ADVOCATE. CONNECT. INNOVATE.

The Art and Science of Productive FDA Meetings

South San Francisco, CA

2/6/2018

10:30am - 1:00pm

Getting solutions to patients can be a long and complicated process. Working with the FDA is a key part of the sequence. Preparing for and understanding the FDA’s needs is essential to smooth the way and shorten your time to approval.

Johnson & Johnson Innovation, JLABS is happy to be hosting Ron Farkas, MD PhD, Vice President, Technical, PAREXEL Consulting, to discuss the ins and outs of FDA meetings. Ron will pull from his vast experience which includes a decade plus run at the FDA to help guide us through these vital interactions. Topics will include:

Understanding the FDA’s position; not just what it wants but why
What to agree on now and later; What does agreement mean?
The key to proceed
Understanding the dynamics within the FDA
Flexibility and norms and what they mean
Experts, Patients and Advocates at Meetings
Meeting minutes and follow up

Understanding the process will help you better prepare for your meetings and build confidence in and ability to adjust your own plan. Come prepared with your questions!

Click Here for More Information

Contact: Nikki Sarantinos
Contact Email: nsarant1@its.jnj.com

Event Address:

JLABS @ SSF
329 Oyster Point Blvd
Floor 3
South San Francisco, CA
94080