Tutorial name:Medical Communications: Compliance in 2013
Day & Time:March 18, 1:30PM - 5:00PM
Room Number:Deer Room
Instructor(s):Monica A. Kwarcinski, PharmD
Executive Director, Medical Services
Purdue Pharma LP, United States
Mark Alan DeWyngaert, PhD,MBA,MS
Managing Director
Huron Life Sciences, United States
Joyce Martin, PharmD
Director, US Medical Affairs
Genentech, A Member of the Roche Group, United States
Description:Pharmaceutical industry compliance obligations have increased dramatically over the last several years. In light of this, it is critical that Medical Communication departments have policies and procedures that address such things as medical inquiry and response documentation, staff training, and monitoring / audit programs. Whether you have been in Medical Communications for a few months or a few decades this tutorial will provide an overview of what policies, procedures and programs Medical Communications departments should consider implementing to help ensure compliance and mitigate risk. This will be an interactive tutorial with opportunity for discussion and questions from the audience.
| Tutorial 2: Medical Communications: Compliance i | ACPE
IACET
RN
| 3.25
3.25
3.25
| 0.325
0.300
0.000
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Learning Objective(s):At the conclusion of this tutorial, participants should be able to:
- Discuss compliance hot topics in Medical Communications such as medical inquiry documentation, response development and documentation, staff training, and sales force facilitated inquiries
- Describe compliance aspects of recently surveyed medical communications practices
- List the factors to consider when developing, implementing, and maintaining QA, compliance, and training programs
- Discuss the policies and procedures the Office of Inspector General (OIG ) is requiring Medical Communications departments to have in place based on recent Corporate Integrity Agreements (CIA)
- Recognize how to mitigate risk in Medical Communications