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The Art and Science of Productive FDA Meetings

JLABS Bay Area

Tuesday, February 6, 2018 from 10:30 AM to 1:00 PM (PST)

The Art and Science of Productive FDA Meetings

Ticket Information

Ticket Type Sales End Price Fee Quantity
General Public Feb 5, 2018 $25.00 $2.37
Student/Academic Feb 5, 2018 $10.00 $1.54
Volunteer   more info Jan 23, 2018 Free $0.00

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Event Details

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!

Speaker:
Ron Farkas | Vice President, Technical, PAREXEL Consulting read bio»

Agenda:
10:30 AM | Registration & Networking
11:00 AM | Presentation
11:40 AM | Q&A
12:00 PM | Networking Lunch
1:00 PM | Program Close


Fees:
$25 | General Public
$10 | Student/Academic
$35 | At the door

Location:
JLABS @ SSF
329 Oyster Point Blvd - 3rd Floor
South San Francisco, CA

Presenter's Biography:
John Bates 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.

Dr. Farkas uses his extensive scientific, drug development and regulatory experience to assist clients in negotiating with regulatory authorities across the entire product life cycle to achieve their company objectives.

Norris earned a bachelor's degree in business administration from the University of California, Riverside and a juris doctorate from Santa Clara University.

Prior to joining PAREXEL, Dr. Farkas was a Cross-Disciplinary Team Leader at FDA in CDER's Division of Neurology Products, with prior assignments to the Office of New Drugs Guidance and Policy Team and the CDRH Office of Device Evaluation. Prior to joining the FDA, Dr. Farkas was an assistant professor and attending surgeon at the Johns Hopkins University Wilmer Ophthalmic Institute.

Dr. Farkas completed residency training in ophthalmology at the Harvard University School of Medicine Massachusetts Eye and Ear Infirmary, subsequent to earning dual MD and PhD degrees in neuroanatomy and neuropharmacology from the University of Illinois at Chicago School of Medicine.
Connect with Ron:   Connect on LinkedIn

Have questions about The Art and Science of Productive FDA Meetings? Contact JLABS Bay Area

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When & Where


Johnson & Johnson Innovation, JLABS
329 Oyster Point Blvd
3rd Floor
South San Francisco, CA

Tuesday, February 6, 2018 from 10:30 AM to 1:00 PM (PST)


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Organizer

JLABS Bay Area

Johnson & Johnson Innovation, JLABS (JLABS) is a global network of open innovation ecosystems, enabling and empowering innovators to create and accelerate the delivery of life-saving, life-enhancing health and wellness solutions to patients around the world. JLABS achieves this by providing the optimal environment for emerging companies to catalyze growth and optimize their research and development by opening them to vital industry connections, delivering entrepreneurial programs and providing a capital-efficient, flexible platform where they can transform the scientific discoveries of today into the breakthrough healthcare solutions of tomorrow. At JLABS we value great ideas and are passionate about removing obstacles to success to help innovators unleash the potential of their early scientific discoveries. JLABS is a no-strings-attached model, which means entrepreneurs are free to develop their science while holding on to their intellectual property. JLABS is open to entrepreneurs across a broad healthcare spectrum including pharmaceutical, medical device, consumer and digital health sectors. The JLABS flagship opened in 2012 in San Diego at Janssen's West Coast Research Center, and since then has grown to eight locations including the Bay Area, Boston & Lowell, MA, Houston, Toronto and a ninth location, New York City, launching in 2018. For more information please visit jlabs.jnjinnovation.com.

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The Art and Science of Productive FDA Meetings
Things to do in South San Francisco, CA Class Business

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