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DEVICE CONGRESS - AT-A-GLANCE

MARCH 28, 2007
PRECONFERENCE SESSIONS
8:30 am - 11:45 am
PRECON I
Implementing International Codes of Conduct
PRECON II
Understanding Private Payers and Maximizing Private Payer Reimbursement Strategies
PRECON III
After the Inspection: Managing FDA Enforcement Actions
GENERAL SESSION
1:00 pm - 5:30 pm
1:00 pm Welcome John Bentivoglio, Esq. and Nancy Singer, Esq.
1:10 pm What We Know and What We Came to Learn Arthur Miller, Esq.
1:35 pm Advocating for Reasonable Regulation Stephen Ubl, AdvaMed
2:15 pm CDRH's Regulatory Agenda for 2007 - 2008 Tim Ulatowski, CDRH
3:15 pm International Harmonization: Reality or Fantasy Larry Kessler, ScD, CDRH and Michael Gropp, Medtronic, Inc.
4:10 pm CMS Priorities for 2007 - 2008: What Device Innovators Should Know about Medicare Reimbursement Carol Kelly, CMS
4:50 pm Fraud and Abuse: Lessons Learned from Government Prosecutions Michael Loucks, US Attorney's Office
5:30 pm Adjournment
5:45 pm Reception - Harvard Faculty Club
7:00 pm PricewaterhouseCoopers Banquet

MARCH 29, 2007
MORNING TRACKS
8:30 am - 12:00 pm

QUALITY TRACK REIMBURSEMENT TRACK FRAUD AND ABUSE TRACK INTERNATIONAL TRACK
8:30 am Welcome Welcome Welcome Welcome
8:40 am Using Management Controls to Translate Policies and Principles into Practice The Alphabet Soup of Clinical Quality Standards: What's Important? What Isn't Results from the PWC, King & Spalding and Compliance-Alliance Survey Current Regulatory Challenges in Asia
9:20 am Implementing Effective Supplier Management Programs Quality, Performance Measures and practice Guidelines: What Technology Manufacturers Should Know The OIG - Getting Companies to Comply with the Law Regulatory Initiatives in Europe
10:30 am Creating an Effective Internal Audit Program A Dash of FDA, a Pinch of CMS and What Do You Get? AdvaMed's Efforts to Promote Regulatory Compliance Opportunities in South America
11:10 am Building a Cradle-to-Grave Approach with Your Design Documentation and Data Making the Case for the Value of Your Device with Practice-Based Evidence What Healthcare Providers Are Doing to Promote Regulatory Compliance Doing Business in Ireland
11:35 am

What GPO's Are Doing to Promote Regulatory Compliance
AFTERNOON TRACKS
1:30 pm - 6:00 pm

QUALITY TRACK REIMBURSEMENT TRACK FAIR MARKET VALUE (FMV) AND PROMOTION
1:30 pm Welcome Welcome Welcome
1:40 pm Assessing Complaints and Service Reports How to Convince the Medical Director Your Product Is Special Fair Market Value (FMV) Assessments for Health Care Professionals
2:20 pm Implementing an Effective CAPA System Coding Trends: How to Get Your Device Through the Coding Maze

3:30 pm Setting Up a Defensible System to Make Reports of Removals and Corrections Countering the Cuts - Acute Care: Managing Hospital and ASC Payment Policy for Your Products The Regulatory Authority for Off-Label Promotion and Recent Enforcement Actions
3:55 pm
Countering the Cuts - Acute Care: Managing Payment Policy and Your Post Acute Care Products Across Systems and Through Competitive Bidding Action Items: Monitoring Off-Label Promotion Do's and Don'ts
4:10 pm Lessons Learned in Integrating Risk management and Process Validation
Action Items: Monitoring Off-Label Promotion Do's and Don'ts
4:35 pm
Coping with Reimbursement Rules and Challenges: Survey Results on How Device Companies Deploy Their Resources

4:50 pm Putting Together a Global Regulatory/Quality System


5:15 pm
Developing a Strategic Reimbursement Plan

5:30 pm Adjournment Adjournment Adjournment Adjournment

MARCH 30, 2007
GENERAL SESSION
8:30 am - 11:30 am
8:30 pm Lessons Learned from the Mistakes of Others Susan Alpert, PhD, MD, Medtronic, Inc.
John Bentivoglio, Esq. King and Spalding
Martin Browning, EduQuest
Bob Klepinski, Esq. Fredrickson & Byron
Robert O'Holla, Johnson & Johnson
Randel Richner, Neocure
Jim Sheehan, Esq. U.S. Attorney's Office
Nancy Singer, Esq. Compliance-Alliance
John Taylor III, Abbott Laboratories
11:30 am What We Learned and What Information Will We Be Able to Put to Use Arthur Miller, Esq.
12:00 pm Adjournment





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