Second Annual
Managing Post-Marketing Studies and Registries:
Overcoming Operational Challenges
February 6-7, 2013 * Hyatt Regency Miami * Miami, FL
Part of: Summit for Clinical Trials Operations Executives (SCOPE)

Dear Colleague:

We are pleased to announce production of Cambridge Healthtech Institute’s Second Annual Managing Post-Marketing Studies and Registries being held February 6-7, 2013 at the Hyatt Regency Miami in Miami, Florida.

This gathering is co-located within the Summit for Clinical Trials Operations Executives (SCOPE), a three-day cluster of events that attracted 400 leaders in clinical operations and research in February 2012. CHI’s Managing Post-Marketing Studies and Registries will be preceded by the Post-Marketing Studies as a Tool for Safety, Outcomes and Comparative Effectiveness Research; Global Site Selection, Feasibility Assessment, Operations and Site Management; Implementing and Managing Strategic Alliances; and Electronic Data in Clinical Trials conferences.  Topics to be discussed include:

• Operational challenges: What are the unique needs for running post-commercialization studies compared to registration studies?
• How to initiate an observational study
• Properly designing and managing patient registries to produce a wealth of valuable data in a cost-effective manner
• Using registries to provide payers and decision-makers with information that will validate the safety and efficacy of interventions reported in Phase III clinical trials
• Effective tools for registries and non-interventional observational studies: Leveraging IT and tools for improved data capture, tracking, reviewing and processing
• Overcoming recruitment challenges: Recruiting patients to join studies that are focused on an already approved drug
• Site selection and site management for an observational study: How to do proper site selection and management in Phase III vs. IV
• Optimizing use and management of patient-reported outcomes (PROs) in clinical research: When are they most useful and what are current limitations; what is next generation capabilities in PRO
• Utilizing patient-level feedback: Patient registries, risk management programs, post-marketing surveillance programs, non-interventional observational studies, disease management programs, and care quality improvement initiatives
• What are the most common failures made?: Learn from these mistakes
• Meeting regulatory requirements for post-authorization in various countries and regions

If you are interested in presenting, please submit a speaking proposal for review. Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators and those from academic /hospital centers. Additionally, as per CHI policy, a select number of vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.

The deadline for submission is May 25, 2012.  Click here to submit a proposal.