27 March - 14:00 -15:00 GMT / 15:00 – 16:00 CET / 09.00 - 10.00 ET

CHMP OEs and FDA Adcoms: Navigating the Differences to Prepare for Success

A Committee for Medicinal Products for Human Use (CHMP) Oral Explanation (OE) is the most critical meeting for getting a product authorized in the EU and strengthening the company’s reputation and credibility with the CHMP. Companies are expected to present alternative analyses, provide new arguments, and offer actions to lessen risks – and all of this is done behind closed doors in one hour. While there are some similarities when companies seek product approval in the US with the Food and Drug Administration (FDA), there are major differences that team’s need to account for when communicating and engaging with the FDA throughout the regulatory approval pathway. 

Regardless of the regulatory interaction, one thing is true. The stakes couldn’t be higher. Companies must strategically plan, prepare, and deliver a strong position that can be remembered. It is critical to their communications and business success. The good news is processes, tools, and technology can be leveraged to help regulatory teams maximize their communications, time, and interactions with regulators across the board.
Target Audience & Learning Outcomes

This webinar is for regulatory professions seeking to better understand the time, resources, and activities needed to prepare for regulatory communications, and specifically key interactions with the FDA and the CHMP/EMA. Attendees will learn the similarities and differences in the regulatory pathways—and how strategies that can be applied to maximize the various communication opportunities, overcome communications challenges—and ultimately win a majority vote. Whether you are responsible for a single regulatory application, leading a team, or managing a broader regulatory portfolio, this webinar will enable you to navigate the opportunities and challenges with communicating to regulatory bodies with confidence.

Speakers

Kell Cannon, MBA, Senior Science Lead, 3D Communications 
kcannon@3dcommunications.us

Michelle Zucatti, MHA, Senior Communications Lead, 3D Communications 
mzucatti@3dcommunications.us

Disclaimer: Whilst TOPRA is running this webinar for 3D Communications, this is not an endorsement of 3D Communications, 3D Communications' affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.

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Pricing

• Members: free
• Non-members: free

Terms and Conditions

By purchasing this webinar, you are agreeing to TOPRA's training terms and conditions.