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BioCurious Message Board › New Meetup: The Business of Drug and Device Development – regulation and app

New Meetup: The Business of Drug and Device Development – regulation and approval essentials

Eri G.
Group Organizer
Palo Alto, CA
Announcing a new Meetup for BioCurious!

What: The Business of Drug and Device Development – regulation and approval essentials

When: Tuesday, June 22, 2010 6:00 PM

Suggested donation: $10.00 per person

supersalad's lab
Grant & El Camino Real
Mountain View, CA 94041

The Business of Drug and Device Development – what you need to know about regulation and the approval process

Tuesday, June 22nd | 6:00 - 9:00 PM

Hosted by Srihari Yamanoor

As an entrepreneur, one of the most important balls you will juggle will be regulation. As you get more serious about your endeavor and seek funds you will notice that investors and others will seek out your “regulatory plan”. It is key to develop a thorough understanding of the regulatory process, what the FDA looks for, and the strategies companies adopt to ensure as smooth an approval process as possible.

The class will discuss the approval processes primarily focused on drugs and medical devices. We will talk about the different stages of the approval process involved in therapeutics. This will be followed by a discussion on medical device approval process. We will discuss the various classes of medical devices, how to determine the classification of your device.

Frequently, your devices and drugs will go through clinical trials in Europe, Mexico and other locations. We will discuss the need for this, how to initiate clinical trials in these locations, and how to work with the FDA throughout the process to ensure that the trials meet the standards for safety and effectiveness, essential for approval.

We will also discuss the regulatory process that is in flux at the FDA.

Cost: Free. $10 suggested donation. All proceeds will be used to support the lab.

Location: Mountain View. Exact address will be emailed to attendees.

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