April Event: Advertising and Promotion - A General Overview


Monthly Program:

Wednesday, April 25th 2018

Advertising and Promotion - A General Overview


Program Speaker:

Micheline Awad, MBA

Directory Regulatory Affairs, Advertising and Promotion

Neurocrine Biosciences, Inc.

San Diego, CA

Event Agenda: Date:

Wednesday, April 25th, 2018

Time: 5:15 – 6:00 PM Registration & Snacks

6:00 – 6:05 PM Welcome and Announcements

6:05 – 7:05 PM Program Presentation

7:05 – 7:30 PM Q & A


BD (former CareFusion)

3770 Torrey View Court

San Diego, CA 92130

View Map Program Topic:

The professional field of regulatory advertising and promotion has become increasingly essential to pharmaceutical companies. To ensure compliance with this progressive and continually changing field, a regulatory advertising and promotion professional must have a comprehensive understanding of laws and regulations governing prescription drug promotion.

Program Summary:

This interactive session will provide you with an introduction to Advertising and Promotion, background on FDA’s role and enforcement action, insights on Promotional Review Committee (PRC) best practices to create an efficient and high-functioning team, as well as launch preparation strategies including tips on overcoming challenges, managing launch teams, and developing senior management support for a successful product launch.

At the end of this program, attendees will:

  • Learn about relevant Advertising and Promotion regulations and guidances

  • Identify trends reflected in the latest enforcement actions and guidances issued by the FDA

  • Recognize current industry Promotional Review Committee (PRC) best practices and challenges facing the review committee

  • Leverage approaches to enhance efficiency in PRC and focus on roles and responsibilities

  • Understand challenges resulting from today's regulatory and technology environment

  • Provide brief overview and helpful tips for launch strategies including cross-functional team collaboration and senior management support

Speaker Biography:

Micheline Awad leads the Neurocrine Biosciences Promotional Review Committee (PRC) as well as represents Regulatory on the Medical Review Committee (MRC). She has over 16 years of Biotechnology/Pharmaceutical industry experience including 3 years in Regulatory Affairs (RA) and 10 years in RA - Advertising & Promotion. She has been at Neurocrine Biosciences for 1.5 years. Micheline’s Regulatory experience includes Biologic, Drug, and Device, and multiple product/indication launches. She received her M.B.A. from University of Southern California with a focus on Strategy and Marketing, and her B.S. in Biology specializing Biotechnology from George Mason University.

Please make your reservation early. The online registration due date is Monday, 23 April 2018. Credit Cards are accepted online only. Cash and Check are accepted at the door.

Online Pre-registration (through Monday April 23rd, 2018): $15 SDRAN Member, $25 Non-Member

Onsite Registration: $25 SDRAN Member, $35 Non-Member

For Questions Email: programs@sdran.org


From the North 5:

I-5 South toward San Diego

Exit toward Carmel Mountain Rd

Left onto Carmel Mountain Rd

Left onto Torrey View Court

Facility is on the right

From the South 5:

I-5 North toward Del Mar

Merge onto I-5 local Bypass

Take Carmel Mountain Rd exit (32)

Turn right onto Carmel Mountain Rd

Turn left onto Torrey View Court

Facility is on the right