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5th Promotional Review
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Wednesday, September 25
 

7:45am EDT

REGISTRATION AND NETWORKING BREAKFAST
Wednesday September 25, 2024 7:45am - 8:45am EDT
Wednesday September 25, 2024 7:45am - 8:45am EDT
  Networking Opportunity

8:45am EDT

CO-CHAIRS OPENING REMARKS
Wednesday September 25, 2024 8:45am - 9:00am EDT
Speakers
avatar for Zoe Dunn

Zoe Dunn

President & CEO, HALE ADVISORS
avatar for Georgia Gayle

Georgia Gayle

Director, Head of US Commercial Promotional Review & Marketing Operations, ASTRAZENECA
Wednesday September 25, 2024 8:45am - 9:00am EDT
  Plenary Session

9:00am EDT

PANEL DISCUSSION: 8 WARNING LETTERS IN 8 YEARS!!!
Wednesday September 25, 2024 9:00am - 9:45am EDT
Let’s Talk About the Necessity to be Compliant Given the Current Behavior from Regulatory Agencies - What you Need to Know about the Future of Enforcement
Speakers
avatar for David Jacobs

David Jacobs

Vice President Legal Affairs, INTERCEPT PHARMACEUTICALS
avatar for Anthony Haddad

Anthony Haddad

Senior Manager, Promotion Compliance, OTSUKA
avatar for Gary Wieczorek

Gary Wieczorek

Director, Regulatory Affairs, U.S. Advertising and Promotion, ABBVIE
Wednesday September 25, 2024 9:00am - 9:45am EDT
  Panel Discussion

9:45am EDT

GET YOUR ENFORCEMENT ACTION PLAN IN PLACE
Wednesday September 25, 2024 9:45am - 10:30am EDT
Received a Warning Letter? Let’s Work on Your “Fire Drills” to Make Sure You Are Prepared to Respond
Speakers
avatar for Melissa Sadowski

Melissa Sadowski

Director, US Advertising and Promotion, EMD SERONO
Wednesday September 25, 2024 9:45am - 10:30am EDT
  Plenary Session

10:30am EDT

NETWORKING BREAK
Wednesday September 25, 2024 10:30am - 11:00am EDT
Wednesday September 25, 2024 10:30am - 11:00am EDT
  Networking Opportunity

11:00am EDT

MODULAR CONTENT SESSION BY CANOPY
Wednesday September 25, 2024 11:00am - 11:45am EDT
Wednesday September 25, 2024 11:00am - 11:45am EDT
  Plenary Session

11:45am EDT

PANEL DISCUSSION: THE FUTURE OF DIRECT CONSUMER ADVERTISING
Wednesday September 25, 2024 11:45am - 12:30pm EDT
Learn How Companies are Adapting and Reacting to DTC Commercials' Final Rule and the Changes Being Made
Speakers
avatar for Ana Rasack

Ana Rasack

Associate Director Global Promotional Review, MENARINi GROUP
Ana Rasack, an enthusiastic leader in the Promotional and Advertising community with over 17 years of Pharmaceutical Regulatory experience.Dedicated to providing a PRC experience that is engaging, efficient, simple, and compliant, Ana continues to develop her knowledge in the AdPromo... Read More →
avatar for Melissa Sadowski

Melissa Sadowski

Director, US Advertising and Promotion, EMD SERONO
Wednesday September 25, 2024 11:45am - 12:30pm EDT
  Panel Discussion

12:30pm EDT

LUNCH BREAK
Wednesday September 25, 2024 12:30pm - 1:30pm EDT
Wednesday September 25, 2024 12:30pm - 1:30pm EDT
  Networking Opportunity

1:30pm EDT

OMNICHANNEL SESSION BY HALE ADVISORS
Wednesday September 25, 2024 1:30pm - 2:15pm EDT
Speakers
avatar for Zoe Dunn

Zoe Dunn

President & CEO, HALE ADVISORS
Wednesday September 25, 2024 1:30pm - 2:15pm EDT
  Plenary Session

2:15pm EDT

DAM IT!
Wednesday September 25, 2024 2:15pm - 3:00pm EDT
Explore Best Practices on How to Optimize your Digital Asset Management (DAM)
Wednesday September 25, 2024 2:15pm - 3:00pm EDT
  Plenary Session

3:00pm EDT

NETWORKING BREAK
Wednesday September 25, 2024 3:00pm - 3:30pm EDT
Wednesday September 25, 2024 3:00pm - 3:30pm EDT
  Networking Opportunity

3:30pm EDT

REAL-WORLD EVIDENCE IN PROMOTIONAL MATERIALS
Wednesday September 25, 2024 3:30pm - 4:15pm EDT
Support Claims Made About the Benefits, Outcomes, and Value of Having RWE Data in Promotional Pieces
Speakers
avatar for Colleen Davenport

Colleen Davenport

Vice President Regulatory Affairs, RADIUS HEALTH
Colleen Davenport leads the Regulatory Affairs Department at Radius Health which is a biopharmaceutical company focused on developing new therapeutics for osteoporosis and other endocrine-mediated diseases. She has over 25 years of experience in regulatory affairs including multiple... Read More →
Wednesday September 25, 2024 3:30pm - 4:15pm EDT
  Plenary Session

4:15pm EDT

INTERACTIVE POTLUCK SESSION 2.0
Wednesday September 25, 2024 4:15pm - 5:00pm EDT
Ask our Expert Panel Members Questions Regarding any Aspect of MLR-PRC. We Will Collect Questions Throughout the Day and Then Have them Answered
Speakers
avatar for Reetu Dandora

Reetu Dandora

Vice President, Compliance & Regulatory Counsel, AVEO PHARMACEUTICALS
avatar for Larry Herring

Larry Herring

Senior Director, Regulatory Affairs, Advertising & Promotion, MERZ AESTHETICS
avatar for Katie McQueen

Katie McQueen

Principal Scientific Communications Manager, MED COMMUNICATIONS
Katie McQueen is a Principal Scientific Communications Manager at Med Communications, Inc. with 13 years ofexperience as a pharmacist. Katie graduated summa cum laude from Mercer University College of Pharmacy and HealthSciences in Atlanta, Ga. Prior to obtaining her PharmD degree... Read More →
Wednesday September 25, 2024 4:15pm - 5:00pm EDT
  Interactive Session

5:00pm EDT

COCKTAIL RECEPTION
Wednesday September 25, 2024 5:00pm - 6:00pm EDT
Wednesday September 25, 2024 5:00pm - 6:00pm EDT
  Networking Opportunity
 
Thursday, September 26
 

7:45am EDT

NETWORKING BREAKFAST
Thursday September 26, 2024 7:45am - 8:30am EDT
Thursday September 26, 2024 7:45am - 8:30am EDT
  Networking Opportunity

8:30am EDT

CO-CHAIRS RECAP OF DAY ONE AND WELCOME TO DAY 2
Thursday September 26, 2024 8:30am - 8:45am EDT
Speakers
avatar for Georgia Gayle

Georgia Gayle

Director, Head of US Commercial Promotional Review & Marketing Operations, ASTRAZENECA
avatar for Zoe Dunn

Zoe Dunn

President & CEO, HALE ADVISORS
Thursday September 26, 2024 8:30am - 8:45am EDT
  Plenary Session

8:45am EDT

SPONSOR SESSION
Thursday September 26, 2024 8:45am - 9:30am EDT
Thursday September 26, 2024 8:45am - 9:30am EDT
  Plenary Session

9:30am EDT

SOPs!
Thursday September 26, 2024 9:30am - 10:15am EDT
Build and Update SOPs (Standard Operating Procedures) to Streamline Processes and Improve the Efficiency of the Review Efforts
Speakers
avatar for Christi Bruce

Christi Bruce

Promotional Excellence & Standards For Advertising & Promotion Head, SANOFI
Thursday September 26, 2024 9:30am - 10:15am EDT
  Interactive Session

10:15am EDT

NETWORKING BREAK
Thursday September 26, 2024 10:15am - 10:45am EDT
Thursday September 26, 2024 10:15am - 10:45am EDT
  Networking Opportunity

10:45am EDT

PANEL DISCUSSION: OPDP SUBMISSIONS
Thursday September 26, 2024 10:45am - 11:30am EDT
Discuss What to Submit and What not to Submit to the Office of Prescription Drug Promotion (OPDP), Websites, and Conference Booths for Increased Efficiency
Speakers
avatar for Heather McFalls

Heather McFalls

Director, Promotion Compliance, OTSUKA
Thursday September 26, 2024 10:45am - 11:30am EDT
  Panel Discussion

11:30am EDT

SOCIAL MEDIA UPDATES
Thursday September 26, 2024 11:30am - 12:15pm EDT
Discover New Trends, Offerings, Applications and Platform Adjustments to Maintain Your Review Processes Up to Date
Speakers
avatar for Dawn Lacallade

Dawn Lacallade

Chief Strategy Officer, VP Healthcare, LIVEWORLD
Thursday September 26, 2024 11:30am - 12:15pm EDT
  Plenary Session

12:15pm EDT

LUNCH BREAK
Thursday September 26, 2024 12:15pm - 1:15pm EDT
Thursday September 26, 2024 12:15pm - 1:15pm EDT
  Networking Opportunity

1:15pm EDT

FIRESIDE CHAT: CFL GUIDELINES
Thursday September 26, 2024 1:15pm - 2:00pm EDT
Analyze How the Recent FDA Enforcement Actions, are Having a Direct Impact on Companies' Stance with the CFL
Speakers
avatar for Dominick DiSabatino

Dominick DiSabatino

Partner, SHEPPARD MULLIN
Dominick’s practice focuses on complex FDA and healthcare regulatory, compliance and legal matters in the life sciences industry. Drawing from in-house secondments with clients of various growth stages, Dominick counsels pharmaceutical, biotechnology, cosmetics and medical device... Read More →
Thursday September 26, 2024 1:15pm - 2:00pm EDT
  Plenary Session

2:00pm EDT

PERSPECTIVE PANEL: THE FUTURE OF PROMOTIONAL REVIEW
Thursday September 26, 2024 2:00pm - 2:45pm EDT
Let’s Discuss With Every Stakeholder Represented, Regulatory, Medical, Marketing, Legal, and Compliance Where is Promotional Review Headed
Speakers
avatar for Joan Rizal

Joan Rizal

Director - Commercial Counsel, AMNEAL PHARMACEUTICALS
“Joan Rizal is Director - Commercial Counsel at Amneal Pharmaceuticals and serves as Legal reviewer on the company’s promotional material review committees. She is also responsible for market access/customer facing contracting for the company’s portfolio products.”
avatar for Larry Herring

Larry Herring

Senior Director, Regulatory Affairs, Advertising & Promotion, MERZ AESTHETICS
avatar for Heather McFalls

Heather McFalls

Director, Promotion Compliance, OTSUKA
Thursday September 26, 2024 2:00pm - 2:45pm EDT
  Panel Discussion
 
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Wednesday, September 25
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