Pharmaceutical Industry Advanced Training

The PIAT Programme
Industrial Pharmacy Clinical Trials Pharmaceutical Business Development and Licensing Pharmaceutical Microbiology

Distance Learning / Home or Workplace Study / MSc / Diploma / Certificate / QP Training / Module Credit

The PIAT Programme
Developed in partnership with the pharmaceutical industry, the PIAT Programme is a postgraduate-level training programme designed for scientists and managers working in the pharmaceutical industry in the fields of Industrial Pharmacy, Clinical Trials, Pharmaceutical Business Development and Licensing, and Pharmaceutical Microbiology. The programme is administered by the School of Pharmacy and Pharmaceutical Sciences, which obtained the highest ratings available in recent teaching and research assessments.

The Benefits
The PIAT Programme is designed to improve your work performance. An important benefit of the programme is that it provides you with the opportunity to achieve University qualifications without the need for prolonged absence from work. In the long term, it should help you to improve your career prospects by gaining industry qualifications validated by a leading University. It also provides the training required for Qualified Person recognition. For many in the Pharmaceutical and other industries CPD is now an essential component of career development and this can be enabled by subscribing to individual modules.

How PIAT Works
A list of module titles is shown overleaf. You select from this list the subject module or programme of modules you wish to study. For each module chosen a text containing teaching material and exercise’s will be sent to you for you to study in your own time. For each module you will be expected to complete the exercises, a written assignment and to attend a one day module workshop and examination session at the university. Throughout your studies a tutor is available to help you if required.

1

Modules
2

Modules are presented as texts w ritten to enable y ou to understand the subject and to study at home or at work. Exercises are included in the text to help the learning process and you will undertake a written assignment dealing with aspects of the subject. Each module will require approx 150 hours of study time to understand the subject matter, to complete the module exercises and the module assignment and to attend the workshop and revise for the examinations.

Industrial Pharmacy

3

Industrial Pharmacy

MODULE 1

MODULE 5

Basic Principles - The physicochemical principles of dosage form design
This introductory module will describe the properties of drugs in the solid state and in solution. The stability of drugs in solid and liquid dosage forms will be discussed, and colloidal dispersions and interfacial phenomena will be explained.
MODULE 2

Liquid and Semisolid Dosage Forms Formulation and process development
Topics covered in this module include an introduction to liquids, solutions and their properties, colloidal and suspension systems, flavours, colours and perfumes, ointments and creams, suppositories, preservatives, and product testing.
MODULE 6

Preformulation Studies 1 - Physicochemical aspects of drug substances and excipients
This module explains the need for preformulation. A number of solubility parameters will be discussed including intrinsic solubility, dissolution rate, pKa and salts, solvents and partition coefficients, and also thermal properties of drug candidates. The concept of stability will be explained, including degradation mechanisms, stability assessment and inhibition. Assay development to establish levels of actives will be described. Particle properties and powder flow and compression properties will be explained.
MODULE 3

Management Tools – (New for October 2013) *
This module provides students with a perceptive insight into their management and leadership styles and strengths. It builds the skills that will enable students to lead their teams effectively, manage change successfully and interact with and influence colleagues in other areas of the business. This specifically designed module will include the skills and strategies for effective management of a pharmaceutical microbiology laboratory.

MODULE 7

Oral Solid Dosage Forms – 2
This module builds on the teaching from Module 4: Oral Solid Dosage Forms – 1. It begins with a unit which covers the basic pharmacokinetic concepts associated oral controlled release and continues with an introduction to polymer science. This is followed by units on matrix release systems and reservoir systems. Further units include the manufacture of soft gelatin capsule, the formulation of poorly soluble compounds, formulation and process design, evaluation of oral solid dosage forms, experimental design and design of experiments and expert systems.

Preformulation Studies 2 - Biopharmaceutical aspects of dosage form design
The contents of this module include an introduction to biopharmaceutics, and the routes of administration and absorption of drugs will be covered. Formulation factors affecting gastrointestinal absorption will be described. The role of the dosage form in preformulation will be explained. Pharmacokinetics of actives will be outlined, and pharmaceutical dissolution testing discussed.
MODULE 4

Oral Solid Dosage Forms – 1
This module begins with an introduction to the anatomy and physiology of the gastro-intestinal tract as it relates to oral absorption of drugs. It then continues with a unit on powder technology, followed by units on the important processes used in the manufacture of tablets and powder-filled capsules, including granulation methods, blending, tablet compression, powder encapsulation and coating. There is also a unit on excipients used in immediate release oral solid dosage forms. (The testing and evaluation of oral solid dosage forms will be covered in Module 7: Oral Solid Dosage Forms – 2)

MODULE 8

Lean Processes – Business Improvement, Statistical Science (New for October 2013)
This unit will help you to develop a practical understanding of the lean processes that can help a business be more efficient – known as business improvement statistical sciences. It will raise your awareness, knowledge and capability in statistical techniques and frameworks so that business leaders, managers and experts are able to champion, support and engage in the effective use of these tools in their business process improvement initiatives and day to day activities.

4

MODULE 9

MODULE 14

Quality Assurance - Concepts, international regulatory requirements and management
This module explains the basic principles and concepts of quality assurance. It covers QC, QA, and Good Manufacturing Practice, QA, GMP, QC regulations and the law, personnel and training, documentation, further aspects of GMP, validation, good laboratory practice and calibration, and regulatory aspects.
MODULE 10

Safety, Health and Environment Concepts, legislation and management*
This module covers the relevant laws, general safety management, hazard and risk, safe systems at work, engineering and loss prevention, health at work, control of the working environment, human factors, environmental protection and audit and reviewing performance.
MODULE 15

Packaging - Materials, methods, regulatory requirements and product requirement
This module includes legislation and consumer aspects, and the relevant properties of widely used materials, and packaging of sterile products and devices. Storage and transport, testing of packages, product security and the packaging line are also explained.

Inhalation Dosage Forms Formulation and process development
This module covers drug delivery to the lung, formulation of metered dose inhalers, metering valves and containers, dry powder inhalers, nebulisers, particles size analysis, and quality control.
MODULE 16

MODULE 11

Regulatory Affairs - International requirements in development, manufacturing and marketing*
This module covers the history and background to regulation of medicines, the legal basis of controls, and the advice available.
MODULE 12

Product Development Management An overview of the process and management*
This module covers compound selection, market research, intellectual property, regulatory affairs, chemical, analytical and formulation development, pharmacology, toxicology, clinical trials, packaging, QA, product and marketing development, product launch, information technology, and management of project and portfolio of projects.
MODULE 17

Pharmaceutical Engineering - An introduction to design, construction and operation of facilities
This module covers the philosophy, project design and management, site selection, process flow diagrams and documentation, process utility systems, the design of laboratories, pilot plant, parenteral facility, automation of packaging systems, GMP and validation.
MODULE 13

Scientific and Medical Writing*
This module covers the development of scientific publications, including how to identify and assimilate source data, the approach to writing and reviewing scientific publications and the overall publication process including submission and postsubmission. Participants will develop a range of publication types including abstracts, posters and manuscripts, based on a clinical trial report. The preparation of standard operating procedures relating to scientific publications will be covered. * assessed by assignments only (no written examination)

Quality Control Laboratory Testing - Laboratory testing of raw materials and finished products
This module covers the sampling, specifications, physical, chemical, spectroscopic, and chromatographic test methods, packaging component testing, microbiological testing, environment, water, steam and gasses, validation and out of specification results.

5

Clinical Trials

6

MODULE 1

MODULE 5

Introduction to Clinical Trials
This introductory module provides an overview of the basic requirements and procedures employed in planning and conducting clinical trials. It also provides guidance on ethical, regulatory and statistical aspects as well as the managerial requirements.

Phase III Global Clinical Trials
This module will provide an appreciation of the factors to consider in establishing and managing a large global phase 3 clinical trial programme.
MODULE 6

MODULE 2

Statistical Requirements and Study Design
This module will provide a clear understanding of the fundamental statistical principles as applied to the design and analysis of clinical trial. Topics covered will include basic statistical concepts, the role of randomisation, blinding and control in trial design and sample size and power. The module will also cover statistical analysis issues such as handling dropouts, missing data and multiplicity.
MODULE 7

Setting up and running Clinical Trials
This module covers the basics of planning, setting up and running clinical trials to current standards of Good Clinical Practice (GCP) and provides practical guidance on clinical trial design, protocol preparation, CRF design, monitoring and project management.
MODULE 3

Phase I
A key module for understanding early drug development, enabling the module participant to understand what can be defined as ‘phase I trials’, the pre-clinical data required by the regulatory authorities before first human dosing, how a phase I trial can be designed and data interpreted alongside risk mitigation. General pharmacokinetic and pharmacodynamic principles are dealt with in terms of phase I data analysis.
MODULE 4

Pharmacovigilance
This module provides an introduction to pharmacovigilance including key definitions and the nature and burden of adverse drug reactions (ADRs). It covers safety monitoring in clinical trials, what ADRs this will detect and its limitations. It goes on to look at the methods for post-marketing surveillance, introduces patient risk management and relevant ICH Guidelines and CIOMS reports.

Phase II
This module will provide a clear understanding of the planning and performance of phase 2 clinical trials, estimation of therapeutic dose and regimen, the importance of biomarkers in giving an early objective insight into likely therapeutic benefits, and decision trees for taking a drug into phase 3 clinical trials.

MODULE 8

Regulatory Issues
This module describes the major regulatory agencies and their committees, the approval procedures for clinical trial applications and the data requirements for their submission, the procedures for interaction with regulatory agencies in order to obtain scientific advice during the drug development programme, and finally, the procedures for submission of marketing authorisation applications.

7

Pharmaceutical Business Development and Licensing

In association with

8

MODULE 1

MODULE 5

Introduction to the Healthcare Industry
This introductory module will provide an overview of the industry with specific reference to the role of business development. The module includes units on the structure and dynamics of the industry, R&D and drug discovery and development including basic regulatory concepts. It addresses company strategies and the external factors which impact on the industry’s future.
MODULE 2

Negotiation and Interpersonal Skills
This module will address the development of the interpersonal skills required for successful pharmaceutical business development. Particular emphasis will be placed on developing negotiation and communication skills and expertise. Units will cover organisational cultures and behaviour; national and corporate issues will also be addressed.
MODULE 6

Business Development Operations
This module will cover the key operational area within business development and licensing. There are units on portfolio management, due diligence, project management and deal implementation. This unit also focuses on technology transfer issues and the role of alliance managers.

Marketing and Commercialisation
This module will cover all aspects of national and international commercialisation of products and technologies. Starting with intelligence, other units will address competition, pricing, generics, parallel imports and marketing strategies.
MODULE 7

MODULE 3

Intellectual Property Rights
This module covers all aspects of intellectual Property Rights. Although more emphasis may be placed on patents and know how, the module includes trademarks, trade secrets, design and copyright.
MODULE 8

Financial Aspects of Business Development and Licensing
This module will cover basic financial concepts and the key tools required for financial modelling of deals. The other units in this module will include valuation techniques, building sales forecasts, current deal trends and the management of risk.
MODULE 4

Research & Development and Manufacturing
This module covers the business development issues arising from both the R&D and manufacturing areas of operation. This includes a review of the business development deals from research alliances, supply agreements and outsourcing.

Legal Issues in Business Development Contracts
This module covers the key legal aspects required to support the negotiation and conclusion of agreements in business development. The unit will cover all types of agreements as well as fundamental issues such as product development, marketing, performance, competition law and product liability.

All modules on this page are assessed by assignments only (no written examination).

9

Pharmaceutical Microbiology

In association with

The Pharmaceutical Microbiology Interest Group (Pharmig) was established in 1991 and is a non-profit
making professional organisation based in the UK, that represents the interests of people who are working in, or having responsibility for (including the provision of commercial services), pharmaceutical microbiology.

10

MODULE 1

MODULE 5

Introduction to Pharmaceutical Microbiology and Technology
This introductory and compulsory module will provide an overview of the Pharmaceutical Industry and Regulatory Affairs covering all aspects of QA, QC, GMP, GLP and consider Documentation and Health & Safety issues. The design of Premises and Equipment for the Laboratory and Facility including Quality Audits will be covered. Commonly encountered micro-organisms and Basic Laboratory Techniques, including Rapid Methods will be discussed along with Validation of Processes & Methods.
MODULE 2

Quality Assurance in Microbiology Laboratories
Principles, Concepts and References used in the QA, QC, GMP & GLP of the Microbiology Laboratory will be covered in more detail here. The Laboratory Facility, Equipment and Consumables used along with the Validation of Processes, Equipment and Methods will also be covered. A more detailed look at Quality Audits and Training issues together with the Documentation Control required will be detailed. The Management of Microbiology Laboratory Customers will be explained.
MODULE 6

Water Aspects
This module will look at the Compendial Water Qualities used in the industry. The Design of Water Generation, Storage and Distribution Systems together with the options for Validation & Change Control, System Operation and Management and System Sanitisation will be reviewed. The Methods of Testing, including the Common Contaminants encountered as well as the Sampling Regimes & Techniques will be explained. Data Management, Trending and Interpretation will be covered.
MODULE 3

Engineering Principles for Pharmaceutical Microbiologists
A list of the Engineering Terminology and Engineering Regulations commonly encountered will be explained. The Project Design & Management of a Facility, Critical Services and Utilities will be covered. The concepts of Hygienic System Design and HVAC Systems and Environmental Control will be included and Sterilisation Issues and Validation will be covered in the module.
MODULE 7

Application of Microbiology in Biopharmaceuticals Microbiological Environmental Monitoring & Control (sterile & non-sterile manufacturing areas)
This module examines the requirements of a robust and flexible environmental monitoring programme, which can be applied to both sterile and non-sterile manufacturing units. It includes an examination of the current Regulatory Requirements; an exploration of Environmental Monitoring Methodologies, including aspects of their Validation, together with a look at the Commonly Isolated Micro-organisms. Data Management and Trending including Basic Statistics will also be covered. A look at Risk Management of procedures, the role of Disinfectants and Rapid Methods will also be explored to enable the student to gain a balanced understanding of this key aspect of pharmaceutical microbiology.
MODULE 4

A review of the current Legislation & Guidelines in Biopharmaceuticals will be conducted. The module will cover Hygienic Plant Design and Sanitisation CIP/SIP. A detailed look at Biopharmaceutical Technology (growth techniques, cell & tissue culture, fermentation, purification, harvesting, final drug products) will be conducted. The Viral Load Reduction/Detection Techniques together with those available for Mycoplasmas will be explained. Lyophilisation Techniques as well as Test Methods for Biotechnology Products will be included.
MODULE 8

Antimicrobials
Disinfectants The current Regulatory Requirements for disinfectant use along with GMP Associated with Disinfectants will be covered in this module. The Types of Disinfectants and their Selection will be included covering aspects of Practical Usage. A detailed look at Test Methods and Validation will be described.
Preservatives

Sterile Pharmaceutical Manufacturing
This module is concerned with sterile pharmaceutical products (both aseptically filled and terminally sterilised), together with the design of facilities and utilities to support their manufacture (including the construction, testing and certification requirements for cleanrooms) and the necessary tests to indicate the probability that sterility has been achieved. With tests, the module considers both end-product testing (sterility, particulate and pyrogens) and in-process testing designed to meet the Quality by Design and Process Analytical Technology initiatives.

The Preservatives Available for Use in Mixtures, Suspensions & Syrups will be examined as well as the Preservation of Sterile Products. The test methods for evaluation of formulations such as Preservative Efficacy Testing and Stability of Drugs & Stability Testing will also be included. The Resistance towards Preservatives in Pharmaceutical Products will be mentioned.

1

Other Information
12

University Awards
Module Credits – are awarded for the successful completion of each module. Certificate – is awarded for the successful completion of an approved set of four modules, normally within two years of registration. The Diploma of Advanced Studies – is awarded for the successful completion of an approved set of eight modules, normally within four years of registration.

Study Requirements
Access to PIAT is open to all. There are no special entry requirements if you want to study individual modules as part of your personal development programme. PIAT is an advanced level programme and some modules require an advanced level knowledge of physical and organic chemistry, biology and mathematics. All modules require some work and experience within the industry. To study for a Diploma in Advanced Studies or the MSc degree you

The Master of Science Degree – is awarded for the same study programme as the Diploma, with the addition of a dissertation on a workplace research project. In most cases the dissertation will deal with a subject that is relevant to your industrial experience and will require approximately 600 hours of study. Each dissertation project will have an academic supervisor who will have primary responsibility for the supervision of the dissertation work, and an industrial tutor. The industrial tutor will be an experienced person from your company. The subject of the dissertation project will be agreed between you, the academic supervisor and your industrial tutor. Workplace study facilities and supervision arrangements must be approved by the University. Assessment – If you want to earn module credits towards a University award, your progress will be examined by completion of the exercises in the module, assessing your written assignment and by taking a two hour unseen examination at the University of Manchester. If you do not want the credits towards a qualification you do not need to take the examination. Note: Some modules are assessed by exercises and extended assignments only, without an unseen examination.

should normally have a degree level scientific qualification. If you do not already have the required qualifications to study for the Diploma in Advanced Studies you can join this programme when you have proved your ability by earning four module credits.

Timetable
Students can start the programme in either October or April. Examinations are held in Manchester over a one week period normally in March and September each year. New for 2013 is a Weekend Summer School, which will run at the end of June. Workshop sessions will run, covering all our modules and will be available to all students.

The summer school will give students the opportunity to meet and network with other students and tutors.

Registration
• to purchase individual modules complete sections 1, 2, 3, 5, 8 and 9 of the PIAT Programmes application form. • to apply to join the Certificate, Diploma in Advanced Studies or the MSc programmes complete all sections of the PIAT Programmes application form.

Details of course fees can be found on the website: •
www.mhs.manchester.ac.uk/postgraduate/programmes/taughtmasters/piat/

to apply to join the QP Training please download a separate application form from the following websites: http://www.primex.co.uk/iob http://www.rsc.org http://www.rpsgb.org.uk

13

For further information on PIAT modules please visit our web site
PIAT, School of Pharmacy & Pharmaceutical Sciences, The University of Manchester, Room 2.19f Stopford Building, Oxford Road, Manchester M13 9PT Tel: +44(0)161 275 1798/2371 ( ) Email: piat@manchester.ac.uk Website: www.manchester.ac.uk/piat

80%

Cert no. SGS-COC-003591

Master your semester with Scribd & The New York Times

Special offer for students: Only $4.99/month.

Master your semester with Scribd & The New York Times

Cancel anytime.