Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the regulators that demands, in turn, that industry be keenly aware of the legal and regulatory duties, as well as key recent trends in enforcement activities by the Federal Government. This course will explore in detail what FDA requires of drug and device firms as well as recent current hot buttons in FDA enforcement activity for the advertising arena.
What’s at stake if your advertising and promotional efforts violate the law? Colossal fines – the latest was $3 Billion; criminal liability, including even prison time; and huge disruption in operations while dealing with federal probes into illegal marketing.
Lunch 
AM-PM Tea/Coffee 
Seminar Material 
USB with seminar presentation 
Hard copy of presentation 
Attendance Certificate 
$100 Gift Cert for next seminar Key goals of the conference will include learning:
Darshan Kulkarni Principal Attorney, Kulkarni Law Firm
Dr. Kulkarni is the Principal Attorney at the Kulkarni Law Firm. As an FDA attorney and product development consultant, he focuses on strategic regulatory and pharmaceutical counseling and has extensive experience handling the needs of international pharmaceutical, biopharmaceutical, and medical device companies and their service providers.
As corporate counsel for an international pharmaceutical holding company, Dr. Kulkarni provided corporate and regulatory legal advice. He has experience in corporate quality control and regularly performs varying legal and regulatory functions, including crafting responses to FDA titled and untited letters, reviewing potential ads, and negotiating with and for advertising agencies and scientific writing agencies.
Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us at +1-646-416-9016 or email us at info@salesmist.com.
Payment:
Payment is required to confirm your registration.
Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this
conference) received at least 10 calendar days prior to the start date of the event
will receive a refund - less a $300 administration fee. No cancellations will be
accepted - nor refunds issued - within 10 calendar days before the start date of
the event.
On request by email a credit for the amount paid minus administration fees ($300) will be transferred to any future SaleMist event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations.
In the event gets cancelled, SalesMist is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and documents to carry to the seminar venue: After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.