Pharmaceutical Industrial Advanced Training (PIAT) Pharmaceutical Industrial Advanced Training (PIAT) University of Manchester ../webroot/files/Institutions/cover_photo/1564115975University-of-Manchester1.jpg
Masters Degree , Uncategorised
Course Description
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 Product Development, Manufacturing and Quality Assurance. The programme is administered by the School of Pharmacy and Pharmaceutical Sciences which obtained the highest ratings available in recent teaching and research assessments. Special features: - Distance learning Using distance learning, the PIAT programme is designed to improve students' work performance and allow them to achieve university qualifications without the need for prolonged absence from work. Students receive a work book containing teaching material and exercises for each module chosen. Tutors are available to assist throughout the course. - Industry-recognised qualification In the long term it improves graduates' career prospects by gaining industry-recognised qualifications validated by a leading university. It also provides the training required for Qualified Person recognition. - Start dates Students can start their studies at any time. The main themese include the following modules: Industrial Pharmacy - Basic principles: The physicochemical principles of dosage form design - Preformulation studies 1: Physicochemical aspects of drug substances and excipients - Preformulation studies 2: Biopharmaceutical aspects of dosage form design - Solid oral dosage forms: Formulation and process development - Liquid and semi-solid dosage forms: Formulation and process development - Sterile dosage forms: Sterilisation processing, aseptic handling and validation control and maintenance of sterile dosage forms - Sustained and controlled release dosage forms: Formulation and process development - Operations management: Control of manufacturing and supply operations - Quality control and quality assurance: Concepts, international regulatory requirements and management - Packaging: Materials, methods, regulatory requirements and product development - Principles of toxicology - Assessment of toxicology - Biotransformation and kinetics - Mechanisms of toxicology - Molecular and cellular methods in toxicology - Regulatory affairs: International requirements in development, manufacturing and marketing* - Pharmaceutical engineering: An introduction to design, construction and operation of facilities - Quality control laboratory testing: Laboratory testing of raw materials and finished products - Safety, health and environment: Concepts, legislation and management* - Inhalation dosage forms: Formulation and process development - Product development management: An overview of the processes and management* - Scientific and medical writing* Clinical Trials - Introduction to clinical trials - Setting up and running clinical trials - Phase I - Phase II - Phase III global clinical trials - Statistical requirements and study design - Pharmacovigilance - Regulatory issues Pharmaceutical Business Development and Licensing The Pharmaceutical Business Development and Licensing pathway was established in collaboration with UK PLG (The Pharmaceutical Licensing Group). PLG is the professional association for people in business development and licensing and again it is a not for profit organisation, industry based, and has no service providers. The primary role of PLG is networking and continuous professional development. In the UK there are over 200 members covering all areas of the industry pharma, OTC, biotech, drug delivery and generics, and there are nine other PLGs in Europe plus Japan and Canada with over 1,500 members. PLG was founded in 1994, and organises a number of training courses in business professional development. The programme consists of eight modules: - Introduction to the healthcare industry* - Business development Operations* - Financial aspects of business development and licensing* - Legal issues in business development contracts* - Negotiation and interpe
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