JKK MUNIRAJAH MEDICAL RESEARCH FOUNDATION'S

ANNAI JKK SAMPOORANI AMMAL COLLEGE OF PHARMACY

PEO - 1

To produce pharmacy post-graduates with strong fundamental concepts and high technical competence in pharmaceutical sciences and technology, who shall be able to use these tools in pharmaceutical industry and/or institutes where ever necessary for success.

PEO - 2

To promote the development of trained human resource in Pharmaceutical Sciences for dissemination of quality education with highly professional and ethical attitude, strong communication skills, effective skills to work in a team with a multidisciplinary approach.

PEO - 3

To generate potential knowledge pools with interpersonal and collaborative skills to identify, assess and formulate problems and execute the solution in closely related pharmaceutical industries.

PSO - 1

Analyze, criticize, organize, improvise and manage documents, data and information related to pharmaceutical production process.

PSO - 2

Execute team based research to implement innovative solutions in the area of formulation, quality assurance and technology transfer.

PO - 1

Scientific knowledge: To apply the scientific and technological principles to design, develop effective pharmaceutical dosage forms and drug delivery systems for better therapeutic results.

PO - 2

Technological applications: To utilize technical knowledge and identify any factors affecting the quality of pharmaceutical production.

PO - 3

Modern tool usage: Learn, select, apply appropriate methods, procedures, resources, and modern pharmacy-related computing tools with an understanding of the limitations.

PO - 4

Entrepreneurship: To understand the basics of establishing and management of pharmaceutical enterprise.

PO - 5

Practical skills: To gain practical expertise in formulating and evaluating various novel drug release systems for minor ailments to major diseases.

PO - 6

Applied science: To employ contemporary scientific knowledge viz., pharmacology, biotechnology for designing disease-centric pharmaceuticals.

PO - 7

Computational and statistical methodologies: Applying and utilizing the statistical tools with the aid of computer software to optimize the formulations.

PO - 8

Pharmaceutical ethics: To respect personal values and apply ethical principles in professional and social contexts. Demonstrate behavior that recognizes cultural, personal variability in values, communication and lifestyles. Use ethical frameworks; apply ethical principles while making decisions and take responsibility for the outcomes associated with the decisions.

PO - 9

Environment and sustainability: To understand, protect and cooperate environmental concerns for sustaining biodiversity.

PO - 10

Life-long learning: To develop the habit of updating knowledge from time to time to meet industrial demands and social needs for having a fruitful career.

M.PHARM (PHARMACEUTICS ) - YEAR - I (SEMESTER - I)

MPH101T

Modern Pharmaceutical Analytical Techniques

CO - 1

Understand the basic instrumentation of HPTLC, HPLC, GC  for identification, and characterization of compounds

CO - 2

Understand the basic concept and instrumentation of Chromatographic techniques 

CO - 3

Understand the basic principles and instrumentation of fluorimeter and atomic absorption spectrometer

CO - 4

Learn general principles and instrumentation of ion selective electrodes.

CO - 5

Explain Instrumentation, separation and identification of compounds by electrophoresis technique

M.PHARM (PHARMACEUTICS ) - YEAR - I (SEMESTER - I)

MPH102T

Drug Delivery System

CO - 1

The various approaches for development of novel drug delivery systems.

CO - 2

The criteria for selection of drugs and polymers for the development of delivering system

CO - 3

 Evaluate drug delivery systems for physic-chemical characteristics, in vitro and in vivo drug release

CO - 4

Formulate and design controlled release and sustained release drug delivery systems.

CO - 5

Conduct stability studies for dosage forms as per prescribed guidelines

M.PHARM (PHARMACEUTICS ) - YEAR - I (SEMESTER - I)

MPH103T

Modern Pharmaceutics

CO - 1

Perform the  elements of pre formulation studies.

CO - 2

Understand the concept of  Active Pharmaceutical Ingredients and Generic drug Product development

CO - 3

Explain the Industrial Management and GMP Considerations.

CO - 4

Understand the concept of Optimization Techniques & Pilot Plant Scale Up Techniques

CO - 5

Describe about  Stability Testing, sterilization process & packaging of dosage forms

M.PHARM (PHARMACEUTICS ) - YEAR - I (SEMESTER - I)

MPH104T

Regulatory Affair

CO - 1

Discuss the regulatory guidance  and guidelines for filing and approval process.

CO - 2

Categorize the preparation of dossiers and their submission to regulatory agencies in different countries

CO - 3

Assess the post approval requirements for actives and drug products

CO - 4

Describe the clinical trials requirements for approvals for conducting clinical trials

CO - 5

Discuss the role of pharmacovigilance and the process of monitoring in clinical trials

M.PHARM (PHARMACEUTICS ) - YEAR - I (SEMESTER - I)

MPH105P

Pharmaceutics Practical I

CO - 1

Analysis of pharmacopoeial compounds and their formulations by UV Vis spectrophotometer

CO - 2

Experiments based on HPLC

CO - 3

To perform  In-vitro dissolution profile of  CR/ SR  marketed formulation

CO - 4

To carry out preformulation studies of tablets

CO - 5

To plot Heckal plot, Higuchi and peppas plot and determine similarity factors.

M.PHARM (PHARMACEUTICS ) - YEAR - I (SEMESTER - II)

 MPH201T

    Molecular Pharmaceutics (Nano Tech and Targeted DDS)

CO - 1

Understand the basic instrumentation of HPTLC, HPLC, GC  for identification, and characterization of compounds

CO - 2

Understand the basic concept and instrumentation of Chromatographic techniques 

CO - 3

Understand the basic principles and instrumentation of fluorimeter and atomic absorption spectrometer

CO - 4

Learn general principles and instrumentation of ion selective electrodes.

CO - 5

Explain Instrumentation, separation and identification of compounds by electrophoresis technique

M.PHARM (PHARMACEUTICS ) - YEAR - I (SEMESTER - II)

MPH202T

Advanced Biopharmaceutics & Pharmacokinetics

CO - 1

Understand basic considerations of pharmacokinetic models. Understand different compartment model and non-compartment model

CO - 2

Explain the design and evaluation of dosage regimens of the drugs using pharmacokinetic and  biopharmaceutical parameters.

CO - 3

Learn different types of drug interactions which alter the pharmacokinetics of such as drug-protein /drug-tissue binding interactions

CO - 4

Elaborate design Bioavailability and Bioequivalence studies of new drugs or dosage forms

CO - 5

Study the application of pharmacokinetics and pharmacodynamics of biotechnology drugs.   

M.PHARM (PHARMACEUTICS ) - YEAR - I (SEMESTER - II)

MPH203T

Computer Aided Drug Delivery System

CO - 1

Know the basic computational modeling principles for drug disposition

CO - 2

Learn computer aided biopharmaceutical characterization of drugs

CO - 3

Learn computer simulation in pharmacokinetics and pharmacodynamics

CO - 4

Study the use of computers in clinical development of drugs

CO - 5

 Understand the need of industrial automation by application of artificial intelligence, robotics and computational fluid dynamics

M.PHARM (PHARMACEUTICS ) - YEAR - I (SEMESTER - II)

MPH204T

Cosmetic and Cosmeceuticals

CO - 1

Describe the regulatory provisions related to the import and manufacture of cosmetics as per the Drugs and Cosmetics Act 1940 and the Rules 1945

CO - 2

Select key ingredients suitable in the formulation of various cosmetics

CO - 3

Design cosmetics and cosmeceuticals with desired safety, stability and efficacy with a knowledge of the various technologies involved in their manufacture

CO - 4

Design cosmeceuticals for sun protection, dry skin, acne, sun-protection, pigmentation, prickly heat, wrinkles, body odor. Dandruff, dental cavities, bleeding gums, mouth odor and sensitive teeth

CO - 5

Select herbal ingredients in the formulation of cosmetics for hair care, skin care and oral care

M.PHARM (PHARMACEUTICS ) - YEAR - I (SEMESTER - II)

MPH205P

Pharmaceutics Practical II

CO - 1

To recall the basic techniques for preparation of microspheres, liposomes, niosomes and solid dispersions.

CO - 2

To compare the dissolution studies of various marketed products.

CO - 3

To develop various novel drug delivery systems.

CO - 4

To test for drug binding characteristics, cell permeation and bioavailability of the formulations.

CO - 5

To evaluate the novel drug delivery systems.

M.PHARM  - YEAR - II (SEMESTER - III)

COMMON TO ALL BRANCHES

MRM 301T

Research Methodology and Biostatistics

CO - 1

Students should understand a general definition of research design

CO - 2

Students should be able to identify the overall process of designing a research study and the use of various statistical test involved

CO - 3

Students should be familiar with human ethical issues in educational research, including those issues that arise in using quantitative and qualitative research

CO - 4

Students should know the guidelines in performing animal study and maintenance of animal house.

CO - 5

Students should be familiar with declaration of Helsinki

M.PHARM  - YEAR - II (SEMESTER - III & IV)

COMMON TO ALL BRANCHES

JOURNAL CLUB

CO - 1

Able to collect relevant literature and critically evaluate them

CO - 2

Learnt to make a PPT presentation scientifically and deliver the same

CO - 3

Able to involve effectively in post presentation  discussion

M.PHARM  - YEAR - II (SEMESTER - III & IV)

COMMON TO ALL BRANCHES

DISCUSSION / PRESENTATION (PROPOSAL PRESENTATION)

CO - 1

Able to select research topic through literature review  

CO - 2

Able to design research methodology

CO - 3

Able to Present the selected research proposal  convincingly

M.PHARM  - YEAR - II (SEMESTER - III & IV)

COMMON TO ALL BRANCHES

RESEARCH WORK

CO - 1

Able to carry out research work scientifically following research ethics

CO - 2

Able to collect date, interpret them using appropriate statistical tools and arrive at conclusion scientifically

CO - 3

 Able to document the research work in the form of thesis in an acceptable format

PEO - 1

To produce pharmacy post-graduates with strong fundamental concepts and high technical competence in pharmaceutical sciences and technology, who shall be able to use these tools in the pharmaceutical industry and/or institutes where ever necessary for success.

PEO - 2

To promote the development of trained human resources in Pharmaceutical Sciences for dissemination of quality education with a highly professional and ethical attitude, strong communication skills, and effective skills to work in a team with a multidisciplinary approach.

PEO - 3

To generate potential knowledge pools with interpersonal and collaborative skills to identify, assess and formulate problems and execute the solution in closely related pharmaceutical industries.

PSO - 1

Identify and utilize the laws and regulations that apply to the development, testing, and production of new medical products, including medical devices, In-Vitro Diagnostics (IVDs), pharmaceuticals, biotechnology-derived therapeutics, and biologics.

PSO - 2

Demonstrate the ability to investigate case studies related to various regulatory topics (e.g. regulatory submissions, product defect, clinical trials and quality assurance strategies etc.,).

PO - 1

To make available a pool of competent professionals in the area of Pharmaceutical Regulatory Affairs with fundamental knowledge on Various Good Regulatory Practices in the Healthcare and related industries

PO - 2

Documentation and general principles involved in regulatory writing and submission to agencies.

PO - 3

Audit, inspections, Quality management system and Product Life Cycle Management.

PO - 4

Clinical drug development and research regulations in India, EU and US

PO - 5

Regulations for Drugs, Cosmetics, Medical Devices, Herbals, Biologics, Food and Nutraceuticals in various countries like India, EU, US, Canada, Japan, ASEAN, etc.,

M.PHARM (PHARMACEUTICAL REGULATORY AFFAIRS )

YEAR - I (SEMESTER - I)

MRA101T

Good Regulatory Practices

CO - 1

The key elements of current Good Manufacturing Practices, Good Laboratory Practices, Good Automated Laboratory Practices, Good Documentation Practices and Good Regulatory Practices.

CO - 2

The check lists for various Good Pharmaceutical Practices and Prepare SOPs for Good Pharmaceutical Practices

CO - 3

Implement Good Pharmaceutical Practices in the Industries and Prepare for the Audit of the Pharmaceutical Industries.

M.PHARM (PHARMACEUTICAL REGULATORY AFFAIRS )

YEAR - I (SEMESTER - I)

MRA102T

Documentation and Regulatory Writing

CO - 1

Know the various documents pertaining to drugs in pharmaceutical industry

CO - 2

Understand the basics of regulatory compilation

CO - 3

Create and assemble the regulation submission as per the requirements of agencies

CO - 4

Follow up the submissions and post approval document requirements

M.PHARM (PHARMACEUTICAL REGULATORY AFFAIRS )

YEAR - I (SEMESTER - I)

MRA103T

Clinical Research Regulations

CO - 1

History, origin and ethics of clinical and biomedical research and evaluation

CO - 2

Clinical drug, medical device development process and different types and phases of clinical trials

CO - 3

Regulatory requirements and guidance for conduct of clinical trials and research

M.PHARM (PHARMACEUTICAL REGULATORY AFFAIRS )

YEAR - I (SEMESTER - I)

MRA 104T

Regulations and Legislation for Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and Food & Nutraceuticals In India and Intellectual Property Rights

CO - 1

Know different Acts and guidelines that regulate Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and Food & Nutraceuticals industry in India.

CO - 2

Understand the approval process and regulatory requirements for

CO - 3

Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and Food& Nutraceuticals

M.PHARM (PHARMACEUTICAL REGULATORY AFFAIRS )

YEAR - I (SEMESTER - I)

MRA105P

Regulatory Affairs Practical I

CO - 1

Students will come to know the different competent regulatory authorities globally.

CO - 2

Students be aware of technical aspects pertaining to the marketing authoritization application (MAA)

CO - 3

The regulatory guidelines and directions framed by the regulatory authorities will be helpful to place the drug products in market for marketing approvals.

CO - 4

Prepare and implement the check lists and SOPs for various Good Regulatory Practices.

CO - 5

Implement Good Regulatory Practices in the Healthcare and related Industries.

CO - 6

Prepare for the readiness and conduct of audits and inspections.

M.PHARM (PHARMACEUTICAL REGULATORY AFFAIRS )

YEAR - I (SEMESTER - II)

MRA201T

Regulatory Aspects of Drugs & Cosmetics

CO - 1

Process of drug discovery and development and generic product development

CO - 2

regulatory approval process and registration procedures for API and drug products in US, EU

CO - 3

Cosmetics regulations in regulated and semi-regulated countries

CO - 4

A comparative study of India with other global regulated markets

M.PHARM (PHARMACEUTICAL REGULATORY AFFAIRS )

YEAR - I (SEMESTER - II)

MRA202T

Regulatory Aspects of Herbal & Biologicals

CO - 1

Know the regulatory Requirements for Biologics and Vaccines 

CO - 2

Understand the regulation for newly developed biologics and biosimilars

CO - 3

Know the pre-clinical and clinical development considerations of biologics

CO - 4

Understand the Regulatory Requirements of Blood and/or Its Components Including Blood Products and label requirements

M.PHARM (PHARMACEUTICAL REGULATORY AFFAIRS )

YEAR - I (SEMESTER - II)

MRA203T

Regulatory Aspects  of Medical Devices

CO - 1

Basics of medical devices and IVDs, process of development, ethical and quality considerations harmonization initiatives for approval and marketing of medical devices and IVDs regulatory approval process for medical devices and IVDs in India, US, Canada, EU, Japan and ASEAN clinical evaluation and investigation of medical devices and IVDs

M.PHARM (PHARMACEUTICAL REGULATORY AFFAIRS )

YEAR - I (SEMESTER - II)

MRA204T

Regulatory Aspects of Food & Nutraceuticals

CO - 1

Know the regulatory Requirements for nutraceuticals.

CO - 2

Understand the regulation for registration and labeling of nutraceuticals and food supplements in India, USA and Europe.

M.PHARM (PHARMACEUTICAL REGULATORY AFFAIRS )

YEAR - I (SEMESTER - II)

MRA205P

Regulatory Affairs Practical II

CO - 1

The clear information about the patent laws, intellectual property rights and drug regulation in India and abroad is gained by the students

CO - 2

Upon completion of the course the student shall be able to Know the various documents pertaining to drugs in pharmaceutical industry

CO - 3

Understand the basics of regulatory compilation

CO - 4

Create and assemble the regulation submission as per the requirements of agencies

CO - 5

Follow up the submissions and post approval document requirements

PEO - 1

The student will possess professional knowledge of pharmaceutical sciences and technology applicable in pharmaceutical, healthcare industry, community pharmacy and academia as per the requirement.

PEO - 2

With the grooming and knowledge gained, the student will play a major role as professional Pharmacist in the health care team and participate in implementation of various health programs at large.

PEO - 3

The student will inculcate the urge for lifelong learning and up - gradation to meet the needs of the profession and society.

PSO - 1

Apply and assess the literature and other research resources to provide evidence-based drug information that meets the needs of patients and other health care providers.

PSO - 2

Discuss how patients and care givers can obtain the most cost-efficient medications and related pharmaceuticals per patient-specific health insurance coverage options.

PO - 1

Pharmacy Knowledge:  Possess knowledge and comprehension of the core and basic knowledge associated with the profession of pharmacy, including biomedical sciences; pharmaceutical sciences; behavioral, social, and administrative pharmacy sciences; and manufacturing practices.

PO - 2

Planning Abilities:   Demonstrate effective planning abilities including time management, resource management, delegation skills and organizational skills. Develop and implement plans and organize work to meet deadlines.

PO - 3

Problem analysis:  Utilize the principles of scientific enquiry, thinking analytically, clearly and critically, while solving problems and making decisions during daily practice. Find, analyze, evaluate and apply information systematically and shall make defensible decisions.

PO - 4

Modern tool us age:  Learn, select, and apply appropriate methods and procedures, resources, and modern pharmacy-related computing tools with an understanding of the limitations.

PO - 5

Leadership skills: Understand and consider the human reaction to change, motivation issues, leadership and team-building when planning changes required for fulfillment of practice, professional and societal responsibilities. Assume participatory roles as responsible citizens or leadership roles when appropriate to facilitate improvement in health and well-being.

PO - 6

Professional Identity:  Understand, analyze and communicate the value of their professional roles in society (e.g. health care professionals, promoters of health, educators, managers, employers, employees)

PO - 7

Pharmaceutical Ethics: Honor personal values and apply ethical principles in professional and social contexts. Demonstrate behavior that recognizes cultural and personal variability in values, communication and lifestyles. Use ethical frameworks; apply ethical principles while making decisions and take responsibility for the outcomes associated with the decisions.

PO - 8

Communication:  Communicate effectively with the pharmacy community and with society at large, such as, being able to comprehend and write effective reports, make effective presentations and documentation, and give and receive clear instructions.

PO - 9

The Pharmacist and society:  Apply reasoning informed by the contextual knowledge to assess societal, health, safety and legal issues and the consequent responsibilities relevant to the professional pharmacy practice.

PHARM D - I^st YEAR

1.2

Pharmaceutics (THEORY)

CO - 1

Understand the basics of different dosage forms.

CO - 2

Understand the professional way of handling the prescription

CO - 3

Prepare various conventional dosage forms

CO - 4

Develop a clear idea about Pharmaceutical incompatibility and  different

pharmaceutical calculations in pharmacy.

CO - 5

 Predict the instability problems in heterogeneous dosage forms

1.2

Pharmaceutics (PRACTICAL)

CO - 1

 Understand the professional way of preparing a prescription

CO - 2

 Prepare various liquid dosage forms

CO - 3

 Prepare various solid dosage forms

CO - 4

 Acquire the knowledge of using equipment’s in pharmaceutical industry

CO - 5

Develop a clear idea about Pharmaceutical incompatibility and   different pharmaceutical calculations in pharmacy.

PHARM D – I^st YEAR

1.6

Remedial Mathematics (THEORY)

CO – 1

To understand the role of mathematics in pharmacy

CO – 2

To know about theory and their application in pharmacy

CO – 3

To relate the mathematical tools in the wide professional views and solve problems of trigonometry, calculus and matrices.

CO – 4

To solve the different types of problems by applying theory.

CO – 5

To adopt both conventional and creative techniques to the solutions of mathematical problems.

CO – 6

Apply the range of techniques effectively to solve problems including theory deduction, approximation and simulation.

CO – 7

Gain knowledge on how to solve different types of problems by applying theory and applications of mathematics in pharmacy

PHARM D - 2^nd YEAR

2.2

Pharmaceutical Microbiology (THEORY)

CO - 1

Know the anatomy, identification, growth factors and sterilization of microorganisms;

CO - 2

 Know the mode of transmission of disease causing microorganism, symptoms of disease, and treatment aspect;

CO - 3

Do cultivation and identification of the microorganisms in the laboratory

CO - 4

Do identification of diseases by performing the diagnostic tests

CO - 5

Appreciate the behavior of motility and behavioral characteristics of microorganisms

2.2

Pharmaceutical Microbiology (PRACTICAL)

CO - 1

 Discuss about the instruments used in experimental microbiology

CO - 2

Understand the sterilization methods followed in laboratory.

CO - 3

Ability to perform  the staining techniques used in microbiology.

CO - 4

Carry out assay of different antibiotics

CO - 5

Execute different sterility tests and bacteriological analysis of water

PHARM D - 3^rd YEAR

3.4

Pharmaceutical Jurisprudence (THEORY)

CO - 1

Practice the Professional ethics

CO - 2

Understand the various concepts of the pharmaceutical legislation in India

CO - 3

Know the various parameters in the Drug and Cosmetic Act and rules

CO - 4

Know the Drug policy, DPCO, Patent and design act

CO - 5

Be able to understand the concepts of Dangerous Drugs Act, Pharmacy Act and Excise duties Act.

PHARM D - 3^rd YEAR

3.6

Pharmaceutical Formulations (THEORY)

CO - 1

  Acquire knowledge about the various pharmaceutical dosage forms and   their  manufacturing  techniques    

CO - 2

Discover various formulation considerations in development of pharmaceutical dosage forms like tablets, capsules.

CO - 3

Understand the quality control tests for the dosage forms.

CO - 4

Detail on parenterals, stringent procedures in the preparation and its evaluation.

CO - 5

Understand clearly about packaging and cosmetic preparations.

3.6

Pharmaceutical Formulations (PRACTICAL)

CO - 1

 Manufacture  of Tablets

CO - 2

Understand the strict formulation considerations in parenteral  and ophthalmic preparations.

CO - 3

Demonstrate the evaluations of different packaging materials in pharmaceutical industry.

CO - 4

Demonstrate the manufacturing of capsules.

CO - 5

 Preparation of various cosmetic formulations.

PHARM D - 4^th YEAR

4.4

Bio Statistics & Research  Methodology (THEORY)

CO - 1

Learn general research methodology

CO - 2

Understand the basic concepts of biostatistics

CO - 3

Learn different parametric and non-parametric tests

CO - 4

Understand the functions of ethics committees in medical research

CO - 5

Develop the ability to apply the methods while working on a research project work

CO - 6

Describe the appropriate statistical methods required for a particular research design.

CO - 7

Choose the appropriate research design and develop  appropriate research hypothesis for  a research project.

CO - 8

Develop a appropriate framework for research studies.