Life Science Compliance Update

September 13, 2017

Retrospect and Looking Forward: A Review of Three Full Years of Open Payments Data and Media Coverage

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Tomorrow, September 14, 2017, from 10:00 am EST – 11:00 am EST, qordata is hosting a webinar on the three years of Open Payments data that has been made public. The speaker is none other than our editor, Thomas Sullivan, who looks forward to sharing highlights on the full three years of Open Payments data, and give some insight on what likely lies ahead in the future.

In addition to reviewing the 2014-2016 Open Payments data, Mr. Sullivan looks forward to providing insights on the following:

  • Media coverage of Open Payments and the released data sets;
  • New State laws, including transparency laws and “gift bans”;
  • Recommendations on the Open Payments program;
  • Congressional actions on Open Payments; and
  • Where do we go from here

If you are a Chief Compliance Officer (CCO), Director of Compliance, or Compliance Manager, we encourage you to register and attend.

In the event that you are unable to attend the webinar live, recordings will be emailed to all registrants once available. Please click here to register.

August 25, 2017

5th Annual Promotional Review Committee Compliance & Best Practices

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ExL Events is hosting the 5th Annual Promotional Review Committee Compliance & Best Practices conference on October 16–17, 2017 at the Wyndham Hamilton Park in Florham Park, NJ.

Promotional review professionals have been challenged by many new regulatory developments in the last four years, due to the rapid growth of social media as a marketing platform, the popularization of online regulatory submission, and the still-growing shockwaves from 1st Amendment court decisions about off-label communication. 

This year’s conference convenes industry experts from AbbVie, Allergan, Daiichi Sankyo, Eli Lilly, Leo Pharma, Pacira, Pfizer, Sanofi, Sunovion, and more. Speakers will provide all-new insights in response to audience requests on topics including proper outreach to managed markets, adaptive website review techniques, and ensuring promotional compliance with FDAMA 114. Attendees will come away with the skills to optimize their PRC roster, teamwork, and speed.

Featured Speakers:

  • Cynthia Akue,

Promotional Planner, ALLERGAN

  • Sergio Alegre,

Vice President, Global Compliance, VERTICAL PHARMACEUTICALS

  • Jill Charbonneau,

Director, Regulatory Affairs, AdProm, Product Launch and Labeling, MARATHON PHARMACEUTICALS

  • Masha Chestukhin,

Senior Manager, North America Compliance, SANOFI

  • Howard Dorfman,

Senior Corporate Counsel, EDGE THERAPEUTICS

  • David Jacobs,

Assistant General Counsel, Commercial Brands, DAIICHI SANKYO

  • Sameer Lal,

Senior Vice President, INDEGENE

  • Nellie Mamuya,

Quality and Compliance Manager, KEDRION BIOPHARMA

  • Anthony Molloy,

Vice President, Legal and Compliance, PACIRA PHARMACEUTICALS

  • Doreen Morgan,

Vice President, U.S. Regulatory Affairs, LEO PHARMA

  • Scott Morrison,

Global Biosimilars Medical Review Lead, PFIZER

  • Leslie North,

Vice President, Sales and Marketing, EAGLE PHARMACEUTICALS

  • Ana Rasack,

Regulatory Affairs Associate, HELSINN THERAPEUTICS

  • Josephine Secnik,

Director, Ad/Promo Regulatory Affairs, ELI LILLY

  • Keri Shugrue,

Senior Project Manager, Promotion Materials Compliance Manager, SUNOVION

  • Amy Van Sant,

Director, Regulatory Advertising and Promotion, JANSSEN

  • Gary Wieczorek,

Director, Regulatory Affairs, U.S. Ad/Promo, ABBVIE

To visit the conference website, please go to: www.exlevents.com/prc.

To register, please go to http://bit.ly/2u0sEbp and use Priority Code C897LSCU.

August 24, 2017

15th Annual Independent Medical Education and Grants Breakthrough Summit

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The Fifteenth Annual Independent Medical Education and Grants Breakthrough Summit will be held September 12 through 13, 2017 at the Sonesta Hotel in Philadelphia, Pennsylvania. The event promises to bring together supporting organizations, medical education providers, and other key stakeholders to address some of the industry-leading issues.

Attendees will gain the latest insights on how to: assess the opportunities for medical education in a value-based healthcare landscape; evaluate and weigh the benefits versus costs to incorporate innovative learning formats and the latest technologies into CME; partner with patient advocacy groups to improve the value and effectiveness of IME programs; and communicate the value of CME to internal stakeholders.

On Tuesday, September 12, 2017, the day opens with a continental breakfast, followed by a welcome and opening remarks by Mike LoPresti of the Global Academy for Medical Education. Andrew Rosenberg with the CME Coalition will then present a Washington Healthcare Update. After a few other presentations and a networking rbeak, the first panel will form, “Patient Advocacy Groups 101 – Understanding How Patient Advocacy Groups Function and their Role in the Healthcare Industry,” with panelists including Stephen Chavez of Health Advocacy Partners, Jennifer Mefford of the Pulmonary Fibrosis Foundation, and Gina Ross Murdoch with the Multiple Sclerosis Association of America. The afternoon will have several workshop offerings, including “Creating More Impactful Reports and Communications,” “Telemedicine – The Next Big Thing in CME and QIE,” and “Innovating in Traditional CME Offerings.” The day ends with a networking, wine and cheese reception.

On Wednesday, the day starts again with a panel on “Shared Risk, Reduced Costs and Improved Outcomes – What’s the Role of CME in Value-based Healthcare,” with panelists Molly Mooney with the Cleveland Clinic, Michael Reilly of Regeneron Pharmaceuticals, and Karyn Ruiz-Cordell of RealCME. Several other panels and a networking lunch will preclude the final panel, “Grants Review – The Art of Crafting Quality Grant Applications.” The final panel will include thoughts from Ann Marie DeMatteo of Regeneron Pharmaceuticals, Samantha Koth of Sunovion Pharmaceuticals, Derek Warnick of Pfizer Inc., and Greselda Butler of Otsuka Pharmaceutical Development and Commercialization, Inc.

Policy and Medicine readers can save $300 on registration by using the code IMEPM3. The discount applies to standard rates only and may not be combined with other offers, category rates, promotions or applied to an existing registration. Offer not valid on academic or non-profit registrations.

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