San Diego, CA (May 23, 2019) — For the very first time, AcKnowledge Regulatory Strategies, LLC is bringing together a highly accomplished group of former-FDA employees to present and discuss regulatory topics and updates to U.S. medical device regulations.
The conference will take place at The Dana at Mission Bay in San Diego, California this summer over the course of three days, August 19th-21st.
The Regulatory Alliance Forum is intended for regulatory affairs and quality assurance professionals, medical device manufacturers and suppliers, investors, and small startups who are seeking insight into the FDA's regulatory process. Topics covered include regulatory strategy, pre-submissions, and the premarket submission process for 510(k)s, de novos, IDEs/HDEs, and PMAs. The conference will also feature sessions dedicated to patient experience, combination products and CBER devices, In Vitro Diagnostics, as well as digital health and cybersecurity. All of the featured speakers are former-FDA employees who worked at the Center for Devices and Radiological Health (CDRH) and will share their diverse experiences and expertise.
Registration for the conference is now open at the Early Bird price of $1,145 per person. Discounted prices are available for students, professionals who are between jobs, and groups from the same company. Prices are set to increase to the full ticket price of $1,245 on Wednesday, June 19th. Registration closes at midnight on Sunday, August 4th. Registration for the conference includes all sessions and events, including a Monday night social event, networking lunches, free parking, WiFi, and a USB containing all presentations, templates, and handouts.
Attendees are encouraged to bring their families and fly into San Diego either a few days early or stay an extra few days to make a memorable trip out of the conference, especially considering that The Dana at Mission Bay has extended their discounted rates to all attendees for three days before and after the conference. Further information on booking a room and activities to do in San Diego can be found here.
For more information on registration, how to become a corporate sponsor, or for any questions about the event, please email Blythe at [email protected]. For companies who wish to support the inaugural Regulatory Alliance Forum, there are a variety of sponsorship options and packages available, including opportunities to sponsor social events, speakers, and more.
About AcKnowledge Regulatory Strategies: AcKnowledge RS was founded in 2014 by Dr. Allison Komiyama, a former FDA-employee herself. AcKnowledge RS specializes in Regulatory Affairs consulting for the medical device industry, and has experience in various submissions types, including 510(k)s, pre-submissions, PMAs, and much more.
Contact Information:
Blythe Sinclair
619-458-9547