Customer Interactions: Law, Policies, Ethics
August 6, 2014 - Fremont CA USGlobalCompliancePanel
globalcompliancepanel@gmail.com
Phone:8004479407
Fax:302 288 6884
Overview: 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