Conducting Audits at Medical Conventions and Meetings

Conducting Audits at Medical Conventions and Meetings - Webinar CD/Transcript

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Conducting Audits at Medical Conventions and Meetings: How to Train Your Staff to Spot Promotional Violations

As drug and device makers well know, the convention floor is a great place to get new customers and make new sales.

It’s also a great place to get into hot water — with the FDA, the EU and who knows who else. Here are just a few laws and regulations you risk violating:

  • US: 21 CFR 202.1, FDAMA Section 401, Sunshine Act
  • EU: 1992 Advertising Directive (and derivative laws in 27 member countries)
  • Laws of countries in which meetings are held
  • Laws of participating physicians’ home countries
  • Industry ethical standards: AMA, PhRMA, IFPMA and Swiss Codex, to name just a few.

In other words, conferences can be minefields for the unwary. “Excessive” hospitality is one good way to get in trouble. Improper use of journal reprint materials is another. Beware of nondisclosure of payments or benefits too. And verbal communications that constitute off-label promotion may be riskiest of all. Since 2001, off-label promotion violations have generated $24.63 billion in fines against drug and device makers.

It’s time you bullet-proofed your meeting sales force, via internal audits. It’s a process you can learn in just 90 minutes.

In the time it takes to hold a staff meeting or have a business lunch, you’ll learn how to implement a four-step audit process that teaches you how to audit your own operations before the FDA or an international regulatory body catches them in the wrong:

  • Step 1: Determining Scope of Audit. What types of promotional activities are you hosting? Who is being invited?
  • Step 2: Determining Standards that Apply to the Event. Local marketing regulations, industry association codes, company policies based on the host country, and more.
  • Step 3: Applying the Standards. Each auditor must understand and be able to observe on-site activity and compare it to the standards.
  • Step 4: Unobtrusively Conducting On-Site Audits. A good auditor will observe without disrupting convention activities, but immediately bring serious issues to on-site management immediately and conduct appropriate follow-up.

Consultant, Joseph McMillian, a veteran of 30 years in drug and device sales and marketing conducts this session. Since 1989, he has been heavily involved in international auditing of adverse event reporting, labeling, advertising and promotion, and privacy.

During this fast-paced webinar CD and transcript, listeners will discover:

  • Why audits are necessary
  • How a fresh set of eyes cuts risks, negative publicity and embarrassment
  • Prepping booth staff for communications with attendees
  • Three things an audit is NOT
  • Helping auditors focus on applicable standards and avoid personal opinions
  • What constitutes a significant violation that on-site management must be notified of immediately
  • And much more!

One loose lip, one carelessly written handout, one cocktail too many and you could be in trouble, deep. Teach staff the right way to conduct themselves at conventions, conferences and meetings … and save your company thousands, even millions of dollars in fines, penalties and settlements. Order your set today.

This session is appropriate for both drug and device makers. Consider signing up if you are a:

  • Sales/marketing executive
  • Compliance professional
  • In-house auditor
  • Regulatory Affairs/Compliance
  • Counsel (in-house or retained)
  • CEOs
  • CFOs

Joseph McMillian, President, Heartland Consulting, spent 9 years with American Hospital Supply and 21 years with Aventis Pharma in sales, sales management, professional education, scientific communications and regulatory compliance. Since 1989, he has been involved in international auditing of adverse event reporting, labeling, advertising and promotion, and privacy. In 2000, he joined Wyeth Pharmaceuticals as Assistant Vice President for Global Business Compliance, developing a labeling, advertising/promotion, pharmacovigilance and privacy compliance auditing function. Mr. McMillian and his colleagues have conducted thousands of audits worldwide.