FDAnews Announces — Conducting Audits at Medical Conventions and Meetings: How to Train Your Staff to Spot Promotional Violations Webinar, April 24, 2014

As drug and devicemakers well know, the convention floor is a great place to get new customers and make new sales. In the time it takes to hold a staff meeting or have a business lunch, learn how to implement a four-step audit process that teaches how to audit operations before the FDA or an international regulatory body catches a misstep.

  • Share on TwitterShare on FacebookShare on Google+Share on LinkedInEmail a friendRepost This
FDAnews

FDAnews

Falls Church (PRWEB) April 14, 2014

How to Train Your Staff to Spot Promotional Violations
**FDAnews Webinar**
April 24, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/AuditsAtConventions

As drug and devicemakers 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 manufacturers 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 to bullet-proof the meeting sales force, via internal audits.

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

  •     Step 1: Determining Scope of Audit. What types of promotional activities is the company 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.

Who better to conduct this session than consultant Joseph McMillian, a veteran of 30 years in drug and device sales and marketing. 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, attendees 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 a manufacturer could be in trouble. Teach staff the right way to conduct themselves at conventions, conferences and meetings and save the company thousands, even millions of dollars in fines, penalties and settlements.

Meet the Presenter:
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.

Who Will Benefit:
This session is appropriate for both drug and device makers

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

Conference Details:
Conducting Audits at Medical Conventions and Meetings:
How to Train Your Staff to Spot Promotional Violations
**FDAnews Webinar**
April 24, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/AuditsAtConventions

Tuition:
$547 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online:     http://www.fdanews.com/AuditsAtConventions
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.