FDA Communication Power Tools – Best Practices

Why Should You Attend:

The US Food and Drug Administration offers a range of mechanisms to communicate with premarket and premarket staff. The timing of communication and best practices to ensure both parties are understand each other’s messages is not well understood. Manufacturers regularly under-estimate the time and preparation required for effective communications for premarket applications and post market communications.

Effective communication with FDA is comprehensive and includes a range of topics including: print, verbal and electronic communication modes. Expert communications requires significant preparation and coordination to ensure both parties have a clear understanding of each other’s planned actions and the related rationale.

Attend this webinar to understand how to get your team prepared and how to plan to communicate with FDA, when to contact and how to contact. What are the risk management techniques to be used to communicate effectively and how to control the narrative for effective result.

Areas Covered in the Webinar:

• Best Practices in FDA Communications Preparation & Planning
1. Getting the team prepared
2. Maintaining communication
• Overview of communication mechanisms
1. 360 degree suite of sources of information
2. When to contact FDA and how
• Evaluation Risk Associated with FDA Communications (Premarket and post market)
1. Considerations when engaging FDA
2. How to control the narrative

Who Will Benefit:

• Compliance Leaders
• Regulatory Affairs Leaders
• Quality Leaders Vice President of Quality Assurance
• Director of Quality Assurance

Kwame Ulmer
Medical Device Executive, Angel Investor

Kwame Ulmer is a MedTech executive with 15 years of experience in government and the private sector. Mr. Ulmer integrates his experience working as an operating company executive, evaluating over 1,000 technologies at FDA, advising early stage companies, and formal business education to deliver high-impact consulting services.

Mr. Ulmer previously served as Vice President, Regulatory Affairs & Quality Assurance at Implant Direct, a Danaher Corporation Operating Company. Mr. Ulmer, led all efforts to accelerate market access via shortened global registrations timelines, improved product quality via process optimization and led activities resulting in best-in-class department engagement scores.

Kwame has served in progressive leadership roles at the US Food and Drug Administration (FDA). He managed the two fold growth of a Division to 74 employees and has personally evaluated hundreds of cardiovascular, ophthalmic and dental technology applications.

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