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5th Promotional Review Committee Compliance & Best Practices — Midwest (exl...

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Conrad Chicago

101 East Erie Street

Chicago, IL 60611

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5th Promotional Review Committee Compliance & Best Practices — Midwest

Last year, FDA issued new draft guidelines on promotional communications, with special emphasis on the use of data that is consistent with product labeling. While highly important, this guidance is also ambiguous — and since there have not yet been many warning letters issued over violations, promotional review professionals may be unsure how to proceed without a clear guiding signal.

The 5th Promotional Review Committee Compliance & Best Practices — Midwest conference is the only industry event devoted specifically to optimizing the skill sets, teamwork, speed, and regulatory awareness of your PRC members. No other event goes into as much detail about both the latest regulatory changes facing your teams and the operations and leadership techniques they require in order to succeed!

Top Five Reasons to Attend

  1. In-depth examination of the use of data consistent with labels
  2. Evaluation of promotional materials for conventions
  3. New skills for compliance in VR and telemedicine
  4. Special insight on PRC responsibilities for Patient Support Programs
  5. New insights on the quality control processes essential for your PRC
PLUS: In-depth, interactive workshop focusing on Maintaining Promotional Review Compliance Under FDAMA 114

Who Should Attend

Pharmaceutical, biotech and medical device professionals responsible for the following areas:

  • Promotion Review / PRC / MPRC / PMRC
  • Promotional Materials / Material Review
  • Regulatory Promotion & Advertising / PromoAd / AdProm / AdPromo / Copy Editing
  • Regulatory Affairs / Process
  • Compliance / Promotional Compliance
  • Labeling
  • Health Economics / Outcomes Research / Outcomes / HEOR
  • Editor / Editorial
  • Medical Affairs / Review
  • Medical Information
  • Communications
  • Medical Communications / Information / Medical Science Liaison
  • Medical Writing / Scientific Writing
  • Medical Director
  • Marketing / Marketing Operations / Communications / Services
  • Commercial Operations
  • Brand Manager / Product Manager / 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

Workshop

THURSDAY, MAY 17, 2018

8:00AM – 9:00AM

Registration and Continental Breakfast

9:00AM – 12:00PM


WORKSHOP: FDAMA 114 — Promotional Review and Compliance Strategies

Erica Chertow, Director, Regulatory Affairs, U.S. Prescription Drug Promotion, ABBVIE

Jessica Cirillo, Director, HEOR — Acute Care Lead, MALLINKCRODT

Day One
THURSDAY, MAY 17, 2018
12:00PM – 1:00PM
Registration

1:00PM – 1:15PM
Chairperson’s Opening Remarks

John Marcus, Director, Regulatory Affairs, Labeling, Advertising and Promotion, HORIZON PHARMACEUTICALS

TECHNIQUES FOR NEW REGULATIONS AND PRODUCT AREAS
1:15PM – 2:00PM
PANEL: Conduct Both Gradual and Immediate Label Updates

Sue Duvall, Head, North America Advertising and Promotion, Regulatory Affairs, MYLAN
Michael Saad, Senior Manager, Marketing Operations, ABBVIE
Christi Bruce, Senior Manager, MLR Operations and Platforms, SANOFI

2:00PM – 2:45PM
Analyze the Promotional Compliance Risks and Successes of Patient Support Programs

John Marcus, Director, Regulatory Affairs, Labeling, Advertising and Promotion, HORIZON PHARMACEUTICALS

2:45PM – 3:30PM
PANEL: The Sound of Silence: Build a Way Forward When Lacking FDA Enforcement Cases

Steve Gersten, Vice President, General Counsel, and Chief Ethics and Compliance Officer, DYNAVAX TECHNOLOGIES
Leeann Bonaventura, Associate Director, Promotional Regulatory Affairs, ASTRAZENECA
Alexander Zachos, Senior Manager, Regulatory Affairs, Labeling and Advertising, INTERCEPT PHARMACEUTICALS
Kevin Hollister, Senior Director, Regulatory Affairs, TESARO

3:30PM – 4:00PM
Networking Break

4:00PM – 4:45PM
PANEL: Evaluate the Use of Data “Consistent With Labels”

Lynn Bowen, Director, Commercial Regulatory Oversight, VERTEX PHARMACEUTICALS
Jennifer Banovic, Executive Medical Communications Liaison, TAKEDA
James Vigil, Director, U.S. Regulatory Affairs, Advertising and Promotion, ABBVIE

4:45PM – 5:30PM
Telemedicine, VR, and More: Anticipate the Greatest Challenges Facing PRCs in the Next Decade

Ilze Antons, Senior Director, Regulatory Affairs, LUNDBECK

5:30PM –
Day One Concludes

Day Two
FRIDAY, MAY 18, 2018
8:00AM – 8:45AM
Continental Breakfast

8:45AM – 9:00AM
Chaiperson’s Recap of Day One

John Marcus, Director, Regulatory Affairs, Labeling, Advertising and Promotion, HORIZON PHARMACEUTICALS

TOOLS FOR TEAMWORK, EFFICIENCY, AND SPEED
9:00AM – 9:45AM
PANEL: Develop QC Processes for Promotional Review

Mimi Giordano, Senior Copy Editor, UCB BIOSCIENCE
Rebecca Burnett, Executive Director and Head of Strategic Services, FRAMEWORK SOLUTIONS
Marge Garcia, Associate Director, Program Review Operations, GENENTECH

9:45AM – 10:30AM
Learn the “Soft Skills” of Negotiation to Avoid Conflict Within Committees

Elke Carter, Regulatory Manager, ZAVATION MEDICAL PRODUCTS

10:30AM – 11:00AM
Networking Break

11:00AM – 11:45AM
Learn to Analyze and Anticipate Patterns in Review Comments

Leeann Bonaventura, Associate Director, Promotional Regulatory Affairs, ASTRAZENECA

11:45AM – 12:30PM
Ensure Compliant Presentation and Successful Evaluation of Convention Materials

Zafar Toor, Senior Director, Commercial Regulatory Affairs, LEXICON PHARMACEUTICALS

12:30PM – 1:30PM
Luncheon

1:30PM – 2:15PM
PANEL: Find the Optimal Timeframe for Your Review Process

Stacy Harker, Manager, Promotional Compliance, ALLERGAN
Megan Francis-Sedlak, Senior Manager, Medical Affairs, HORIZON PHARMACEUTICALS

2:15PM – 3:00PM
Highlight the Role of PRC Coordinators to Streamline Processes

Christi Bruce, Senior Manager, MLR Operations and Platforms, SANOFI

3:00PM –
Conference Concludes

Speaker

Ilze Antons
Senior Director, Regulatory Affairs, LUNDBECK

Ilze started her career in the pharmaceutical industry at the Upjohn Company in Kalamazoo, Michigan over 25 years ago. Prior to her extensive time in Regulatory Affairs, she held several positions in Quality Assurance. Her regulatory path not only spanned International, US and Global approaches, but also included Pharmacia, Genzyme, Baxter and Serono before Lundbeck. While she worked on INDs, NDAs, DMFs and in numerous therapeutic areas, over the past 17 years her work has included Advertising and Promotional work, with the last 10 focused solely in this area of regulatory compliance. She now heads up a team that provides promotional review and internal as well as external compliance training, and has been involved with the development and inclusion of social media in various programs in the company.

Ilze received her B.S. from Purdue University and her M.S. from The Ohio State University. She is RAC certified; participated in developing the original Code of ethics for Regulatory Professionals for RAPS; was an organizer for RAPS’s annual meetings; and has been a presenter on both labeling and advertising, and promotional topics at various conferences.

Jennifer Banovic
Executive Medical Communications Liaison, TAKEDA

Jennifer Banovic, PharmD, MBA, BCPS, is an Executive Medical Communications Liaison at Takeda Pharmaceuticals in Deerfield, IL. Jennifer supports multiple products in the neuroscience and rheumatology therapeutic areas from a medical information and medical review perspective. She has more than 17 years of experience in various settings with a focus on medical communications, including 10 years in the pharmaceutical industry, as well as clinical practice, managed care and academia.


Leeann Bonaventura
Associate Director, Promotional Regulatory Affairs, ASTRAZENECA

Leeann joined AstraZeneca in 2008 in a Marketing Operations role. She has been with the company nine years in a series of roles, with increasing responsibilities in Regulatory Affairs. She is currently an Associate Director of Promotional Regulatory Affairs, primarily responsible for the Women’s Cancer Franchise. Leeann received her undergraduate degree from Lafayette College with a double major in neuroscience and English, and a Master’s degree from Binghamton University in Behavioral Neuroscience. Prior to AstraZeneca, Leeann worked at Biogen Idec in Boston in a Marketing Operations role. She lives in Frederick, Maryland with her fiancé and their 3 cats. In her spare time, she volunteers with various mentoring programs that help foster career growth and STEM support for young women.

Lynn Bowen
Director, Commercial Regulatory Oversight, VERTEX PHARMACEUTICALS

Christi Bruce
Senior Manager, MLR Operations and Platforms, SANOFI


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

In her current role as Executive Director and Head of Strategic Services for Framework Solutions, Rebecca Burnett has more than 17 years of biopharmaceutical industry experience. She was most recently the Head of North America Marketing Operations for Mylan where she was responsible for leading her team in the support of five business units and more than 1,400 products.

Ms. Burnett began her career as a clinical research associate and held numerous roles in clinical research and medical affairs before finding her true passion in advertising and promotional review management in 2008. Since that time she has worked with and led teams across a spectrum of biopharmaceutical companies. Her teams have won industry awards for excellence in implementing technology solutions to drive process review efficiency and optimization. Her expertise is in diagnosing and providing recommendations to promotional review teams to ensure compliant and efficient review processes.

Ms. Burnett received her undergraduate and masters degree from the University of Colorado and has an MBA from George Washington.

Elke Carter
Regulatory Manager, ZAVATION MEDICAL PRODUCTS

Elke Carter is the Director of Regulatory Affairs for Pernix Therapeutics where she provides the expertise and leadership to assure the company is in full compliance with the regulatory requirements for the FDA, DEA, OPDP, and multiple state regulatory requirements. Ms. Carter also ensures Pernix’s adherence to best practices outlined in PhRMA code. From 2008-2012, Ms. Carter served in the same capacity as Director of Regulatory Affairs with Cypress Pharmaceutical, Inc., which was acquired by Pernix in 2012. Prior to her Director of Regulatory Affairs roles, Ms. Carter served as an R&D Chemist for Vistakon (a Johnson & Johnson Company) in Jacksonville, FL, where she worked on developing multiple combination drug and device products and was promoted to the role of R&D Operations Manager, where she and her team was responsible for the manufacture, testing and record keeping of these products, including clean room practices and FDA reviews.

Ms. Carter earned a bachelor’s degree in chemistry from The University of South Alabama. She currently resides in Jackson, MS.

Erica Chertow
Director, Regulatory Affairs, U.S. Prescription Drug Promotion, ABBVIE

Jessica Cirillo
Director, HEOR — Acute Care Lead, MALLINCKRODT

Jessica Cirillo, MHS is a Director, Health Economics & Outcomes Research and Acute Care Lead at Mallinckrodt Pharmaceuticals. She is responsible for leading the development and execution of the value evidence generation and dissemination strategies for pain management and hemostats businesses.

Jessica has a broad range of experience supporting the pharmaceutical and medical device industries. Previously, Jessica was a Director in the Value Evidence and Outcomes division of GlaxoSmithKline, Inc. where she developed and implemented strategies to establish value propositions, market access, and health economics tools to support the business. Her work spanned regions around the world, including North and South Americas.

Jessica also previously worked in the Global Health Economics and Market Access division at Ethicon, Inc. (Johnson & Johnson family of companies) supporting hernia solutions. Jessica also worked at Janssen (Johnson & Johnson family of companies) in the areas of schizophrenia, major depression disorder, and bipolar disorders within in the US Health Economics and Outcomes Research team. Prior to joining Johnson & Johnson, Jessica has been a manager in operations for Wolters Kluwer Health. She was a healthcare advisor, specifically in building corporate compliance programs for major pharmaceutical clients, at PricewaterhouseCoopers. Jessica’s career began at Merck as a health outcomes intern, a medical writer, a publications coordinator, and a customer analyst located in Hoddesdon, England for 6 months.

With over 20 years of healthcare industry experience, she has developed expertise in data analytics, project management, as well as economic value modeling. Jessica is passionate about keeping patients’ well-being at the center of her work.

Jessica graduated with a Masters in Health Science from the Johns Hopkins Bloomberg School of Public Health, specializing in Health Finance and Management, which included a yearlong fellowship. She holds a BS from The Pennsylvania State University. More recently, she has earned a graduate certificate in Health Policy from the Jefferson School of Population Health. Jessica is a member of her alumni groups, the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) as well as the Healthcare Businesswoman’s Association (HBA). Over the course of her career, Jessica has received numerous awards and recognition.

Sue Duvall
Head, North America Advertising and Promotion, Regulatory Affairs, MYLAN

Megan Francis-Sedlak, Manager, Global Medical Affairs, BAXALTA


Megan Francis-Sedlak
Senior Manager, Medical Affairs, HORIZON PHARMA

Megan Francis-Sedlak is a Senior Manager of Medical Affairs at Horizon Pharma in Lake Forest. Prior to working for Horizon Pharma, Megan served as a senior member of the advertising and promotional review committee in Medical Affairs at Baxalta U.S. Inc. and Baxter Healthcare prior to the split. Megan has 12 years of experience as a research scientist and manager in the healthcare field. Megan earned a Bachelor of Science in biomedical engineering from Saint Louis University as well as a Ph.D. in biomedical engineering from Illinois Institute of Technology.


Marge Garcia
Associate Director, Program Review Operations, GENENTECH


Steve Gersten
Vice President, General Counsel, and Chief Ethics and Compliance Officer, DYNAVAX TECHNOLOGIES


Mimi Giordano
Senior Copy Editor, UCB BIOSCIENCE

Stacy Harker
Manager, Promotional Compliance, ALLERGAN


Kevin Hollister
Senior Director, Regulatory Affairs, TESARO


John Marcus
Director, Regulatory Affairs, Labeling, Advertising and Promotion, HORIZON PHARMACEUTICALS


Michael Saad
Senior Manager, Marketing Operations, ABBVIE

Zafar Toor, Senior Director, Global Regulatory Affairs, EISAI


Zafar Toor, Pharm.D.
Senior Director, Commercial Regulatory Affairs, LEXICON PHARMACEUTICALS

Dr. Toor is the Head and Senior Director of Commercial Regulatory Affairs at Eisai Inc. He provides strategic direction to the organization on ways to optimize the promotional review process and plays a key role in introducing technologies to enhance the efficiency of the review and approval process for promotional materials.

Previously, Dr. Toor was the Director of Client Services at an advertising firm, Bimark Inc., where he worked with many pharmaceutical industry clients in the development of promotional campaigns for a variety of therapeutic areas. His experience has spanned most therapeutic areas, although he has worked extensively in the areas of oncology, cardiometabolic disorders, GI, and allergy and asthma.


James Vigil
Director, U.S. Regulatory Affairs, Advertising and Promotion, ABBVIE

Jim has been in regulatory affairs for 19 years, of which 16 have been in the area of advertising and promotion, and he is presently with AbbVie. Jim earned a J.D. from Indiana University School of Law at Indianapolis, and has a B.A. in molecular cellular and development biology and chemistry from the University of Colorado.

Alexander Zachos
Senior Manager, Regulatory Affairs, Labeling and Advertising, INTERCEPT PHARMACEUTICALS

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101 East Erie Street

Chicago, IL 60611

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