Slide background

Slide background
Slide background
Slide background

Loading Events
March
2018
29
The Art and Science of Productive FDA Meetings

10:30 AM — 1:00 PM

Ron Farkas | Vice President, Technical, PAREXEL Consulting

See New York Genome Center’s lecture series, events and archives VIEW FULL CALENDAR

About

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!

 

 

REGISTER

 

Agenda:
10:30 AM | Registration Opens
11:00 AM | Presentation
11:45 AM | Q&A
12:00 PM | Networking Lunch
1:00 PM | Program Close

 

Fees:
$25 | General Public
$35 | At the door

 

Venue:
New York Genome Center
101 6th Avenue
New York, NY 10013

 

Presenter’s Biography:
Ron Farkas | Vice President, Technical, PAREXEL Consulting

 

Dr. Ronald Farkas is a senior regulatory professional with over 15 years of experience in all phases of drug development from preclinical development through marketing application, advisory committee meetings, labeling negotiations, and the post-approval period. Dr. Farkas has  in-depth cross-disciplinary expertise in clinical safety and efficacy, clinical pharmacology and pharmacogenomics, preclinical development, statistical analysis, and biomarker/surrogate endpoint development and utilization.

 

To learn more about Dr. Ronald Farkas, click this link.