Master of Science Kilimanjaro School of Pharmacy Saint Luke Foundation, Moshi, Tanzania Purdue University ) United Nations Industrial Development Organization (UNIDO) INDUSTRIAL PHARMACY ADVANCED TRAINING PROGRAM The program gives professionals with a background in pharmacy, chemistry, or related sciences the opportunity to specialise in Industrial Pharmacy/ Biotechnology Innovation/Regulatory. The program consists of 11 courses and a capstone project, administered and taught by experienced teaching staff from Kilimanjaro School of Pharmacy, Purdue University, Howard University, and Merck Co., USA. Upon successful completion the course a Master’s Degree in Biotechnology Innovation and Regulatory Science will be awarded by Purdue University, USA. This professional qualification is a unique opportunity for employees in the private sector and in public institutions in Africa to gain expertise in pharmaceutical manufacturing according to international Good Manufacturing Practice (GMP) that prepares professionals for positions related to pharmaceutical manufacturing, biotechnology, innovation, and regulatory science. COURSE MODULES 1. Drug Development 2. Good Regulatory Practice 3. Molecular Basis of Manufacturing 4. Quality Management Audits and Inspections 5. Documents and Dialogues of Drug Development and Regulation 6. Measurement and Evaluation in Industry and Technology 7. Quality and Productivity in Industry and Technology 8. Project Management in Industry and Technology 9. Analysis of Research in Industry and Technology 10. Technology from a Global Perspective 11. Global Supply Chain Management 12. Emerging World Class Leadership Strategies MERCK FOUNDATION/ UNIDO SPONSORED PROGRAM Merck Foundation, USA and United Nations Industrial Development Organization (UNIDO) have teamed up to offer two different scholarships to participants: o Manufacturers Scholarship Program: Applicants working for a pharmaceutical manufacturing company can apply for a scholarship for tuition. Fees for this group of students are USD500 per course. o Public Sector Scholarship Program: Applicants working for a public institution (university or regulatory agency) can apply for a scholarship for the course. Fees for this group of students are USD50 per course. o Note: Scholarships cannot be guaranteed beyond 2016 Venue: Kilimanjaro School of Pharmacy (KSP)/Saint Luke Foundation, Moshi, Tanzania. In addition to live courses at KSP in Moshi, some courses will be presented using an online system. Students need to have a good laptop and internet connection for lectures and assignments. Start date: 1 September 2014 with the courses “Drug Development” and “Quality and Productivity in Industry” Applications: Apply to Sr. Zita Ekeocha, KSP ([email protected]). Pre‐screened applicants will then apply to Purdue. Contacts: Sr. Zita A. Ekeocha, SLF: [email protected], Ms. Mary Speer, [email protected] There is a USD75 application fee to Purdue University. Total course tuition & fees without scholarship: USD36,300. COURSE MODULES TLI 521 Drug Development 1‐12 September 2014 A review of drug discovery and drug development, with emphasis on the regulatory aspects of these activities. Animal preclinical research and human clinical research are discussed in detail. In addition, the process for the assembly of an IND and NDA is discussed along with the Phases (I,II,III) of human clinical trials. The CMC (chemistry manufacturing and control) aspects of drug development are presented along with ICH documents and manufacturing process analytical technologies. The course concludes with a brief review of international regulatory issues and patents. IT508 Quality and Productivity in Industry and Technology 1‐12 September 2014 Examines the contemporary issues of continuous improvement in quality and productivity in manufacturing and service industries. Includes a close examination of the evolving philosophies bearing on the scope, improvement, and costs of quality assurance programs in industry and technology. IT 598 Directed MS Project 1‐12 September 2014 A formal investigation of a particular problem under the guidance of an advisory committee. Not applicable to a thesis option plan of study. Enrolment for at least two consecutive terms for a total of three credits is required. Permission of department is required. TLI522 Good Regulatory Practices Two weeks in March 2015 This course includes a review of the FDA and ICH regulations on good manufacturing, good laboratory, good clinical practices. The meaning of these regulations, the globalization of practices and the roles and responsibilities of various professionals implementing these regulations will be addressed. Special emphasis will be detailed coverage of the process for the assembly and submission of an IND or NDA, and the function of the regulatory affairs department in a pharmaceutical company. IT571 Project Management in Industry and Technology Two Weeks in March 2015 The factors influencing decisions during the initiation, implementation, and termination of industrial and manufacturing projects are examined. Students work as project teams, using project management tools to develop implementation strategies. TECH 646 Analysis of Research in Industry and Technology Sometime in March 2015 Analysis of research and evaluation of research reports. Emphasis on understanding the application of fundamental statistical methods in design and interpretation of research findings in industrial, technical, and human resource development environments. COURSE MODULES Continued TLI 525 Molecular Basis of Manufacturing (includes laboratory) Two weeks in August 2015 This advanced course addresses important Chemistry Manufacturing and Control (CMC) issues related to manufacturing and quality by design. The course provides important information on strategies for quality by design, manufacturing strategies for early development, the best approaches to analyzing data, and strategies for reporting the information to the FDA. This course will also focus on product design and processing. Using product and process design helps achieve quality by design (QbD), strong development reports, and excellent regulatory submissions and allows continuous improvement. The course includes laboratory exercises, laboratory tours, and/or workshops outlining how to interpret the data. TLI 524 Documents and Dialogues of Drug Development and Registration Two weeks in March 2016 This capstone advanced course will integrate previous learning relating to laws and regulations, quality principles and practices, and the preparation and submission of documents for preclinical research clinical trials and new drug approvals. Special topic lectures will be given. Considerable time will be devoted to preparing regulatory documents and conducting “mock” dialogs and negotiations with “pretend” agency officials. IT 507 Measurement and Evaluation in Industry and Technology Sometime in 2016 An introduction to measurement strategies in industrial, technical, and human resource development environments. The evaluation of measurement outcomes will be the primary focus of the course. MET 527 Technology from a Global Perspective Introduction to the challenges faced by the practicing technologist when working and interacting with international technical personnel, both here and abroad, including history, standards, education, and practice of technology outside the United States.. TLI 523 Quality Management, Audits and Inspections The course provides advanced topics in quality management and business improvement methods that apply to pharmaceutical industry. Emphasis will be placed on specific issues of industry and audits and inspections as well as the successful selection and presentation of business and quality improvement projects to produce compliance and competitive advantage. Additional courses that will become available in 2015 IT 535 Global Supply Chain Management TLI xxx Biotechnology Innovation Devices and Diagnostics Course Schedule The course schedule shown in the table is our best understanding of the course schedule as of June 29, 2014. However this schedule is subject to change. New students completing 521, 522, 525, and 524 will receive a Certificate from Kilimanjaro School of Pharmacy, IPAT program.