Pharmaceutical Engineering: The Lisbon Masters Program
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1 EAFP Catania June 24-26, 26, 2010 Pharmaceutical Engineering: The Lisbon Masters Program José Menezes, Rogério Gaspar, João Bordado,, José Morais Technical University of Lisbon (Portugal) Faculty of Pharmacy, University of Lisbon (Portugal) EAFP, Catania Jun 24-26, 2010 The Lisbon Masters Program in Pharmaceutical Engineering 1
2 Outline What is the program all about? Why a Program like that was needed? Why others have failed? Was it worth doing it (measuring success)? What are the challenges (past / future)? Discussion EAFP, Catania Jun 24-26, 2010 The Lisbon Masters Program in Pharmaceutical Engineering 2
3 A 2 nd Cycle Bologna Program Pre-requisite 3 year program on either Pharmaceutical Sciences Engineering Life or Basic Sciences Program 3 Minors Structure Medicinal Chemistry Pharmaceutical Engineering Quality Systems EAFP, Catania Jun 24-26, 2010 The Lisbon Masters Program in Pharmaceutical Engineering 3
4 120 ECTS Program: 3+1 semesters 1 st Year 1 st Semester Intro to Engineering Sciences OR Intro to Pharmaceutical Sciences Intro to Chemical Technology OR Intro to Pharmaceutical Technology Monitoring & Control Chemometrics Medicinal Chemistry Project I 1 st Year 2 nd Semester Rational Drug Design and Synthesis Industrial Pharmacotechnology I Biotechnology and Bioengineering Process Analytical Technology Project II EAFP, Catania Jun 24-26, 2010 The Lisbon Masters Program in Pharmaceutical Engineering 4
5 120 ECTS Program: 3+1 semesters 2 nd Year 1 st Semester Industrial Pharmacotechnology II Pharmaceutical Facilities Production Planning and Management Regulatory Affairs Quality Management Systems Project III 2 nd Year 2 nd Semester Masters Dissertation EAFP, Catania Jun 24-26, 2010 The Lisbon Masters Program in Pharmaceutical Engineering 5
6 Why a PharmEng Program is Needed? EAFP, Catania Jun 24-26, 2010 The Lisbon Masters Program in Pharmaceutical Engineering 6
7 Why a PharmEng Program is Needed? The Nation Needs a Comprehensive Pharmaceutical Engineering Education and Research System A. Hussain, Pharm Technol. 2005,9, EAFP, Catania Jun 24-26, 2010 The Lisbon Masters Program in Pharmaceutical Engineering 7
8 Quality by Design: EFPIA PQLI EFPIA model for the application of QbD through a product's lifecycle C.J. Potter et al., in Pharm. Eng. 2010, 30(2),1 6. EAFP, Catania Jun 24-26, 2010 The Lisbon Masters Program in Pharmaceutical Engineering 8
9 Why (we think) Others Failed! All 4 significant experience of the industry (current status & needs) 2 of us have significant regulatory expertise 2 of us were fully involved with new paradigms (PAT, QbD, RBM) Our Institutions and us participate in EU boards and networks Because all the above, we built we think a good & sound program! EAFP, Catania Jun 24-26, 2010 The Lisbon Masters Program in Pharmaceutical Engineering 9
10 Was it worth doing? YES! (M.M. Nasr, FDA - IFPAC 2007 Baltimore, Jan 28,2007) EAFP, Catania Jun 24-26, 2010 The Lisbon Masters Program in Pharmaceutical Engineering 10
11 Was it worth? Multi disciplinary! Monitoring Supervision Control Diagnosis PAT = process analytical technology (cf. ICH Q8) J.C. Menezes, 2000 EAFP, Catania Jun 24-26, 2010 The Lisbon Masters Program in Pharmaceutical Engineering 11
12 Was it worth? P/P/P Whole Analysis! SDF Manufacturing Raw-Materials: API & Excipients IPCs CPPs IPCs CPPs IPCs CPPs RELEASE QC QA & IPCs PAT Data IPCs CPPs + PAT Data RELEASE QC RMs PAT Data SDF EAFP, Catania Jun 24-26, 2010 The Lisbon Masters Program in Pharmaceutical Engineering 12
13 Students Feedback: 1 st & 2 nd MSc s 70% 75% EAFP, Catania Jun 24-26, 2010 The Lisbon Masters Program in Pharmaceutical Engineering 13
14 What are the Challenges Ahead? Improve the Program Content Streamline / focus content Increase weight of Biologics & Bioprocessing Improve Student Selection More strict and selective Better advertising Improve Teaching Methods & Staff Bologna-Syndrome : real course restructuring not compression Modules are great! Overuse of invited speakers is not! Go International International Summer School when all above is in place EAFP, Catania Jun 24-26, 2010 The Lisbon Masters Program in Pharmaceutical Engineering 14
15 Thank for your attention! EAFP, Catania Jun 24-26, 2010 The Lisbon Masters Program in Pharmaceutical Engineering 15
16 Pharmaceutical Engineering: The Lisbon Masters Program CONTACT and FURTHER INFORMATION pharmeng EAFP, Catania Jun 24-26, 2010 The Lisbon Masters Program in Pharmaceutical Engineering 16
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