Global Medical Device Submissions and Strategy –
REGL.X401 –
Description
The global nature of the medical device industry presents both opportunities and challenges for medical device companies and regulatory affairs professionals who must navigate a diverse regulatory terrain. Through interactive lectures and facilitated group projects, students gain a practical understanding of international medical device requirements and regulations for major and emerging markets around the world, with emphasis on the EU, Canada, Japan, China and Brazil. A comparative approach highlights regulatory and process similarities and differences between countries and underscores the impact they have on global regulatory and business strategies. This course will benefit regulatory affairs professionals who need to help their organizations understand the barriers to entry into global medical device market.
http://course.ucsc-extension.edu/modules/shop/index.html?action=section&OfferingID=5645291&SectionID=6469145
Prerequisites:
REGL.X404 (“Regulation of Medical Devices and Diagnostics” or equivalent course or work experience.)
Section Description
Two meeting dates: Saturday, April 06 and Saturdday April 13 (8:30 AM to 5:00 PM)
Course materials other than the required textbook will be available through UCSC Extension’s Online Learning Center. For access instructions, go to UCSC Extension’s Online Learning Center at http://www.ucsc-extension.edu/online-faqs. The account will be activated one day prior to the first class meeting.
Note: Given the fast-paced, information-rich nature of this course, prior completion of the “Regulation of Medical Devices and Diagnostics” or equivalent course or work experience is required.
| Dates: Apr 6, 2019 – Apr 13, 2019 | Time: 08:30 AM PDT |  FULL SCHEDULE |
Location
SANTA CLARA
Instructors
Cost Information
Additional Information
Event Information
Event Topic:
Course: Global Medical Device Submissions and Strategy
Event Description:
http://course.ucsc-extension.edu/modules/shop/index.html?action=section&OfferingID=5645291&SectionID=6469145
Date/Time:
Date(s) - 04/06/19 - 04/13/19
All Day
Event Location:
Other: UCSC Extension, 3175 Bowers Ave., Santa Clara, CA
Event Details
Event Type
Classroom