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SPONSORED BY:
20+ PRESENTATIONS
5+HOURS OF NETWORKING
100+ PROFESSIONALS
Uniting Team Expertise and Performance, Maximizing Quality Oversight During Review, and Maintaining Regulatory Compliance in All Multimedia Promotional Materials
PROMOTIONAL REVIEW COMMITTEE COMPLIANCE
& BEST PRACTICES
ALL-NEW SESSIONS ON: ➜ Empowering Coordinators to Streamline PRC
Operations
➜ Upgrading Submission Techniques for Adaptive Promotional Websites
➜ Confronting Compliance Challenges from Retail Pharmacy Promotions
➜ Managing a Multi-Company Review of Co-Promoted Drugs
October 17-18, 2016 // The Madison Hotel // Morristown, NJ
A SPECIAL FOCUS ON PRC CHALLENGES FOR: ➜ Orphan Drugs
➜ Generic Drugs
➜ Biosimilars
➜ Medical Devices
4TH
“Presentations were entertaining, relevant, on-point and useful. I was very impressed with the knowledge and best practices available.”
—Senior Regulatory Affairs Specialist, Ad/Promo, ABBOTT VASCULAR
CELGENE Analyzes Compliance Needs for Promotional Apps Lisa Drucker Senior Director, Regulatory Affairs
SUNOVION Plans Long-Term Budgeting for PRC ActivitiesElizabeth Theophile Director, Promotional Materials Compliance Management
PERNIX Safeguards PRC Talent After Corporate Mergers and AcquisitionsElke Carter Director, Regulatory Affairs
ASTRAZENECA Updates PRC Techniques for Search Engine OptimizationYemisi OluwatosinDirector, Promotional Regulatory Affairs
INTERACTIVE WORKSHOP: DEVELOP AND MAINTAIN A PROMOTIONAL CLAIMS COMPENDIUM FOR EACH PRODUCT
YOUR CO-CHAIRS:
John Marcus Associate Director, Regulatory AffairsABBVIE
Rebecca Rebmann Senior Promotional Review AssociateUNITED THERAPEUTICS
For More Information Call 866–207–6528 or Visit www.exlevents.com/reviewboards
DEAR COLLEAGUE,Even the best knowledge of OPDP expectations for promotional materials will do you no good, unless you can construct and manage a promotional review committee that functions as a true team, meeting all its deadlines and adapting to the unique compliance challenges that come with specialized therapeutics and disease indications.
The 4th PRC Compliance & Best Practices conference is the only summit that focuses specifically on building and benchmarking the teamwork of your review committee. Join us in Morristown, New Jersey to ensure your PRC is prepared to generate, collect and constructively act on expert comments for your entire drug and device portfolio.
This year, our all-new speaking faculty tackles the most pressing promotional compliance topics — as chosen by YOU, our audience! These never-before-heard discussions will empower you to:
• Select and train the ideal coordinator to drive your PRC process
• Design compliant promotional messaging on apps and social networks
• Go beyond the letter of the law to protect your company’s reputation among patients for depicting their needs seriously and respectfully
• Diversify your PRC’s skill sets to meet the unique approval challenges of generic drugs, biosimilars, orphan drugs, medical devices and much more
• Maintain PRC talent and cohesion after corporate mergers and acquisitions
Plus: Return to work armed with even more information by attending our in-depth interactive workshop devoted to best practices for assembling and using a claims compendium for each product under review!
I look forward to welcoming you to the premier platform for discussing and learning about
promotional review strategies this fall!
Matt GreenbaumMatt Greenbaum
Production Team Leader, ExL Events
• Promotion Review/PRC/MPRC/PMRC
• Material Review
• Regulatory Promotion and Advertising/PromoAd/AdProm/AdPromo/Copy Editing
• Regulatory Affairs/Processes
• Compliance/Promotional Compliance
• Labeling
• Medical Affairs/Review
• Medical Information
• Communications
• Medical Communications/Information
• Medical Science Liaisons
• Marketing/Marketing Operations/Communications/Services
• Commercial Operations
• Brand Management/Product Management/Brand Marketing
• Legal Affairs/Counsel/Regulatory Counsel
WHO SHOULD ATTEND This conference is specifically designed for pharma, biotech and med device professionals responsible for:
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
SPONSORSHIP AND EXHIBITION OPPORTUNITIESDo 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, Senior Business Development Manager, at [email protected] or 212-400-6228.
“Great content. Very thorough explanation of committee roles and importance.”
—Contracts Manager, SPECTRUM PHARMA
VENUETHE MADISON HOTELOne Convent RoadMorristown, NJ 07960
To make reservations, please call 973-285-1800 or 1-800-526-0729 and request the negotiated rate for ExL’s October Meeting. The group rate is available until September 26. Please book your room early, as rooms available at this rate are limited.
*ExL Events, Inc. is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, housing bureaus or travel and events companies. 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.
For More Information Call 866–207–6528 or Visit www.exlevents.com/reviewboards
MONDAY, OCTOBER 17, 2016 // WORKSHOP DAY
12:00 REGISTRATION
1:00 CO-CHAIRS’ OPENING REMARKS John Marcus, Associate Director, Regulatory Affairs, ABBVIE Rebecca Rebmann, Senior Promotional Review Associate,
UNITED THERAPEUTICS
PROMOTIONAL REVIEW BREAKTHROUGHS FOR NEW MEDIA
1:15 CALCULATE NEW STRATEGIES FOR THE REVIEW AND SUBMISSION OF ADAPTIVE PROMOTIONAL WEBSITES
Regulatory expectations for adaptive websites remain ambiguous. There is no strictly defined preferred method for submitting the appearance of an adaptive website, and some of the potential methods are far more time- and labor-intensive than others.
[ Build on previous successes in website promotional review [ Target the best methods for presenting and submitting multiple layouts of
adaptive websites to OPDP [ Confront the likelihood of website reviews that last months, possibly with
subsequent rounds canceling out earlier ones
John Marcus, Associate Director, Regulatory Affairs, ABBVIE
1:45 OVERCOME THE HURDLES OF REVIEWING SEARCH ENGINE MARKETING TECHNIQUES
PRCs oversee search engine optimization and keyword marketing, a new field that leaves many reviewers struggling. Your organization needs to firmly establish and categorize which search engine uses it sees as promotional, and then build a mechanism for reviewing these.
[ Differentiate between organic and paid searches [ Finalize the methods for reviewing and submitting results to OPDP [ Bring in digital experts to educate reviewers on the specific promotional
aspects of SEOs
Yemisi Oluwatosin, Director, Promotional Regulatory Affairs, ASTRAZENECA
2:15 BUILD CONFIDENCE IN THE COMPLIANT DESIGN OF PROMOTIONAL APPS
App designers may be both very sophisticated at designing multi-staged product for your review while simultaneously using more rudimentary techniques when presenting the same apps to FDA. Understanding the best way to track user feedback while streamlining the regulatory submission process is critical to gaining market presence for your promotional apps.
[ Move on from primitive methods that required hundreds of screenshots [ Harmonize an internal dynamic review system with your FDA submission
methods [ Target the best methods for capturing user comments and submitting them to
the FDA as needed Lisa Drucker, Senior Director, Regulatory Affairs, CELGENE
Ilyssa Levins, President, CENTER FOR COMMUNICATION COMPLIANCE
IMPROVE TRAINING AND STRUCTURAL SKILLS FOR PRC MEMBERS
2:45 ONBOARD NEW TALENT AND LEVERAGE YOUR PRC PROCESS TO INCREASE QUALITY OF MATERIALS AND APPROVAL TIMES
An ideal PRC would spend less time editorializing and more time approving material assets, but a high level of turnover — particularly in marketing departments — can be an obstacle. New prioritization and management techniques can help make sure you always have materials ready for review and publication, and that your talent is producing review-ready content.
[ De-prioritize other reviewer activities to add extra time to the docket [ Employ new resource modeling projects [ Avoid contract resources that don’t deliver sufficient project-based
orientation or effectively manage contract resources
Ariail Roberts, Senior Manager, Review Services, UCB PHARMA
3:15 CASE STUDY: IMPROVE THE EFFECTIVENESS AND EFFICIENCY OF PRCS
Anand Kiran, Executive Vice President, Global Operations, Medical Solutions, INDEGENE
Lu Ann Binda, North America Lead, Promotional Operations, PFIZER
3:45 NETWORKING BREAK
4:15 IMPROVE PRC PERFORMANCE THROUGH ONLINE REVIEW MEETINGS
If your entire PRC process is held “live,” it tends to be a bigger drain on time and resources. By prioritizing an e-review system, you can give your team more flexibility, avoid inefficiencies and better meet your shared performance goals.
[ Position online review as your default method unless coordinators find some reviewer comments problematic
[ Quantify the differences in number and speed of PRC meetings [ Keep lines open between the coordinator and PRC members
Rebecca Burnett, Senior Director, Marketing Services, MYLAN
4:45 CLARIFY EDUCATIONAL CONTENT AND CONTEXT AMONG MSLs
PRC individuals may also oversee review for items used by MSLs, yet each must remember that this is a separate review process with its own guidelines and goals. Guaranteeing that your MSL understands the differences between messages provided in each venue can help you avoid redundant messaging and regulatory risk.
[ Clamp down on the reuse of internally reviewed material at external venues [ Create universal education guidelines and training for new MSL staff [ Expand training to accommodate new team members brought on for
product launches
Deirdre Smith, Medical Information Lead, CSL BEHRING
8:00 REGISTRATION AND CONTINENTAL BREAKFAST
9:00 DEVELOP AND MAINTAIN A PROMOTIONAL CLAIMS COMPENDIUM FOR EACH PRODUCT
It is the brand team’s responsibility to develop a core claims compendium, with input from 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 significantly impact 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 nonverbal 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
Rebecca Rebmann, Senior Promotional Review Associate, UNITED THERAPEUTICS Denise Sanchez, Director, Commercial Regulatory Affairs, IRONWOOD PHARMACEUTICALS Yemisi Oluwatosin, Director, Promotional Regulatory Affairs, ASTRAZENECA
There will be a 30-minute networking break as part of the workshop.
12:00 LUNCHEON FOR WORKSHOP PARTICIPANTS
MONDAY, OCTOBER 17, 2016 // MAIN CONFERENCE, DAY ONE
For More Information Call 866–207–6528 or Visit www.exlevents.com/reviewboards
TUESDAY, OCTOBER 18, 2016 // MAIN CONFERENCE, DAY TWO
8:00 CONTINENTAL BREAKFAST
8:45 CO-CHAIRS’ RECAP OF DAY ONE John Marcus, Associate Director, Regulatory Affairs, ABBVIE Rebecca Rebmann, Senior Promotional Review Associate, UNITED
THERAPEUTICS
9:00 ASSEMBLE THE TRAINING MANUALS THAT CAN BOOST THE EXPERTISE OF YOUR PRC
You can significantly revamp your promotional review techniques by focusing on the factors that cause reviewers to miss deadlines. If PRC member training is inconsistent, you can address this by designing detailed training manuals and e-learning modules that have a real chance of changing participant behavior.
[ Properly disseminate spot-check documents [ Prevent mixed messages from multiple teams that would confuse ad
agencies [ Standardize PRC processes across drugs and indications
Iris Gibbs, Associate Director, Regulatory Affairs, Advertising and Promotions, REGENERON
9:30 SIMPLIFY MULTI-COMPANY PROMOTIONAL REVIEW FOR CO-PROMOTED DRUGS When multiple drug companies co-develop and co-market a drug, it magnifies the logistical and time-management challenges PRCs face. There are several different ways to guide a joint effort, and you must bear in mind that both companies are being judged by each others’ efforts.
[ Weigh the advantages of parallel versus merged review committees [ Avoid redundant work and delays in co-promotions [ Rely on a combined team’s strengths when submitting materials for review
John Marcus, Associate Director, Regulatory Affairs, ABBVIE
10:00 CASE STUDY
Presented by VODORI
10:30 Networking Break
ADVANCED PRC APPLICATIONS FOR SPECIFIC PRODUCTS
11:00 CULTIVATE PRC SKILLS FOR BIOSIMILARS The first wave of FDA-approved biosimilars have hit the U.S. market, and with them come many new challenges and opportunities from a commercialization standpoint.
[ Share the latest best practice for winning physician and patient uptake for this new product class
[ Adapt the most useful lessons from biologics and generic drugs [ Case studies of early successes
Denise Sanchez, Director, Commercial Regulatory Affairs, IRONWOOD PHARMACEUTICALS
11:30 PREPARE FOR THE PROMOTIONAL REVIEW CHALLENGES RELEVANT TO ORPHAN DRUGS
Promotions for orphan drugs need to be very specifically targeted, with a small number of patients, healthcare providers and relevant media. Working with patient advocacy groups can be more effective than the routes traditionally favored by pharma companies.
[ Identify the journals and patient organizations that best fit your messaging [ Track and benefit from patient-to-patient recommendations and word of
mouth [ Build a dedicated social media promotional review strategy for orphan drugs
Deirdre Smith, Medical Information Lead, CSL BEHRING
12:00 SPOTLIGHT ON NEW SOCIAL MEDIA AND REGULATORY OPPORTUNITIES FOR MEDICAL DEVICES Advertising for medical devices is distinct from pharma, with less stringent regulations frequently overseen by the FTC instead of the FDA. This can yield greater flexibility when promoting medical devices on social media, as well as developing promotional apps for new devices.
[ Benefit from the new world of apps available for medical devices [ Differentiate between general and specific clearance [ Take advantage of less strict AdvaMed Codes
Bill Waller, Senior Corporate Counsel, VARIAN MEDICAL SYSTEMS
5:15 SHIFT THE ESTABLISHED CONTENT MANAGEMENT PARADIGM TOWARD A HOLISTIC AND MULTICHANNEL APPROACH
In order to accommodate and better manage costs and resources across all types of marketing materials, including the increasing use of digital materials, life sciences manufacturers have to utilize enhanced and streamlined approaches in the management and review of promotional materials. Based on research and experience in helping clients enhance the timeliness and impact of these activities, this session explores three areas that can shift promotional content management to a holistic and multichannel approachs.
[ Reuse content to increase efficiencies and reduce redundancies in global and regional markets
[ Leverage new technology, tools, and tactics to better manage cost and resources
[ Accommodate multiple communication channels and keeping their use compliant
Aditi Taylor, Principal, DELOITTE & TOUCHE LLP
Jyothi Fernandes, Senior Manager, DELOITTE & TOUCHE LLP
Bill Carter, Manager, DELOITTE & TOUCHE LLP
5:45 IMPROVE YOUR ADVANCED PLANNING AND BUDGETING FOR PRC ACTIVITIES
It is difficult for PRCs to handle high volumes of review material, you can get a better idea of just what the volume will be by working cross-functionally with regulatory, medical, legal and marketing colleagues. . By planning for fiscal quarters or even years into the future, you can better integrate it with the budgeting capacity of your marketing team and assure you have the resources available to support the projected volume.
[ Identify deliverables and tactics far in advance [ Work with planning experts from each participating specialty area [ Learn from other organizations that manage higher volumes
Elizabeth Theophile, Director, Promotional Materials Compliance
Management, SUNOVION
6:15 COCKTAIL NETWORKING RECEPTION sponsored by
7:15 Day One Concludes
“This is the only conference related to management of the PRC process. Content was relevant and engaging - really drove discussions.” —Marketing Services Project Coordinator, UCB PHARMA
For More Information Call 866–207–6528 or Visit www.exlevents.com/reviewboards
12:30 LUNCHEON
1:30 OPTIMIZE THE ROLE OF LEGAL IN YOUR PRC Strong regulatory and medical reviewers are of the highest importance in promotional review; this allows legal to focus on overall initiatives from the FDA as well as any potential fraud and abuse concerns, rather than only considering one specific piece.
[ Emphasize the importance of concept meetings from a legal perspective [ Focus on issues that regulatory/medical reviewers do not or cannot, i.e., IP
issues, the Lanham Act, etc. [ Protect the reputation of your product and company
Marianne Slivkova, Director, Commercial Legal, ACORDA THERAPEUTICS
2:00 MAINTAIN PRC TALENT AND FLEXIBILITY AFTER CORPORATE MERGERS AND ACQUISITIONS After an M&A of a company with its own PRC structure, you need to carefully weigh whether to incorporate or dissolve this new committee. Otherwise, materials may slip through cracks and end up in the field without proper review.
[ Update risk tolerance based on the cultures of the merged companies [ Evaluate the methods and pros and cons of uniting PRCs [ Understand how improperly managed mergers can lead to OPDP letters
Elke Carter, Director, Regulatory Affairs, PERNIX THERAPEUTICS
2:30 Conference Concludes
Group Discount ProgramsOffers cannot be combined. Early Bird rates do not apply. To find out more on how you can take advantage of these group discounts, call 866–207–6528.
Save 25% per person when registering four For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register four at one time).
Save 15% per person when registering three Can only send three? You can still save 15% off of each registration.
Registration FeesEARLY BIRD PRICING
Register by Friday, September 9, 2016
Conference and Workshop: $2,195
Conference Only: $1,895
STANDARD PRICING
Register After Friday, September 9, 2016
Conference and Workshop: $2,395
Conference Only: $2,095
ONSITE PRICING
Conference and Workshop: $2,495
Conference Only: $2,195
QUESTIONS? COMMENTS?Do you have any questions, comments on the program or specific topics you would like addressed? Would you like to get involved as a speaker, moderator or discussion leader? Please email Production Team Leader Matt Greenbaum at [email protected].
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Uniting Team Expertise and Performance, Maximizing Quality Oversight During Review, and Maintaining Regulatory Compliance in All Multimedia Promotional Materials
4TH
PROMOTIONAL REVIEW COMMITTEE COMPLIANCE
& BEST PRACTICES
Lisa Drucker Senior Director, Regulatory Affairs
CELGENE
Elizabeth Theophile Director, Promotional Materials Compliance Management
SUNOVION
Elke Carter Director, Regulatory Affairs PERNIX
John Marcus Associate Director, Regulatory Affairs
ABBVIE
Yemisi Oluwatosin Director, Promotional Regulatory Affairs ASTRAZENECA
October 17-18, 2016 // The Madison Hotel // Morristown, NJ
www.exlevents.com/reviewboards
866-207-6528
888-221-6750
ExL Events, Inc.494 8th Avenue, Fourth FloorNew York, NY 10001
5 Ways to Register
For More Information Call 866–207–6528 or Visit www.exlevents.com/reviewboards
