Life Science Compliance Update

May 24, 2017

Improving Outcomes – Analyzing a Compliance Training Curriculum to Reduce Risk


Life sciences compliance departments are under constant pressure to roll out updated and comprehensive training that addresses a growing milieu of subject matter, from off-label promotion, HIPAA, and data security, to antibribery laws around the globe. The rush to cover all the topics across all the potential audiences can lead to a convoluted curriculum, with gaps or redundancies in terms of which audiences receive what training. Building a curriculum that appropriately addresses the company’s unique risks is an important first step, but a regularly-scheduled analysis of all content, and audiences and delivery methods, is critical to ensure on-going effectiveness against risk.

In response to regulatory changes, compliance departments continually push out training focused on changing rules, regulations, and policies. Redundancies, misalignments, and occasionally, even gaps, emerge. This threatens the effectiveness of the curriculum. Regular, comprehensive analysis, with subsequent reconfiguration and realignment, is necessary to ensure that targeted training is being deployed to the appropriate audiences, at a frequency that maximizes engagement.

An effective, three-phase process begins with a comprehensive documentation of existing training content and components.

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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 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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