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Quality Assurance in Graduate Programs The Pfizer and Hibernia College experience in Pharmaceutical Medicine

Quality Assurance in Graduate Programs The Pfizer and Hibernia College experience in Pharmaceutical Medicine. Honorio Silva, MD VP, Science and Medical Professional Development, Pfizer Inc. New York, USA Sean Rowland, PhD CEO, Hibernia College, Dublin, Ireland

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Quality Assurance in Graduate Programs The Pfizer and Hibernia College experience in Pharmaceutical Medicine

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  1. Quality Assurance in Graduate ProgramsThe Pfizer and Hibernia College experiencein Pharmaceutical Medicine Honorio Silva, MD VP, Science and Medical Professional Development, Pfizer Inc. New York, USA Sean Rowland, PhD CEO, Hibernia College, Dublin, Ireland IV LINC- MIT Conference, Amman, Jordan, October 27-29, 2007

  2. Biomedical Research and Development: From Discovery to Approval Years Multiple discovery approaches For each target address: • Idea to screen • Screen to lead • Lead development • Candidate seeking • Pre-clinical work on CAN Millions ofCompounds Screened 0 2 A Few Leads ~250 toPreclinical Testing 4 Phase I • 20–80 healthy volunteers used to determine safety and dosage ~10 to Clinical Testing 6 Phase II • 100–300 patient volunteers to determine efficacy and side effects 8 ~3 Phase III • 1,000–5,000 or more patient volunteers monitor long term use 10 ~2 ONE Approvedby the FDA 12 1 FDA Review Approval 14 High-risk Process Takes 12–15 Years Journal of Health Economics, The Price of Innovation: New Estimates of Drug Development Costs, 2002.

  3. What is Pharmaceutical Medicine? • “PM is the medical scientific discipline concerned with the discovery, development, evaluation, registration, monitoring and medical aspects of marketing of medicines for the benefits of patients and public health” (IFAPP) • Biomedical professionals working in this discipline, while not dealing with individual patients, influence the health and well-being of populations, cohorts and groups of patients, and place their safety and interest as a priority in their activities and decisions.

  4. An Emerging Medical Discipline • PM is a broad medical specialty that requires pharmaceutical physicians to have a wide range of expertise: basic research, drug development and evaluation, clinical trials, regulatory , pharmacoeconomics, medical aspects of marketing, business administration, safety and risk management. • Most biomedical professionals are not fully aware of the mission and vision of pharmaceuticals and the complexities and regulations associated with drug discovery, development and commercialization • IFAPP (1975) is the umbrella organization for 30 national professional associations on Pharmaceutical Medicine • Accepted as a medical specialty in a few countries (UK, Ireland, Switzerland, Mexico, Philippines).

  5. Education in Pharmaceutical Medicine • Not included in the undergraduate medical curriculum • 12 Universities in Europe offers on-site graduate programs (Diploma, Masters) with few on-line activities. Most are IFAPP accredited. Few students per course. • Certified Physician Investigator Examination (USA) • CME related initiatives are led by the DIA in the USA and Europe • Biomedical professionals working in the pharmaceutical industry may not be aware of the discipline!!! • Steady influx of biomedical professionals into pharmaceuticals

  6. Why we at Pfizer foster the creation of web based programs? • Emerging needs in graduate medical education • Unique partnership with medical schools and professional associations • Opportunity to leverage skills for Pfizer medical personnel • Leadership in Pharmaceuticals • Increased use of Internet for medical education purposes

  7. Why we considered this program? • Needs for further graduate training detected through internal surveys • Opportunities for further professional development • Lack of training opportunities for working professionals from the emerging world • Talent development initiative • Internal expertise as a resource.

  8. What does Hibernia College do? Hibernia College offers accessible high quality third-level education to students who would otherwise find it difficult or impossible to study for a qualification. How do they do it? 1. Develop blended third-level degree learning 2. Bring together national and international experts 3. Develop and provide technology and support

  9. Some Background • Ireland’s first and only online third level institution, founded 2000 • Nationally accredited by HETAC, the govt agency for Higher Education • Niche suite of programmes, mostly postgraduate • International linkages with Harvard, MIT, IBM • Academic Chair – Prof. Thomas Mitchell former Provost of Trinity College Dublin • Over 1200 students in graduate programs and over 4000 students enrolled in CPD activities

  10. A Global Education Provider

  11. Learning with HELMS Discrete student learning events can be mapped to physical architecture within the HELMS system. • STUDENT LEARNING EVENTS • Motivational Event • Concept Learning Event • Concept Application Event • Problem Posing Event • Problem Solving Event • Research Event • Project Management Event • Innovation & Brainstorming Event • Quiz Event • Homework Event • HELMS ARCHITECTURE • Course Home and Announcements • Core Course Content • Interactive Features and Links • Multiple Question Formats • Immediate grading with feedback • Immediate access to online library • Team break-outs • Discussion groups • End of Lesson MCQs • Protected assessment area with full online grading facility

  12. INTERWISE – Raise Hand icon Click the Raise Hand icon to if you want to speak to the tutor Full duplex audio

  13. Hibernia/PfizerPlanning phase (1Q’04-1Q’05) • Internal confirmatory Needs Assessment • Benchmarking with other graduate training courses • Planning and set up of academic network: Advisory Boards, curriculum, faculty • Submission and accreditation by HETAC (Ireland-EU) and IFAPP • Internal processes for identification of candidates • Administrative approvals

  14. Dr. Dermot Cox (Royal College of Surgeons) Dr. Tom Mitchell (Hibernia College) Dr. William Shannon (Royal College of Surgeons) Dr. Joseph McCarthy- JFK School of Government Harvard University Dr. Richard Larson, MIT Dr. Robert Rubin, Harvard/MIT Dr. Rory O’Connor, Pfizer Dr. Pablo Pulido (Pan American Federation of Medical Schools-PAFAMS) Advisory Board to ensure Program Quality

  15. Collaboration network to ensure Quality Faculty from MIT/ RCSI & Harvard HETAC Advisory Boards Pfizer Professional Bodies IFAPP

  16. Q u a l i t y Assurance A foundation of quality assurance Quality Assurance Leading Faculty External Validation IFAPP Academic Chairman HETAC

  17. Academic Structure for the Course • MSc in Pharmaceutical Medicine • 10 modules given in a 24-month period based upon core curriculum required by the IFAPP • 12-weeks per module • 8 h/week work per module (3 online lessons, 1 hour online tutorial, and 4 hours for student research and assignments) • Annual in-campus gathering for all students (Harvard University and Royal College of Surgeons) • 25-45 students for class

  18. Curriculum for MSc in Pharmaceutical Medicine - Modules • Drug discovery and pharmaceutical development • Leadership (on site at Harvard University) • Clinical pharmacology and drug development • Clinical trials and data management • Regulatory Affairs and Knowledge management • Safety and Risk management • Health Economics and business administration • Business Ethics (on site at Royal College of Surgeons) • Information Technology and E-medicine • Research project and dissertation

  19. Selection process as part of Pfizer Internal Talent Development Program - 2005 Cohort • Process coordinated with HR and OE • Identification of candidates through top management levels • 65 Total Applicants recommended by functional heads and Country Medical Directors • 23 Countries represented • Harmonized attrition process with involvement of regional and functional heads • Customer and stakeholder satisfaction

  20. Performance for the 2005 cohort • Graduation ceremony held in Dublin on 8/1/2007 • Good grades (majority with First Class Honors, externally examined) • Surveys show high level of students’ participation, satisfaction, and retention. • Recommended by PhRMA as a best practice to be followed by the rest of pharmaceutical companies (2006)

  21. 2 0 0 7 First Graduating Class Largely positive feedback – course review process takes account of student feedback Technology works well Heavy workload in challenging times Focus group to report in more detail

  22. The 2006 and 2007 cohorts • Similar selection processes • 36 students enrolled in 2006 (Pfizer only) and 38 enrolled in 2007 (including 9 non-Pfizer students) • Scholarships offered (2007) • Continuous feedback requested after each module is complete

  23. Plans for 2007and beyond • Support further expansion of the MSc in Pharmaceutical Medicine beyond pharmaceutical industry to the regulatory agencies and research groups • Refine capacity to generate and support other graduate programs • Foster innovative partnerships to provide value to the healthcare community

  24. Conclusions • Innovative approach to meet emerging needs in bio-medical education • Unique partnership among the pharmaceutical industry, medical and academic institutions • Opportunity to leverage skills and increase productivity within professional environment • Success story for e-learning graduate education

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