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AUDIOCONFERENCE ON TAPE OR CD

Sponsored by MSL Compliance Training Workshops

presented on JANUARY 16, 2007

Featuring a behind-the-scenes case study about one company’s new speaker program policy—how they built it and how they plan to monitor the field for adherence!

Situation: Dr. James has  another speaking engagement at your dinner program next month in Chicago. How can you be sure he follows your new policy so we avoid another Dr. Gleason situation? Should we adjust our policy, training or monitoring?

Speaking engagements are valuable tools to help educate providers and KOLs about your product …but as we've seen with the indictment of Dr. Gleason, the prosecutorial and federal spotlight has turned to speaker programs. As former OIG chief Dara Corrigan told us last April, a mistake in speaker compensation or field-level activities could open your compliance program to a broader investigation. That’s the intent.

Solution: Listen to Jane Wright-Mitchell, PharmD, JD, and Daniel Kracov to hear:

• A case study on how a company has successfully built a new speaker program policy
• How legal and compliance can work internally with commercial /marketing for compliance with speaker program policies
• How to handle difficult situations involving compensation, FMV, and day-to-day speaker program issues

AGENDA

I. Case study - Actelion Pharmaceuticals
A. Policy development
i. What were the sticking points?
ii. Who was involved in the process?
iii. How we achieved internal buy-in?

B. Policy details
i. What are our objectives?
ii. What sources did we use to build policy?
iii. Language from the policy—what we are asking of the field force?

C. Training
i. How we trained the field force?

D. Monitoring to assure speaker adherence
i. How we’ll monitor the speakers for compliance?
ii. The 3rd party approach
iii. Initial results since roll out (December 2006)

II. Benchmarking the issue
A. How to apply recent enforcement actions involving speaker programs to our own monitoring

III. Situations/gray areas that are problematic and how to deal with them
Each situation will include an example from the field, the legal considerations, and possible solutions

A. Addressing challenges with compensation
B. How many speakers is too many?
C. How do we make sure our training for speakers is compliant?
D. Slide set usage by speakers
E. Material preparation
F. When should slide sets go to DDMAC for promo review? And why?
G. Appropriate speaker selection
H. How to talk about risk with speakers
I. What do you do if your speaker talks off label and you find out?
J. What can your doc say about studies, for unapproved drugs/indications?

Q&A

MEET OUR SPEAKERS

Jane Wright-Mitchell, PharmD, JD, is the Director of Legal Affairs for Actelion Pharmaceuticals US, Inc.  Her practice focuses on the areas of regulatory compliance, corporate, healthcare and litigation, as well as all aspects of intellectual property law including patent, trademark, copyright and anti-competition law.  In this role, Ms. Wright-Mitchell is responsible for regulatory compliance oversight, development and implementation of compliance training, grant review processing, and communications with the various federal and state agencies.

Daniel Kracov co-heads the Pharmaceutical and Medical Device Practice at Arnold & Porter. He assists clients in negotiating the requirements relating to the development, approval and marketing of drugs, biologics and medical devices. Mr. Kracov assists clients in negotiating the legal requirements relating to the development, approval and marketing of, and payment for, FDA-regulated products.

WHO SHOULD LISTEN?

Pharmaceutical manufacturers in these divisions and focus areas:

• Compliance
• Legal
• Marketing
• Speaker program directors
• Medical Affairs/MSL Directors
• Product Teams

Purchase a tape or CD of the program and listen when you can. It's a perfect training tool for new staff or as a refresher for veteran staff.

PROGRAM MATERIALS

Program materials will be provided with PDF links.

• Audioconferences

• Other Life Sciences Products