The 2019 Regulatory Alliance Forum, hosted by AcKnowledge Regulatory Strategies, will take place on August 19-21, 2019 in San Diego, California.
The conference will primarily focus on FDA regulatory topics and updates to US medical device regulations. All of our speakers are former-FDA employees who worked at the Center for Devices and Radiological Health.
Attendees will represent a variety of backgrounds including:
Quality Assurance Professionals
Medical Device Manufacturers and Suppliers
Small Startups in the Medical Device, Digital Therapeutic, and In Vitro Diagnostics Space
VC and Angel Investors
People Who Love Regulatory Affairs!
If you’re interested in being a corporate sponsor, please contact email@example.com
More about the conference
All of our speakers are former FDA reviewers. We will continue to update this page as speakers continue to accept their invitations.
The conference will focus on the following topics:
Regulatory strategy: device classification, FDA pre-submissions, breakthrough designation
FDA premarket submissions: 510(k)s, de novo submissions, IDEs, and PMAs
Other relevant regulatory topics: combination products, cybersecurity, using real-world evidence in submissions, digital health considerations, changes to EMC/Electrical safety requirements, how the US FDA regulations compare to the new EU MDR/IVDR
Date: August 19 - August 21, 2019 (Monday-Wednesday)
Time: 8:00am-5:00pm daily
Location: The Dana on Mission Bay
1710 W Mission Bay Dr, San Diego, CA 92109
Early Bird - $1145 (on/before June 19)
Standard - $1245 (on/before August 4)
Registration closes at midnight, August 4 (PDT). There will be no day-of registration.
Registration includes all sessions, a Monday night social event, networking lunches, WiFi, and a thumbdrive with all presentations and handouts.
For students or for companies planning to send three or more people to attend the conference, please email firstname.lastname@example.org for discounted rates.
Attendees can earn up to 12 RAC Continuing Education Credits.
Please call (800) 445-3339 or (619)-222-6440 to make your hotel reservations, or click here to make your reservations online. The Dana is offering a discounted room rate of $179.00/night for conference attendees. To receive this discount, you must book your room by August 4, 2019.
Please reference the following when you make your reservation:
Things to do in san diego
We hope you fly in early to make a mini-vacation of your stay in San Diego, or that you find some extra time on your hands before you leave. The Dana hotel has extended their discounted rates to all attendees for the 3 days before and 3 days after the conference. If you’re stuck on deciding what to do, click below for some of our local favorites.
Still not sure about attending? Don’t wait too long as this conference is likely going to sell out! While some conferences simply expand into a bigger room to accommodate a larger group, we have capped the registration to make sure the conference stays small, personal, and fun. We hope you’ll join us!