Pharmaguy interviews Preeti Pinto, a regulatory consultant and former Executive Director & Head of Promotional Regulatory Affairs at AstraZeneca (see Bio), who talks about how regulatory-savvy pharma marketers are in a better position to challenge their regulatory colleagues when they say "No." Pinto's comments were made in context of the Advertising and Promotions Course she will offer as a part of the Temple University School of Pharmacy's Quality Assurance/Regulatory Affairs Graduate Program.
Aired LIVE on: Friday, August 8, 2014
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The Advertising and Promotions Course is offered as a part of the Temple University School of Pharmacy's Quality Assurance/Regulatory Affairs Graduate Program. In addition to regulations, it teaches critical thinking and leadership skills. While the course provides 3 graduate credits, the course can also be taken by those who are not enrolled in the degree program.
This course delves into the regulatory intricacies of Rx Drugs advertising and promotions for the pharmaceutical and related industries, including OTCs and biologics. What regulatory requirements distinguish product claim ads, reminder ads, and help-seeking ads? What restrictions govern how graphics are used in a drug claim ad? When and how do risks need to be stated in advertising? What constitutes false and misleading advertising and what are the penalties for doing so? How do regulations apply to social media? Comparisons will also be made to restricted medical devices and food products.
A case scenario approach will be used where possible, giving students hands-on experience with critiquing advertising and promotional materials to assure that they are regulatory compliant.
The course meets on Tuesdays and Thursdays from 6-9:30 PM from September 11th through October 14th at the Fort Washington, PA campus. The tuition for the entire course is $3,003 per course for a PA resident, $3,801 per course for a non-PA resident.
Questions/Topics of Discussion
- As a marketer, what will I learn from this course?
- Is the learning just theoretical, or will the classes include hands-on learning, where students work collaboratively to solve problems?
- Are there any career opportunities available for someone who takes this course?
- What kind of background would I need to take this course?
- Does Temple offer other related courses?
Preeti Pinto is currently Principal at Preeti Pinto Consulting, LLC. She is a regulatory and compliance expert with over 20 years experience in the pharmaceutical and healthcare industries, with a strong working relationship with the FDA. Her experience extends to both drug development and marketing of Rx products. After many years in senior corporate roles, she is now an independent consultant and advises businesses in overcoming both the organizational and regulatory challenges in ensuring compliance with marketing regulations.
Preeti's achievements include establishing the first field-based Promotional Regulatory Affairs (PRA) department and Medical Education office at AstraZeneca, where she was the Executive Director and head of PRA from 1999 to 2010. Preeti also led the social media team at AstraZeneca to respond to FDA's Call for Comments regarding regulatory guidance on social media.
As a speaker and panelist for several Healthcare Businesswomen's Association programs, Preeti has shared her experiences with her colleagues. She has been inspirational to other women on how to excel professionally while maintaining a work-life balance. Along with her husband, Preeti raised two children while working full-time.