizations. I hope you can join us on November 12-14, 2008 in Arlington, VA to discuss and debate this emerging drug safety paradigm and how innovative drug safety risk assessment, management and mitigation hold the promise of creating considerable value for the industry.

Very sincerely,

Micah's Signature

Micah Lieberman





Conference Menu Overview Dear Colleague Day 1 Day 2 Day 3 Register PDF Download Hotel & Travel Sponsor Contact Corporate Sponsors Corporate Support Sponsor Media Partners:	Post-Approval Drug Safety Strategies - Dear Colleague Dear Colleague: I am pleased to announce the production of the Pharmaceutical Strategy Series' Third annual executive forum "Post-Approval Drug Safety Strategies: Best Practices to Assess and Mitigate Risks throughout the Product's Life Cycle" being held November 12-14, 2008 at The Ritz-Carlton, Pentagon City in Arlington, VA. Improving products' effective clinical safety will increase the industry's fundamental value proposition to patients, healthcare providers, payors and regulators. The program will focus on pharmacovigilance program implementation and specific strategies and approaches to creating true value from a peri- and post-approval drug safety program. Drug safety programs and monitoring and the approach of this conference are not to look at safety in the silos of early-phase safety or post-approval safety but to view safety holistically, across the lifecycle, especially at the transition from approval to broader use in the marketplace. The special, three-day executive forum entitled "Post-Approval Drug Safety Strategies: Best Practices to Assess and Mitigate Risks throughout the Product's Life Cycle" will tackle many of the pressing issues that executives are facing today. Topics Include: Implementing programs that increase the probability of timely approval and mitigate safety risks Aligning resources to design and execute a proactive risk management plan Integrating drug safety knowledge longitudinally across a compound's lifecycle Optimizing the allocation of an organization's drug safety assessment resources Understanding regulatory authorities' evolving drug safety risk management expectations Utilizing quantitative approaches for surveillance and signal detection in pharmacovigilance Driving your business for the best benefit-risk ratio Active surveillance and the Sentinel System Effectively working with Data and Safety Monitoring Boards (DSMBs) to ensure patient safety and study integrity Opening Workshop: Developing and Implementing a Risk Management Plan The Pharmaceutical Strategy Series' ( PSS ) mission is to assist in improving the overall health of the pharmaceutical industry by producing high-level meetings that bring together R&D leaders to discuss and debate potential solutions to overcoming the most pressing challenges facing their organizations. I hope you can join us on November 12-14, 2008 in Arlington, VA to discuss and debate this emerging drug safety paradigm and how innovative drug safety risk assessment, management and mitigation hold the promise of creating considerable value for the industry. Very sincerely, Micah Lieberman	Choose your language: Market Research Insight Pharma Reports
Global Information, Inc. - International Marketing Partner of Cambridge Healthtech Institute.

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