Transcript Purdue University School of Pharmacy and Pharmacal Sciences

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
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Department of Industrial and Physical Pharmacy
Purdue University 2006
Educating Regulatory,
Quality and Compliance
Professionals
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Department of Industrial and Physical Pharmacy
Purdue University 2006
Unique Features of Purdue’s Program Design
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Comprehensive program
Clearly defined criteria
Consistency in content and delivery
Student accountability
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Department of Industrial and Physical Pharmacy
Purdue University 2006
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 2006
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Learning Environment
• Instructors
– University professors
– Industry experts
• Experience based discussion
– Peer to peer learning
– Instructor expertise
• University setting
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Department of Industrial and Physical Pharmacy
Purdue University 2006
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
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Department of Industrial and Physical Pharmacy
Purdue University 2006
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
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Department of Industrial and Physical Pharmacy
Purdue University 2006
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
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Department of Industrial and Physical Pharmacy
Purdue University 2006
Overview of Drug Discovery Process
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From Nature Reviews 2:919, 2003
Department of Industrial and Physical Pharmacy
Purdue University 2006
Drug Development in a Dynamic Global Industry
Discovery
Large # of
Affected Patients
Laboratory Trials
(Animal)
Regulatory Review &
Approval
Department of Industrial and Physical Pharmacy
Purdue University 2006
Healthy
Volunteers
Marketed Drug
Small # of Affected
Patients
Generic
Competition
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Graduate Certificate Degree
Required Course
Credits
Instructor
Food and Drug Law I
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G. Thomas Wilson, Prof.
Drug Discovery and
Drug Development
Good Regulatory
(GXP) Practices
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Stephen Byrn & Michael
Schmidt, Prof.
Stephen Byrn & Michael
Schmidt, Prof.
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Department of Industrial and Physical Pharmacy
Purdue University 2006
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
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Department of Industrial and Physical Pharmacy
Purdue University 2006
Masters Degree Program
Required Courses
Food and Drug Law I
Food and Drug Law II
Drug Discovery and Development
Good Regulatory (GXP) Practices
Special Project
TOTAL Required Course Credits
Semester
Credits
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3
3
3
6
18
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Department of Industrial and Physical Pharmacy
Purdue University 2006
Masters Degree Program
Elective Courses
Quality Management Audits and
Inspections
The Documents & Dialogues of Drug
Development and Registration
Process Analytical Technology
Semester
Credits
3
Other elective courses as approved by
Masters Committee
TOTAL ELECTIVE COURSE CREDITS = 14
Department of Industrial and Physical Pharmacy
Purdue University 2006
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3
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Masters Degree
• Requirements
– 4 Required Courses
– 1 Special Project
• Approved by Masters Committee
– Elective courses
• Total 32 Semester Credits
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Department of Industrial and Physical Pharmacy
Purdue University 2006
Masters Degree Special Project
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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
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Department of Industrial and Physical Pharmacy
Purdue University 2006
All Special Projects are completed and reviewed
under strict confidentiality to protect company
intellectual property
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Department of Industrial and Physical Pharmacy
Purdue University 2006
Program Goal
• To provide a meaningful educational
experience in regulatory and quality
compliance
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Department of Industrial and Physical Pharmacy
Purdue University 2006
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
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Department of Industrial and Physical Pharmacy
Purdue University 2006
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
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Department of Industrial and Physical Pharmacy
Purdue University 2006
Improvement Project Outcomes
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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!
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Department of Industrial and Physical Pharmacy
Purdue University 2006
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 2006
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Now some commentary from and Q & A
with our ALUMNI…and your colleagues!
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Department of Industrial and Physical Pharmacy
Purdue University 2006
Now What…?
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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) 494-6545
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Department of Industrial and Physical Pharmacy
Purdue University 2006
We would like to thank the many employees of
Abbott and Lilly, and the FDA who have
contributed to the success of our program.
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Department of Industrial and Physical Pharmacy
Purdue University 2006
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”
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Department of Industrial and Physical Pharmacy
Purdue University 2006