Life Science Compliance Update

April 24, 2017

Eighth Aggregate Spend and Sunshine Act Conference


On June 15th and 16th, 2017, the Eighth Aggregate Spend and Sunshine Act Conference will be held at the Sonesta Philadelphia Rittenhouse Square in Philadelphia, PA. The conference has proven to be industry’s leading educational event where compliance and reporting professionals convene to discuss past submissions and upcoming changes in order to better prepare for the future.

The conference focuses on the Physician Payments Sunshine Act, which was intended to advance the life sciences industry standard of transparency, but the ambiguity of current regulatory principles continues to puzzle compliance and reporting professionals, leaving them with more questions than solutions. In addition to those issues, the actual collection of aggregate data is challenging for departments across organizations, further complicating even the most effortless tasks. Through interactive discussions and expert presentations, the conference will provide attendees with the tools needed to leverage data analytics and elevate daily operations.

Some of the conference’s featured speakers include:

  • Amie Phillips Pablo, Novo Nordisk Inc;
  • Michael O’Connor, Alexion Pharmaceuticals, Inc.;
  • Richard Velardi, Sun Pharma;
  • Michael Hunn, Draeger Medical;
  • Ishita Arora, Horizon Pharma, LLC; and
  • Gretchen Reyes Cseplo, Convatec.

According to ExL Events, the top five reasons to attend are: you will learn how to (1) uncover ways to optimize your organization’s daily operations using aggregate spend data required by the Sunshine Act; (2) comply with new CMS documentation guidelines surrounding aggregate spend reporting; (3) effectively communicate with healthcare providers across national and global data reporting landscapes; (4) consider frameworks for conducting internal audits designed to measure success; and (5) discuss best practices for leveraging your data analytics to assess compliance risk.

If you are interested in attending, you can register here.

April 20, 2017

FDA Public Workshop on Opioid Training


The Food and Drug Administration (FDA) has announced a public workshop to obtain input on issues and challenges associated with federal efforts to train prescribers on pain management and the safe use of opioids.

The workshop has three major goals. First, participants will be asked to discuss the role that health care provider training plays, within the broader context of ongoing activities, to improve pain management and the safe use of opioids. Second, participants will be asked to comment on how best to provide health care providers, who prescribe or are directly involved in the management or support of patients with pain, appropriate training in pain management and the safe use of opioids. As a part of this discussion, current training efforts by States, hospitals and health care systems, Federal Agencies, professional associations and other groups will be considered in order to strategize how best to facilitate training for these health care providers. Finally, participants will also be asked about issues and challenges associated with possible changes to Federal efforts to educate health care providers on pain management and the safe use of opioids.

The public meeting, “Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics – Exploring the Path Forward,” is scheduled for May 9th and 10th, 2017, from 8:30 am to 5:00 pm on the 9th and 8:30 am – 4:30 pm on the 10th. The event will be hosted at the Sheraton in Silver Spring, Maryland.

Seating for this event is limited and the FDA may limit the number of participants from each organization. If you are interested in attending, either in person or via webcast, you can register here. Registration closes for the event on May 1, 2017.

During online registration, you may indicate if you wish to provide a statement during the Open Public Comment Period. The FDA will do what it can to accommodate requests to make public comments based on time allocated for public comment. Individuals and organizations with common interests are urged to consolidate or coordinate their comments, and request time for a joint presentation. Following the close of registration date, the FDA will determine the amount of time allotted to each commenter and the approximate time each oral comment is scheduled to begin; commenters should arrive ahead of their scheduled time in case the agenda moves ahead of schedule so as to be sure not to forfeit their speaking time. All requests to make oral comments must be received by the close of registration on May 1, 2017. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.

If time and space permit, the FDA will allow for onsite registration on the day of the workshop, starting at 7:30 am.

Comments can be submitted either electronically or written by July 10, 2017.  

April 03, 2017

Fourth Promotional Review Committee Compliance and Best Practices – Midwest


On May 16th and 17th, 2017, ExL Events will host the Fourth Promotional Review Committee Compliance and Best Practices Conference at The James Chicago in Chicago, IL. The Conference is the only industry forum devoted entirely to boosting the skills and teamwork of all the stakeholders in the PRC process. Whether you are a submitter, reviewer, project manager, or meeting facilitator, this conference promises to provide you with a unique opportunity to learn and network with your peers and work to improve the cooperation, compliance, and speed of your PRC.

This year’s conference features speakers such as:

  • Denise Sanchez, Executive Director, Regulatory Affairs Advertising and Promotion, Allergan
  • John Caruso, Senior Manager, Promotion Compliance, Otsuka
  • Kevin Stark, Director, Office of Promotion and Advertising, Merck
  • Leann Bonaventura, Senior Manager, Promotional Regulatory Affairs, Medimmune

The first day starts off with a workshop on how to develop and maintain a promotional claims compendium for each product, and the official conference kicks off at 1:00 pm with an introduction, followed by panels, discussions, and case study presentations on a variety of topics focusing on new guidelines and new media for promotional review.

Day Two focuses on improving PRC teamwork and performance metrics with panel discussions and presentations. Some of the discussions include: how to prepare PRCs to respond to label changes; focus on facilitators to keep PRCs functioning smoothly; and how to leverage team member skills to enhance the PRC process. 

ExL Events cites as the top five reasons to attend, as attendees will learn: the latest methods for reassessing risk in light of First Amendment court case decisions in off-label messaging; promotional review strategy optimization for social media and adaptive websites; techniques to empower facilitators and leaders for a smoother PRC process; methods to select the ideal metrics for PRC performance improvement; and in-depth interactive workshop on developing and maintaining a promotional claims compendium.

The conference is designed for pharma, biotech, and medical device professionals who have responsibilities in the following areas: promotion review; regulatory affairs; compliance; medical affairs; communications; medical and scientific writing; and more.

If you are interested in attending, you can register here.


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