What manufacturers need to know about the new 340B Final Rule

Presented By: Marcy Imada | Mike Benedict

There is a lot to consider in the new regulations on calculating 340B ceiling prices, issuing refunds to covered entities, and imposing civil monetary penalties. An Interim Final Rule that extends the effective date from March 21, 2017 to the new effective date of May 22, 2017. Join Marcy Imada and Apexus’ Mike Benedict for a free webcast where they will explain the key changes and provide guidance on the potential impacts to your business.

3:00 p.m. ET

Manufacturer 340B price restatements and refunds to covered entities

Presented By: Marcy Imada | Christopher Hatwig

The 340B Drug Pricing Program is growing in complexity, as are your responsibilities regarding 340B price restatements and refunds to customers. Deloitte and Apexus have simplified the process, so that when you need to prepare restatements and provide refunds, you have experienced advisors who can help save time, money, and resources.

3:00 p.m. ET

FMV and the life sciences – managing challenges in a dynamic environment

Presented By: Prateep Menon | Rick Moore | Donna Vinluan | Nick Lynch

With the pharmaceutical supply chain shifting and becoming more complex due to the increase of specialty products and regulatory and political pressures, performing and managing Fair Market Value is challenging and evolving. This webinar will provide insights and may assist you and your team in developing effective and efficient methods for performing and managing Fair Market Value of third-party service arrangements.

2:00 p.m. ET

Taking control of Gross-to-Net: An innovative approach for life sciences companies

Presented By: Michael Makovec | Walter Worsham | Muna Tuna

Understanding Gross-to-Net (GTN) forecasting and accruals can be confusing in the life sciences industry. Join us for a free webcast where we’ll share leading practices designed to help you learn how to take control of your GTN estimation and modeling process.

2:00pm EDT

A closer look at AMP and other regulations – the impact on generics

Presented By: Rick Moore | Cortnaye Swan | Stephanie Trunk

We will break down the provisions of the AMP final rule and other regulatory guidance with a special focus on the needs and considerations of generic manufacturers.

2:00pm EST

The impact of AMP – operational and legal considerations

Presented By: Marcy Imada | John Shakow

Marcy Imada (Principal, Deloitte & Touche LLP) and John Shakow (Partner, King & Spalding) will provide a general overview of the AMP final rule, its implications from both operational and regulatory requirement considerations, and what CMS has stated they expect manufacturers to implement by April 1.

2:00pm EST

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