Domestically pharma and device companies are in the heart of their efforts to meet the March 2014 reporting date mandated by the Physician Payments Sunshine Act. The Summit offers the following sessions focused on crucial short-term issues related to sunshine reporting and compliance and the challenges that are likely to arise thereafter:
- March 31st Filing Deadline: The Top Six Steps to Prepare
- Assumptions and Completing Context Boxes: To Do or Not to Do; That is the Question
- Managing the Dispute Resolution Process
- Coordination of Compliance among Multiple Affiliates
- Transaction Reviews for Non-CIA Organizations
- Protecting Reputation and Relationships with Physicians and Teaching Hospitals
- Disclosure Fair Market Value Determinations
- Interaction and Coordination between State and Federal Reporting Requirements
- Anticipated State and Federal Enforcement Initiatives
- Will Sunshine Data help Whistle Blowers and Qui Tam Attorneys?
Concurrently, national regulatory regimes and voluntary code guidelines regulating the disclosure of HCP spend are rapidly proliferating across the globe. National initiatives exist or are being rolled out in France, Portugal, Denmark, Estonia, Hungary, Russia, Slovakia, Spain and Ukraine. Voluntary codes are in place in the Czech Republic, Germany, Greece, Italy, the Netherlands, Spain, Turkey and UK (ABPI). On June 24, 2013, the European Federation of Pharmaceutical Industries and Associations ("EFPIA") adopted a new code, "EFPIA Code on Disclosure of Transfers of Value From Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations" which requires pharmaceutical companies to publicly disclose, in 2016, their 2015 financial relations with healthcare organizations and healthcare professionals. In Asia Pacific, Australia (Medicines Australia) and Japan (Japan Pharmaceutical Manufacturers Association ("JPMA") guidelines on Transparency on Corporate Activities with Medical Institutions and Healthcare Professionals" ("JPMA Guidelines") are examples of the trend towards transparency. These developments will be covered in detail.
The Summit will also provide a comprehensive update of the rapidly evolving transparency requirements now taking shape across the globe and offer timely advice on creating a global aggregate spend and disclosure program. In-house experts will share their experience on a wide array of emerging best practices ranging from project management to building scalability and sustainability. Panels of in-house and outside experts will weigh in on key topics.
WHO SHOULD ATTEND
- Aggregate Spend Reporting
- State Reporting
- Regulatory Affairs
- Business Analytics
- Commercial Operations
- Clinical Operations
- Medical Affairs
- Corporate Communications
- Ethics and Compliance
ABOUT THE PHARMACEUTICAL COMPLIANCE FORUM (PCF)
The Pharmaceutical Compliance Forum (PCF) is a coalition of senior compliance professionals and legal counsel from more than 50 of the largest research based pharmaceutical manufacturers. The PCF was founded in early-1999 by compliance professionals from the pharmaceutical industry to promote effective corporate compliance programs. The members meet twice a year, for two days, focusing on open and informal sharing of compliance information, best practices, and current developments in the field. PCF also sponsors a three-day compliance congress each Fall. For membership information, contact Kelly Freeman via email at firstname.lastname@example.org. Please visit their website at www.PharmaComplianceForum.org.