BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T234940Z UID:7568f3e6-a33c-4df7-b1d1-af75cb556cf1 DTSTART:20210301T083000 DTEND:20210302T083000 CLASS:PRIVATE DESCRIPTION:
Attendees will have th e opportunity to consult with the instructor during breaks and after hours on specific issues relative to seminar content and for two days we will r eview and discuss the most recent enforcement trends and common red-flags and triggers. The seminar will provide attendees with a better understandi ng of responsibilities and gain a greater knowledge of the issues faced wh ich can affect common marketing and promotional activities on behalf of th eir companies. Participants will have an excellent understanding of the la ws and policies and certainly FDA expectations affecting advertising\, mar keting and promotion\, and the manner of their application in real practic e. You will be better able to develop marketing and advertising programs a nd avoid issues which regulatory agencies\, like FDA\, continually review and certainly by establishing proactive strategies to mitigate compliance exposure. Attendees are encouraged to bring &ldquo\;real-life&rdquo\; exam ples to the seminar for interactive group discussion and benchmarking and address compliance solutions that work
\n\n \;
\n\n&bull\; Gain a better und
erstanding of how the regulatory and legal environment has evolved and aff
ects the marketing and promotion of pharmaceuticals and medical devices
\n&bull\; Receive practical\, day-to-day guidance based from the latest
FDA enforcement actions\, and the changes taking place and being contempl
ated
\n&bull\; Get a first-hand update on the status of social media
guidance documents
\n&bull\; Identify the trends reflected in the lat
est enforcement actions and policies issued by the FDA
\n&bull\; Disc
uss the policies and actions being taken by OIG and DOJ under the False Cl
aims Act and other Acts
\n&bull\; Summarize regulations\, enforcement
actions\, guidelines and trends affecting the advertising and promotion o
f medical devices and drugs
\n&bull\; Identify key regulatory issues
surrounding complex and rapidly shifting hot topics in advertising and pro
motion
\n&bull\; Conduct risk assessments for products and promotiona
l strategies
\n&bull\; Reviews of business plans to identify potentia
l misbranding issues
\n&bull\; Evaluate substantiation for promotiona
l claims and potential clinical studies
\n&bull\; Integrating FDA com
pliance elements into Healthcare Compliance or Corporate Compliance progra
ms
\n&bull\; Support the regulatory oversight for all advertising and
promotional materials
\n&bull\; Assure that advertising and promotio
nal materials meet applicable regulatory requirements
\n&bull\; Suppo
rt regulatory submissions to the FDA&rsquo\;s Division of Drug Marketing A
dvertising and Communications (DDMAC)
\n&bull\; Development and imple
mentation of training sessions and materials specific to regulatory compli
ance of advertising and promotional materials
\n&bull\; Support the e
valuation of data to support marketing claims
\n&bull\; The basics of
FDA law and regulations governing advertising and promotion\, as well as
affiliated agencies such as the FTC\, which shares jurisdiction with FDA o
n certain regulated products (e.g.\, OTC drugs).
\n&bull\; The distin
ctions between labels\, labeling and advertising and how that impacts FDA&
#39\;s powers and how to properly position Direct-to-Consumer (DTC) promot
ions
\n&bull\; The Dos and Don'\;ts of promoting products on the i
nternet\, including social media sites and recent concerns
\n&bull\;
Issues with off-label promotion\, including criminal and civil actions tha
t have led to multi-billion dollar settlements by regulated drug companies
\n&bull\; When disseminating medical educational materials crosses t
he line into improper promotion
\n&bull\; Key considerations on how t
o implement appropriate procedures and controls in your company to minimiz
e the potential for regulatory action by the FDA or the FTC relative to pr
omotion and advertising.
\n&bull\; Recognizing when inspectional find
ings or events indicate potential regulatory actions
\n&bull\; Semina
r attendees are encouraged to bring examples of their work from the functi
onal area on the various topics as applicable for group discussion as appl
icable
\n&bull\; Review and discuss pain points\, challenges and solu
tions
\n&bull\; Identify and discuss the latest FDA and industry tren
ds with statistics and data regarding enforcement and inspection data
 \;
\n\nThis seminar will provide an overview and in-depth snapshot of the key
principles and requirements for advertising and promotion expectations an
d ensuring compliance success. This seminar will assist personnel who have
varying levels of experience in drug and device advertising\, marketing a
nd promotion. It is intended for those involved with Regulatory Affairs\,
Marketing and promotional legal issues\, Marketing\, sales and support fun
ctions but could benefit other personnel. Employees who will benefit inclu
de all levels of management and departmental representatives from key func
tional areas and those who desire a better understanding or a "\;refre
sh"\; overview of the advertising and promotional requirements for dru
gs and medical devices\, including:
\n
\n&bull\; Management resp
onsible for regulatory and GMP/GLP/GCP compliance and seeking a better und
erstanding of FDA\, advertising and promotional requirements\, regulatory
actions and how they can improve their own firm'\;s operations and moni
toring of their state of compliance and meeting requirements
\n&bull\
; Individuals who come in contact with regulatory inspectors
\n&bull\
; Auditors
\n&bull\; Compliance/Regulatory affairs professionals
\n&bull\; QA/QC professionals
\n&bull\; Senior management executives
\n&bull\; Manufacturing managers\, supervisors &\; personnel
\n&bull\; Project Managers
\n&bull\; Regulatory Affairs Management\n&bull\; Regulatory Affairs Specialist
\n&bull\; Compliance Offi
cer
\n&bull\; Compliance Specialist
\n&bull\; Clinical Affairs\n&bull\; Quality Assurance Management
\n&bull\; Marketing &\;
Sales
\n&bull\; Distributors/Authorized Representatives
\n&bull
\; Legal Counsel
\n&bull\; Consultants
\n&bull\; Marketing Commu
nications
\n&bull\; Medical Information and Affairs