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7th Promotional Review Committee Compliance & Best Practice...
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Wednesday, May 13
 

8:00am

Registration and Continental Breakfast
Wednesday May 13, 2020 8:00am - 9:00am

9:00am

Morning Workshop: Learn OPDP Expectations During a Sample Regulatory Review Scenario
OPDP reviewers and outside counsel provide crucial feedback on your commercial pieces. By sitting in and learning from the thought processes of people familiar with OPDP’s review of your promotional materials, you can better understand how they take claims apart and how regulatory analysis may come down against you if you don’t have the right evidence. This interactive workshop enables you to internalize and work with OPDP expectations during a real-time “mock” review meeting. The interactive workshop will also enable you to recognize where real world evidence (RWE) may play a role as a source of evidence for both regulatory and medical products coverage or reimbursement decisions.
  • Clarify where your expectations of labeling and promotional information differ from those of OPDP reviewers
  • Zero in on areas where terminology use may cause confusion from a regulatory perspective
  • Explain what “adequate substantiation” means and how to apply the “competent and reliable scientific evidence” standard in a manner that is consistent with FDA’s approach for the substantiation of promotional claims
  • Gain understanding of truthful, balanced, and accurately communicated information
  • Anticipate the level of investment in both time and resources required for successful review

Speakers
avatar for Cristina Masseria

Cristina Masseria

Methods and Capabilities Lead, Pfizer
Cristina is currently leading the Methods and Capability team for HEOR and Market Access at Pfizer. Cristina has extensive experience in HEOR and RWD generation and communication in Pharma (Pfizer and GSK).Before joining the pharmaceutical industry in 2011 at GSK, Cristina was a lecturer... Read More →
avatar for Keren Tenenbaum

Keren Tenenbaum

VP and Assistant General Counsel, Head of Legal, Salix at Bausch Health
avatar for Nneka Onwudiwe, PharmD., Ph.D., MBA

Nneka Onwudiwe, PharmD., Ph.D., MBA

Founder and Chief Executive Officer, Pharmaceutical Economics Consultants of America (PECA) LLC
Nneka C. Onwudiwe, Ph.D., Pharm.D., MBA, received her doctorate in Pharmacy (Pharm.D.) from the University of Maryland School of Pharmacy, Ph.D. in Health Services Research with a specialization in Pharmacoeconomics from the University of Maryland School of Pharmacy, and an MBA (Honors... Read More →


Wednesday May 13, 2020 9:00am - 12:00pm

2:00pm

Afternoon Workshop: What do Efficient Operations for a PRC Process Look Like"
    • Which key parameters are influencing the efficiency of the PRC process?
    • How to plan for LMR resources effectively?
    • How to meet PRC needs when marketing plans are changing?
    • How to build agility in the PRC process?

Speakers
avatar for Caroline Leruth

Caroline Leruth

Director, Content Delivery - Content Strategy Operations, GlaxoSmithKline
As the Director of Content Planning and Delivery at GSK, Caroline Leruth leads a team of professionals focused on the planning, content review, and execution of the Promotional Review Compliance process. Her multi-faceted career in Commercial, Compliance, and Production coupled with... Read More →
avatar for Sabrina Mays-Diagne

Sabrina Mays-Diagne

Senior Corporate Attorney, Otsuka Pharmaceuticals


Wednesday May 13, 2020 2:00pm - 5:00pm
 
Thursday, May 14
 

8:00am

Registration and Continental Breakfast
Thursday May 14, 2020 8:00am - 9:00am

9:00am

Chairperson's Opening Remarks
Speakers
avatar for Linda Pollitz

Linda Pollitz

Senior Director, Regulatory Affairs, Advertising and Promotion, Alkermes


Thursday May 14, 2020 9:00am - 9:15am

9:15am

Keynote: Getting Promotional Review Committees Past the Point of Groupthink
  • Examine how Promotional Review has taken a variety of turns in its tortuous history 
  • Evaluate what the future of the discipline looks like from a practice, as well as a regulatory perspective 
  • Learn how behavioral change such as becoming more adept at looking for and identifying nonsensical information can improve your practice 
  • Social Media’s 7 Deadly Sins & Incorporating new technologies 
  • Discuss the ethical price of “price"

Speakers
avatar for Ben Locwin, Ph.D., MBA, M.S.

Ben Locwin, Ph.D., MBA, M.S.

Senior Vice President of Quality, Lumicell, Inc.


Thursday May 14, 2020 9:15am - 10:00am

10:00am

Leverage Unbranded and Disease State Campaigns to Increase Awareness in Targeted Areas
  • Discuss the differences in the PRC process for branded and unbranded messaging 
  • Recognize the benefits of being involved in unbranded and disease state campaigns 
  • Focus on engaging with patients to effectively establish trust and connect with consumers and other stakeholders 

Speakers
avatar for Virginia Fitt

Virginia Fitt

Senior Director, U.S. Commercial Counsel, Alexion Pharmaceuticals


Thursday May 14, 2020 10:00am - 10:45am

10:45am

Networking Break
Thursday May 14, 2020 10:45am - 11:15am

11:15am

Employ Communication and Collaboration to Maximize Efficiency, Value, and Compliance When Working with Marketing Agencies
  • Understand the value of developing and maintaining a positive relationship between your PRC and external marketing agencies 
  • Establish open lines of communication and respect between the two parties and identify common goals 
  • Increase touchpoints between your PRC and agency 
  • Discuss enforcement trends, regulatory updates, guidance documents and feedback to continually improve operations and understanding 

Speakers
avatar for John Paul Marcus, Pharm.D.

John Paul Marcus, Pharm.D.

Director, Regulatory Affairs, Labeling, Advertising and Promotion, Horizon Pharmaceuticals
John Paul Marcus leads the Regulatory Affairs team on the Promotional Review Committee at Horizon Pharma. He has over ten years of experience in the Pharmaceutical industry working within advertising and promotion as part of both Regulatory Affairs and Medical Affairs. John received... Read More →


Thursday May 14, 2020 11:15am - 12:00pm

12:00pm

Combination Products Safety: Regulations with End to End Impact on Post-Marketing Safety Reporting
  • FDA has pushed out their post-market reporting for the second year in a row – Are you ready for July 2020 implementation? 
  • What does FDA expect for PMSR for combination products? 
  • Challenges faced by industry to adapt to the global variability of reporting 

Speakers
avatar for Khaudeja Bano

Khaudeja Bano

Senior Medical Director, Head of Medical Affairs, Abbott Molecular
Khaudeja is a Physician with a Masters in Clinical Research, Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional. She is an Abbott President’s award winner, avid Toastmaster and Coach.  Khaudeja has more than 25 years... Read More →


Thursday May 14, 2020 12:00pm - 12:45pm

12:45pm

Luncheon
Thursday May 14, 2020 12:45pm - 1:45pm

1:45pm

Future Packaging and REMS Considerations for PRC Committees
· Safe and Effective Medication through Packaging That is SMART (Simple, Measured, Accessible, Restricted, Timely)
· Brainstorm innovative approaches to packaging such as SMART MEDICINE BOTTLES (i.e., the use of technology so the packaging "talks to you" by integrating chip technology with Google Voice devices
· Design full-proof containers and storage that are safe, secure, but easy to open for the disabled
· Containers of the future that better distinguish medications (i.e., through different bottle color or shape) and educate consumers about the risk through innovative learning
· B2B marketing innovation and Brand Awareness in the LinkedIn era

Speakers
avatar for Thomas Carganico

Thomas Carganico

Marketing and Communications Manager, PQE Group
Graduated with a Degree in Communications, Media & Advertising at IULM University of Milan, he pursued his studies with a Master Executive in Brand Reputation & Digital Communication. He started his career in digital branding and PR at the Public Broadcasting Service in New York City... Read More →
avatar for Willis H. Thomas, Ph.D.

Willis H. Thomas, Ph.D.

Project Management Professional (PMP) and Certified Performance Technologist (CPT), PQE Group
Willis H. Thomas, PhD, PMP, CPT has worked for large corporations and academic institutions in the areas of human resources, learning and development, quality assurance, project management, sales and marketing, measurement and evaluation, and operations.He has been in senior management... Read More →


Thursday May 14, 2020 1:45pm - 2:30pm

2:30pm

Panel: Can Agility and Risk Management Co-exist?
Brand teams are under significant pressure to be more responsive to customer information needs.  That’s why Commercial is increasingly turning to Agile frameworks like Scrum and Sprints to innovate more quickly.  Promotional review represents an opportunity to apply Agile best practices especially for digital materials and campaigns where rapid decisions about content compliance must be made.   Is it possible to manage risk in a fast moving ad/prom review process? 
  • Describe the Agile methodology and its role in speeding up innovation through quicker decision-making 
  • Hear what your colleagues our saying about Agile based on use cases and benchmark survey results 
  • Formulate strategies and tactics that balance faster decision-making with regulatory compliance requirements 
  • Add to a growing list of examples for applying agile ad/prom review

Moderators
avatar for Ilyssa Levins

Ilyssa Levins

Founder and President, Center for Communication Compliance

Speakers
avatar for John Paul Marcus, Pharm.D.

John Paul Marcus, Pharm.D.

Director, Regulatory Affairs, Labeling, Advertising and Promotion, Horizon Pharmaceuticals
John Paul Marcus leads the Regulatory Affairs team on the Promotional Review Committee at Horizon Pharma. He has over ten years of experience in the Pharmaceutical industry working within advertising and promotion as part of both Regulatory Affairs and Medical Affairs. John received... Read More →


Thursday May 14, 2020 2:30pm - 3:15pm

3:15pm

Networking Break
Thursday May 14, 2020 3:15pm - 3:45pm

3:45pm

Panel: Understand and Meet Consumer’s Needs of Social Media While Mitigating Regulatory Risk
  • Pinpoint the expectations of consumers and define the messaging you’d like to get across 
  • Work with all involved stakeholders to identify risk proactively and have multiple channels of review 
  • Discuss various strategies for engaging with patients and communicating key information 

Moderators
avatar for Linda Pollitz

Linda Pollitz

Senior Director, Regulatory Affairs, Advertising and Promotion, Alkermes

Speakers
avatar for Jia-Huey Huey, R.Ph., Pharm.D.

Jia-Huey Huey, R.Ph., Pharm.D.

Director, Regulatory Advertising and Promotion, Johnson & Johnson
avatar for Kristy Barnes Williams

Kristy Barnes Williams

Manager, Promotional Review, kaléo
Kristy Barnes draws on more than 20 years of project and product management to guide the continuous review process of Promotional, Medical and Corporate documents for kaléo.  In her current role as Manager, Promotional Review she has built the review process from the ground up... Read More →
avatar for Sabrina Mays-Diagne

Sabrina Mays-Diagne

Senior Corporate Attorney, Otsuka Pharmaceuticals
avatar for Madhavi Bellamkonda

Madhavi Bellamkonda

Director, Regulatory Affairs, Global Advertising and Promotion, Abbott


Thursday May 14, 2020 3:45pm - 4:45pm

4:45pm

DTC Mobile Promotions and Fair Balance Labeling
  • Share examples of platforms for mobile promotion of medical devices 
  • Discuss implications of web-based advertising and geographical distinctions 
  • Look at geo-targeting of web-based DTC advertising and geo-targeting on social media 
  • Examine mock advertisements with fair balance requirements 

Speakers
avatar for Madhavi Bellamkonda

Madhavi Bellamkonda

Director, Regulatory Affairs, Global Advertising and Promotion, Abbott


Thursday May 14, 2020 4:45pm - 5:30pm
 
Friday, May 15
 

8:00am

Continental Breakfast
Friday May 15, 2020 8:00am - 9:00am

9:00am

Chairperson's Recap of Day One
Speakers
avatar for Linda Pollitz

Linda Pollitz

Senior Director, Regulatory Affairs, Advertising and Promotion, Alkermes


Friday May 15, 2020 9:00am - 9:15am

9:15am

Reading the Tea Leaves: What We Can Learn From Recent FDA, DOJ, FTC and Other Regulatory Actions
    • Highlight key promotional areas of regulatory and government focus
    • Evaluate potential regulatory trends that could arise within the next couple years
    • Tackle the challenges of complying with multiple different regulatory agencies

Speakers
avatar for Julie Tibbets

Julie Tibbets

FDA Partner, Technology & Life Sciences Group, Goodwin Procter, LLP
Julie Tibbets leads the FDA practice at Goodwin Procter where she focuses her practice on drug, biologic, and medical device product development, marketing and corporate communications. She has counseled the promotional review committees of both large and emerging drug and device... Read More →
avatar for Linda Pollitz

Linda Pollitz

Senior Director, Regulatory Affairs, Advertising and Promotion, Alkermes


Friday May 15, 2020 9:15am - 10:00am

10:00am

Enhance Collaboration with Patient Advocacy Groups While Maintaining Compliance
  • Pinpoint the desired results of working with patient advocacy groups to create aligned and complementary goals 
  • Discuss execution strategies while keeping in mind current regulations 
  • Understand the intersection of timelines for drug development and unbranded promotions with advocacy groups 
  • Connect with relevant stakeholders during R&D to gain early input and gain awareness of patient needs 

Speakers
avatar for Eve Dryer

Eve Dryer

Executive Director, Patient Advocacy, Retrophin
During more than 25 years as a healthcare communicator, Eve has served as a patient advocacy leader, a champion for underserved populations, an innovator in patient communications, and much more. Her unwavering passion and dedication to advancing healthcare literacy and multicultural... Read More →
avatar for William Benvenuto

William Benvenuto

VP, Legal Affairs & Chief Compliance Officer, Retrophin
William R. Benvenuto is Vice President, Legal Affairs & Chief Compliance Officer for Retrophin, Inc. with 20 years of pharmaceutical, medical device, and diagnostic industry experience.  Prior to joining Retrophin, he served in both corporate counsel and compliance officer roles... Read More →


Friday May 15, 2020 10:00am - 10:45am

10:45am

Networking Break
Friday May 15, 2020 10:45am - 11:15am

11:15am

PRC Panel: Maximize Efficiency and Enhance Collaboration with Internal PRC Stakeholders
  • Hear from multiple perspectives including operations, marketing, regulatory, medical affairs and legal representatives 
  • Gain insight into one company’s journey to an evolved promotional review team 
  • Discuss common industry challenges and analyze best practices 
  • Pinpoint factors that lead to successful collaboration between all stakeholders 

Speakers
CF

Christopher Foster

Associate Director, Global Labeling, Advertising, and Promotional Compliance., Alexion Pharmaceuticals
avatar for Kate Carter

Kate Carter

Director, US atypical-HUS Marketing, Alexion Pharmaceuticals
avatar for Virginia Fitt

Virginia Fitt

Senior Director, U.S. Commercial Counsel, Alexion Pharmaceuticals
avatar for Alana Goodman

Alana Goodman

Director, Global Marketing Operations, Alexion Pharmaceuticals


Friday May 15, 2020 11:15am - 12:15pm

12:15pm

Panel: Identify Metrics and KPIs to Improve Your Promotional Review Process
  • Discuss what data can tell you about your promotional review process 
  • Identify metrics and KPIs that are relevant and actionable to increase efficiency 
  • Gain insight on the importance of speed to market, first round approvals, overall cycle time, expedited jobs and frequency of reviews 
  •  Analyze the relationship between your promotional review process and ROI by comparing the quality of submitted material and opportunities to cut time and costs 

Moderators
avatar for Mario Mendoza, MD, MS

Mario Mendoza, MD, MS

BioExecutive-In-Residence, New York State Center for Biotechnology at Stony Brook University
Dr. Mario R Mendoza is a clinical anesthesiologist (practiced at the NIH), chemist, and currently an independent healthcare and pharma medical affairs consultant with over 13 years of combined experience in patient care, clinical development, R&D, medical affairs (Abbott, Pfizer and... Read More →

Speakers
avatar for Nicole McCourt

Nicole McCourt

Senior Manager, Strategic Services, Framework Solutions
avatar for Crisha Advincula

Crisha Advincula

Program Operations Manager, Genentech


Friday May 15, 2020 12:15pm - 1:00pm

1:00pm

Luncheon
Friday May 15, 2020 1:00pm - 2:00pm

2:00pm

Case Study: PRC Dynamics Best Practices
  • Recognize the differing backgrounds and incentives on participants in different roles, and your organization’s expectations for PRC 
  • Importance and benefits of early engagement, context and mutual recognition of goals and constraints 
  • Strategies for getting on the same page, and recognizing when you’re not 
  • Case study discussion of the benefits of the prior points in action 

Speakers
avatar for Michael Smith

Michael Smith

Senior Counsel, PDL BioPharma, Inc.
Michael is a FDA attorney and business counselor with a focus on advertising and promotion issues for pharmaceutical and biotechnology companies. He is currently Senior Counsel at PDL BioPharma where he supports commercial initiatives of subsidiary companies, Noden Pharma and Lensar... Read More →


Friday May 15, 2020 2:00pm - 2:45pm

2:45pm

Demonstrate How Soft Skills Can Be the Root of a Successful Committee
  • Explore the opportunities of incorporating soft skills into your Reviewer role 
  • Recognize the situations in which conflict may arise and learn about tools that can aid in resolution
  • Identify potential obstacles faced when there is a lack of soft skills amongst committee members 

Speakers
avatar for Stacy Harker

Stacy Harker

Director, Medical Promotional Review, Allergan
avatar for Janet Gottlieb, Ph.D.

Janet Gottlieb, Ph.D.

Executive Director, Medical Promotional Review, Allergan


Friday May 15, 2020 2:45pm - 3:30pm

3:30pm

Building Trust Between PRC Stakeholders
  • Discuss the key players who make up a strong PRC 
  • Identify metrics and KPIs that are relevant and actionable to increase efficiency 
  • Gain insight on the importance of speed to market, first round approvals, overall cycle time, expedited jobs and frequency of reviews 
  • Analyze the relationship between your promotional review process and ROI by comparing the quality of submitted material and opportunities to cut time and costs 

Speakers
avatar for Alana Goodman

Alana Goodman

Director, Global Marketing Operations, Alexion Pharmaceuticals


Friday May 15, 2020 3:30pm - 4:15pm