Проект 511092-1-Tempus-2010-1-UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» Enhancement of biotechnology (Pharmaceutical. - презентация

1 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» Enhancement of biotechnology (Pharmaceutical engineering) curriculum at masters level in Russian Universities User Needs Survey and Analysis Enhancement of biotechnology (Pharmaceutical engineering) curriculum at masters level in Russian Universities Analytical presentation (1) User Needs Survey and Analysis

2 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» Work Package 1-2: Activities leading to the clear definition of learning outcomes, competences and learning centred curricula: Establish and run Stakeholder working group to define learning outcomes, competences and curricula. Learning outcomes will be aligned to the relevant level descriptors within the European Framework and a visit made to the ECTS representative in Moscow to verify the approach leading to a clearly defined list of learning outcomes and competences aligned with ECTS requirements. Curricula will be developed through expert assessment using matrix instruments with the assessment of student input standards to identify needs for additional training leading to the specification of modes of study, programme structure, syllabus, student workload and assessment methods The proposed curricula will be discussed with stakeholders and coordinated with ECTS and EU Tuning points to ensure compatibility leading to clearly defined Curricula for the Masters programme aligned with ECTS requirements.

3 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» Biotechnology – a priority in EU and RF: A thematic area (along with health) in the EUs Seventh Framework Programme for Research and Technological Development ( ) A top priority in the Russian governments Concept of Long Term Social and Economic Development till Tempus IV National Priorities - curriculum development in biotechnology. Russian government priority - the modernization of industry paying special attention to producing safe and accessible pharmaceutical products for the Russian market.

4 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» Shortage of trained personnel: According to Zoya Kozlova, general director of the Pharmaceutical Recruiting Agency Generis (Interview October 2009) on average, there is a 30-50% shortfall of production technologists and an 80% shortfall of laboratory technologists across the pharmaceutical producers in Russia.

5 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» To overcome personnel shortage; To increase the quality of education; Training new types of specialists. To overcome personnel shortage; To increase the quality of education; Training new types of specialists. Personnel requirements for the pharmaceutical sector (1 st stage of strategy Pharm-2020) Scientific staff

6 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» To train: production specialists; R&D specialists. To train: production specialists; R&D specialists.

7 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» Innovative medicine training in the EU: Several EU Higher Education bodies have moved in this direction by offering progammes in Bioscience, Biotechnology or Pharmaceutical engineering, which offer not purely the scientific disciplines such as the basics of chemistry, physics, biology and microbiology but also provide a sound knowledge of biopharmaceutical manufacturing, bioreactor design, process control and processing, metabolic engineering as well as the key regulatory aspects and a risk based approach to safety, quality and efficacy.

8 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

9 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

10 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» Regulatory environment: International: WHO, FDA, European Directives and national systems Harmonised structures through the life cycle through such organisations as PIC/S, EMA, EDQM Russian: Ministries of Health, Education, Industry RosZdravNadzor

11 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» Key personnel (as defined by European Directive): Qualified Person (often linked to Quality manager) Head of Production Head of Quality Control

12 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» Other important personnel: Pharmaceutical development specialists Process development engineers Process managers Transfer technologists Quality assurance (GMP) specialists Validation personnel Computer validation engineers Technical support personnel IT specialists Supply chain managers GMP inspectors/auditors Regulatory managers

13 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» The EU Qualified Person (Directive 201/83): A qualified person shall be in possession of a diploma, certificate or formal qualifications (4 years). Applied physics General and inorganic chemistry Organic chemistry Analytical chemistry Pharmaceutical chemistry General and applied biochemistry (medical) Physiology Microbiology Pharmacology Pharmaceutical technology Toxicology Pharmacognosy

14 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» The Qualified Person (QP Study Guide - UK): The three foundation knowledge elements: a Pharmaceutical law and administration b The role and professional duties of a Qualified Person c Quality management systems Additional knowledge requirements for the Qualified Person: d Mathematics and statistics e Medicinal chemistry and therapeutics f Pharmaceutical formulation and processing g Pharmaceutical microbiology h Analysis and testing i Pharmaceutical packaging j Active pharmaceutical ingredients k Investigational medicinal products

15 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» ISPE Programme Process development specialists Quality assurance and GMP specialists Quality control personnel Validation personnel Manufacturing/production supervisors Technical support personnel IT personnel and validation specialists Supply chain managers Engineering professionals Inspectors/Auditors Regulatory managers Fundamentals of biotechnology xxxxxxxx Microbiology xxxxx xxx Biopharmaceutical manufacturing processes xx xx x x Sterile drug manufacturing Xxxxx x x Engineering systems (HVAC, Water etc) xxxxx x x Project management x xxx x Cleaning fundamentals and validation xx xx x GMP fundamentals and application xxxxxxxxxxx Basic principles and risk based Commissioning and qualification x x Principles and practice of computerized systems compliance xxxxxx Auditing for GMP xxxxx xxxx Technology transfer for API and finished dosage forms xx xx x x Implementing Process Analytical Technology xx xx x x Practical approach to calibration xx x xx Concepts of validation, a risk based approach to process validation xxxxxx x x

16 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» Results of industry survey: Companies such as: OOO Gerofarm, Stada CIS Zio Zdorovie KRKA Rus, OAO Akhrikhin Backed by meetings of SPFO Work group, ARFP Committee on Education and Training Sub Committee of European Business Association Biotechnology forum

17 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

18 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

19 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

20 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

21 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

22 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

23 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

24 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

25 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

26 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

27 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

28 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» Student survey 4 departments 5 th and 6 th years.

29 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» Basic science

30 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» Basic science

31 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» Basic science

32 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» Applied science

33 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» Applied science

34 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» Management skills

35 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» Management skills

36 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» Comparison – basic science

37 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» Appendix 1 The EU Qualified Person (QP Study Guide - UK) - 2: The three foundation knowledge elements: Pharmaceutical law and administration A thorough understanding of: European pharmaceutical directives (including but not limited to 2001/83/EC, 2001/82/EC, 2001/20/EC, 2003/94/EC, 2004/24/EC, 2004/27/EC, 2004/28/EC); the UK Medicines Act (1968) and other UK national medicines legislation, and the Veterinary Medicines Regulation, including amendments; Marketing, Manufacturing and Wholesaler Authorisation requirements and responsibilities; the role, legal status and structure of both the European and British Pharmacopoeias, including the Certification procedure of the EDQM; the organisation of the UK MHRA, the role of the European Agency for the Evaluation of Medicinal Products (EMEA), and the role of the Veterinary Medicines Directorate (VMD); procedures for dealing with complaints and product recalls and the role of the MHRAs Defective Medicines Reporting Centre, CHMP and CVMP guidelines on quality; The International Conference on Harmonisation (ICH and VICH) guidelines; Mutual Recognition Agreements (MRAs); Pharmaceutical Inspection Co-operation Scheme (PICS);

38 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» The EU Qualified Person (QP Study Guide - UK) - 3: The three foundation knowledge elements: The role and professional duties of a Qualified Person A thorough understanding of: batch review and decision making on disposition. the principles and practice of current GMP and QA as given in European Directives and Guides on Good Manufacturing Practice including relevant Regulations made under the Medicines Act 1968 and the current edition of the MHRAs Rules and Guidance for Pharmaceutical Manufacturers and Distributors, ("the Orange Guide"); the conduct and obligations of MA and MAA holders; the preparation for and management of Regulatory Inspections.

39 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» The EU Qualified Person (QP Study Guide - UK) - 4: The three foundation knowledge elements: Quality management systems A thorough understanding of: the philosophy and basic principles of QA; the design criteria for an effective QMS; auditing and self inspections; deviations and change control; documentation and record keeping; the interpersonal skills (leadership, delegation, communication, etc) necessary to implement an effective QMS; the concepts associated with risk management; the principles of design, selection, qualification and maintenance of premises, equipment, utilities, and services; calibration, preventative maintenance and training; the principles of purchasing and supplier certification, including knowledge of supply chains and material control and the roles of brokers, distributors and repackagers; production planning, scheduling, and inventory control; annual product quality reviews; the interface between QA and the Development, Regulatory Affairs, and Marketing Departments; the skills and competences needed to provide effective Good Pharmaceutical Manufacturing Practice training; organisational structures and reporting relationships; technical agreements and auditing in contract giving and acceptance.

40 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» The EU Qualified Person (QP Study Guide - UK) – 5 Mathematics and statistics The practical application of basic statistical tools in pharmaceutical production and QA is essential in demonstrating the capability of processes or the acceptability of materials. Applicants will be expected to demonstrate an understanding of the following: Statistical Process Control; BS (Sampling plans); Process Control Charts; Acceptable Quality Levels (AQLs) (subset of 6001/2); statistics applied during analytical method validation.

41 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» The EU Qualified Person (QP Study Guide - UK) – 6: Medicinal chemistry and therapeutics The Qualified Person must have an understanding of the actions and uses of medicines in clinical practice in order to judge their significance for the manufacture of sales material or clinical trial supplies. Evaluating the significance of cross-contamination hazards or product complaints are examples where such knowledge is important. Applicants will be expected to demonstrate an understanding of the following: basic physiology; outline knowledge of the autonomic nervous system and some general aspects of chemical structure/pharmacological action relationships; summary of key therapeutic drug classifications with examples; examples of disease states and their treatment with medicinal products; general absorption, distribution, metabolism and excretion of drugs; principal routes of drug administration; role of the company medical department; pharmacovigilance related to quality monitoring; general implications of clinical knowledge of drugs upon facility design, plant segregation/isolation, cleaning verification and production scheduling.

42 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» The EU Qualified Person (QP Study Guide - UK) – 7: Pharmaceutical formulation and processing The formulation and processing conditions employed in the manufacture of medicinal products have a significant effect upon their safety, quality and efficacy. Even subtle changes to the input materials and/or processing conditions can have a profound adverse effect on content uniformity, stability, bioavailability, and other attributes which are not detectable by routine QC testing. It is vitally important that the Qualified Person understands the principles of formulation and pharmaceutical processing to ensure that informed release decisions are made. Applicants will be expected to demonstrate an understanding of the following: the major processing techniques, their limitations and critical control parameters; the factors that could potentially affect content uniformity, stability (chemical, physical and microbiological) and bioavailability in manufacture; the principles of process validation and control; the principles of technology transfer and production scale-up; pre-formulation studies and product development; the storage and distribution of materials and finished products.

43 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» The EU Qualified Person (QP Study Guide - UK) – 7: Pharmaceutical microbiology The Qualified Person must understand the significance of the presence of bacteria, yeasts, moulds, viruses and toxins in pharmaceutical raw materials, products and production environments. In addition, they must understand how to prevent contamination by good product design, GMP and control over starting materials, intermediates, finished products, production plant and processes, people and the environment. Applicants will be expected to demonstrate an understanding of the following: sources and types of micro-organisms as related to pharmaceutical production; production of sterile and non-sterile products and associated environmental controls; bacterial endotoxins and pyrogens, their sources, removal and testing; microbiology of water, its production and distribution systems; sterilisation and disinfection methods; interpretation of microbiological data; validation of microbiological test methods; microbiological specifications; selection and use of preservatives; microbiological test methods used in routine manufacture and product development; rapid methods of microbiological testing.

44 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» The EU Qualified Person (QP Study Guide - UK) – 8: Analysis and testing The sampling and testing of materials does not by itself assure product quality. It must be seen as one part of a comprehensive Quality management system, including QA and GMP, which must be correctly implemented and controlled. The data generated by laboratory testing of samples must be evaluated before materials are released for sale. Applicants will be expected to demonstrate an understanding of the following: GCLP (Good Control Laboratory Practice); quality control of sterile and non-sterile dosage forms; interpretation of analytical data and non-conforming results; the principal qualitative and quantitative analytical methods in common use; analytical chemistry as relevant to the properties of medicinal products and materials; the principles of method selection and validation; the design of sampling regimes; biological test methods and interpretation of results; physical and organoleptic testing; stability testing (protocols & methods); the significance of degradation, contamination and adulteration of pharmaceutical materials; the types, purpose, significance and management of systems of in-process control; the International Conference on Harmonisation (ICH) guidelines for method validation, impurities and stability testing;

45 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» The EU Qualified Person (QP Study Guide - UK) – 9: Pharmaceutical packaging It is a requirement of GMP that holders of Manufacturing Authorisations establish procedures for their packaging operations to minimise the risk of cross-contamination, mix- up or substitutions. The Qualified Person must understand the importance of controlling packaging components (both primary and printed materials) throughout the supply chain to assure the quality of finished products. Applicants will be expected to demonstrate an understanding of the following: control of packaging components by suppliers and throughout production; the chain of systems which ensure the integrity and accuracy of textual information from originator to routine production; the layout and organisation of packaging operations; causes of label and other printed component mix-ups; packaging and labelling processes and equipment; the testing of packaging materials including pack integrity testing; product security (automated systems, reconciliation, line clearance etc); in-process controls; effects of packaging materials on product stability; selection of packaging materials; tamper-evidence and anti-counterfeiting measures.

46 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» The EU Qualified Person (QP Study Guide - UK) – 10: Active pharmaceutical ingredients The Qualified Person must understand the influence of manufacturing pathways and associated physical and physico-chemical attributes, of both active pharmaceutical ingredients and major excipients, on the quality of the finished dosage form. Applicants will be expected to demonstrate an understanding of the following: the steps commonly taken in the manufacture of active pharmaceutical ingredients and excipients (including biopharmaceuticals), their purpose and limitations; the generation of impurities, their identification, quantification, and elimination; the physico-chemical and biological properties of active pharmaceutical ingredients, and excipients, and their effect on the attributes of the final dosage form; the specific requirements for bulk materials intended for sterile products; the nature of controls for the manufacture of bulk biological and biotech products; auditing of API manufacturers.

47 Проект Tempus UK-JPCR «Улучшение учебных программ Биотехнология (фармацевтический инжениринг)» The EU Qualified Person (QP Study Guide - UK) – 11: Investigational medicinal products The manufacture, packaging and distribution of investigational medicinal products must be controlled. There are significant differences between the manufacture of IMPs and licensed dosage forms. The Qualified Person must understand these differences together with the safeguards required to assure the quality of IMP supply. Applicants will be expected to demonstrate an understanding of the following: specific GMPs associated with the manufacture of investigational medicinal products; the control of active and placebo forms; the control of packaging operations and blinding; the control and release of imported IMPs; the control and release of comparators; effective batch documentation, sampling and batch release; change control and material traceability; controls surrounding the procurement of Clinical Trial (CT) supplies; the principles of clinical trial design and Good Clinical Practice (GCP).