Marketing Products 2015 - 2-day In-person Seminar on Marketing Products without Getting Hammered by FDA at Zurich, Switzerland

Course "Marketing Products without Getting Hammered by FDA" has been pre-approved by RAPS as eligible for up to 12credits towards a participant's RAC recertification upon full completion.
Overview:
With this seminar you will learn how to navigate FDA's established legal requirements and its interpretations of promotion and advertising practices for enforcement purposes. The FDA now applies a new perspective with the use of psychological and social media behavior to aid in its determination of what a message really conveys. This becomes a new and seemingly subjective rather than objective factor in trying to stay within FDA's legal jurisdiction. Are cognitive functions really the driving motivation for decision-making?
This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. The seminar will include an analysis of FDA Warning Letters and hypotheticals to inform your decision about what your firm should or should not do. 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 rather than argue over it in a meeting room.
Why should you attend?
If you go "off label" in your advertising and promotion, you become embroiled in FDA's advertising and promotion regulatory enforcement. For devices, the law is weak and lacks legal clarity. FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. The Center for Drug Evaluation and Research (CDER) has established an extensive and ever expanding regulatory program. For example, policing social media has become a new regulatory responsibility. For drugs, FDA's law and extensive regulations seemingly erode your legal protection for commercial free speech. Depending on your point of view, FDA's promotion and advertising requirements can help you, hurt you or knock you out of the market. In any case, you need to identify practical criteria to make marketing decisions. That begs the question of whether or not marketing managers and regulatory affairs managers will even try to agree on an issue. Do you know when you are running afoul of FDA's requirements or are you guessing
Areas Covered in the Session:
? FDA's legal authority and limitations
? FDA labeling requirements and exemptions
? FDA guidance documents, such as for social media, direct -to-consumer advertising, message formatting and providing risk/benefit information
? Motivational factors in decision making
? FDA-wide Warning Letters
? Enforcement
? Mock marketing strategy exercise
Who will benefit:
Managers for:
? Regulatory Affairs
? Quality Assurance
? Medical Director / clinical claims
? Manufacturing
? In-house sales and marketing
? Internet services and control
? Media specialists
? FDA consultants and legal counsel
? Capital investment firms
? Marketing and business development consultants
Agenda:
Day 1 Schedule:
Lecture 1:
FDA legal authority
? FDA's statute and regulations
o Drugs authority
o Devices authority
o Dietary supplements authority
Lecture 2:
Promotion and Advertising: scope of labeling
? Definitions for "label" and "labeling"
o Hard copy and electronic
o Testimonials
o Blogs
o Sales force
? False and misleading information
o Statutory basis (21 U.S.C. 352(a))
o New use
o Comparative claims
o Claims for safety and effectiveness
o Sales for solicitation
? What is "off-label"?
? Practice of Medicine exemption
Lecture 3:
The boundaries of commercial free speech
? Constitutional protection
? Caronia Case
? Safe harbor
? Case Study
Lecture 4:
Policy
? FDA organizational responsibility
? Fair and balanced disclosure of risk vs. benefit
? Direct to Consumer Advertising
? Social Media
Lecture 5:
Enforcement
? FDA's options
? Case examples
Day 2 Schedule:
Lecture 6:
Warning Letters: Identify, Correct and prevent the problem
? Drugs
? Medical Devices
? Biologics
? Food
Lecture 7:
Hypotheticals vis-a-vis Warning Letters
Lecture 8:
Motivation and marketing
? Script versus message package
? Target population
? Aspiration/motivation
? Emotional factors and signals
Lecture 9:
Group Exercise: Mock marketing plan
Lecture 10:
Corporate regulatory responsibility
? FDA - false and misleading product information
? FTC - false advertising
? DOJ - government reimbursement false claims
? HHS - fraud / research grants
? Government Wide Contracts (all federal agencies)
Lecture 11:
Do's and Don'ts When Meeting With the FDA
Speaker:
Casper Uldriks
Ex-FDA Expert and former Associate Center Director of CDRH
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. He served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements for FDA. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA's domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.
Location: Zurich, Switzerland Date: November 2nd and 3rd, 2015 Time: 9 AM to 6 PM
Venue: Hilton Zurich Airport
Address: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Zurich,Switzerland.
Price: $1,895.00 (Without Stay for One Delegate)
Price: $2,295.00 (With Stay for One Delegate)
Registration Details:
NetZealous LLC - DBA GlobalCompliancePanel
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
Phone: 1-800-447-9407
Fax: 302-288-6884
support-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
Registration Link - http://bit.ly/1FRzf98