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Industrial Pharmacy Advanced Training Program – 2012/2014
Participants in the 2012 intake will complete
I. DEFINITION the Industrial Pharmacy Advanced Training
This training under Kilimanjaro School of Program (all four courses)in two years.
Pharmacy – Industrial Pharmacy Teaching
Unit (IPTU) is an Advanced Training Program III. ELIGIBILTY
in Drug Development, Drug Manufacturing, Requirements:
Regulatory & Quality Compliance. An applicant for this program must be a
holder of at least a bachelor’s degree in
II. INTRODUCTION Pharmacy or Biochemistry, or Chemistry or
The purpose of this advanced training Microbiology and Food technology industries.
program is to provide in-depth level
education/ training in the important aspects Participants:
of Drug Development, Drug Manufacturing, Applicants include persons employed in the
Regulatory and Quality Compliance in the pharmaceutical industry including positions in
Pharmaceutical Industry. Thereby, pharmaceutical manufacturing,
participants/students will have an opportunity pharmaceutical analysis, quality or regulatory
to improve their knowledge of drug affairs. Applications from qualified persons
development, drug manufacturing, regulatory employed in universities looking to expand
and compliance issues and to explore careers their curriculum or other public institutions
in these exciting areas in the pharmaceutical such as medicines regulatory authorities are
industry or related institutions. also welcome.
The development of this program has been a
joint effort between Purdue University, USA V. APPLICATION PROCEDURE
and Kilimanjaro School of Pharmacy - St. Luke Applicants must complete the application
Foundation, Tanzania. form by 30 June 2012 for August 2012 intake.
Individuals who successfully complete the The application form is provided in the annex
advanced training program will be provided a of this brochure, last page.
certificate of completion signed jointly by
Kilimanjaro School of Pharmacy - St. Luke
Foundation and Purdue University. Please send the completed form to:
This advanced training program consists of Kilimanjaro School of Pharmacy;
four courses; each involves 45 contact hours IPTU,
as well as associated homework assignments St. Luke Foundation
and examinations. P.O.BOX 481 –MOSHI, TANZANIA.
The certificate program consists of the TEL/FAX: +255-2727-52303;
following four courses:
E-mail: zekeocha@gmail.com
1. Drug discovery,
2. Drug development and regulatory & Short-listed / selected applicants will be
quality compliance, contacted through email.
3. Drug manufacturing process, Application fee of $50 (USD) to be paid by
4. Regulatory documents and generic cheque or Bank draft;
drug approval submissions. payable to Saint Luke Foundation,
Deadline for the completed application form
with fee to reach Saint Luke Foundation by 30
June 2012, for August 2012 in-take.
1
Industrial Pharmacy Advanced Training Program – 2012/2014
VI. COURSE DURATION & STARTING DATES
For each course, the duration is 14 days.
The program will begin with the courses as
outline below:
• Drug discovery- 6 – 18 August 2012
• Drug development, regulatory &
quality compliance, –March 2013
Followed by:
• Drug manufacturing process – August
2013
• Regulatory documents and generic
drug approval submissions – March
2014
VII. COURSE FEES AND COSTS
Application fees 50 USD non refundable
Registration fees 20 USD non refundable
Tuition fees, materials and examination
1,500 USD
1,500 USD per course,
excluding Application fee and Registration
fee.
Total for the program 6,000 USD
Accommodation:
For the duration of the courses SLF can
• Organise accommodation with half
board
• Transportation from airport (arrival &
departure for 50 USD per trip.
Lunch will be provided at SLF at a rate of 10
USD per day.
2
Industrial Pharmacy Advanced Training Program – 2012/2014
14 Exam
VIII. COURSE CONTENTS Module 3 – Chemistry Manufacturing and
Controls
The course contents shown can vary slightly at
the discretion of the instructor to meet the 1 USP
requirements of students. 2 Pisano
3 IND
4 DMF
th th
Course 1: August 6 –18 2012: 5 End of Phase 2
Drug Discovery
6 Specifications
Lecture Topic 7 Impurities
Number
Module 1 – Drug Discovery 8 Stability
1 Introduction 9 Case Studies
2 Drug Discovery 10 Case Studies
3 Discovery Process 11 FDA Structure
4 Discovery Biologists 12 Submitting an NDA/IND
5 Synthetic Chemistry 13 Review and Conclusion
6 Discovery 14 Exam
7 Toxicology for Discovery
8 Drugs from Biotech
Course 2: March 2013
9 Early Formulations
10 Patents Drug development, Regulatory & Quality
11 Conclusion Compliance
12 Review and Exam Lecture Number Topic
Module 2 – Early Development and Toxicology Module 1 - GMP Drug Product
1 Organization and Administration 1 Intro to GMP
2 Toxicology 2 GMP’s
3 Contract Research 3 Cleanliness and
4 Ethics Contamination Exercise
5 Phase I 4 Six Systems-31
6 Phase II 5 Six Systems Exercise
7 Marketing and Sales 6 ICHQ1
7 ICHQ2
8 Product Decisions 8 ICHQ3
9 Clinical Trials 9 ICHQ6
10 Clinical Trials 10 ICHQ8
11 Clinical Trials 11 ICHQ9
12 Case Study 12 QC-QA
13 Review and Conclusion 13 QC
14 GMP’s.
3
Industrial Pharmacy Advanced Training Program – 2012/2014
15 GMP’s as Learning Syst. 5 QC in Clinical Res defective.
16 SUPAC - Changes 6 Reg. Aff. In Clin. Res.
17 Comparability Protocols 7 FDA GCP Inspections
SUPAC 8 Pharmacovigilance
18 Comparability Protocols - 9 Summary – useful things -
Biologicals delete
19 USP for GMP 10 Exam
20 SOPs
21 SOP Example
22 OOS
23 Computer systems
24 GMP’s and Quality by
Design
25 KRMPAT-I
26 KRMPAT-II
27 Review and Conclusion
28 Exam
Module 2 – GMP API
1 Introduction
2 GMP’s
3 Systems & CAPA
Module 3 - GLP
1 Quality
2 Toxicology
3 GDRPs
4 Information
5 Quality in Discovery
6 GLP
7 QC in Tox
8 IM Tox Archives
9 QA in Tox
9 Management
9 Furrow top 10
10 Regulatory Facts
11 Role of Study Director In tox
12 FDA GLP Inspections
13 Exam
Module 4 - GCP
1 Quality and Compliance
Clinical Research
2 What goes wrong
3 RQA GCP - defective
4 RQA Auditing
4
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