· Web viewManagement “Global Perspective Heinz Weihrich, Harold Koontz by Tata Mcgraw Hill”. 11 Personnel Management and Industrial Relations by P. C. Tripathi. HEMCHANDRACHARYA

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HEMCHANDRACHARYA NORTH GUJARAT UNIVERSITY, PATANMPHARM (Pharmaceutical Management and Regulatory Affairs) CBCS Syllabus 2011Document code : SYLLABUS MPHAM2011Revision No: 00Name of Faculty PharmacyFaculty Code PSProgramme Name : Master of Pharmacy (Pharmaceutical Management and Regulatory Affairs)Programme Code : MPHAMEffective from: June 2011

2

Sem

Combination code

Old Paper Code

Paper Code Paper Type

Paper Name

Marking schemeCredit

Total

Remarks External Internal

The

Pra

The

Pra

1 PY10001 MPHAM101CC CC

Modern Analytical Techniques (Theory) (MAT)

70 30 4 100

1 PY10001P

MPHAM101PR PR

Modern Analytical Techniques (Practical) (MAP)

70 30 6 100

1 PY10103 MPHAM101CE CE

CGMP And Documentation (Theory) (CDT)

70 30 4 100

1 PY10103P

MPHAM102PR PR

CGMP And Documentation (Practical) (CDP)

70 30 6 100


Pharm Management-I (Theory) (PMG)

70 30 4 100

3

Sem Combination code

Old Paper Code


Paper Name


Total


The

Pra

The

Pra


Research Methodology (RMT)

70 30 4 100


Pharm Management-II (Theory) (PMT)

70 30 4 100


Regulatory Affairs-I (Theory) (RAT)

70 30 4 100

2 PY20203P

MPHAM201PR PR

Regulatory Affairs-I (Practical) (RAP)

70 30 6 100

4

Sem

Combination code

Old Paper Code


Paper Name


Total


The

Pra

The

Pra


Experimental Design and Patent(EDP)

70 30 4 100


Regulatory Affairs-II (Theory) (RAT)

70 30 4 100

3 PY30103P

MPHAM301PR PR

Regulatory Affairs-II (Practical) (RAP)

70 30 6 100

3 PY30203P

MPHAM301MP MP

Introduction to Dissertation (ITD)

70 30 10 100

5

Sem

Combination code

Old Paper Code

Paper CodePaper Type

Paper Name


Total

RemarksExternal Internal

The

Pra

The

Pra

4 PY40301P

MPHAM401DI DI Dissertation

& Viva-voice 70 30 30 100

6

HEMCHANDRACHARYA NORTH GUJARAT UNIVERSITY, PATANProgramme code : MPHAM Programme Name : MPHARMCourse Code MPHAM101CC Semester : 1

MODERN ANALYTICAL TECHNIQUES (THEORY) (MAT)Course type : Core Course Total Credit : 04

Teaching time(hours) Examination Marking scheme

Theory (hrs)

Practical (hrs)

Internal(Marks)

External(Marks)

Total(Marks)

4 X 15 = 60 30 70 ( Paper of 3 hrs) 100

UnitNo.

TopicNo

Content Hrs. MarksW +%

Credit

1 1.1 UV-VISIBLE SPECTROSCOPY : Brief review of electromagnetic spectrum and absorption of radiations. The chromophore concept,absorption law and limitations. Theory of electronic spectroscopy, absorption by organic molecules,choice of solvent and solvent effects. Applications of UV-Visible spectroscopy, Woodward –Fischer rulesfor calculating absorption maximum, interpretation of spectra, multi-component assay, difference spectraand derivative spectra.

5

2 2.1 INFRARED SPECTROPHOTOMETRY :Introduction, basic principles, and sampling techniques, interpretation of spectra, applications inPharmacy. FT-IR, Attenuated Total Reflectance (ATR), Near infra red Spectroscopy (NIR) -theory andapplications.

5

3 3.1 NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY : Fundamental Principle and Theory, Instrumentation, solvents, chemical shift, and factors affectingchemical shift, spin-spin coupling, coupling constant, and factors influencing the value of couplingconstant, spin-spin decoupling, proton exchange reactions, simplification of complex spectra, FT-NMR,2D -NMR and applications in Pharmacy, interpretation of spectra. C13 NMR-Introduction, Naturalabundance, C13 NMR Spectra and its structural applications.

7

4 4.1 MASS SPECTROMETRY:Basic principles and instrumentation, ion formation and types, fragmentation processes and fragmentationpattern, Chemical ionization mass spectroscopy (CIMS), Field Ionization Mass Spectrometry (FIMS),Fast Atom Bombardment MS (FAB MS), Matrix Assisted laser

7

7

desorption / ionization MS (MALDI-MS),interpretation of spectra and applications in Pharmacy

5 5.1 ATOMIC ABSORPTION AND PLASMA EMISSION SPECTROSCOPY: Principle, instrumentation, interferences and applications in Pharmacy.

3

6 6.1 X-RAY DIFFRACTION METHODS : Introduction, generation of X-rays, X-ray diffraction, Bragg’s law, X-ray powder diffraction,interpretation of diffraction patterns and applications.

3

7 7.1 OPTICAL ROTARY DISPERSION : Principle, Plain curves, curves with cotton effect, octant rule and its applications with example, circulardichroism and its relation to ORD.

3

8 8.1 THERMAL METHODS OF ANALYSIS :Theory, instrumentation and applications of Thermo Gravimetric Analysis (TGA), Differential ThermalAnalysis (DTA), Differential Scanning Calorimetry (DSC) and Thermo Mechanical Analysis (TMA).

4

9 9.1 CHROMATOGRAPHIC TECHNIQUES: a) Classification of chromatographic methods based on

mechanism of separation, Theories of chromatographic separation.

b) Principles, elution techniques, instrumentation, derivatization and applications of gas chromatography, HPLC and HPTLC.

c) Principles, elution techniques, applications of ion exchange and ion pair chromatography, affinity chromatography, size exclusion chromatography, chiral chromatography, super fluid chromatography (SFC), GC-MS and LC-MS.

15

10 10.1 ELECTROPHORESIS : Theory and principles, classifications, instrumentation, moving boundary electrophoresis, ZoneElectrophoresis (ZE), Isoelectric focusing (IEF) and applications.

3

11 11.1 RADIO IMMUNO ASSAY : Introduction, Principle, Theory and Methods in Radio Immuno Assay, Related Immuno Assay proceduresand applications of RIA Techniques. Enzyme immuno assay- ELISA and EMIT.

3

12 12.1 REFERENCE STANDARDS: Source, preparation, characterization, usage, storage and records.

2

HEMCHANDRACHARYA NORTH GUJARAT UNIVERSITY, PATAN

8

Programme code : MPHAM Programme Name : MPHARMCourse Code MPHAM101PR Semester : 1

MODERN ANALYTICAL TECHNIQUES (PRACTICAL) (MAP)Course type : Practical Total Credit : 06


Theory (hrs)

Practical (hrs)

Internal(Marks)

External(Marks)

Total(Marks)

6 X 15 = 90 30 70 ( Paper of 3 hrs) 100

PRACTICAL LIST1 Use of colorimeter for analysis of Pharmacopoeial compounds and

their formulations. 2 Use of Spectrophotometer for analysis for Pharmacopoeial

compounds and their formulations.3 Simultaneous estimation of combination formulations (minimum of 4

experiments): e.g.a. Vitaminsb. Oral antidiabeticsc. NSAIDsd. Antimicrobialse. Antihistaminesf. Antihypertensive etc

4 Effect of pH and solvent on UV Spectrum of certain drugs.5 Experiments on flame photometry6 Use of fluorimeter for analysis of Pharmacopoieal compounds7 Experiments on Electrophoresis8 Experiments of Chromatography.

a. Thin Layer Chromatography.b. Paper Chromatography

9 Experiments based on HPLC & GC10 IR, NMR and Mass Spectroscopy – Interpretation of spectra &

Structural elucidation (atleast for 4 compounds each).11 Any other relevant exercises based on theory.

Reference books :-No. Book name1 Spectrometric identification of Organic Compounds, Robert. M. Silverstein, Basseler, Morril (John Wiley and

Sons. N.Y). 2 Spectroscopy of Organic Compounds by P. S. Kalsi.3 Principles of Instrumental Analysis by Donglas A. Skoog, James, J. Leary, 4th Edition4 Pharmaceutical Analysis – Modern Methods – Part A, Part B, James W. Munson 20015 Organic Spectroscopy – William Kemp, 3rd Edition.6 Chromatographic Analysis of Pharmaceuticals, John A. Adamovics, 2nd Edition.7 Practical Pharmaceutical Chemistry, Part two, A. H. Beckett & J. B. Stenlake – 4th edition.8 Instrumental Methods of Analysis – Willard, Merritt, Dean, CBS, Delhi.9 Techniques and Practice of Chromatography – Raymond P. W. Scott, Vol. 70.10 Identification of Drugs and Pharmaceutical Formulations by Thin Layer Chromatography – P. D.Sethi, Dilip

9

Charegaonkar, 2nd Edition.11 HPTLC – Quantitative Analysis of Pharmaceutical Formulations – P. D. Sethi.12 Liquid Chromatography – Mass Spectrometry, W. M. A. Niessen, J. Van Der Greef, Vol. 58.13 Modern Methods of Pharmaceutical Analysis, Vol.1, 2, RE Schirmer,Franklin Book14 Colorimetric Methods of analysis- F. D. Snell and C. T. Snell (Van Nostrand Reinhold Company, N.Y.).15 Indian Pharmacopoeia16 British Pharmacopoeia17 U.S. Pharmacopoeia18 Clarke’s Analysis of Drugs and Poisons, A.C.Moffat, M. David Osselton, Brain Widdop, L. Y. Galichet. 3rd

edition, Pharmaceutical Press19 Text book of Pharmaceutical Analysis, K. A. Connors, 3rd Ed., John Wiley & Sons, New York

10

HEMCHANDRACHARYA NORTH GUJARAT UNIVERSITY, PATANProgramme code : MPHAM Programme Name : MPHARMCourse Code MPHAM101CE Semester : 1

CGMP AND DOCUMENTATION (THEORY) (CDT)Course type : Core Elective Total Credit : 04


Theory (hrs)

Practical (hrs)

Internal(Marks)

External(Marks)

Total(Marks)

4 X 15 = 60 30 70 ( Paper of 3 hrs) 100

UnitNo.

TopicNo


Credit

1 1.1 Concepts of Philosophy of QA, GMP, GLP 3

2 Good Manufacturing Practices:2.1 Organization & Personnel, responsibilities, training, hygiene. 32.2 Premises: Location, design, Plant Layout, Construction, Maintenance

and Sanitation,Environmental control, utilities and services like gas,water, maintenance of sterile areas, and control of contamination

4

2.3 Equipments: Selection, purchase specifications, maintenance, clean in place, sterilize in place, Methods (TP & STP)

4

2.4 Raw Materials: Purchase specifications, maintenance of Stores, selection of Vendors, control onraw materials and finished dosage forms.

2

2.5 Manufacture of & control on dosage forms: manufacturing documents, master formula, batch formula records, standard operating procedures, quality audits of manufacturing processes and facilities

8

2.6 In Process quality controls on various dosage forms: Sterile and non sterile, standard operatingprocedures for various operations like cleaning, filling, drying, compression, coating, disinfections, sterilization, membrane filtration etc

5

2.7 Packaging and labeling control, Line clearance, reconciliation of labels, cartons and other packaging materials

2

2.8 Quality control Laboratory: Responsibilities. Routine controls instruments, reagents, sampling plans, standard test Procedures, protocols, data generation and storage, quality control documents, retention samples, records, audits of quality control facilities.

6

2.9 Finished product release, quality review, quality audits and batch release documents

3

2.10 Warehousing, design, construction, maintenance and sanitation; good warehousing practice, materials and management.

2

2.11 Distribution and distribution records, handling of returned goods, recovered materials and reprocessing

2

2.12 Complaints and recalls, evaluation of complaints, recall procedures, 2

11

related records and documents.2.13 Waste disposal, scrap disposal procedures and records 2

3 3.1 Good Laboratory Practices 4

4 4.1 WHO certification 2

5 5.1 Testing of Packaging materials 2

6 6.1 Quality Audit 2

7 7.1 Specifications for materials, intermediates and finished product. 2

Reference books :-No. Book name1 Sidney H. Willig, "Good Manufacturing Practices for Pharmaceuticals", Drugs and Pharm. Sci. Series, Vol.

109, Marcel Dekker Inc., N.Y. 2 S. Bolton, "Pharmaceutical Statistics: Practical & Clinical Applications", Drugs and Pharm. Sci. Series, Vol.

135, 4th Ed., Marcel Dekker Inc., N.Y3 G. S, Banker & C.T. Rhodes, "Modern Pharmaceutics", Drugs and Pharm. Sci. Series, Vol. 121, 4th Ed.,

Maracel Dekker Inc., N.Y.4 P. P .Sharma “How to practice GMPs”, 3rd edition Vandana Publication.5 P. P. Sharma “How to practice GLP” Vandana Publication.6 S. Weinberg, “Good Laboratory Practice Regulation” Drugs and Pharm. Sci. Series, Vol. 124, 2nd Ed.,

Maracel Dekker Inc., N.Y.7 WHO’s “Drug” Bulletins.8 Remingtons “Pharmaceutical Sciences”.9 GMP practices for pharmaceutical-James.

HEMCHANDRACHARYA NORTH GUJARAT UNIVERSITY, PATANProgramme code : MPHAM Programme Name : MPHARM

12

Course Code MPHAM102PR Semester : 1CGMP AND DOCUMENTATION (PRACTICAL) (CDP)

Course type : Practical Total Credit : 06Teaching time

(hours) Examination Marking scheme

Theory (hrs)

Practical (hrs)

Internal(Marks)

External(Marks)

Total(Marks)

6 X 15 = 90 30 70 ( Paper of 3 hrs) 100

PRACTICAL

1Laboratory examination including oral and practical examination in general course illustrative of theorysection in the syllabus.

13


PHARM MANAGEMENT-I (THEORY) (PMG)Course type : Core Elective Total Credit : 04Teaching time(hours) Examination Marking scheme

Theory (hrs)

Practical (hrs)

Internal(Marks)

External(Marks)

Total(Marks)

4 X 15 = 60 30 70 ( Paper of 3 hrs) 100

UnitNo.

TopicNo Content Hrs.

Marks

W +%Credi

t1 1.1 Pharmaceutical Management: Meaning, Evolution-scientific,

administrative and human relationapproach.Process of management: Planning, organizing, staffing, directing, coordinating andcontrolling–a preliminary idea of concepts, processes and techniques.

8

2 2.1 Fundamental concepts of production, financial, personal, legal and marketing functions with special reference to Pharmaceutical Management. Introduction to budgeting, costing, accounting, auditing and budgetary control. Entrepreneurship development.

10

3 3.1 Understanding organizations: Meaning, process, types of organization structures and departmentation, line/staff authority, promoting organizational culture. Organizations,pharmaceutical services and functioning of hospital pharmacy, bulk drug unit, formulation unit, Ayurvedic and Unani manufacturing units and testing labs etc.

10

4 4.1 Professional Mangers; Tasks, responsibilities and skills needed. Leadership; Styles and managing change. Decision Making; Types, procedures, evaluation and selection of alternatives, decision making under various situations. Management information and decision support systems and time management.

12

5 5.1 Personnel Management: Job Analysis, recruitment, selection, orientation and training, performance appraisal and compensation. Retrenchment, lay off and discharge.

6

6 6.1 Management of Industrial Relations: Industrial disputes, settlement of disputes through various routes such as bargaining, etc.

6

7 7.1 Motivational aspects, theories of motivation, group dynamics, rewards and incentives, interpersonal skills, significance of communication, its processes, measures for effective communication, conflict management

6

14

8 8.1 Stress management. 2

Reference books :-No. Book name1 Marketing Management by Philip Kotlar; Prentice-Hall of India Ltd., New Delhi. 2 Management and Organization by Louis A. Allen; McGraw Hill, Tokyo..3 Corporate Strategy by Ansoff, H.T.; McGraw Hill, New York4 Modern Management by Hempran David R.; McGraw Hill, New York.5 Management by Stoner and Freeman; Prentice Hall, New Delhi.6 Motivation and Personality by Maslow, Abraham, Harper & Row, New York.7 Management of Organizational Behavior, Utilizing the Human Resources by Harcey, Paul and Blanchard

Kenneth; Prentice Hall of India, New Delhi8 Organization Structure, Process and out comes V th Edition Richard. H. Hall9 Principles and Methods of Pharmacy Management III rd Edition Harry A. Smith.10 Management “Global Perspective Heinz Weihrich, Harold Koontz by Tata Mcgraw Hill”.11 Personnel Management and Industrial Relations by P. C. Tripathi.

15


RESEARCH METHODOLOGY (RMT)Course type : Core Course Total Credit : 04


Theory (hrs)

Practical (hrs)

Internal(Marks)

External(Marks)

Total(Marks)

4 X 15 = 60 30 70 ( Paper of 3 hrs) 100

UnitNo.

TopicNo


Credit

1 1.1 Research: Meaning, purpose, Types, (Educational, Clinical, Experimental, historical descriptive, Basic applied and Patent oriented Research) objective of research.

4

2 2.1 Literature survey: Use of Library, books and journals-Medlines-Internet, Patent Search, and reprints of articles as a source for Literature survey.

3

3 3.1 Selecting a problem and preparing Research proposals. 3

4 4.1 Methods and tools use in research : a. Qualities studies, quantitative studiesb. Simple data organization descriptive data analysis,c. Limitation & sources of Errord. Inquiries in form of Questionnaire, etc.

12

5 5.1 Documentation: a. “How” of documentationb. Techniques of documentationc. Importance of documentationd. Use of computer packages in documentation.

11

6 6.1 The Research Report Paper writing/ thesis writing. Different parts of the Research papera. Title –Title of project with authors nameb. Abstract- Statement of the problem, Background list in brief and

purpose and scope.c. Key Words.d. Methology-subject, apparatus, instrumentation & procedure.e. Results- tables, graphs, figures & statistical presentation.f. Discussion support or non support of hypothesis, practical &

theoretical Implicationsg. Conclusionh. Acknowledgements.i. Referencesj. Erratak. Importance of Spell check for entire project

12

16

l. Uses of footnotes

7 7.1 Presentation (especially for oral presentation): Importance, types different skills, contained, format of model, introduction, Poster, Gestures, eye contact, facial, expressions, stage, fright, volume- pitch, speed, pause & language, Visual aids & seating, Questionnaire.

6

8 8.1 Cost analysis of the project: cost incurred on raw materials, Procedure, instrumentations and clinical trials.

3

9 9.1 Sources for procurement research grants: international agencies, Government and private bodies.

3

10 10.1 Industrial-institution interaction- Industrial projects, their, feasibility reports. Interaction withindustries

3

Reference books :-No. Book name1 Research In Education- John V. Best, John V. Kahn 7th edition2 Presentation skills - Michael Hallon- Indian Society for Institute education

Practical Introduction o copyright.- Gavin Mcfarlane3 Thesis projects in Science & Engineering – Richard M. Davis.4 Scientist in legal Systems- Ann labor science5 Thesis & Assignment – Jonathan Anderson6 Writing a technical paper- Donald Menzel7 Effective Business Report Writing –Leland Brown8 Protection of industrial Property rights- P. Das & Gokul Das9 Spelling for the millions- Edna Furmess10 Preparation for publication – King Edward Hospital Fund for London11 Information Technology – The Hindu speaks12 Documentation – Genesis & Development 3792.13 Manual for the preparation of industrial feasibility studies14 Manual for the preparation of industrial feasibility studies

17


PHARM MANAGEMENT-II (THEORY) (PMT)Course type : Core Elective Total Credit : 04


Theory (hrs)

Practical (hrs)

Internal(Marks)

External(Marks)

Total(Marks)

4 X 15 = 60 30 70 ( Paper of 3 hrs) 100

UnitNo.

TopicNo


Credit

1 1.1 Production Management: Fundamentals of production, organization, economic policy, manufacturing economics, production capacities, production lines and job balancing, visible and invisible inputs, methodology of activities.

6

2 2.1 Development of efficient work methods, quality control and management of R&D

3

3 3.1 Production planning and control, production processes - mass, job and project; plant location and lay out; work study (preliminary idea only), materials management- purchase, inventory control and store keeping. Productivity management: Concepts, problems, tools and techniques for improvement. Operation research techniques by PERT and CPM

8

4 4.1 Considerations for design of large scale manufacturing units including intricate design criteria for units to manufacture sterile and non-sterile products with special reference to tablets, capsules, and injections

6

5 5.1 Design and development of packaging units including recent advances in packaging techniques for various types of sterile and non-sterile dosage forms

4

6 6.1 Warehousing design, construction, maintenance and sanitation; good warehousing practice, materials management.

4

7 7.1 Pharmaceutical Marketing: Evolution of marketing concept; production oriented, sales oriented, promotion oriented and consumer oriented (modern concept); market segmentation; concept ofmarketing mix Role of 7 P’s (Product, Price, Promotion, Place, Physical Evidence, Process, People) in Pharmaceutical Marketing

8

8 8.1 Management, corporate planning & strategy, Pharmaceutical industrial marketing management. Pharmaceutical marketing environment. Product management. E-Pharma Marketing

5

9 9.1 Product Planning: Selection of product, new product development 6

18

and product differentiation, pricing, promotion – personal selling; salesmanship, qualities of salesman, management of salesforce, advertising, publicity and window display, channels of distribution.

10 10.1 Marketing Research: Definition and importance, Pharmaceutical Marketing Research techniques, marketing information system, pharmaceutical marketing research area.

4

11 11.1 Market Demands and Sales Forecasting: Major concepts in the demand measurement, estimating current demands, geo-demographic analysis, estimating industry sales, market share and future demand, sales forecasting

6

Reference books :-No. Book name1 Management by Tripathi P. C. and Reddy P. N.; Tata Mc Graw Hill. 2 Business Organization and Management by Shukla M. C.; S. Chand and Company3 Business Organization and Management by Sherlakar S. A.; Himalaya4 Personnel Management by Filippo E. B.; McGraw Hill.5 Marketing Management by Kotler Philip.; Prentice Hall of India.6 Organizational Behavior by Rao and Narayan; Konark Publishers.7 Personnel Management by Tripathi P. C.; S. Chand and Company.8 Principle and Practice of Marketing in India by Memoria C. B.9 Principles of Pharmaceutical Marketing By Mickey Smith C.B.S. Publications.10 Marketing Hand Book Vol. II , Marketing Management by Edwin – E Bobrow, Mark – D. Bobrow11 Production and Operations Management by S.N.Chary

19


REGULATORY AFFAIRS-I (THEORY) (RAT)Course type : Core Elective Total Credit : 04


Theory (hrs)

Practical (hrs)

Internal(Marks)

External(Marks)

Total(Marks)

4 X 15 = 60 30 70 ( Paper of 3 hrs) 100

UnitNo.

TopicNo


Credit

1 1.1 Origin, development, scope, objectives and nature of Pharmaceutical legislation in India. History and ethics of profession of Pharmacy.

4

2 2.1 A study of regulatory aspects that affect drug product design, manufacture and distribution in India with special emphasis on the detailed study of the following Acts (with latest amendments)

5

3 3.1 The Narcotics Drugs and Psychotropic Substances Act. 3

4 4.1 Medicinal and Toilet Preparations (Excise Duties) Act, 1955 5

5 5.1 The Pharmacy Act, 1948 5

6 6.1 The Drugs and Cosmetics Act, 1940 and Rules there under 5

7 7.1 Drugs (Price Control) Order in force. 2

8 8.1 Introduction to Intellectual Property Rights; Copy Right Act, Trade Mark Act, Patent Act and Biodiversity Act, WTO, TRIPS and TRIMS

5

9 9.1 The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1955.

5

10 10.1 Act Prevention of Cruelty to Animals 4

11 11.1 Schedule U requirements- Product development stage documentation, factory procedures – Standard operating procedures and standard test procedures

5

12 12.1 Legal Environment of Business- Need for government regulations; financial regulations, SEBI, BIFR, FEMA and others, Contract Act and Sale of Goods Act, Company Act, Corporate tax laws – Direct and Indirect

7

13 13.1 Indian Patent Law: Critical evaluation of development of Indian Patent law with necessary changes. Comparison with US and EP Patent Law

5

20

Reference books :-No. Book name1 Original laws published by Govt. of India.2 Text Book of Forensic Pharmacy by Mithal B. M.; Vallabh Prakashan, New Delhi3 Laws of Drugs in India by Hussain4 Text Book of Forensic Pharmacy by Jain N. K.; Vallabh Prakashan, New Delhi.

21

HEMCHANDRACHARYA NORTH GUJARAT UNIVERSITY, PATANProgramme code : MPHAM Programme Name : MPHARMCourse Code MPHAM201PR Semester : 2

REGULATORY AFFAIRS-I (PRACTICAL) (RAP)Course type : Practical Total Credit : 06


Theory (hrs)

Practical (hrs)

Internal(Marks)

External(Marks)

Total(Marks)

6 X 15 = 90 30 70 ( Paper of 3 hrs) 100

PRACTICAL1 Laboratory examination including oral and practical examination in

general course illustrative of theory section in the syllabus

22


EXPERIMENTAL DESIGN AND PATENTS (EDP)Course type : Core Course Total Credit : 04


Theory (hrs)

Practical (hrs)

Internal(Marks)

External(Marks)

Total(Marks)

4 X 15 = 60 30 70 ( Paper of 3 hrs) 100

UnitNo.

TopicNo


Credit

1 1.1 Experimentals Designs Introduction to full and fractional factorial designs, Central composite designs, Evolution of full and reduced mathematical models in experimental designs, Applications of the experimental designs for the subject mentioned under Pharmacoinformatics, Introduction to contour plots.

20

2 2.1 Patents Definition, Need for patenting, Types of Patents, Condition to be satisfied by an invention to be patentable, Introduction to patent search, The essential elements of patents, Guidelines for preparations of laboratory notebook, non-obivousness in patents, Drafting of patent claims, Important patent related websites.

25

3 3.1 Brief introduction to trademark protection and WO patents Introduction to “ The Patents Act 1970” and “The Patents Rule 2003”, with special emphasis on the formsto be submitted along with a patent.

15

Reference books :-No. Book name1 S. Bolton, "Pharmaceutical Statistics: Practical & Clinical Applications", Drugs and Pharm. Sci. Series, Vol.

135, 4th Ed., Marcel Dekker Inc., N.Y2 G. S, Banker & C.T. Rhodes, "Modern Pharmaceutics", Drugs and Pharm. Sci. Series, Vol. 121, 4th Ed.,

Maracel Dekker Inc., N.Y.3 Henri J A Charmasson and John Buchaca, Patents, Copyrights & Trademarks For Dummies, 2 nd edition4 Richard Stim Attorney, David Pressman Attorney, Patent pending in 24 hours, 5 th edition, NOLO

Publications, Washington.5 Fred Grissom, David Pressman Attorney Inventor's Notebook: A Patent It Yourself Companion, 5 th edition,

NOLO Publications, Washington.6 Richard Stim Attorney, Patent, Copyright & Trademark: An Intellectual Property Desk

Reference, 11 th edition, NOLO Publications, Washington.

23


REGULATORY AFFAIRS-II (THEORY) (RAT)Course type : Core Elective Total Credit : 04


Theory (hrs)

Practical (hrs)

Internal(Marks)

External(Marks)

Total(Marks)

4 X 15 = 60 30 70 ( Paper of 3 hrs) 100

UnitNo.

TopicNo


Credit

1 1.1 A detailed study of regulatory aspects that affect drug product design, manufacture and distribution in a developed country such as USA and in a developing country such as Brazil, Hatch Waxmann Act; Bolar Provisions and other FDA Regulations.

6

2 2.1 Regulatory aspects of pharmaceutical and bulk drug manufacture, regulatory drug analysis

3

3 3.1 Loan license (contract manufacture). 3

4 4.1 Recent amendments to Drugs and Cosmetic Act and other relevant rules

3

5 5.1 Certification and licensing procedures 4

6 6.1 Documentation related to manufacturing, cleaning methods, retention samples and records, quality control, batch release documents, distribution records, complaints and recalls.

6

7 7.1 Quality, safety and legislation for cosmetic products and herbal products.

5

8 8.1 Approval of New Drug: Investigational new drug (IND) submission, for mat and content of IND, content of investigator brochure, clinical research protocols, objective and protocol design. FDA guidelines for clinical trials,reviews and approval of a clinical study, general consideration of the new drug approval (NDA), specific requirements, content and format of NDA, manufacturing and control requirements of NDA. New Chemical Entity(NCE).

10

9 9.1 International business and inland & foreign trade, procedure of exporting and importing goods. General international environment; political, legal, socio-cultural and economic factors, tax aspects, marketing factors, labour factors and economic integration. BOP analysis, foreign exchange control, governmental policies, international finance, economic community, IMF, managing multinationals/ globalization of operations

10

24

10 10.1 Emerging Trends in Biotechnology Patenting. 4

11 11.1 Patent Cooperation Treaty 3

12 12.1 Strategies for effective Patent Drafting. IP Issues in contract Manufacturing. Exporting to the US and Prelitigation Consideration

3

Reference books :-No. Book name1 Original Laws of the Respective Country.2 Original Laws published by Govt. of India.3 Guidelines for Developing National Drug Policies; WHO Publications, 1998.4 Export Marketing by Cherian and Parab; Himalaya Publishing House, Delhi5 Handbook of Procedures, Import and Export Promotion; Government of India, New Delhi6 International Financial Management–An Indian Perspective by Varshney, R.L. and Bhashyam, S.; Sultan

Chand & Co., New Delhi.7 International Financial Management by Weston, J. Fred and Brat W. Sorge.; New York, McGraw Hill.

25

HEMCHANDRACHARYA NORTH GUJARAT UNIVERSITY, PATANProgramme code : MPHAM Programme Name : MPHARMCourse Code MPHAM301PR Semester : 3

REGULATORY AFFAIRS-I (PRACTICAL) (RAP)Course type : Practical Total Credit : 06


Theory (hrs)

Practical (hrs)

Internal(Marks)

External(Marks)

Total(Marks)

6 X 15 = 90 30 70 ( Paper of 3 hrs) 100

PRACTICAL1 Laboratory examination including oral and practical examination in

general course illustrative of theory section in the syllabus.

26

HEMCHANDRACHARYA NORTH GUJARAT UNIVERSITY, PATANProgramme code : MPHAM Programme Name : MPHARMCourse Code MPHAM301MP Semester : 3

INTRODUCTION TO DISSERTATION (ITD)Course type : Minor Project Total Credit : 10


Theory (hrs)

Practical (hrs)

Internal(Marks)

External(Marks)

Total(Marks)

10 X 15 = 150 30 70 ( Paper of 3 hrs) 100

Instructions:1 Student must complete literature search and preliminary experimental

work of his/her research project and submit the synopsis, dully signed by Research Guide and Principal of Institute to University on completion of Semester – III.

2 Utmost care should be taken in selection of research topic so that repetition of research work is avoided.

3 For change in research topic, written permission of institute level research committee should be taken.

4 Candidates work will be evaluated by the external exam.

27

HEMCHANDRACHARYA NORTH GUJARAT UNIVERSITY, PATANProgramme code : MPHAM Programme Name : MPHARMCourse Code MPHAM401DI Semester : 4

DISSERTATION & VIVA-VOICECourse type : Dissertation Total Credit : 30


Theory (hrs)

Practical (hrs)

Internal(Marks)

External(Marks)

Total(Marks)

30 X 15 = 450 100 100

Documents

· Web viewManagement “Global Perspective Heinz Weihrich, Harold Koontz by Tata Mcgraw Hill”. 11 Personnel Management and Industrial Relations by P. C. Tripathi. HEMCHANDRACHARYA