San Francisco, California
London, United Kingdom
I-Corps Graduate Ongoing Education, or "GrOE", is a program dedicated solely to helping I-Corps grads from the NYCRIN region learn how to form and grow a sustainable and successful venture.
The meetup in NYC is for grads to network, share challenges and solutions, find new mentors or other team members, and perhaps most importantly: learn about a specific topic you currently need guidance with from an expert in the field.
The topic this month will be "Regulatory Affairs 101 for Startups" and will be hosted by Jules Mitchel, President of Target Health.
WebEx link here.
- 5:00-5:15pm Arrival and Welcome
- 5:15-6:00pm Presentation "Regulatory Affairs 101 for Startups"
- 6:00-6:15pm Q&A
- 6:15-6:45pm Networking & workshop with speaker(s)
Dr. Jules Mitchel
Dr. Jules T. Mitchel is President of Target Health Inc., a New York City based CRO with expertise in Regulatory Affairs, including FDA interactions and all submissions, Strategic Planning, Clinical Research Management, Biostatistics and Data Management, Medical Writing, Good Manufacturing Practices (GMP) and other support services to the pharmaceutical industry. Dr. Mitchel has broad base pharmaceutical experience in drugs, biologics, devices and diagnostics including three NDA submission, many FDA meetings and IND/IDE submissions, study reports, manuscripts and strategic planning. Areas of expertise include but are not limited to, Women's Health, Dermatology, Antimicrobials, Pharmacokinetics, Rheumatology, Ophthalmology, Natural Products, Oral Care, Oncology and Regulatory Affairs. Dr. Mitchel has held industry positions at American Home Products, Pfizer Laboratories and Pfizer Consumer Health Care and academic positions at New York Medical College, Cornell University School of Medicine and NYU School of Medicine.