S/N

CODE

TITLE

CONTENT

UNITS

1

PCP

101

Pharmaceutical
Care I

Data
collection and evaluation, drug therapy problems, Development, Implementation
and Monitoring of care plans.

2

2

PCP

102

Pharmacy
Management

Functions
of management, human resources management, Financial and time management,
Leadership, Management tools and their application to pharmacy

6

3

PCP

103

Inferential
Biostatistics

Hypothesis
testing, exploring differences between groups, t-test paired and unpaired, ANOVA, and their non parametric
equivalents (Mann Whitney test, Kruskal Wallis etc), student t-test, exploring relationships:
Pearson’s correlation, Chi squared test. Making predictions: regression;
factor analysis. Biocomputation and use of statistical packages.

6

4

PCP

104

Research
Methodology I

Conceiving
(characteristic and development) research, literature search, study design,
systematic reviews and meta analysis. project/research management,
referencing, proposal writing.

6

5

PCP

105

Advanced
Communication Skills

Cross cultural communications;
Emphatic listening; Assertiveness; Perception and its role in communication;
Conflict management; Interview techniques and Skills; Negotiation skills;
Advocacy skills and practices; Public education techniques and skills; Public
speaking; Writing skills; Communication strategies across diverse audiences; Communication
program models; Evaluation techniques for communication programs in health
and pharmacy.

4

6

PCP

131

Formulation and Delivery of
Medicines

Formulation
techniques, Drug delivery systems-modified-release, rate-controlled delivery
systems and Drug Targeting,

Polymorphism
in the pharmaceutical industry (formulation, stability, bioavailability).

4

7

PCP

132

Pediatric and Geriatric
Formulations

Study of peculiarity of paediatric
and geriatric patients; pharmaceutical calculations for doses in children and
elderly; formulation and formulation factors, specific storage conditions;
stability of these products.

2

8

PCP

231

Ethnopharmacy and  Complementary Therapy

Natural
Sources of Medicines: Design, Formulation, Standardization and Evaluation of
Herbal Medicines and nutraceuticals, Herbal Medicines and nutraceuticals in
Current Use, Clinical Application of Herbal Medicine, Interactions with food
and preparations, Alternative/Complementary Therapies. Microbial
contamination and Preservation.

6

9

PCP

232

Good Manufacturing Practice

Current
Good Manufacturing Practice (cGMP), Personnel, Qualification, Experience, Responsibility, Premises and
Equipment, Suitability of site/ventilation/nature
of construction and finishes, Documentation and

Records (Master Formula, Batch manufacturing records, starting
material specifications, Intermediate bulk and finished product specification
and test records) Packaging material specification, Distribution,
Quarantine/Detention/Release procedure, Complaints, Development and
Utilization of Standard
Operating Procedures, (SOPs). Process
Validation, Packaging and Pharmaceutical Containers/Closures, Labelling,
Stability Studies (ICH Recommended Evaluation), Shelf-Life
Calculation/Predictions.

4

10

PCP

233

Quality
Management Systems

TQM
System Review (Validation and the Cost of Quality, Assuring Product Quality,
Total Quality Culture, Quality Management Relationships).

Overview
of Management Procedures of ISO 17025:2017 IEC.

Quality Management
System (QMS)Overview
of QMS (Context of the Organization, Leadership, Performance Management,
Continual Improvement, Product Realization etc.),Process Performance and
Product Quality Monitoring System, Relationship between ICHQ10 and ISO 9000
family.

Quality Audits and
Inspections –Benefits
of Audits and Inspections, Attributes of a Good Audit/Inspector, Six Systems
Approach to GMP Inspections/Audits, Introduction to Quality System
Inspection  Techniques (QSIT), Overview
of Audit Process (Planning/Scheduling, Audit Execution).

Preparing
Quality Manuals.

8

11

PCP

234

Bioavailability and Bioequivalence

General
concepts and definition, Bioavailability (Principles and Methods) Therapeutic
Equivalent Evaluations: Clinical relevance, Methods for determining
Bioequivalence, Minimizing the need for Bioequivalence testing,  Bioequivalence
Testing:  Evaluation of
Bioequivalence Data, Bioequivalence Assessment, Criteria for Bioequivalence,
Study Design (Case Studies), Drug Product Selection, Waivers for
Bioequivalence Testing/and product registration.

Biopharmaceutics
(Principle, Biopharmaceutical Classification System / Drug Absorption / In Vitro, In Vivo Comparison (IVIVC).

4

12

PCP

235

Production
and Quality Assurance of Herbal Medicines

Introduction
and Definitions,  Assessment of
quality,  Crude plant material, plant preparations, finished products,
stability, Assessment of safety,
Toxicological studies,
Documentation, Assessment of efficacy,

Activity, Evidence to support indications,
combination products, Intended Use, Product
information for the consumer, Promotion and packaging.

4

13

PCP

200

Seminar

Presentation
on selected topics.

4

14

PCP

201

Residency I

Experiential
Learning

4*

Total

64

S/N

CODE

TITLE

CONTENT

UNITS

1

PCP
301

Research Methodology II

Measurements,
Experimental/Questionnaire design, sample size, methods and techniques, data
analysis, result presentation, discussion and conclusion. Report writing,
grantsmanship

4

2

PCP

331

Inventory Management

The
context of Inventory Management System, Standard Reports and Records,
Inventory Control Models and Re-order, Mathematical Models for Reordering,

Identifying
and Controlling Costs, Assessment Guide.

4

3

PCP

332

Drug and Food Regulation and
Control

Pharmaceutical Production Policy-Levels, types and policies of Local Production (Market factors,
Regulatory and Legal Provisions, Investment and Industrial development issues,
physical infrastructure and human resources) National
Regulatory Requirement in Drug Production,

Food
production, Comparative studies; Dossier
preparation, Allopathic Drugs, Herbal medicines and others, Clinical
investigations, Clinical Trials, The New Drug Application/License,
Post-Approval Activities- Safety Monitoring and Post-Marketing
Surveillance,  Patents and Patents
Rights.

4

4

PCP

333

Logistics Management
Information System (LMIS)

Terms
and Definitions relating to LMIS, Decision-making based on LMIS

4

5

PCP

334

Management Information System
(MIS)

Importance
of a Drug Management Information System (functions, Information System, Data
and Information, The Information system pyramid), Typical components of a
Drug MIS,  Designing or revising a Drug
MIS,  Implementing a Drug MIS, From
information to action (processing data, presenting information, interpreting,
information and taking action)

Computers in Drug MIS-Uses of Computers, Specialized software for Drug Management and
Control,   Building
a Drug Master file in a database.

Application:
Laboratory Information Management Systems (Function, Decision, Information
and Interpretation of Data).

4

6

PCP

335

Pharmaceutical Biotechnology

Biotechnology and Drugs, Milestones in Biotechnology, Biotechnology
Drugs, Application of Biotechnology in Pharmaceutical Manufacturing,
Pharmacogenomics, Modified-release Drug
Therapy, Drug
properties relevant to Extended Release formulation, Rate Controlled Delivery
Systems, Targeted Delivery Systems, Delivery of Biotechnology Products, Novel
Delivery Systems

4

Sub-specialties

7

PCP

431

Pharmaceutical Quality Systems

Quality
Assurance/Quality Control, Definition
of Terms: QC, QA, Concept of
Quality by Design (QbD)-Quality
Management; Drug Information/Research, Quality Control Lab-Release of Raw
Materials, Products, Assay, etc., Environmental Control.

Overview
of technical Procedures of ISO 17025:2017 IEC.

Quality Control within the Production Unit.
Documentation.

Advances
in Analytical Methods and techniques Non-instrumental
Methods-Titrimetry, Gravimetry, Instrumental Methods-Spectrophotometry,
Chromatography, HPLC, GC MS, NMR, Sampling, Sampling, Chemical and Microbiological, Detection of impurities and
documentation, Self-Inspection, Composition
of Team, Inspection Report, Follow up Action, Complaints and Product
Recall.

Good
Laboratory Practice (GLP).

Contract
Manufacture and Analysis, GMP
assessement, Assessment of the ability of the Contract Laboratory, Drug
Registration, Counterfeit Medicines, Drug Donation, Orphan Drugs.

10

8

PCP

432

Production
Management

Production
Planning: Update, Manpower requirements for            Pharmaceutical
Services in the public and private sectors,
Manufacturing Data Base: Sales forecast methods, Computation of
man-hours, Computation of labour personnel,
Capacity Utilisation on Equipment,
Monitoring Efficiency: Labour,
Material, Cost Improvement Projects,
Faking and Counterfeiting of Drugs and counter-measures,  Drug Production: Problems, Constraints and Prospects, Regulatory Control of
Drug Production.

10

9

PCP

433

Pharmaceutical Sales and
Marketing

Sales
Forecast Methods, Setting Drug Sales Prices and Drug Sales Revenue, Medical
Representatives (functions/responsibilities),
Market Economics,  Markets and
competition,  Economics of Scale,
Ethics and business, Market surveillance (data collection on sales), Drug
Promotion – Ethical guidelines.  Product Launch-Definitions of Key
Concepts-Product Launch, Product Re-Launch, Product Life Cycle, Life Cycle
Management, Regulatory Requirements for Product Launch, Strategies for New
Product Launch in the Pharma Industry, Applications of Social Media in
Product Launch. Post Marketing
Surveillance (PMS)-Definitions of Key Concepts- PMS, Pharmacovigilance,
Drug Safety, Adverse Drug Reactions, Adverse Events, Product Recall , The
Need for Post Marketing Surveillance, Challenges of Substandard, Spurious,
Falsely labelled, Falsified & Counterfeit (SSFFC) Medical Products,
Product Quality Surveillance/Combating SSFFC Medical Products, Post Marketing
Changes & Variations.

10

10

PCP 400

Seminar

Presentation
on selected topics

4

11

PCP 401

Residency
II (Sub-specialty)

Experiential
Learning

30*

12

PCP 402

Dissertation
(Sub-specialty)

Research
Work

12

Total

80