Indiana has a rich presence of medical device, pharmaceutical, and other life science companies. There is also a surprising number of startups and entrepreneurs in this space. On April 25, 2013, Catherine Tanner, one of Indiana’s life science entrepreneurs, will share her story with INpact, a medical device networking group. Be sure to RSVP.
There is a great opportunity this Friday (3/22) to hear from Scott Durlacher of Anson Group on preparing for a FDA audit. If you are part of a medical device company, I highly recommend you participate. Having worked with and knowing Scott, he has a ton of experiences and suggestions to assist you in being prepared.
Here is a link to the INpact event page.
INpact is trying something new in February–an evening event at a cool space known as the Speak Easy. A local vascular surgeon, Dr. George Akingba will be speaking to the group, sharing some of his work and thoughts on healthcare.
Plenty of opportunities to network. Oh, and pizza and beer with your admission.
A colleague, Rob Packard is conducting a webinar on October 30, 2012 for those in IVD medical device industry. Specifically, the webinar is titled “Companion Diagnostics: Regulatory Updates for FDA, EU, Canada”. Rob knows his stuff, especially when it comes to analyzing impact changing regulations will have on bringing new medical products to market.
Lots of exciting medical device events are approaching, including:
Be sure to check out these and more from the our Events page.
There are quite a few interesting medical device related events throughout the Midwest, many in Indianapolis, in the month of July.
Check out the CQ Events page for all the details.
June 5, 2012- The State of STEM Education In Indiana: Challenges Today and Strategies for Future Success
2012 FDA Regulatory 101 Course Wednesday, May 23, 2012
Approved for 5.3 Hours of CLE Credit
Presented by a host of Indiana Medical Device Manufacturing Sector Experts
Sponsored by Samco & Associates, Inc.
2 Sponsorships Available (Sponsorship includes promotions, signage at the event as well as a shared table for materials distribution. Sign up at the bottom of the Registration Form)
|8:30-9:00 am||Registration / Continental Breakfast / Networking|
|9:00-9:15||Welcome||Ralph Hall, Counsel, Faegre Baker Daniels|
|9:15-10:00||Clinical Trials and IDEs 21 CFR 50, 54, 812 Roles and responsibilities FDA submission process Informed consents, IRBs, etc. European Issues||Keli Hankee, Manager, Clinical Affairs, Biomet, Inc.|
|10:15-11:15||Submissions PMA requirements Submission contents Process and issues 510(k) requirements Process and requirements 513(g)||Russell Gray, Sr. Regulatory Consultant The Anson Group|
|11:15-11:45||Combination Products||Suzanne O’Shea, Partner Faegre Baker Daniels|
|11:45-12:15||Complaint Handling/Corrections and Removals Part 806, Part 7 Part 803||Dale Miller, Manager, Regulatory Affairs Zimmer, Inc.|
|12:15-1:15||Lunch and Networking|
|1:15-2:15||QSR Overview 820 Design controls Management responsibility Process controls Adverse Event Reporting Other QSR topics||Chris Kilander Regulatory Affairs Manager Cook, Inc.|
|2:30-3:15||Advertising and Promotional Controls||Danelle Miller, Global Regulatory Counsel Roche Diagnostics|
|3:15-4:00||Enforcement / Wrap Up Administrative, civil and criminal Other Provisions (qui tam, 1001, 371)||Ralph Hall, Counsel Faegre Baker Daniels|
Register Online Now! Use your username and password to expedite registration by prefilling the registration form!
Registration Only: 8:30 am Program: 9:00 – 4:00 pm Location: Montage Catering Facility, 8580 Allison Pointe Blvd., Indianapolis, IN 46250
Members: $195 per person (Member discounts apply when registering more than 4 attendees at the same time)
Non-Members: $275 per person For more information or to join the IMDMC, please contact Blake Jeffery at IMDMCoffice@ameritech.net.
|May 18 GIIRT Breakfast: Make Organizational Change Happen with the “Patterns of Innovation”|
RAPS Indiana Chapter Event: May 14th, 2012
Please join us for a lively discussion directed by Jody Roth about “Key Regulatory Trends in 2011 Biological Approvals” at the next RAPS Indiana Chapter event. The event will be held on May 14th, 2012 from 4:00pm-6:00pm at the IUETC Ice Miller Room. To register, click here.