Promotional Review Committee Performance Optimization

Gathering and Leading the Best Teams Toward the Best Regulatory Outcomes

March 22-24, 2021

Online LIVE Stream

What To Expect

Promotional review committees work on materials that are viewed subjectively and emotionally – both by patients, physicians, and regulatory reviewers.  They have to deal with regulatory guidelines that are unclear and unevenly enforced – and they have to do all that while working on group projects!

The Promotional Review Committee Performance Optimization conference is the only event you need to construct teams that understand regulatory requirements, meet deadlines, and excel at cooperation across all product categories and media.

Hilton East Brunswick

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3 Tower Center Blvd.
East Brunswick, NJ 08816

(732) 828-2000

Hotel Website

About the Chairperson

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Dr. Matthew T. Roe has been a faculty member at Duke University School of Medine and the Duke Clinical Research Institute (DCRI) since 1999. As a senior investigator at the DCRI, he has been the principal investigator for numerous phase II-IV cardiovascular clinical trials and is currently a co-principal investigator for the ADAPTABLE trial—the first large-scale pragmatic trials being conducted in the PCORnet network. He has also served in leadership roles for several observational registries focusing upon the treatment and outcomes of patients with cardiovascular disease and has served as the Director of the DCRI Clinical Research Fellowship since 2010.

Featured Speakers

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Craig Lipset

Head of Clinical Innovation
Pfizer

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Jeff Kingsley

Chief Executive Officer
IACT Health 

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Dawn Anderson

Managing Director, Life Sciences Strategy and Operations, R&D Practice
Deloitte

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Ross Friedberg

General Counsel & Chief Privacy Officer
Doctor on Demand

Why Attend?

  1. Interactive panels and workshops that replicate the cross-disciplinary atmosphere of promotional review committee meetings
  2. Detailed insight on OPDP expectations, enforcement patterns, and submission management
  3. Surefire strategies for building, accelerating, and maintaining committee teamwork and speed
  4. Up-to-date strategies for reviewing multimedia messages, social networks, and apps
  5. Best practice for incorporating new technologies, resources, and databases into your PRC

Who is Attending?

This conference is designed for senior leaders and executives in pharmaceutical, biotech, and medical device companies responsible for:

  • Promotional Review / Promotional Materials / PRC / MPRC / PMRC
  • Regulatory Promotion & Advertising / AdPromo / AdProm / PromoAd
  • Regulatory Affairs
  • Compliance
  • Labeling
  • Health Economics / Outcomes / HEOR
  • Medical Affairs
  • Medical Information
  • MSL
  • Medical Communications
  • Marketing / Marketing Operations / Marketing Communications
  • Commercial Operations
  • Product Manager
  • Brand Manager
  • Legal Affairs / Counsel

Monday

October 19th, 2020 | Day 1

8:00 AM - 9:00 AM

Registration & Continental Breakfast

9:00 AM - 9:15 AM

Conference Opening Remarks

9:15 AM - 10:00 AM

Paper to Hybrid to eTMF – Best Practices for Selecting, Implementing, Transitioning and Assuring Compliance from Day One

Maha Saad, Ph.D., MBA - Americas Pharmacovigilance Head, Bioresearch Quality and Compliance, Quality Assurance
JOHNSON & JOHNSON

10:00 AM - 10:45 AM

Moving Toward a Risk-based eTMF Operating Model

Laura Naranjo - Associate Director, TMF Operations
DAIICHI SANKYO, INC.

10:45 AM - 11:00 AM

Morning Networking Break

11:00 AM - 12:00 PM

Using Metrics to Optimize Business Decisions

REGENERON PHARMACEUTICALS, INC.

12:00 PM - 1:00 PM

Networking Lunch

1:00 PM - 1:45 PM

Sponsor Opportunity

1:45 PM - 2:45 PM

TMF Inspection Readiness

2:45 PM - 3:00 PM

Afternoon Networking Break

3:00 PM - 4:00 PM

Best Practices for Compliant eTMF Archiving

REGENERON PHARMACEUTICALS, INC.

4:00 PM - 4:45 PM

TMF Governance

4:45 PM - 5:00 PM

Day 1 Closing Remarks

FEATURED SPEAKERS

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Oscar Segurado

ASC Therapeutics

Chief Medical Officer

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Judy Hsiung

Arena Pharmaceuticals

Vice President Safety & Pharmacovigilance

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Israel Gutierrez

Geron Corporation

Vice President, Pharmacovigilance and Drug Safety

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Joan A. Chambers

The Center for Information & Study on Clinical Research Participation (CISCRP)

Senior Director, Marketing & Outreach

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Michael Forstner

PrimeVigilance

Senior Vice President and Head of Pharmacoepidemiology and Risk Management

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Sheila Bose

SB Lifesciences Consulting, Inc

President

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Christine Von Raesfeld

More Than Lupus

Patient Advocate and Board Member

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Angela Ramirez Holmes

Cal Rare

Founder/President

CONFERENCE REGISTRATION

ATTENDEE PRICING

Super Early Bird


$896

Register by 12/28/20

Early Bird


$1,096

Register by 1/25/21

Standard


$1,296

Register before event

Register 2 Attendees, Get 1 Complimentary Registration*!

Interested in sending groups of 7 or more? Contact us directly for pricing.

EVENT SPONSORS


SPONSOR THIS EVENT

Contact Amy Chapman at (561) 571-7687
or achapman@dgeconfs.com


MEDIA PARTNERS

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PREMIER MEDIA PARTNER