The Art and Science of Productive FDA Meetings
May 03, 2018
Houston, TX (USA)
Thursday, May 3, 10:30 am – 1:00 pm
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.
Join Ron Farkas 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
Dr. Ronald Farkas is a senior regulatory professional with 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. 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.
General Public $15