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Customer Interactions Law Policies Ethics

8/6/2014 10:00 AM - 11:00 AM


The proliferation of legal requirements (law and regulation) governing the financial relationships between medical product companies and the doctors who order their products has led to what can only be described as a tangled mess. Many device companies have had to add personnel, or employ expensive consultants in order to have a hope of complying.

Additionally, doctors offices and clinics, now abreast of the paperwork required by Medicare and the private insurers (including Stark compliance), are now beginning to work on documentation they need to be sure they can either validate or contest the reports industry makes under Sunshine.

Areas Covered in the Session:

Who is affected?

What do they have to do?

Under what circumstances (time, amount of financial interest, etc. )do they have to do it?

Are there exceptions or exclusions available?

Are there requirements for an Ethics program in-house

Industry Ethics policies-trade organization and individual company

Stark Law-physician referrals, "financial relationships"designated health services and useful exceptions

FDA and NIH.-clinical trials, Bias, Components of reg, scope, sanctions (different for each regulation-FDA has criminal-NIH only civil), exceptions

Promotion regulation-what is regulated, where, who sanctions

Sunshine: describe law, compliance issues, effect on clinical investigation, record-keeping for industry, MDs

Who Will Benefit:

Counsels for medical product companies (drug, device, biologics)

Ethics Officers

Sales and Marketing Personnel

Clinical Research Associates

Quick Contact:


USA Phone:800-447-9407

Fax: 302-288-6884

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