Upcoming medical device webinar/training

Here is the updated list of few upcoming webinar on medical device -

1. The EU Clinical Trial Directive
2. Preparing and Executing Medical Device Quality Audits: How to Meet the FDA’s Expectations
3. Gamma Sterilizer Validation: Method 1 and VDmax25 per ISO 11137
4. Risk Management - Do Not Throw Dice on Your Company!
5. Maintaining a Sustainable and Compliant Design Validation System and Using FMEA for Device Manufacturers
6. Risk and Hazard Assessment for Medical Devices - ISO 14971
7. New Medical Device Vigilance Guidelines

Source: ComplianceOnline

PhRMA Code’s revised guidelines take effect January 2009

The Pharmaceutical Research and Manufacturers of America (PhRMA) released updates to its voluntary Code on Interactions with Healthcare Professionals on July 10. The new guidelines take effect January 2009.

In addition to prohibiting small gifts and reminder items, the revised Code:Prohibits company sales representatives from providing restaurant meals to healthcare professionals, but allows them to provide occasional meals in healthcare professionals’ offices in conjunction with informational presentations

1. Prohibits company sales representatives from providing restaurant meals to healthcare professionals, but allows them to provide occasional meals in healthcare professionals’ offices in conjunction with informational presentations

2. Includes new provisions requiring companies to ensure their representatives are sufficiently trained about applicable laws, regulations, and industry codes of practice.

3. Provides that each company will state its intentions to abide by the Code and that company CEOs and compliance officers will certify each year that they have processes in place to comply

4. Includes more detailed standards regarding the independence of continuing medical education

5. Provides additional guidance for speaking and consulting arrangements with healthcare professionals

Challenges

1. Tracking aggregate spending is one of the biggest challenges for pharmaceutical companies

2. Some companies do not have a system that will accurately record aggregate spending across the organization.

3. Training employees is another. It’s going to be a challenge getting everyone on the same page.

Benefits

1. The new guidelines could help the industry regain public trust after “just getting shelled” and constantly being accused of wrongdoing. In addition, some

2. Companies will be relieved they can reduce their spending on traditional marketing activities.