Cambridge Healthtech Institute’s Third Annual
Managing Post-Marketing Studies and Registries:
Overcoming Operational Challenges
February 4-5, 2014 | Hyatt Regency Miami | Miami, FL
Dear Colleague:
I am pleased to announce production of CHI’s 5th “Managing Post-Marketing Studies and Registries: Overcoming Operational Challenges” being held February 4-5, 2014 at the Hyatt Regency Miami in Miami, FL.
The gathering will be part of the Summit for Clinical Trials Operations Executives (SCOPE), a three-day cluster of events that attracted 600 leaders in clinical operations and research in February 2013. Please click here to see the overall program map for 2014. Topics to be discussed at the “Managing Post-Marketing Studies and Registries: Overcoming Operational Challenges” conference include:
Development of a company-wide, cross-functional, comprehensive long-term strategic business goals and objectives for post-marketing studies
Gaining buy-in from all internal stakeholders for non-interventional studies
Issues and approaches related to lack of comparison groups in observational studies
Methods and designs for various types of studies including safety vs. healthcare outcomes studies, database studies vs. data collection studies
Building an effective healthcare outcome study
Post-marketing study as a tool for safety, outcomes and comparative effectiveness research
Operational challenges: What are the unique needs for running post-commercialization studies compared to registration studies?
How to initiate an observational study
Establish strategic links to research organizations associated with key observational databases containing health information related to company’s products
Patient recruitment and retention in non-interventional observational studies
Site recruitment and retention in non-interventional observational studies
Legal and ethical issues related to observational studies and registries
Properly designing and managing patient registries to produce a wealth of valuable data in a cost-effective manner
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 click here to submit a speaking proposal for review.
Deadline for submission is June 26, 2013.
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.
For questions or suggestions about the meeting, please contact:
Marina Filshtinsky, M.D.
Conference Producer
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5496
E: mfilshtinsky@healthtech.com
For partnering and sponsorship information, please contact:
Ilana Quigley
Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457
E: iquigley@healthtech.com
For media and association partnerships, please contact:
Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456
E: rhandy@healthtech.com