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Register Today! 

Key Deliverables: 

  • HEAR how leading companies are defining and implementing a formal framework of corporate risk management 
  • ATTAIN strategies to place risk management more in connection with benefits 
  • EXAMINE the use of quantitative and qualitative methods to better balance benefit-risk 
  • MASTER global regulatory authorities’ evolving expectations 
  • UNDERSTAND how to improve clinical trial safety and surveillance 
  • LISTEN to practical FDAAA and REMS case studies from industry leaders 
  • LEARN how others are optimizing Electronic Health Records for pro-active pharmacovigilance 
  • DISCUSS the opportunities and challenges of linking pre-market and post-market data 
  • INTEGRATE drug safety knowledge longitudinally across a compound’s lifecycle 

Dear Colleague:

Improving products’ 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 postapproval drug safety program. The approach of this conference is not to look at safety in the silos of early-phase safety or postapproval safety but to view safety holistically, across the lifecycle, especially at the transition from approval to broader use in the marketplace.

The special, two-day executive forum entitled, Post-Approval Drug Safety Strategies will tackle many of the pressing issues that executives are facing today. Some of the topics to be covered include:

  • Defining and Implementing a Formal Framework of Corporate Risk Management
  • Strategies to Place Risk Management More in Connection with Benefits
  • Qualitative Strategies Towards Benefits Optimization, Risk Minimization and Uncertainties Management
  • Understand Global Regulatory Authorities’ Evolving Expectations
  • Fulfilling Post-Marketing Commitments and REMS Required Studies in the Current Regulatory Environment
  • Optimizing Electronic Health Records for Pro-Active Pharmacovigilance
  • Integrating Drug Safety Knowledge across a Compound’s Lifecycle and Across a Company

In addition, once again in 2010 we will be dedicating time to the informal breakout discussion groups wherein attendees and faculty will continue sharing ideas on the topics above. The BioPharma Strategy Series (BPSS) 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 8-9, 2010 in Philadelphia, PA 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

For suggestions about the meeting:
Micah Lieberman
Executive Director, Conferences
BioPharma Strategy Series
Cambridge Healthtech Institute (CHI)
T: (+1) 541.482.4709
E: mlieberman@healthtech.com

For exhibit, partnering and sponsorship: 
Joseph Vacca
Business Development Manager
BioPharma Strategy Series
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5431
E: jvacca@healthtech.com 

For marketing and media partnerships:James Prudhomme
Marketing Manager
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5486
E: jprudhomme@healthtech.com 



Mitigating Safety Risks in Early Clinical Development: 

Bridging the Gap between Preclinical and Clinical Safety to Improve Prediction 

November 8-9, 2010