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6th Promotional Review Committee Compliance & Best Practices - Midwest -

6th Promotional Review Committee Compliance & Best Practices - Midwest
May 15–17, 2019
Chicago, IL

The ONLY industry event devoted specifically to uniting cross-team expertise, maximizing quality oversight during review, and improving regulatory compliance in all multimedia promotional messaging

Agenda – 6th Promotional Review Committee Compliance & Best Practices - Midwest



Workshop Day

 WEDNESDAY, MAY 15, 2019 // WORKSHOP DAY

8:30AM – 9:00AM

Registration


9:00AM – 12:00PM

MORNING WORKSHOP: Learn OPDP Expectations During a Sample Regulatory Review Scenario


Nneka Onwudiwe, Senior Scientific Reviewer, OPDP, FDA
Keren Tenenbaum, Assistant General Counsel, PFIZER
Cristina Masseria, Methods and Capabilities Lead, PFIZER
Renee Ambrosio, Director, Advertising and Promotion, Regulatory Affairs, MERCK

12:00PM – 12:00PM

MORNING WORKSHOP CONCLUDES


1:30PM – 2:00PM

Registration


2:00PM – 5:00PM

AFTERNOON WORKSHOP: Create Tools and Training to Efficiently Forecast, Manage, and Allocate Volume


Heather Goldstein, Marketing Services Effectiveness Manager, TAKEDA
Anghela Gonzalez, PRO Associate Manager, GENENTECH


Main Conference DAY ONE

 THURSDAY, MAY 16, 2019 // Main Conference DAY ONE

 NEW REGULATIONS, NEW INDICATIONS, NEW MEDIA

9:00AM – 9:45AM

Navigate the Intersection of Medical and Regulatory in Product Education


Ilze Antons, Senior Director, Regulatory Affairs, LUNDBECK

9:45AM – 10:30AM

Keep Your Social Media Approaches Diverse and Flexible


Sandra Vladisavljevich, Senior Director, Regulatory Advertising and Promotion, TAKEDA

10:30AM – 11:00AM

Networking Break


11:00AM – 11:45AM

PANEL: Develop QC Processes for Promotional Review


Moderator:
Rebecca Burnett, Executive Director, Head of Strategic Services, FRAMEWORK SOLUTIONS

11:45AM – 12:30PM

Adjust PRC Operations and Expectations to Mergers, Acquisitions, and Divestitures


Rebecca Burns, Medical Affairs Manager, ARBOR PHARMACEUTICALS

12:30PM – 1:30PM

Luncheon


 OPTIMIZING PRC TRAINING AND TEAMWORK

1:30PM – 2:15PM

Properly Sequence Input From Medical Reviewers


Alexander Shaw, Manager, Medical Information, ALKERMES

2:15PM – 3:00PM

Select and Implement CAPAs for Promotional Review


Nan Knickerbocker, CQM, RAC, Associate Director, Regulatory Affairs, U.S. Advertising and Promotion, ABBVIE
Nan Clarke, Manager, Promotional Marketing Operations and Compliance, Abbvie

3:00PM – 3:30PM

Networking Break


3:30PM – 4:15PM

PANEL: Transmit Consistent Metrics and KPIs to Process Owners and Partners


Moderator:
Jason Benagh, Manager, Marketing Operations, ALKERMES

4:15PM – 5:00PM

Manage Digital Assets for Approval and Submission of Templated or Dynamic Materials


Bradley Coushman, Vice President, ELEMIS CORPORATION

5:00PM – 5:00PM

Day One Concludes



MAIN CONFERENCE DAY TWO

 Friday, May 17, 2019 // Main Conference Day Two

9:00AM – 9:45AM

Tier Your Review Process Based on Material Complexity


Kim Maney, Senior Counsel, GLAXOSMITHKLINE

9:45AM – 10:30AM

PANEL: Leadership Tactics to Improve PRC Efficiency


MODERATOR:
Steve Gersten, Vice President, General Counsel, DYNAVAX
PANELISTS:
Brad Patrick, Division Counsel, ABBVIE
Bill Benvenuto, VP, Legal Affairs and Chief Compliance Officer, RETROPHIN
Christi Bruce, Senior Manager MLR Operations and Platforms, SANOFI

10:30AM – 11:00AM

Networking Break


11:00AM – 11:45AM

Strategies to Mitigate Conflicts and to Play and Fight Fair in PRC


Peter Lee, Vice President, Chief Compliance Officer, HERON THERAPEUTICS

11:45AM – 12:30PM

Fine-Tune Your Training Methods for Marketing Agencies


Robert Masi, Associate PRO Specialist, GENENTECH

12:30PM – 1:30PM

Luncheon


1:30PM – 2:15PM

Eliminate Error Sources in E-Detailing


Christi Bruce, Senior Manager MLR Operations and Platforms, Sanofi

3:00PM – 3:00PM

Conference Concludes



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