Regulatory Affairs & Services 2018 2019 Course Schedules SCSU at Plymouth 9750 Rockford Road Plymouth, MN 55369 M.S. Program www.msras.com Term Cohort Course Number Course ID Course Title Credits Day and Time Instructor Room Summer 2018 & stand & stand RAS 627 000037 Intl Reg. Aff.: European Union, East, Eur, Canada, Australia RAS 643 000038 Reimbursement and Cost management for Med. Tech. RAS 644 000748 RAS internship 3 Monday and Wednesday: 5:00pm Wed. May 9th, Wed. May 16th; Mon. May 21st, Wed. May 23rd; Mon. Jun 4th, Wed. Jun 6th; Wed. Jun 13 th ; Wed. Jun 20th; Wed. Jun 27th; (No Class Mon. May 28 th and Wednesday, May 30th) 3 Monday and Thursday: 5:00pm Thurs. May 10th, Mon. May 14th; Thurs. May 17th, Thurs. May 24th; Thurs. May 31st, Thurs. Jun 7th; Mon. Jun 11 th ; Mon. Jun 18th; Mon. Jun 25th; (No Class Mon. May 28 th ) As arranged with instructor Mona Magnuson Kristin Fountain Mary Fautsch Mary Kay Sobcinski Jen Mischke 103
Fall 2018 & stand RAS 621 001685 Legal Basis for Medical Product Regulation 3 Wednesday 5:00pm Sept 12 th, 19 th and 26 th Oct 3rd, 10 th, 17th, and 24 th Nov 7th and 14 th make-up Nov 28 th (no class Oct 31st) Prithul Bom Amy Fowler 104 & certificate & stand MTQ 620/ RAS 633 001686 Medical Device Quality & Regulatory Fundamentals Required Text: Memory Jogger 2 - Tools for Continuous Improvement and Effective Planning, ISBN: 978-1- 57681-113-9 3 Tuesday, 5:00pm - Sept 18 th, and 25 th Oct 2 nd, 16 th, 23 rd, and 30 th Nov 6 th, 13 th, and 27 th make-up Dec 4 th (no class Oct 9 th and Nov 20 th ) Steve Gompertz Dave Koosman Mona Magnuson Kristin Fountain Michael Schnabel & stand & stand RAS 625 001687 Regulatory Routes to Market: PMAs 3 Monday 5:00pm Sept 10 th, 17 th, and 24 th Oct 1 st, 8 th 15 th, and 29 th Nov 5 th and 19 th make-up Nov 26 th (no class Oct 22 nd or Nov 12 th ) RAS 655 001688 Intl Reg. Aff: Japan, Other Asia, 3 Wednesday 5:00pm Latin America, Middle East Sept 12 th, 19 th and 26 th Oct 3rd, 10 th, 17th, and 24 th Nov 7th and 14 th make-up Nov 28 th (no class Oct 31st) RAS 644 001689 Regulatory Affairs Internship Brian Novak Dave Mueller Scott Sardeson Rica Morris Mary Korte 105 RAS 690 001690 Regulatory Affairs Culminating RAS 600 001713 Independent Study 1-3
Spring 2019 & stand & stand RAS 623 001332 Regulatory Routes to Market: 510(k)s 3 Saturday 9:00am 1:00pm Jan 19 th and 26 th Feb 2 nd, 9 th and 23 rd Mar 2 nd, 16 th and 23 rd April 6 th make-up April 13 th (no class on Feb 16 th, Mar 9 th and Mar 30th) RAS 623 002871 Regulatory Routes to Market: 510(k)s 3 Tuesday 9:00am 1:00pm online Jan 22nd and 29 th Feb 5 th, 12 th, and 26 th Mar 5 th, 19 th and 26 th April 9 th and 16 th Amy Fowler & stand & stand & stand RAS 631 001333 IDE Regulations and Clinical Trial 4 Monday 5:00pm Design Jan 14 th and 28 th Feb 4 th, 11 th, and 25 th Mar 11 th, 18 th and 25 th April 1 st, 8 th, 15 th and 22 nd make-up April 29 th (no class Jan 21 st, Feb 18 th, or Mar 4th) RAS 635 001334 Regulatory Affairs Compliance 3 Monday 5:00pm Jan 14 th and 28 th Feb 4 th, 11 th, and 25 th Mar 11 th, 18 th and 25 th April 1 st and 8 th make-up April 15 th (no class Jan 21 st, Feb 18 th, or Mar 4th) RAS 651 00137415 Regulation of Combination Products 3 Wednesday 5:00pm (must have at least 6, Jan 23 rd and 30 th may only be offered every other year) Feb 6 th, 13 th, 20 th ; and 27th Mar 13th; and 20 th April 3 rd make-up April 10 th (no class March 6 th or 27th) Sue Norenberg Anne Swearington Mary Henderson Athula Abeyratne Kathy Lundberg Jim Broge Brent Hathcock Renee Cveykus Brian Novak Marie Kuker Mark Kramer Daniel Moelands
RAS 600 001338 Regulatory Affairs - Advanced- Independent Study RAS 644 001336 Regulatory Affairs Internship RAS 690 001337 Regulatory Affairs Culminating RAS 600 001338 Independent Study 1-3 Summer 2019 & stand RAS 627 Intl Reg. Aff.: European Union, East, Eur, Canada, Australia 3 Monday and Wednesday: 5:00pm Wed May 15 th Mon May 20 th Wed May 22 nd and 29 th Mon Jun 3 rd Wed Jun 5 th, 12 th, 19 th & 26 th & stand RAS 643 Reimbursement and Evidence Based Medicine (meets with ACR 626) 3 Mondays and Thursdays 5:00pm Thurs May 16 th, 23 rd & 30 th Thurs June 6 th Mon June 10 th Thur June 13 th Mon 17 th Thur 20 th & 27 th RAS 644 Regulatory Affairs Internship
RAS 690 Regulatory Affairs Culminating