Invalid quantity. Please enter a quantity of 1 or more.
The quantity you chose exceeds the quantity available.
Please enter your name.
Please enter an email address.
Please enter a valid email address.
Please enter your message or comments.
Please enter the code as shown on the image.
Please select the date you would like to attend.
Please enter an email address.
Please enter a valid email address in the To: field.
Please enter a subject for your message.
Please enter a message.
You can only send this invitations to 10 email addresses at a time.
$$$$ is not a properly formatted color. Please use the format #RRGGBB for all colors.
Please limit your message to $$$$ characters. There are currently ££££.
$$$$ is not a valid email address.
Please enter a promotional code.
N/A
Sold Out
Unavailable
Please enter a password with at least 8 characters.
You have exceeded the time limit and your reservation has been released.
The purpose of this time limit is to ensure that registration is available to as many people as possible. We apologize for the inconvenience.
This option is not available anymore. Please choose a different option.
Please read and accept the waiver.
All fields marked with * are required.
Please double check your email address. The email address format does not appear valid.
Please double check your email address. Your emails do not match.
$$$$ requires a number between ££££ and §§§§
US Zipcodes need to be 5 digits.
Postal code may contain no more than 9 letter or number characters.
Please double check your website URL.
All fields marked with * are required.
Your card expiration date is in the past.
Your card CSC needs to be 4 digits.
Please confirm your order: $$$$ You have selected to Pay by Check.
Click OK to confirm your order.
Please confirm your order: $$$$ You have selected to Pay at the Door.
Click OK to confirm your order.
Please confirm your order: $$$$ You have selected to Pay upon Receiving an Invoice.
Click OK to confirm your order.
Your card CSC needs to be 3 digits.
Sofort is only available in Germany and Austria.
Boleto Bancario is only available in Brazil.
PagoFacil is only available in Argentina.
Rapipago is only available in Argentina.
Please enter a valid IBAN number.
You need to accept to charge your bank account.
Your billing zip code needs to be 5 digits.
Please double check your CEP info. The CEP format should be something like 12345-678.
Please double check your tax identifier.
There was a problem saving your address.
There was a problem saving your card info.
There was a problem saving your personal information.
Please select the date you would like to attend.
McAfee Secure sites help keep you safe from identity theft, card fraud, spyware, spam, viruses and online scams.
Copying Prohibited by Law - McAfee Secure is a Trademark of McAfee, Inc.
Unknown card type.
No card number provided.
card number is in invalid format.
Wrong card type or card number is invalid.
card number has an inappropriate number of digits.
Please enter numbers here.
Please enter an integer value.
Numbers must be less or equal to $$$$
All the required fields have not been filled out. Click OK to proceed without all the required information, or click Cancel to finish entering the missing data.
Job titles must be less than 50 characters.
Please enter a donation amount.
Please select an attendee for donation.
There is currently an issue with card submission on Safari with iOS7. Please try again with a different browser or device.
Sorry, invalid event registration form.
Sorry, invalid event or database error.
Sorry, quantity must be a positive integer.
Sorry, you did not select a valid ticket.
Sorry, invalid event organizer email address.
Your order was canceled.
Thank You. Your order has been successfully completed. Your name and email address have been added to the list of event attendees.
Sorry, that option is sold out.
Sorry, that option is no longer available.
Sorry, there are only 78 tickets of that type still available.
Sorry, you entered an invalid quantity. Please enter a quantity of 1 or more next to the type or types of tickets you would like to purchase.
Sorry, you did not select any tickets to purchase. Please enter a quantity of 1 or more next to the type or types of tickets you would like to purchase.
Sorry, there are no tickets left for this event.
The tickets, ticket quantity or date and time you've requested are no longer available, due to previous sales. Please choose a different date, time or number of tickets and place your order again.
Sorry, one or more of the tickets you requested are no longer available for purchase.
Sorry, you need to select the date you want to attend.
Sorry, the promotional code you entered is not valid yet.
Sorry, the promotional code you entered has expired.
Sorry, the promotional code you entered is not valid.
Your session has expired. Try ordering again.
Sorry, your requested ticket quantity exceeds the number provided by your promotional code.
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 Consultingread 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
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.
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:
Have questions about The Art and Science of Productive FDA Meetings?
Contact JLABS @ TMC
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.
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. 
Ron Farkas | Vice President, Technical, PAREXEL Consulting
Share The Art and Science of Productive FDA Meetings
Email Share Tweet