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Temple University-NUSAGE Certification Programme

Our collaboration with Temple University was established in November 2008. We welcome you to explore the following links on the Agreement (http://news.temple.edu/news/going-global) and the latest about our Partnership(http://www.temple.edu/pharmacy_qara/Temple_QARA_and_National_University_of_Singapore.htm).

Temple University, based in the heart of Philadelphia, USA, was founded in 1884. It is a major international university, and a world-class centre of teaching, research and health care. It has faculty in 17 schools and colleges, and four professional schools.
Temple University offers its Quality Assurance/Regulatory Affairs (QARA) Postgraduate Programme(http://www.temple.edu/pharmacy_qara/) through its School of Pharmacy. It was the first institution of higher learning to develop a master’s programme in QARA since 1968, making it the pioneer and leader in this area. Today it offers the largest number of comprehensive courses on this discipline, and continues to add courses to incorporate the latest trends in the biomedical-pharmaceutical-manufacturing-regulatory industry.
Classes are held on a part-time basis at the Department of Pharmacy, National University of Singapore through a series of live lectures, tutorials, pre-recorded lectures and on-line discussion forum with the faculty and students from USA OR on-line delivery by the faculty. An expert-facilitator provides guidance for students at NUS, Singapore. Each course is conducted over 13 weeks, for 2 to 3 hours per week and assessment is via tests, take-home assignments and a written examination. The NUSAGE Certificate of Attendance is awarded for attaining a pass grade for each course.
The student may apply for the Postgraduate Certificate in Drug Development/Pharmaceutical Manufacturing I from the Temple University and NUSAGE upon passing four prescribed courses with an average B grade within three years from the first day of commencement of any four courses.

The four courses are:

1. PR5301 Food and Drug Laws
2. PR5302 Regulation of Drug Development
3. PR5303 Good Regulatory Practices
4. One of the following electives

  • Unit Operations
  • Regulatory Science
  • Process Monitoring
  • Cleaning Validation
  • Good Clinical Practice
  • Computer Validation
  • High Purity Water Systems
  • Global Medical Device Regulation

 

For more information, please email PHABOX7@nus.edu.sg

Application Requirements

 

A bachelor degree, preferably one of the following or equivalent:

  • Bachelor of Science in Pharmacy OR
  • Bachelor of Science in Chemistry OR
  • Bachelor of Science in Life Sciences OR
  • Bachelor of Applied Science in Food Science & Technology, OR
  • Bachelor of Applied Science in Applied Chemistry, OR
  • Bachelor of Engineering (Biomedical Engineering), OR
  • Bachelor of Engineering (Chemical Engineering), OR
  • Other degree with related experience are welcome and will be reviewed by admission panel.

 

Application:

  • For those who have sat for and passed a Temple University course, download & complete application form here
  • Other applicants, download & complete application form here
  • Check which courses are offered each of the 2 semesters over an academic year
  • Closing date: 30 June for August intake and 30 November for January intake
  • Fax or email or mail completed application form with required photo & documents to:

 

Attn Manager, Postgraduate Pharmacy Programmes

Fax:        65-67791554
Email:    PHABOX7@nus.edu.sg

 

Mailing Address:

National University of Singapore
Department of Pharmacy
Faculty of Science
Pharmacy Department Office at S4A Level 3
18 Science Drive 4
Singapore 117543
Republic of Singapore
Attn Manager, Postgraduate Pharmacy Programmes

Fees

 

Fees payable shall be self-financing. Employers of candidates may provide financial support:

Tuition Fees:

 

Tuition Fees
Singapore Citizen or Permanent Resident International Student

(Must have a valid employment/dependent pass in Singapore)

Per NUS or Temple University module S$3000 per module S$3000 per module

 

Note:

  1. Fees must be paid in full and received by the Department of Pharmacy at least 7 working days before the commencement date of the module/course.
  2. Fees are subjected to change at any time.
  3. Please send payment via cheque or bank draft, addressed to “National University of Singapore”.
    1. Write clearly on the back of the cheque or bank draft “NUSAGE Application Fee” and your full name.
    2. Submit cheque or bank draft with the completed Application Form.
    3. Cheque or bank draft will be returned to the applicant if the application for the modules/courses is not successful.
  4. For payment by cheque, please send to:

 

Mailing Address:

National University of Singapore
Department of Pharmacy
Faculty of Science
Pharmacy Department Office at S4A Level 3
18 Science Drive 4
Singapore 117543
Republic of Singapore
Attn Manager, Postgraduate Pharmacy Programmes

Courses for Jan to May 2018

 

  1. Drug Development (PR5302)
  2. Good Regulatory Practices (PR5303)
  3. Global Medical Device Regulation (5505)
  4. Global Regulatory Affairs (5591)
  5. Global CMC Issues and Regulatory Dossiers (5576)
  6. Regulatory eSubmissions (5514)
  7. Quality Audit (5494)
  8. Pre-Approval Inspections (5491)
  9. Biotechnology: Bioprocess Basics (5471)
  10. Good Pharmacovigilance Operations (5508)

Drug Development (PR5302)

This course studies the drug development process from discovery through FDA marketing approval. It reviews the process of development and the interrelationships linking the various disciplines, introducing students to regulations governing the process, including the interactions with FDA, ICH, and other regulatory agencies.

Required text: Drugs: From Discovery to Approval, 3rd Edition, Rick Ng.

 

Timetable

(in Singapore time)

Note: all classes are “live” online meeting, unless a recording is noted.
8:00 am – 10:00 am Saturdays: Jan 20 (Videoconference in NUS), 27, Feb 3, 10, 17 (Recording – Chinese New Year), 24, Mar 3 (Recording – Spring Recess NUS), 10 (Midterm), 17, 24, 31 (Recording – Good Friday), Apr 7, 14, 21, 28 (Final exam).
Midterm/CA: Mar 10. Final exam: 28 Apr.
Videoconference Venue: NUS Pharmacy Department, S4A Level 3

 

Biodata of Lecturer

berger

Barry A. Berger, JD, MBA

Barry A. Berger is an attorney at GlaxoSmithKline with over 25 years of experience in multinational and start-up settings in the pharmaceutical and biotech industries. Prior to GlaxoSmithKline, Mr. Berger served in senior positions with Aventis (Rhone-Poulenc Rorer), Praxis Biologics, Bausch & Lomb, and Schering-Plough in areas including food and drug law, mergers and licensing, management of complex litigation, and training and development on corporate compliance and preventive law. Mr. Berger holds a JD from Temple University (Philadelphia, PA), an MBA in Management from Rutgers University (Newark, New Jersey) and a BA from City College of New York. He is the author of numerous legal articles. He has participated in professional training seminars and also in the Executive Management Program at Dartmouth College (New Hampshire). He is admitted to practice in New Jersey, New York, and Pennsylvania. He has taught for the QA/RA graduate program for over a decade including, Food and Drug Law I, Advanced Topics in Food and Drug Law, and Current Issues in the Pharmaceutical and Medical Device Industries.

Good Regulatory Practices (PR5303)

This course provides an introduction to cGMPs (current good manufacturing practices). Regulations for drugs under the Food, Drug and Cosmetic Act (21 CFR 210 and 211) and their implication for personnel, buildings, equipment, and records will be thoroughly reviewed and studied. It includes a study of pertinent legal decisions and regulatory actions based on non-compliance.

No required text.

 

Timetable

(in Singapore time)

Note: all classes are “live” online meeting, unless a recording is noted.
10:15 am – 12:15 pm Saturdays: Jan 20, 27, Feb 3, 10, 17 (Recording – Chinese New Year), 24, Mar 3 (Recording – Spring Recess NUS), 10, 17 (Midterm), 24, 31 (Recording – Good Friday), Apr 7 (Recording), 14, 21, 30 (Final exam).
Midterm/CA: Mar 17. Final exam: Apr 30.

 

Lecturer

Faculty: K. Zimm

Global Medical Device Regulation (5505) 

Note: this course will use Software Secure, an online proctoring service that enables students to take exams at home.

This course provides an overview of international medical device regulations. Beginning with a discussion of the similarity of global requirements (including both voluntary and mandatory standards and directives and progressing to in-depth analyses of market specific requirements), the course provides students with resources to meet the regulatory requirements for the largest world markets. The Medical Device Directive, the In Vitro Diagnostic Directive and the Active Implantable Medical Device Directive will be discussed, as well as initiatives by the Global Harmonization Task Force related to the classification, development, and complaint handling for medical devices. As part of this course, the student will learn the quality system requirements of ISO13485, risk management according to ISO14971, and how to CE mark their product. Country-specific regulatory requirements for Canada, EU, Australia and Japan are included.

No required text.

 

Timetable

(in U.S. East Coast time)

6:00 pm – 9:00 pm Wednesdays:  Jan 24, 31, Feb 7, 14, 21, 28, Mar 7, 14, 21, 28, Apr 4, 11.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 18 or 25.

Proctored exam:  Mar 7 (Software Secure)

 

Lecturer

Faculty:  M. Arentz

Global Regulatory Affairs (5591) 

Note: this course will use Software Secure, an online proctoring service.

Prerequisites: Drug Development (5459) or Food and Drug Laws (5592)

This course provides a detailed analysis of the regulatory processes for new drug approvals outside of North America. Students gain experience in comparing the European and Japanese registration trends with those of the US. Future regulatory structures in the major world markets are explored.

No required text.

 

Timetable

(in U.S. East Coast time)

6:00 pm – 9:00 pm Thursdays:  Jan 25, Feb 1, 8, 15, 22, Mar 1, 8, 15, 22, 29, Apr 5, 12.  Meets 12 times plus final exam.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 19 or 26.

Proctored exam:  Mar 1 (Software Secure)

 

Lecturer

Faculty:  D. Larkins

Global CMC Issues and Regulatory Dossiers (5576) 

 

The course provides students with an in-depth knowledge of the major chemistry, manufacturing. and controls (CMC) issues facing the global pharmaceutical industry. Students learn the practical and theoretical skills necessary to develop successful CMC dossiers from the initial clinical application through marketing and post-marketing support. The class emphasizes long range CMC planning to combine technical and regulatory knowledge with strategic thinking. The class is designed for regulatory professionals, managers, and scientists with significant responsibility for CMC dossiers.

No required text.

 

Timetable

(in U.S. East Coast time)

6:00 pm – 9:00 pm Tuesdays:  Jan 23, 30, Feb 6, 13, 20, 27, Mar 6, 13, 20, 27, Apr 3, 10.  Meets 12 times plus final exam.  Make-ups, if needed, Apr 17 or 24.

Proctored exam:  Mar 6

 

Lecturer

Faculty:  F. Diana

Regulatory eSubmissions (5514) 

Special note: this course will use Software Secure, an online proctoring service.

Suggested prerequisite: Drug Development (5459)

This course will explore the evolution of global regulatory submissions from the original paper format to the current electronic common technical document (eCTD) and non-eCTD electronic submissions (NeeS). This course will primarily focus on current regulations, tools, and specifications associated with electronic submissions and electronic requirements of included documentation.

No required text.

 

Timetable

(in U.S. East Coast time)

6:00 pm – 9:00 pm Wednesdays:  Jan 24, 31, Feb 7, 14, 21, 28, Mar 7, 14, 21, Apr 4, 11, 18.  Meets 12 times plus final exam. No class on Mar 28. Make-ups, if needed, Apr 25 or May 2.

Proctored exam:  Mar 7 (Software Secure)

 

Lecturer

Faculty:  K. Davino

Quality Audit (5494) 

Prerequisite: Good Regulatory Practices (5477)

This course covers topics in quality assurance principles, audit techniques, audit types, audit presentation and reports, auditing procedures for GMPs, GCPs, and GLPs.

Required text: The ASQ Auditing Handbook, 4th ed, J.P. Russell. Available from ASQ Quality Division: www.asq.org (ISBN: 10-0873898478 only). Do not purchase an ebook copy. Also available on Amazon.com

 

Timetable

(in U.S. East Coast time)

6:00 pm – 9:00 pm Wednesdays:  Jan 24, 31, Feb 7, 14, 21, 28, Mar 7, 14, 21, 28, Apr 4, 11.  Meets 12 times plus final exam. Make-ups, if needed, Apr 18 or 25.

Proctored exam:  Feb 28

 

Lecturer

Faculty:  K. Huynh-Ba

Pre-Approval Inspections (5491) 

Prerequisites: Drug Development (5459) and Good Regulatory Practices (5477)

This course provides a detailed overview of Pre-Approval Inspections and how to conduct audits of facilities based on the responsibilities delineated in a pending drug application, including NDAs, ANDAs and NADAs. Emphasis is placed on reviewing the pre-approval audit process, pre-approval laboratory issues (including analytical and microbiological), technology transfer, case studies involving various dosage forms, and outsourcing issues. This course stresses key areas for pre-approval inspection audits. Case studies help prepare students for issues arising during a pre-approval inspection. The history and evolution of the pre-approval program are discussed.

No required text.

 

Timetable

(in U.S. East Coast time)

6:00 pm – 9:00 pm Wednesdays:  Jan 24, 31, Feb 7, 14, 21, 28, Mar 7, 14, 21, 28, Apr 4, 11.  Meets 12 times plus final exam. Make-ups, if needed, Apr 18 or 25.

Proctored exam:  Feb 28

 

Lecturer

Faculty:  K. Campbell and D. Pagano

Biotechnology: Bioprocess Basics (5471) 

Prerequisites: undergraduate introductory biochemistry and chemistry courses

This course empasizes regulatory and control aspects of biologics manufacturing as well as Quality by Design (QbD) principles. It provides students with a basic understanding of the major steps involved in the manufacture of biologics/biopharmaceuticlas, including preparation of media, fermentation, harvesting/recovery, purification and formulation. Included is a review of basic bioscience topics (e.g., microbiology, biochemistry, and molecular biology) with particular relevance to the study of bioprocessing techniques.

No required text.

 

Timetable

(in U.S. East Coast time)

6:00 pm – 9:00 pm Mondays:  Jan 22, 29, Feb 5, 12, 19 (President’s Day), 26, Mar 5, 12, 19, 26, Apr 2, 9.  Meets 12 times plus final exam. Make-ups, if needed, Apr 16 or 23.

Proctored exam:  Mar 5 (Software Secure)

 

Lecturer

Faculty:  J. Quinn

Good Pharmacovigilance Operations (5508) 

Special note: this course will use Software Secure, an online proctoring service.

Prerequisites: Drug Development (5459)

This course provides a solid foundation for understanding/managing the complexities of the lifecycle of an individual case safety report (ICSR). It reviews the process from receipt of the ICSR to reporting to regulatory authorities (both as an expedited ICSR and within a periodic safety update report). It compares US and EU regulations and ICH guidances in this area. It also covers the requirements for a validated safety database to process ICSR and Quality Systems in a Pv department. The course discusses the management of a Pv department and the business decisions required to manage the volume of cases received. Also discussed is the role of Pv agreements and preparation for a Pv inspection.

No required text.

 

Timetable

(in U.S. East Coast time)

6:00 pm – 9:00 pm Thursdays:  Jan 25, Feb 1, 8, 15, 22, Mar 1, 8, 15, 22, 29, Apr 5, 12.  Meets 12 times plus final exam. Make-ups, if needed, Apr 19 or 26.

Proctored exam:  Mar 8 (Software Secure)

 

Lecturer

Faculty:  C. Wittrock

Testimonials

alvin-news-ad-8jan12

alvinyang

Alvin Yang, NUS BEng (Chemical Engineering), previously employee in electronics industry, now trainee at Genentech: “The NUSAGE programme has equipped me with the core disciplines of pharmaceutical science and technology. I was unsuccessful previously when I went for pharmaceutical job interviews before coming through NUSAGE. After taking two NUSAGE-Temple University modules, namely Good Regulatory Practices and Unit Operations, I was then selected for the Singapore Economic Development Board’s Strategic Attachment and Training programme with Genentech (USA) for the development and manufacturing of chemical and biological drugs.”

pangyunkeng

Pang Yun Keng, NUS BSc Life Sciences: “The GCP course offered by NUSAGE-Temple University enabled me to take on a new job role in clinical research at the National University Health System. I am now shouldering greater responsibilities in overseeing the administrative aspects of drug trials.”

koosiangchueng

Koo Siang-Chueng, Regional OE Manager of GSK and NUSAGE facilitator (part-time): “The video conference lectures have been amazing. I am impressed with the state-of-the-art technology and how NUS leveraged on technology to facilitate global learning. The quality of the sound and video images of the video conference lectures were excellent and it really felt like the lecturers were right in front of the class. Smart features like the video zooming in on students who press the button to ask a question are impressive too. The IVLE platform is user-friendly and enables students to review a lecture again or for those who miss the lecture to catch up at home. This helps working students who may miss classes because of work commitments.”

terencecheung

Terence Cheung, BPharm (UK), registered pharmacist, now Managing Director of Kemimac: “I worked in a clinical field before switching to the pharmaceutical manufacturing sector. The courses have been very useful as they gave me a new set of skills and knowledge that is applicable to this industry. The background knowledge gave me a bird’s eye view to the entire drug manufacturing process.”

nicoleye

Nicole Ye Yuying, BSc (Biomedical Science), now Associate Scientist, GSK Research Center: “I enjoyed the Temple University (TU) modules most when I did my Masters, especially Food and Drug Laws. Barry is a very good lecturer. He teaches in a very applicable way such that students will remember them to interesting examples and repetition, not by hard core memory – which you forget after exams. TU modules may seem less taxing on the students but they are actually more efficient in terms of dynamism, remembering and application of what was learnt. TU modules make the Master Course more interesting. We should continue to add more TU options for students to take them up.”

junetay

June Tay Ling Hwee, BSc (Drug option), now Senior Quality Associate, MSD Singapore: “The courses provided an insight to the Pharmaceutical industry that the world live by today and provided a realistic view on the fundamentals of cGMP as well as challenges that traditional Pharmaceutical companies face today. The lecturers are well balanced with both Industry and theoretical knowledge which made learning easier. They provide a realistic amplification of issues that struck a core with students as they face similar challenges in their daily roles, hence the lessons create a lasting impression even after graduation. It emphasized actual events which stretch the intuitive mind and explore the underlying concepts employed by the Pharmaceutical industry today. The MSc (PST) programme covers a wide scope of the Biopharmaceutical and Pharmaceutical industry today and broadens one’s perspective of the pharmaceutical network. It provides insight to the “What’s new” in the market for the future. It has certainly benefited me as I can better appreciate the workings of this industry from both the manufacturing and quality perspective. It is a bird’s eye view of the industry!”

limhuiming

Lim Hui Ming, BSc Chem (Food Science and Technology), NUS MSc (Pharm Science & Technology), now Quality Control Biochemist, Givaudan (S’pore): “This postgraduate course provides a broad selection of modules that sums up the core functions of pharmaceutical manpower and is well balanced in coverage of both the technical skills and academic knowledge in biomedical industry. Taking up this course has provided me with the necessary skill set to face future challenges that I will likely to encounter in my career.”

Frequently Asked Questions (FAQ)

 

  1. I do not have the relevant degrees stated in the admission requirements, but I have some years of working experience in the pharmaceutical industry. Am I eligible to apply for the programme?
  • Interested applicants with a university degree and relevant working experience may apply for the NUSAGE modules, even though they may not have the relevant degrees. The Department welcome applicants who are enthusiastic to upgrade themselves in the pharmaceutical field, and the admission committee will review the suitability of each application based on their background and merits for admission.

 

  1. I do not have the relevant degrees stated in the admission requirements, but I have some years of working experience in the pharmaceutical industry. Do I need to apply for the bridging module PR 3301 before I can apply for the NUSAGE modules?
  • To apply for NUSAGE modules, you do not need to apply for the bridging module first.

 

  1. I am interested in doing the NUSAGE Certificate courses and in future, the Masters of Science in Pharmaceutical Science and Technology, MSc.(PST). Do I need to pass any GRE exam before I apply for the NUSAGE modules?
  • You need not pass any GRE examination at this point of time, as NUSAGE is unique in that it offers Certificates of Attendance for individual modules. You can explore the programme by taking a maximum of 3 such modules before formally matriculating into the MSc(PST) programme. It is only then that you will need to submit your GRE scores. You may use the GRE score taken within the last 5 years. All other information regarding the admission criteria for the MSc (PST) programme can be viewed from http://www.pharmacy.nus.edu.sg/prospective/prog_gadmcintro.html
  • GRE scores to be eligible for applying into the Master’s programme:
  • Verbal: 500, Quantitative: 700, Analytical writing: 3
  • Effective 1 Aug 2011, there are updates to the GRE scoring system. For more information please visit http://www.ets.org/gre/institutions

 

  1. I am now enrolled in the MSc(PST) programme and have previously taken the Temple U modules (Regulation of Drug Development/Good Regulatory Practices/Food & Drug Laws) as a NUSAGE student. Can I carry over credits for these 3 modules to the MSc(PST) programme?
  • Yes you may since these 3 modules are also the essential modules that are required to be read in the MSc programme. Upon acceptance to the MSc(PST) programme, please write an email to PHABOX7@nus.edu.sg listing the modules and grades that you wish to transfer, attach with supporting documents such as exam result slips/transcripts for the advance placement of grades and credits to be considered.

 

  1. What is the cancellation policy for NUSAGE programme?
  • Upon submission of your application forms and fees, you will be issued an acknowledgement via email. You may cancel the application after the acknowledgement of receipt and before the class commences. Once the class commences, there will be no refund of fees.

 

  1. It is mentioned that either original scrolls/transcripts should be provided for application. May I know will the original documents be returned to the applicants?
  • Supporting documents, originals or photocopies (which have been certified true copies), submitted for application will not be returned to applicants.

 

  1. Certified True Copies of scrolls/transcripts have to be submitted in place of originals. May I know whom should I approach to certify the photocopies?
  • NUS graduates will have to approach the Student Service Centre to certify their documents. See http://www.nus.edu.sg/osa/ssc/
  • For foreign graduates, if you wish to submit your transcript together with your application form, the offical transcript must be enclosed in a SEALED envelope with its flap bearing the security seal of the university and the signature of the Registrar or his representative.
  • You are responsible for requesting your transcript from the university concerned. Please download the Transcript Request Form for this purpose. If you have attended more than one university, you should make photocopies of the Transcript Request Form as required.

 

  1. How many intakes per year are there for this NUSAGE programme?
  • There are 2 intakes per year one in January and the other August. Application deadline for January intake is in September. For August intake, the application deadline is 15 April of the same year.

 

  1. I graduated from NUS with a Bachelor’s Degree. Do I need to submit originals/photocopies of the scrolls/transcripts for application? Can the Department refer to my information internally?
  • Applicants who are alumni of NUS will have to submit the required supporting documents.

 

  1. Can I make payment by CPF?
  • No, you cannot make payment by CPF. Payment will have to be made in full via cheque, addressed to “National University of Singapore”. Please indicate “NUSAGE Application fee” and your name clearly at the back of the cheque. Cheques are to be submitted together with the Application form. Applicants who are not successful in getting a place in the course will have their cheque refunded.

 

  1. Upon graduation, will the NUSAGE Certificate of Attendance be of help for me to pursue a career in Pharmaceutical industry. What are the career prospects and the starting salary like?
  • NUSAGE Certificates aims to equip the participants with versatility and basic know-how as he acquires the technical language system which is the passport for diverse career opportunities in manufacturing, clinical trial research and the regulatory aspects of the pharmaceutical industry. It definitely will form a structured background education and training that you will need in order to improve your competitiveness in pursuing a career in the pharmaceutical industry. If you are already in the pharma industry, it may help to advance your career.