Global

CompliancePanel

Knowledge, a Way Forward

2-day In-person Seminar:

Marketing Products Without Getting Hammered by FDA

Sydney, Australia

9:00 AM to 6:00 PM

October 29th & 30th, 2015

Course "Marketing Products Without Getting Hammered by FDA" has been pre-approved by RAPS as eligible for up to 12
credits towards a participant's RAC recertication upon full completion.

Seminar Pricing Includes (With Stay)

2 Days Stay
Pick-up and Drop Facility (Nearest Airport)

Break-Fast and Lunch

High Tea

Pack of 3 Webinars will be provided which

has been done in the past on similar
subject

Casper Uldriks
ex-FDA Expert and former Associate Center Director of CDRH, Olsson
Casper Uldriks through his rm "Encore Insight LLC," brings over 32 years of experience from the FDA. As an investigator,
he was responsible for countless 483s, scores of Warning Letters, injunctions, individual seizures, mass seizures and was
coined by industry as FDA's "Darth Vader." He inspected foods, drugs, methadone clinics and clinical investigators, but
specialized in the FDA's medical device program.

Overview
With this seminar you will learn how to navigate FDA's legal requirements and its interpretations for enforcement purposes.
The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys.
This becomes a new factor in trying to stay within FDA's legal corral.This conference will provide insight on how to manage
your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate
management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and
nance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA
enforcement.

Global

CompliancePanel

Knowledge, a Way Forward

Agenda:
DAY ONE

DAY TWO

FDA legal authority

FDA's statute and regulations
Drugs authority
Devices authority
Dietary supplements authority

Warning Letters: Identify, Correct and Prevent the

problem
Drugs
Medical Devices
Biologics
Food

Promotion and Advertising: scope of labeling

Denitions for "label" and "labeling
Hard copy and electronic
Testimonials
Blogs
Sales force
False and misleading information
Statutory basis (21 U.S.C. 352(a))
New use
Comparative claims
Claims for safety and effectiveness
Sales for solicitation
False and misleading information
Practice of Medicine exemption

Hypotheticals vis-a-vis Warning Letters

Motivation and marketing

Script versus message package
Target population
Aspiration/motivation
Emotional factors and signals
Group Exercise: Mock marketing plan
Corporate regulatory responsibility
FDAs false and misleading product
information
FTC s false advertising

The boundaries of commercial free speech

Constitutional protection
Caronia Case
Safe harbor
Case Study
Policy
FDA organizational responsibility
Fair and balanced disclosure of risk vs. benet
Direct to Consumer Advertising
Social Media

DOJ s government reimbursement false

claims
HHS s fraud / research grants
Government Wide Contracts (all federal

agencies)
Do's and Don'ts When Meeting With the FDA

Enforcement
FDA's options
Case examples

Why you should attend

Data Science is becoming the must-have skill in technology and business. But do you know what it is, why it is important, and how it differs
from business intelligence and big data? Do you know that there are very useful open source tools on multiple platforms that allow you to
perform data science? That you can leverage your existing Python or .NET programming skills, or use other domain specic languages
such as R? Data science is deep knowledge discovery through the interactive exploration of data. This discipline often involves using
mathematic and algorithmic techniques to solve some of the most analytically complex business problems, leveraging troves of raw
information to gure out hidden insight that lies beneath the surface. It centers on evidence-based analytical rigor and building robust
decision capabilities.

Global

CompliancePanel

Knowledge, a Way Forward

Group participations

Without Stay

With Stay

Seminar for One Delegate

Seminar for One Delegate

Price: $1,695.00

Price: $2,095.00

Register now and save(Early Bird)

$200. Price

Register now and save(Early Bird)

$200. Price

Register Now

Register Now

**Please note the registration will be closed

**Please note the registration will be closed

2 days (48 Hours) prior to the date of

2 days (48 Hours) prior to the date of

the seminar.

the seminar.

What you will get

Learning Objectives
Participation certificates

2 Attendees to get offer

10%

3 to 6 Attendees to get offer

20%

7 to 10 Attendees to get offer

25%

10+ Attendees to get offer

30%

Payment Option
Credit Card: Use the Link to make Payment by
Visa/Master/American Express card click on the
register now link

Interactive sessions with the US expert

Post event email assistance to your queries.

Check: Kindly make the check payable to

NetZealous DBA GlobalCompliancePanel and
mailed to 161 Mission Falls Lane, Suite 216,

Special price on future purchase of web

Fremont, CA 94539, USA

based trainings.
Special price on future consulting or expertise
services.
Special price on future seminars by
GlobalCompliancePanel.

PO: Please drop an email to

support@globalcompliancepanel.com or call the
our toll free +1-800-447-9407 for the invoice and
you may fax the PO to 302 288 6884

Seminar Kit includes presentation handout,

Wire Transfer: Please drop an email to

ID card, brochure, trainings catalog, notepad

support@globalcompliancepanel.com or call our

and pen.

toll free +1-800-447-9407 for the wire transfer

Networking with industry's top notch professionals

information

Contact Information: Event Coordinator

Kindly get in touch with us for any help or information.

NetZealous LLC, DBA GlobalCompliancePanel

Look forward to meeting you at the seminar

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

GlobalCompliancePanel

Toll free: +1-800-447-9407

Fax: 302 288 6884
Email: support@globalcompliancepanel.com