PROMOTIONAL REVIEW COMMITTEE …info.exlevents.com/rs/195-NER-971/images/C896_Cruz.pdf · ALL-NEW...

ALL-NEW discussions on how your promotional review committee can:

The recognized leading event for uniting cross-team expertise, maximizing quality oversight during review and maintaining regulatory compliance in all multimedia promotional materials

PROMOTIONAL REVIEW COMMITTEE COMPLIANCE & BEST PRACTICES MIDWEST

“Presentations were awesome – very relevant and interactive.” —Director, Marketing Operations, SUPERNUS PHARMA

4th

Sponsors:

Denise SanchezExecutive Director, Regulatory Affairs Advertising and PromotionALLERGAN

John CarusoSenior Manager, Promotion ComplianceOTSUKA

Kevin StarkDirector, Office of Promotion and Advertising Review, Regulatory AffairsMERCK

Ilze AntonsSenior Director, Advertising and Promotion, US Regulatory AffairsLUNDBECK

Leah BeattyEditor, Sales and Marketing OperationsGRIFOLS

Robert WittenbergAssociate Director, Regulatory Affairs, Advertising and PromotionBAXTER

Leann BonaventuraAssociate Director, Promotional Regulatory AffairsASTRAZENECA

Gary WieczorekDirector, Regulatory Affairs, US Advertising and PromotionABBVIE

_ Navigate FDA guidelines and preferences for off-label communication

_ Alternate reviewer responsibilities at different stages of product life cycles

_ Comply with local and global review priorities

_ Create product advocates through patient-centric approaches to rare disease

_ Invest in PRC process excellence for launches

_ Guide the listening, negotiating and leadership techniques of team members

_ Fine-tune compliance for adaptive websites

_ Maintain PRC skills while onboarding new members

BETTER REVIEWERS BETTER RESULTS “Excellent faculty and good audience participation made this very productive.” —Global Counsel, MYLAN

“Great industry networking and outstanding presentations.” —Senior Manager, Marketing Operations, ABBVIE

May 16-17, 2017 || The James Chicago || Chicago, IL

IN-DEPTH INTERACTIVE WORKSHOP:

“Develop and Maintain a Promotional

Claims Compendium for Each Product”

To Register Contact Marcie Cruz 917-258-5143 or [email protected]

The James Chicago55 East OntarioChicago, IL 60611

To make reservations please call 312-660-7131 or email [email protected] and request the negotiated rate for ExL’s 4th PRC Midwest. You may also make reservations online at http://bit.ly/2iks7KI with the group code CEXL17. The group rate is available until April 24, 2017. Please book your room early as rooms available at this rate are limited.

*ExL Events is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, housing bureaus or travel companies. ExL Events is affiliated with event company Questex, LLC. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly email us at [email protected]. ExL has not authorized these companies to contact you, and we do not verify the legitimacy of the services or rates offered. Please book your guest rooms through ExL’s reserved guest room block using the details provided.

Do you want to spread the word about your organization’s solutions and services to potential clients who will be attending this event? Take advantage of the opportunity to exhibit, underwrite an educational session, host a networking event or distribute promotional items to attendees. ExL Events will work closely with you to customize a package that will suit all of your needs. To learn more about these opportunities, please contact Eric Morrin at 212-400-6228 or [email protected].

SPONSORSHIP AND EXHIBITION OPPORTUNITIES

Dear Colleague,At the end of 2016, the FDA’s Office of Prescription Drug Promotions handed down warning letters to several large pharma companies whose consumer advertisements, while factually accurate, used music and editing techniques that regulators felt could lead to a false impression. Promotional review professionals must predict and adapt to this type of subjective oversight — and in order to do that, they must function expertly as a team. Since better reviewers yield better results, promotional review committees are often unsung heroes for their companies.

ExL’s Promotional Review Committee Compliance & Best Practices conference series is the only industry forum completely devoted to boosting the skills and teamwork of all of the stakeholders in the PRC process. Whether you are a submitter, a reviewer, a project manager or a meeting facilitator, this conference will provide you with a unique opportunity to learn and network with your peers and improve the cooperation, compliance and speed of your PRC.

Our expert faculty will teach you how to:

_ Reassess risk in light of 1st Amendment court case decisions on off-label messaging

_ Modify your promotional review strategy for social media and adaptive websites

_ Empower facilitators and leaders to steadily guide your PRC process

_ Interpret guidelines and expectations both locally and globally

_ Select the ideal metrics for PRC performance improvement

Plus, by popular demand, the 4th Promotional Review Committee Compliance & Best Practices — Midwest program features an in-depth interactive workshop on creating and maintaining a promotional claims compendium for each product.

I look forward to seeing you in Chicago!

Sincerely,

Matt GreenbaumMatt GreenbaumProduction Team Leader ExL Events, a division of Questex, LLC

WHO SHOULD ATTEND This conference is designed for pharma, biotech and medical device professionals with responsi-bilities in the following areas:

( Promotion Review/PRC/MPRC/PMRC ( Promotional Materials/Material Review ( Regulatory Promotional and Advertising/

PromoAd/AdProm/AdPromo/Copy Editing ( Regulatory Affairs/Processes ( Compliance/Promotional Compliance ( Editorial ( Medical Affairs/Review ( Medical Information ( Communications ( Medical Communication/Medical Science

Liaisons ( Medical/Scientific Writing ( Marketing/Marketing Operations/

Communications/Services ( Commercial Operations ( Brand Management/Product Management/

Brand Marketing ( Legal Affairs/Counsel/Regulatory Counsel

This event is also of interest to:

( CRM/Data Management Software Suppliers

( MLR Process Vendors and Facilitators ( Advertising/Marketing Agencies ( Regulatory Consultants ( Medical Writing Firms ( Law Firms

“Very pertinent to my current PRC activities and process questions.” —Promotional Review Management Associate, TAKEDA

“Great discussions. I heard many different perspectives and gained insights on PRC improvement.” —Senior Manager, Promotion Compliance, OTSUKA


TUESDAY, MAY 16, 2017 // WORKSHOP

TUESDAY, MAY 16, 2017 // MAIN CONFERENCE DAY ONE

12:00 Main Conference Registration Opens

1:00 Co-Chairs’ IntroductionRebecca Rivera Torres, Senior Promotional Review Associate, UNITED THERAPEUTICS John Marcus, Associate Director, Regulatory Affairs, ABBVIE

OFF-LABEL MESSAGING: RISKS AND OPPORTUNITIES

1:10 Navigate FDA Guidelines and Preferences for Off-Label CommunicationThe FDA has extended the comment period for their guidelines concerning approved communications of off-label information. A thorough review of some of the comments that have reached the agency will help pinpoint what biopharma experts believe should be changed.

( Compare and contrast statements during the comment period and at public meetings

( Provide a window into what industry has done and can continue to do in the absence of clear, finalized guidelines

( Ascertain the areas where a shift in regulation is most heavily desired and may be most likely to take place

Linda Pollitz, Senior Director, Regulatory Affairs, Advertising and Promotion, ALKERMES

PROMOTIONS FOR NEW MEDIA AND NEW AUDIENCES

1:50 Advanced Collaboration Tactics to Improve Agency Partnership in the Promotional Review ProcessThere can be multiple different structures at work within your agency, and it is critical to identify each of them and improve your communication across diverse teams.

( Effectively navigate the planning and creation process with your agency partners to reduce cycle time, review rounds and improve quality

( Create joint goals to drive adherence and engagement in continuous process optimization

( Establish a regular cadence of scorecarding your agency partners to monitor and evaluate performance

Rebecca Burnett, Executive Director and Head of Strategic Services, FRAMEWORK SOLUTIONS

2:30 CASE STUDY: Best Practices in Externalizing Promotional Material ReviewAsheena Munjal, Senior Director, INDEGENE

3:10 Networking Break

3:40 Build Relationships with Rare Disease PatientsOrphan disease communities tend to be tight-knit, so anything you as a company can do to build up channels of communication with them is worthwhile. There are tools at the disposal of your PRC that can help with patient engagement and involvement.

( Recognize the PRC activities that work best with strong patient communities

( Establish dialogue between PRCs and rare disease patients and caregivers

( Visualize improvements to promotional campaigns based on the needs of rare disease patients

Ilze Antons, Senior Director, Advertising and Promotion, US Regulatory Affairs, LUNDBECK

4:20 Deal with Global Messaging Priorities on a Local LevelLatin American and Asia-Pacific groups may have a review process strikingly different from that of North America and Europe. In the face of recent corporate mandates, these groups are now all trying to streamline their approach; this can be particularly challenging when team members from these regions must each take on what would be multiple roles in the same committee.

( Predict how internationally based groups will respond to inheriting a promo piece

( Build metrics and motives for every localized version of a promotional campaign

( Adapt to the varying work structures of colleagues in different countries

( Create job aides and FAQs for new additions from international markets

Robert Wittenberg, Associate Director, Regulatory Affairs, Advertising and Promotion, BAXTER

5:00 Day One Concludes

8:00 Workshop Registration and Continental Breakfast

9:00 WORKSHOP: Develop and Maintain a Promotional Claims Compendium for Each ProductIt is the brand team’s responsibility to develop a core claims guide or compendium with the input of the PRC. Challenges arise when you encounter rapid industry changes and the spread to new media formats. If a new claim does not exist in your core claims guide, what is the process under which you could use it? Additionally, the construction and word choice in a new claim can have a significant impact on your review process. Does abbreviating a phrase or omitting a bullet point to save space change the meaning of what is presented? If so, how should you proceed? This workshop will address how to:

( Distinguish between the perceived definitions of claims among both marketing and reviewers ( Prepare to consider even non-verbal background material as being a claim or claim-related ( Specify whether new visual aids or website elements need separate concept preapproval processes ( Conceptualize the impact of wording changes as perceived by regulatory reviewers ( Firmly instill knowledge of which terms can be modified and abbreviated and which cannot ( Overcome the challenges of modifying DTC and healthcare provider material

Denise Sanchez, Executive Director, Regulatory Affairs Advertising and Promotion, ALLERGANYemisi Oluwatosin, Director, Senior Promotional Regulatory Affairs, ASTRAZENECARebecca Rivera Torres, Senior Promotional Review Associate, UNITED THERAPEUTICS

There will be a 30-minute networking break during this workshop.

12:00 Luncheon for Workshop Participants


WEDNESDAY, MAY 17, 2017 // MAIN CONFERENCE DAY TWO8:00 Registration and Continental Breakfast

8:45 Co-Chairs’ Recap of Day OneRebecca Rivera Torres, Senior Promotional Review Associate, UNITED THERAPEUTICS John Marcus, Associate Director, Regulatory Affairs, ABBVIE

IMPROVING PRC TEAMWORK AND PERFORMANCE METRICS

9:00 Project SWARM: One Year LaterAt this conference last year, AbbVie presented a case study about Project SWARM (Swift and Agile Review of Materials). This initiative focused on improving team dynamics and behaviors as a means to provide the most competitive and compliant promotional materials to the market in the shortest time possible. One year later, Project SWARM continues to thrive, with new learnings that can be of value to many other teams.

( Continue the momentum of success achieved for pilot programs ( Contextualize program results as compared to expectations ( Carry key learnings into 2017 and beyond

Gary Wieczorek, Director, Regulatory Affairs, US Advertising and Promotion, ABBVIE Christine Larsen, Director, Marketing Operations, ABBVIE Tim Arnold, Senior Manager, Marketing Services & Operations, ABBVIE

9:40 Cultivate the Listening and Negotiating Skills of Team Members to Streamline CooperationPRCs should prioritize the listening skills of their members, as it is important to be able to influence team members in a respectful manner. Changing others’ minds and coming to agreement must be done in a way that doesn’t jeopardize future interactions.

( Seek out evidence and clear communication of your stance ( Acknowledge ambiguity and define risk ( Evolve your stance in an ever-changing regulatory environment

Kevin Stark, Director, Office of Promotion and Advertising Review, Regulatory Affairs, MERCK

10:20 Stagger Review Responsibilities Throughout Product Life CyclesNew product launches take business priority, but you have an obligation for products at all stages of their life cycle, including the early R&D phase. Lowering the number of reviewers working on an older product or piece can help you boost efficiency — but can you be certain that all of the changes they see will be minor?

( Internalize that content-driven changes need to be examined on an individual basis

( Begin to work with marketing as soon as candidates complete phase III trials

( Create disease awareness campaigns that can segue into product campaigns as drugs approach the market

Michelle Folz, Regulatory Advisor, ELI LILLY

11:00 Networking Break

11:30 Prepare PRCs to Respond to Label ChangesRebekah Logan, Advisor, Global Regulatory Affairs, US Advertising and Promotional Materials, ELI LILLY

12:10 Focus on Facilitators to Keep PRCs Functioning SmoothlyWithout good team dynamics, you’ll have much bigger problems than compliance. Each team member must be able to properly communicate with and interpret guidance from colleagues and must feel empowered to suggest revisions. The ideal facilitator for the process will keep conversations efficient and focused, avoiding tangents and confrontation.

( Keep team members oriented toward the common goal, and avoid ambiguity by giving them a collective voice

( Resolve conflicts among team members and between the team and the project initiator

( Develop best practices for making edits, suggesting revisions and acting on these inputs quickly

Leah Beatty, Editor, Sales and Marketing Operations, GRIFOLS

12:50 Luncheon

1:50 Recruit and Partner With the Ideal Project Leader to Manage the Review of Materials for Product LaunchesEmploying a project manager to specifically guide the creation and review of launch materials can be a strong advantage. It requires an intense focus, the ability to work cross-functionally and especially rigid adherence to timelines. Websites, KOL speaker decks, digital pieces and annotated package inserts are just some of the materials that must be conceived and reviewed for release within 24 hours of product launch.

( Select candidates with extensive strategic and process excellence, as well as Six Sigma certification

( Identify key cross-functional partners and define their roles and responsibilities

( Prep the launch process 18 months in advance ( Invest in process excellence and 1:1 management for launches

Leann Bonaventura, Associate Director, Promotional Regulatory Affairs, ASTRAZENECA

2:30 Leverage Team Member Skills to Enhance the PRC ProcessThe PRC process can be challenging at times. It’s important to maximize the skills of reviewers and submitters, and to ensure an understanding of roles and responsibilities in order for the process to be successful.

( Visualize what makes a well-functioning PRC ( Tackle challenges by leveraging each function (e.g., sales meetings,

label updates) ( Focus on the importance of organization, communication and

collaborationJohn Caruso, Senior Manager, Promotion Compliance, OTSUKA

3:10 Construct an Onboarding Program in Medical and Regulatory Affairs Advertising and PromotionOrientation is typically considered a one-time event that prepares a new employee for their first day of work. Onboarding is a broader and longer process. A formal onboarding program helps new employees understand your organization’s values, roles and the expectations others have for them. It also provides resources and tools for employees to more quickly become engaged, successful contributors to your team.

( Properly scope what is needed for your department’s successful onboarding program

( Evaluate what is important to senior management and provide the support that is needed

( Analyze modular self-learning programsJanet Reardon, Regulatory Affairs Manager, Advertising and Promotion, ABBVIE Nancy Knickerbocker, Senior Manager, Regulatory Affairs, Advertising and Promotion, ABBVIE Jennifer Banovic, Executive Medical Communications Liaison, Medical Affairs, US Region, TAKEDA

3:50 Conference Concludes

QUESTIONS? COMMENTS? Do you have a question or comment that you would like to be ad-dressed at this event? Would you like to get involved as a speaker or discussion leader? Please contact Conference Production Director Matt Greenbaum at [email protected].

“Very engaging presentations.” —PRS Leader, JOHNSON & JOHNSON


Registration fees for attending ExL’s 4th Promotional Review Committee Compliance & Best Practices – Midwest conference:

STANDARD PRICING

Conference $1,995

Conference + Workshop $2,295

ONSITE PRICING

Conference $2,095

Conference + Workshop $2,395

TERMS AND CONDITIONS: By registering for an ExL Events (“ExL”) event, you agree to the following set of terms and conditions listed below:

REGISTRATION FEE: The fee includes the conference‚ all program materials‚ and designated continental breakfasts‚ lunches and refreshments.

PAYMENT: Make checks payable to ExL Events and write C896 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full by the conference date. Any discount applied cannot be combined with any other offer and must be paid in full at the time of order. Parties must be employed by the same organization and register simultaneously to realize group discount pricing options.

**Please Note: There will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague within five business days of any ExL conference.**

CANCELLATION AND REFUND POLICY: If you cancel your registration for an upcoming ExL event, the following policies apply, derived from the Start Date of the event:

• Four weeks or more: A full refund (minus a $295 processing fee) or a voucher to another ExL event valid for 12 months from the voucher issue date.

• Less than four weeks: A voucher to another ExL event valid for 12 months from the voucher issue date.

• Five days or less: A voucher (minus a $395 processing and documentation fee) to another ExL event valid for 12 months from the voucher issue date.

To receive a refund or voucher, please email [email protected] or fax your request to 888-221-6750.

CREDIT VOUCHERS: Credit vouchers are valid for 12 months from date of issue. Credit vouchers are valid toward one (1) ExL event of equal or lesser value. If the full amount of said voucher is not used at time of registration, any remaining balance is not applicable now or in the future. Once a credit voucher has been applied toward a future event, changes cannot be made. In the event of cancellation on the attendees’ behalf, the credit voucher will no longer be valid.

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SUBSTITUTION CHARGES: There will be an administrative charge of $300 to substitute, exchange and/or replace attendee badges with a colleague occurring within five business days of the conference.

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ExL Events’ liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date‚ content‚ speakers and/or venue.

*The opinions of ExL’s conference speakers do not necessarily reflect those of the companies they represent, nor ExL Events.

Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, significant effort to find a suitable replacement will be made. The content in ExL slide presentations, including news, data, advertisements and other information, is provided by ExL’s designated speakers and is designed for informational purposes for its attendees. It is NOT INTENDED for purposes of copywriting or redistribution to other outlets without the express written permission of ExL’s designated speaking parties. Neither ExL nor its content providers and/or speakers and attendees shall be liable for any errors, inaccuracies or delays in content, or for any actions taken in reliance thereon. EXL EVENTS EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, AS TO THE ACCURACY OF ANY CONTENT PROVIDED, OR AS TO THE FITNESS OF THE INFORMATION FOR ANY PURPOSE. Although ExL makes reasonable efforts to obtain reliable content from third parties, ExL does not guarantee the accuracy of, or endorse the views or opinions given by any third-party content provider. ExL presentations may point to other websites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites.

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advantage of these group discounts, please call 866-207-6528.

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WAYS TO REGISTER

The recognized leading event for uniting cross-team expertise, maximizing quality oversight during review and maintaining regulatory compliance in all multimedia promotional materials

PROMOTIONAL REVIEW COMMITTEE COMPLIANCE & BEST PRACTICES MIDWEST

4th

BETTER REVIEWERS BETTER RESULTS

May 16-17, 2017 || The James Chicago || Chicago, IL

To Register Contact Marcie Cruz

917-258-5143 or [email protected]


PROMOTIONAL REVIEW COMMITTEE …info.exlevents.com/rs/195-NER-971/images/C896_Cruz.pdf · ALL-NEW...

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