Department of Industrial and Physical Pharmacy Purdue University  Purdue University School of Pharmacy and Pharmaceutical Sciences Department of Industrial and Physical Pharmacy Graduate Certificate and Masters Degree Programs in… Regulatory and Quality Compliance

Department of Industrial and Physical Pharmacy Purdue University  Educating Regulatory, Quality and Compliance Professionals

Department of Industrial and Physical Pharmacy Purdue University  Unique Features of Purdue’s Program Design Comprehensive program Clearly defined criteria Consistency in content and delivery Student accountability

Department of Industrial and Physical Pharmacy Purdue University  Our Purpose… To grow your professional capabilities in the areas of regulatory affairs and quality and compliance practices. To make you more insightful and perceptive, and a better problem seeker and solver. To make you a more effective team member, and a learned mentor to others. To prepare you to help your organization avoid costly and time consuming problems in new product development and registrations. To develop you to grow professionally and to contribute significant value to your company.

Department of Industrial and Physical Pharmacy Purdue University  Learning Environment Instructors –University professors –Industry experts Experience based discussion –Peer to peer learning –Instructor expertise University setting

Department of Industrial and Physical Pharmacy Purdue University  Benefits for Student Format compatible for working professionals Focused on relevant and current content Broad basic understanding across discovery, development, registration, and marketing Opportunity for career acceleration and professional development Graduate Certificate Degree or Masters Degree

Department of Industrial and Physical Pharmacy Purdue University  Business Benefits Exposure to pharmaceutical and medical device regulations FDA and ex-US regulations Masters’ project pertinent to business situations Focuses on value of continuous improvement Professional growth for employee

Department of Industrial and Physical Pharmacy Purdue University  History of the Program Begun in 2001in the School of Industrial and Physical Pharmacy Driven by independent input from Todd Chermak (Abbott) and Michael Schmidt ( Lilly, retired) Established at Purdue by Steve Byrn, Department Head Grown from –One to seven courses –Graduate certificate plus Masters degree

Department of Industrial and Physical Pharmacy Purdue University  Overview of Drug Discovery Process From Nature Reviews 2:919, 2003

Department of Industrial and Physical Pharmacy Purdue University  Discovery Laboratory Trials (Animal) Healthy Volunteers Small # of Affected Patients Large # of Affected Patients Regulatory Review & Approval Marketed Drug Generic Competition Drug Development in a Dynamic Global Industry

Department of Industrial and Physical Pharmacy Purdue University  Graduate Certificate Degree Required CourseCreditsInstructor Food and Drug Law I3G. Thomas Wilson, Prof. Drug Discovery and Drug Development 3Stephen Byrn & Michael Schmidt, Prof. Good Regulatory (GXP) Practices 3Stephen Byrn & Michael Schmidt, Prof.

Department of Industrial and Physical Pharmacy Purdue University  Graduate Certificate Program Format –1 weekend per month –3 weekends per course –3 courses per Certificate Program Note: Credit hours can be applied to the Masters Degree program

Department of Industrial and Physical Pharmacy Purdue University  Masters Degree Program Required CoursesSemester Credits Food and Drug Law I3 Food and Drug Law II3 Drug Discovery and Development3 Good Regulatory (GXP) Practices3 Special Project6 TOTAL Required Course Credits18

Department of Industrial and Physical Pharmacy Purdue University  Masters Degree Program Elective CoursesSemester Credits Quality Management Audits and Inspections 3 The Documents & Dialogues of Drug Development and Registration 3 Process Analytical Technology3 Other elective courses as approved by Masters Committee 5 TOTAL ELECTIVE COURSE CREDITS = 14

Department of Industrial and Physical Pharmacy Purdue University  Masters Degree Requirements –4 Required Courses –1 Special Project Approved by Masters Committee –Elective courses Total 32 Semester Credits

Department of Industrial and Physical Pharmacy Purdue University  Masters Degree Special Project Project Statement presented to Masters Committee Emphasis on process/continuous improvement Add value to organization…integrated into job Approximately 1 year to develop and complete Purdue staff available for counsel End Result: –Written report (30-40 pages) –Oral presentation for approval by Masters Committee

Department of Industrial and Physical Pharmacy Purdue University  All Special Projects are completed and reviewed under strict confidentiality to protect company intellectual property

Department of Industrial and Physical Pharmacy Purdue University  Program Goal To provide a meaningful educational experience in regulatory and quality compliance

Department of Industrial and Physical Pharmacy Purdue University  Program Objectives To Provide: –A broadened understanding of product development –An understanding of interdisciplinary relationships –Emphasis on strengthening problem solving skills –Framework to educate and mentor colleagues –Interaction between professionals with different experiences and backgrounds

Department of Industrial and Physical Pharmacy Purdue University  This Course Meets These Objectives by: Presenting and discussing relevant topics Utilizing experienced professionals to teach and to answer questions Assigning good reading and reference materials Requiring homework that renders deep insights and new personal growth Encouraging and providing time for professional interactions amongst classmates and with instructors Being academically demanding…highly credible…and widely recognized

Department of Industrial and Physical Pharmacy Purdue University  Improvement Project Outcomes Some Students’ Comments -Value added…for sure! -Won my company’s “Improvement Award” prize. -Complex, detailed…a great learning experience. -Fit perfectly into my job description…nice. -Appreciated, and now being replicated elsewhere. -Got to know a lot of new people and areas as a result of doing my project. Great networking!

Department of Industrial and Physical Pharmacy Purdue University  Personal Benefit Outcomes Some Students’ Comments -Got promoted! -Out-competed the others for the job, even though I didn’t have as much service credit. -Positive comments from my supervision at Performance Management Review time. -Moved to a new job. The program gave me insights about this new career path for me. -I now can understand and track the conversations in team meetings. I don’t “check-out” when toxicology starts talking!

Department of Industrial and Physical Pharmacy Purdue University  Now some commentary from and Q & A with our ALUMNI…and your colleagues!

Department of Industrial and Physical Pharmacy Purdue University  Now What…? Come talk to us now Grab information now Follow-up via our web site at www. ipph.purdue.edu Talk to your supervision. Talk to the Continuing Education Department. Call us at (765)

Department of Industrial and Physical Pharmacy Purdue University  We would like to thank the many employees of Abbott and Lilly, and the FDA who have contributed to the success of our program.

Department of Industrial and Physical Pharmacy Purdue University  Purdue University School of Pharmacy and Pharmaceutical Sciences Department of Industrial and Physical Pharmacy Graduate Certificate and Masters Degree Programs in… Regulatory and Quality Compliance “Educating Quality and Compliance Professionals”