Regulatory Affairs & Services Course Schedules SCSU at Plymouth 9750 Rockford Road Plymouth, MN M.S. Program

Transcription

1 Regulatory Affairs & Services Course Schedules SCSU at Plymouth 9750 Rockford Road Plymouth, MN M.S. Program Term Cohort Course Number Course ID Course Title Credits Day and Time Instructor Room Summer 2018 & stand & stand RAS Intl Reg. Aff.: European Union, East, Eur, Canada, Australia RAS Reimbursement and Cost management for Med. Tech. RAS 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

2 Fall 2018 & stand RAS 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 Medical Device Quality & Regulatory Fundamentals Required Text: Memory Jogger 2 - Tools for Continuous Improvement and Effective Planning, ISBN: 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 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 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 Regulatory Affairs Internship Brian Novak Dave Mueller Scott Sardeson Rica Morris Mary Korte 105 RAS Regulatory Affairs Culminating RAS Independent Study 1-3

3 Spring 2019 & stand & stand RAS 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 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 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 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 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

4 RAS Regulatory Affairs - Advanced- Independent Study RAS Regulatory Affairs Internship RAS Regulatory Affairs Culminating RAS 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

5 RAS 690 Regulatory Affairs Culminating