18th Annual Pharmaceutical and Medical Device Compliance Congress: A Preview

PCF’s annual Pharmaceutical and Medical Device Compliance Congress kicks off next week. The conference offers attendees the rare opportunity to network with industry leaders and hear their thoughts and suggestions on the bevy of topics and regulations affecting those who work in the pharmaceutical or medical device compliance field. Narrowing the list of impressive panels and sessions down to a manageable schedule may seem overwhelming, but we’ve perused the agenda for what we are looking forward to the most:

Day 1, Monday November 6, 2017

Keynote: OIG Update
Hearing the list of topics that led to settlements and the OIG’s fiscal year 2017 workplan from Mary Riordan, Senior Counsel, Office of Inspector General, Department of Health and Human Services is always valuable for anyone responsible for rolling out compliance training. We are also looking forward to hearing how the agency expects to apply information from the Compliance Program Effectiveness Resource Guide released earlier this year as it conducts investigations.

U.S. Attorney’s Roundtable
While we expect to hear about topics such as off-label promotion, we look forward to hearing what the U.S. Attorneys say about the emerging trend of investigating manufacturer relationships with patient assistance charities. Several companies have been subpoenaed for information about these relationships. One company recently entered into a Deferred Prosecution Agreement, as well as a Corporate Integrity Agreement, after being accused of paying kickbacks to a patient assistance charity.

Chief Compliance Officer Roundtable
For those working in compliance for emerging companies, this session offers an opportunity to learn what risks their brethren from larger companies are facing so they know where to focus their priorities for the upcoming year. With Arjun Rajaratnam, from Smith & Nephew, joining the roundtable, medical device company representatives should also find the information worthwhile and relevant.

Day 2, Tuesday November 7, 2017

HCP Engagement: The Road to Proactive Risk Management

The title is intriguing and we’re curious to know what steps industry professionals like Tom Glavin of Olympus and Michelle Murphy of Regeneron utilize to change their corporate cultures and convince leadership to shift to a more proactive model for addressing risk.

Managed Market Considerations for Hub and Specialty Pharmacy Arrangements

Training and messaging for those who work with specialty pharmacies is a topic not often addressed in these forums, so hearing what industry professionals like Terra Buckley of Celgene and Greg Sherman of Gilead Sciences say should be of value.

Compliance Considerations for Small and Mid-Sized Pharma and Medical Device Companies

Here is a direct opportunity for attendees from emerging companies to evaluate their programs against companies of a comparable size and learn best practices for managing risks with less resources.

Brief Overview of the Policy and Politics of Pharma Pricing

Transparency around drug pricing is a hot topic with state and federal legislators. Learning more about the current laws, as well as what to expect from politicians in an election year, should prove to be valuable when evaluating risk, writing policy, and developing training.

The Exhibit Hall (Especially Booth #112!)

We’re looking forward to catching up with clients and friends (old and new) at the 18th Annual Pharmaceutical and Medical Device Compliance Congress. During the networking breaks, we invite you to stop by the PharmaCertify Booth to see demos of our newest compliance training solutions. Our mission is to help you build a stronger compliance culture and reduce risk, and we welcome the opportunity to show you how we’ve done just that for our clients. While you are there, don’t forget to enter the drawing to win a JBL Flip 4 Waterproof Portable Bluetooth Speaker!

See you in Washington!

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