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OverviewWith 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 finance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion.
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GlobalCompliancePanel Knowledge, a Way Forward…
OverviewWith 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
finance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA
enforcement.
2-day In-person Seminar:
Marketing Products Without Getting Hammered by FDA
Casper Uldriks
ex-FDA Expert and former Associate Center Director of CDRH, Olsson
Casper Uldriks through his firm "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.
9:00 AM to 6:00 PM October 29th & 30th, 2015Sydney, Australia
Course " " has been pre-approved by RAPS as eligible for up to 12 Marketing Products Without Getting Hammered by FDA
credits towards a participant's RAC recertification 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
GlobalCompliancePanel Knowledge, a Way Forward…
DAY ONE
Agenda:
FDA legal authority
FDA's statute and regulations
Drugs authority
Devices authority
Dietary supplements authority
DAY TWO
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 specific 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 figure out hidden insight that lies beneath the surface. It centers on evidence-based analytical rigor and building robust
decision capabilities.
Promotion and Advertising: scope of labeling
Definitions 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
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. benefit
Direct to Consumer Advertising
Social Media
Enforcement
FDA's options
Case examples
Warning Letters: Identify, Correct and Prevent the
problem
Drugs
Medical Devices
Biologics
Food
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
FDA’s false and misleading product
information
FTC ‘s false advertising
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
GlobalCompliancePanel Knowledge, a Way Forward…
Group participations
Seminar for One Delegate
Without Stay
**Please note the registration will be closed
2 days (48 Hours) prior to the date of
the seminar.
Register Now
Kindly get in touch with us for any help or information.
Look forward to meeting you at the seminar
GlobalCompliancePanel
Learning Objectives
Participation certificates
Interactive sessions with the US expert
Post event email assistance to your queries.
Special price on future purchase of web
based trainings.
Special price on future consulting or expertise
services.
Special price on future seminars by
GlobalCompliancePanel.
Seminar Kit – includes presentation handout,
ID card, brochure, trainings catalog, notepad
and pen.
Networking with industry's top notch professionals
What you will get
Credit Card: Use the Link to make Payment by
Visa/Master/American Express card click on the
register now link
Check: Kindly make the check payable to
NetZealous DBA GlobalCompliancePanel and
mailed to 161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA
PO: Please drop an email to
[email protected] or call the
our toll free +1-800-447-9407 for the invoice and
you may fax the PO to 302 288 6884
Wire Transfer: Please drop an email to
[email protected] or call our
toll free +1-800-447-9407 for the wire transfer
information
Payment Option
2 Attendees to get offer
3 to 6 Attendees to get offer
7 to 10 Attendees to get offer
10+ Attendees to get offer
Contact Information: Event Coordinator
NetZealous LLC, DBA GlobalCompliancePanel
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
Toll free: +1-800-447-9407
Fax: 302 288 6884
Email: [email protected]
Register now and save(Early Bird)
$200. Price
10%
20%
25%
30%
With Stay
Price: $1,695.00
Seminar for One Delegate
**Please note the registration will be closed
2 days (48 Hours) prior to the date of
the seminar.
Register Now
Register now and save(Early Bird)
$200. Price
Price: $2,095.00
