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Q: Regulatory Guidelines on Pharma's Interactions with Key Opinion Leaders Globally ( No Answer,   0 Comments )
Question  
Subject: Regulatory Guidelines on Pharma's Interactions with Key Opinion Leaders Globally
Category: Health > Medicine
Asked by: skiadv-ga
List Price: $75.00
Posted: 02 May 2006 16:58 PDT
Expires: 01 Jun 2006 16:58 PDT
Question ID: 724884
I am working with brand managers in the pharmaceutical industry and
would like to understand how companies can manage their Key Opinion
Leaders* (aka Thought Leaders or Opinion Leaders) globally given that
the different countries may have different regulations and healthcare
systems.
 
Specifically, I think this issue will center around understanding the
different regulatory restrictions or guidelines pertaining to
interactions with medical or healthcare professionals within different
countries.  For example, in the US there is a PhRMA CODE on
interactions with healthcare professional and OIG Guidelines on the
subject.  However, it seems to be generally agreed that these
guidelines leave a lot of room for interpretation and are being
interpreted in different ways by different pharma companies.

The answer I seek should be in two parts:
 
1. I am looking to compare the regulatory guidelines in these general
areas/countries:
 
- United States
- Germany/UK/EU
- Mexico/Latin America
- Australia
- Japan/Asia
  
2. If possible, I would like to uncover industry issues and best
practices regarding global TL programs.

References & links to supporting documents would be appreciated.

*KOLs in this case would be doctors engaged in clinical research and
publishing in medical journals, ie leaders in their therapeutic area
who Pharma companies commonly tap for advisory boards and as speakers.
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