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WEST AFRICAN POSTGRADUATE COLLEGE OF PHARMACISTS (COLLEGE DE TROISIEME CYCLE DES PHARMACIENS DE L’AFRIQUE DE L’OEUST) LAGOS UPDATE LECTURES PART ONE (LEVEL ONE) COURSE TIMETABLE DATE 9.00 A.M.-11.00 A.M. 11.00 A.M.-1.00 P.M. 1-2 P.M. 2.00P.M.-4.00 P.M. Monday 18th May, 2015 Orientation/Overview of Fellowship Program PCP 102 Pharmaceutical Care I History and evolution of pharmaceutical care Concept and philosophy of pharmaceutical care Need for pharmaceutical care Steps in providing pharmaceutical care Pharmaceutical care skills B R E A K PCP 102 Pharmaceutical Care I Barriers to pharmaceutical care and measures to overcome them Marketing pharmaceutical care Tuesday 19th May, 2015 PCP 101 Pharmacy Practice & Regulation: Narcotic Laws Medicine Regulation Professional Ethics: National and International Codes of Ethics. Guidelines for Medicine Promotion & Donation Pharmacy Entrepreneurship PCP 103 Pathophysiology and Therapeutics 1: Diabetes mellitus Asthma Wednesday 20th May, 2015 PCP 101 Pharmacy Practice & Regulation: Good Pharmacy Practice Clinical: Prescription Management: Receipt, Assessment and Dispensing. Good dispensing practice Patient Records & Documentation Importance of Patient Education, Counseling & Monitoring Referrals and Substitution PCP 101 Pharmacy Practice & Regulation: Regulation of Pharmacy Practice National Health & Drug Policies (Country policies on healthcare and on medicines; Development of Practice Policies) PCP 101 Pharmacy Practice & Regulation: Good Pharmacy Practice Industrial: Good Manufacturing Practice Records & Documentation Post-marketing Surveillance & Recalls Thursday 21st May, 2015 PCP 103 Pathophysiology and Therapeutics 1: Hypertension Cardiac failure PCP 101 Pharmacy Practice & Regulation Unit Dose Dispensing Class Discussion
13

LAGOS UPDATE LECTURES · Marketing pharmaceutical care Tuesday 19th May, 2015 PCP 101 Pharmacy Practice & Regulation: Narcotic Laws Medicine Regulation Professional Ethics: National

Oct 18, 2020

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Page 1: LAGOS UPDATE LECTURES · Marketing pharmaceutical care Tuesday 19th May, 2015 PCP 101 Pharmacy Practice & Regulation: Narcotic Laws Medicine Regulation Professional Ethics: National

WEST AFRICAN POSTGRADUATE COLLEGE OF PHARMACISTS (COLLEGE DE TROISIEME CYCLE DES PHARMACIENS DE L’AFRIQUE DE L’OEUST)

LAGOS UPDATE LECTURES

PART ONE (LEVEL ONE) COURSE TIMETABLE DATE 9.00 A.M.-11.00 A.M. 11.00 A.M.-1.00 P.M. 1-2 P.M. 2.00P.M.-4.00 P.M.

Monday

18th May, 2015

Orientation/Overview of Fellowship

Program

PCP 102 Pharmaceutical Care I

History and evolution of

pharmaceutical care

Concept and philosophy of

pharmaceutical care

Need for pharmaceutical care

Steps in providing pharmaceutical

care

Pharmaceutical care skills

B

R

E

A

K

PCP 102 Pharmaceutical Care I

Barriers to pharmaceutical care and

measures to overcome them

Marketing pharmaceutical care

Tuesday

19th May, 2015

PCP 101 Pharmacy Practice &

Regulation:

Narcotic Laws

Medicine Regulation

Professional Ethics: National and

International Codes of Ethics.

Guidelines for Medicine Promotion &

Donation

Pharmacy Entrepreneurship

PCP 103 Pathophysiology and

Therapeutics 1:

Diabetes mellitus

Asthma

Wednesday

20th May, 2015

PCP 101 Pharmacy Practice &

Regulation:

Good Pharmacy Practice Clinical:

Prescription Management: Receipt,

Assessment and Dispensing.

Good dispensing practice

Patient Records & Documentation

Importance of Patient Education,

Counseling & Monitoring

Referrals and Substitution

PCP 101 Pharmacy Practice &

Regulation:

Regulation of Pharmacy Practice

National Health & Drug Policies

(Country policies on healthcare

and on medicines; Development of

Practice Policies)

PCP 101 Pharmacy Practice &

Regulation:

Good Pharmacy Practice Industrial:

Good Manufacturing Practice

Records & Documentation

Post-marketing Surveillance &

Recalls

Thursday

21st May, 2015

PCP 103 Pathophysiology and

Therapeutics 1:

Hypertension

Cardiac failure

PCP 101 Pharmacy Practice &

Regulation Unit Dose Dispensing

Class Discussion

Page 2: LAGOS UPDATE LECTURES · Marketing pharmaceutical care Tuesday 19th May, 2015 PCP 101 Pharmacy Practice & Regulation: Narcotic Laws Medicine Regulation Professional Ethics: National

PART ONE (LEVEL THREE) COURSE TIMETABLE DATE 9.00 A.M.-11.00 A.M. 11.00 A.M.-1.00 P.M. 1-2 P.M. 2.00P.M.-4.00 P.M.

Monday

18th May, 2015

PCP 202: Primary Health Care (PHC):

Origin and Concept of PHC;

Components and Principles of PHC;

WHO/UNICEF primary health care measures for

children

PCP 202 (Cont’d):

Essential Medicines Concept;

Bamako Initiative;

Orphaned Medicines;

Health Systems Reforms

B

Group Discussions

Tuesday

19th May, 2015

PCP 203: Clinical Pharmacokinetics:

- Principles of Pharmacokinetics –

Absorption, Distribution and

Elimination (Metabolism and

Excretion)

PCP.203 (Cont’d):

Clinical Significance of

Pharmacokinetic Parameters in

Medicine Therapy;

Determination and uses (Clearance,

Volume of Distribution, Half-life.)

R

PCP.203 (Cont’d):

Bioavailability (relative and absolute) and

Bioequivalence of Medicines,

Concept, Principles and Methodologies of

Determination

Wednesday

20th May, 2015

PCP.203 (Cont’d):

Principles and Mechanisms of

Medicine Interactions ( Medicine-medicine, medicine-

food and medicine-disease interactions)

Management of Medicine interactions

PCP 201: Introduction to Public Health

Pharmacy:

Concepts of health, public health and

public health pharmacy;

Determinants of Health;

E

PCP.204: Self-care Therapeutics:

Introduction to self-care and self-medication

Economic, psychological and other variables

that lead to and affect self-medication

Modern medicines and self-medication

Education and training and place of the

pharmacist

Pharmacist/prescriber co-operation/substitution

Responsibilities of the pharmacist in self-

medication

Pharmacy promises/sales promotion

Advice on treatment of symptoms

Over the Counter prescribing/confidentiality

Referral notes

Importance and need for referrals. Referral

notes /advice

Thursday

21st May, 2015

PCP 201 Introduction to Public Health Pharmacy:

Role of the pharmacist in health promotion, health

education, and disease control;

Reproductive and Child Health;

Sexuality Education

PCP.204: Self-care Therapeutics

(Cont’d):

Basic first-Aid Techniques and

Emergencies

Introduction

Requirements for first – aid

Common conditions requiring first-aid:

Severe allergic conditions, Insect stings,

black eyes, Bruising, dislocations,

Sprains, Minor burns, Nose Bleeding,

Choking, cuts, Eye injuries, Impaled

objects, Food poisoning,

Hypo/Hyperglycemia, Poisons, Puncture

and Stab wounds, Seizures, Difficulty

with breathing, Snake bite, fits (febrile

convulsions, Grand/Petit mal, epilepsy),

Fever Emergency procedures in the

pharmacy and referrals

A

K

Class Discussion

Page 3: LAGOS UPDATE LECTURES · Marketing pharmaceutical care Tuesday 19th May, 2015 PCP 101 Pharmacy Practice & Regulation: Narcotic Laws Medicine Regulation Professional Ethics: National

FACULTY OF CLINICAL PHARMACY PART TWO (LEVEL 1) COURSE TIMETABLE

DATE 9.00 A.M. – 11.00 A.M. 11.00 A.M. – 1.00 P.M. 1-2 P.M. 2.00 P.M. – 4.00 P.M.

Monday

18th May, 2015

PCP 311& 321 Pharmaceutical Care II

Patient data collection and evaluation Documentation of pharmaceutical care

PCP 311& 321 Pharmaceutical Care II

Drug therapy problems Developing pharmaceutical care plans

B PCP 311 & 313 & 321 &323 Pharmaceutical Care II & Therapeutics Case Studies

Renal system & GIT

Tuesday

19th May, 2015

PCP 311 & 313 & 321 &323 Pharmaceutical Care II & Therapeutics Case Studies

Diabetes, Hypertension, Cardiac failure

PCP 311 & 313 & 321 &323 Pharmaceutical Care II & Therapeutics Case Studies

Pharmaceutical care in disease states: Malaria , Asthma, Metabolic Diseases,

R

PCP 311 & 313 & 321 &323 Pharmaceutical Care II & Therapeutics Case Studies

Pharmaceutical care in disease states: HIV/AIDS, Tuberculosis

Wednesday

20th May, 2015

PCP 312 Applied Clinical Pharmacokinetics Therapeutic Drug Monitoring (TDM) in patient therapy; relevance of TDM, sampling time, assaying and Interpretation of TDM results.

PCP 312 Applied Clinical Pharmacokinetics Organ dysfunction and its effect on total clearance and dosage regimens; Dosage regimen design- determination of daily dose, dosage intervals and dosage regimen Adjustment of dosage regimens in organ dysfunction - Changes in renal/hepatic function

E

PCP 312 Applied Clinical Pharmacokinetics Role of Clinical Pharmacokinetics in rational drug therapy. Implications of medicine substitutions based on bioavailability/ bioequivalence of medicines Pharmacokinetic basis of medicine interactions and resolution

Thursday

21st May, 2015

PCP 301 Research Methodology – An Introduction ( ALL FACULTIES in P2L1):

Research process

Literature Research

Questionnaire Design

Data Analysis

Operational Research & Experimental

Design

PCP 301 Research Methodology – An Introduction (ALL FACULTIES in P2L1): Project Management (Planning,

implementation, monitoring & evaluation)

Conceiving the Research Study Characteristics of a good Research Question, Developing the Research Question and Study Design

Choosing the Study Subjects Selection Criteria, Sampling and Recruitment

Planning the Measurements Measurement Scales, Precision and Accuracy

A K

PCP 301 Research Methodology – An Introduction (ALL FACULTIES in P2L1)

Estimating Sample Size and Power

Hypotheses and Underlying Principles Sample Size Techniques for Analytical and

Descriptive Studies

Study Designs

Designing Observational Studies

Enhancing Causal Inference in

Observational Studies

Designing Experimental Studies

Critical Appraisal of Scientific Literature

Dissertation Execution and Writing

Page 4: LAGOS UPDATE LECTURES · Marketing pharmaceutical care Tuesday 19th May, 2015 PCP 101 Pharmacy Practice & Regulation: Narcotic Laws Medicine Regulation Professional Ethics: National

FACULTY OF CLINICAL PHARMACY PART TWO (LEVEL 3) COURSE TIMETABLE

DATE 9.00 A.M. – 11.00 A.M. 11.00 A.M. – 1.00 P.M. 1-2 P.M. 2.00 P.M. – 4.00 P.M.

Monday

18th May, 2015

PCP 414 Pharmacovigilance and Clinical Toxicology Definitions, classification and importance of ADR in patients

Causality assessment of suspected ADRs (Certain, Probable,

Possible, Unlikely causes)

Pharmacology of ADR related to therapy

Diagnosis, management and treatment of ADRs

Reporting of ADRs

Cost and safety implications

PCP 414 Pharmacovigilance and Clinical

Toxicology

Clinical Toxicology:- causes, determination,

identify, prevention, implications and

management

B

Winning Tips in

Community Pharmacy

Tuesday

19th May, 2015

PCP 414 Pharmacovigilance and Clinical Toxicology General, Symptomatic and Specific Management of Poisoning

- sources and forms of poisoning and principles underpinning

management of poisoning

-Medicines (paracetamol, digoxin, benzodiazepam, aspirin, warfarin),

Cosmetics and personal care products, Hydrocarbon products, Pesticides,

Cleaning and hygiene products, Heavy metals

Case Studies

R

Dissertation Reports

Wednesday

20th May, 2015

PCP 413 & 423: Drug Supply Management

Procurement and supply management:

Drug selection

Procurement planning and monitoring: Suppliers, Budgets,

Storage and distribution

PCP 413 & 423: Drug Supply Management

The methods of quantification and forecasting

of medicines: -

Consumption-based using Logistic

management Information System (LMIS)

Morbidity-based using Treatment Guidelines

and Formularies

Proxy Consumption-based

Information requirements for quantification:-

Health problems, Conditions managed and

Services provided, Consumption data, Scale-

ups, Demographic data of locality

E

A

Residency Reports

Thursday

21st May, 2015

PCP 412 & 431 Formulary Management & Drug Utilization

Studies

Concepts in development and management of Formularies

Standard treatment Guidelines

PCP 412 & 431 Formulary Management &

Drug Utilization Studies

Programme Medicine

Medicines and Therapeutics Committee

K

Group Discussions

Page 5: LAGOS UPDATE LECTURES · Marketing pharmaceutical care Tuesday 19th May, 2015 PCP 101 Pharmacy Practice & Regulation: Narcotic Laws Medicine Regulation Professional Ethics: National

FACULTY OF COMMUNITY PHARMACY PART TWO (LEVEL 1) COURSE TIMETABLE

DATE 9.00 A.M. – 11.00 A.M. 11.00 A.M. – 1.00 P.M. 1-2 P.M. 2.00 P.M. – 4.00 P.M.

Monday

18th May, 2015

PCP 311& 321 Pharmaceutical Care II

Patient data collection and evaluation

Documentation of pharmaceutical care

PCP 311& 321 Pharmaceutical Care II

Drug therapy problems

Developing pharmaceutical care plans

B

PCP 311 & 313 & 321 &323 Pharmaceutical

Care II & Therapeutics Case Studies

Renal system & GIT

Tuesday

19th May, 2015

PCP 311 & 313 & 321 &323 Pharmaceutical Care

II & Therapeutics Case Studies

Diabetes, Hypertension, Cardiac failure

PCP 311 & 313 & 321 &323

Pharmaceutical Care II & Therapeutics

Case Studies

Pharmaceutical care in disease states: Malaria,

Asthma, Metabolic Diseases,

R

PCP 311 & 313 & 321 &323 Pharmaceutical

Care II & Therapeutics Case Studies

Pharmaceutical care in disease states:

HIV/AIDS, Tuberculosis

Wednesday

20th May, 2015

PCP 322 Business Management

Legal Organization of pharmacy business ( types

of ownership)

Business Incorporation and post incorporation

requirements such as trade certificate

Overview of business/commercial law

Location analysis and evaluation

PCP 322 Business Management

Starting and financing a pharmacy practice

– including purchasing an existing

pharmacy

Inventory Management

E

PCP 322 Business Management

Human Resources management

Staff Supervision and motivation

Thursday

21st May, 2015

PCP 301 Research Methodology – An Introduction

( ALL FACULTIES in P2L1):

Research process

Literature Research

Questionnaire Design

Data Analysis

Operational Research & Experimental Design

PCP 301 Research Methodology – An

Introduction (ALL FACULTIES in P2L1):

Project Management (Planning,

implementation, monitoring & evaluation)

Conceiving the Research Study

Characteristics of a good Research Question,

Developing the Research Question and Study

Design

Choosing the Study Subjects

Selection Criteria, Sampling and Recruitment

Planning the Measurements

Measurement Scales, Precision and Accuracy

A

K

PCP 301 Research Methodology – An

Introduction (ALL FACULTIES in P2L1)

Estimating Sample Size and Power

Hypotheses and Underlying Principles

Sample Size Techniques for Analytical and

Descriptive Studies

Study Designs

Designing Observational Studies

Enhancing Causal Inference in Observational

Studies

Designing Experimental Studies

Critical Appraisal of Scientific Literature

Dissertation Execution and Writing

Page 6: LAGOS UPDATE LECTURES · Marketing pharmaceutical care Tuesday 19th May, 2015 PCP 101 Pharmacy Practice & Regulation: Narcotic Laws Medicine Regulation Professional Ethics: National

FACULTY OF COMMUNITY PHARMACY PART TWO (LEVEL 3) COURSE TIMETABLE

DATE 9.00 A.M. – 11.00 A.M. 11.00 A.M. – 1.00 P.M. 1-2 P.M. 2.00 P.M. – 4.00 P.M.

Monday

18th May, 2015

PCP 424 & 414 Pharmacovigilance and Clinical Toxicology Definitions, classification and importance of ADR in patients Causality assessment of suspected ADRs (Certain, Probable, Possible, Unlikely causes) Pharmacology of ADR related to therapy Diagnosis, management and treatment of ADRs Reporting of ADRs Cost and safety implications

PCP 424 & 414 Pharmacovigilance and Clinical

Toxicology

Clinical toxicology:- causes, determination,

identify, prevention, implications and management

B

Winning Tips in Community Phamacy

Tuesday

19th May, 2015

PCP 424 & 414 Pharmacovigilance and Clinical Toxicology General, Symptomatic and Specific Management of Poisoning - sources and forms of poisoning and principles underpinning management of poisoning -Medicines (paracetamol, digoxin, benzodiazepam, aspirin, warfarin), Cosmetics and personal care products, Hydrocarbon products, Pesticides Cleaning and hygiene products, Heavy metals

Case Studies

R

E

Dissertation Reports

Wednesday

20th May, 2015

PCP 423: Drug Supply Management

Procurement and supply management:

Drug selection

Procurement planning and monitoring: Suppliers,

Budgets, Storage and distribution

PCP 423: Drug Supply Management

The methods of quantification and forecasting of

medicines: -

Consumption-based using Logistic management

Information System (LMIS)

Morbidity-based using Treatment Guidelines

and Formularies

Proxy Consumption-based

Information requirements for quantification:-

Health problems, Conditions managed and

Services provided, Consumption data, Scale-

ups, Demographic data of locality

A

Residency Reports

Thursday

21st May, 2015

PCP 422 & 454 Health Promotion

Concept of health promotion

Health promotion models comprising: Health protection, disease prevention, and health education.

Health education and pharmacy practice: the role of the pharmacist

Objectives of health education Methods/Techniques of health

Healthy people 2010 health target for the 21st

Century

PCP 422 & 454 Health Promotion

Specific health education themes Health Screening/ Risk assessment Hypertension, Diabetes, Breast Cancer, Osteoporosis; Intervention Program: Hypertension, Diabetes, Oesteoporosis Folic acid supplementation, Low dose aspirin supplementation Smoking cessation program

K

PCP 422 & 454 Health Promotion Practical Skills / Activities: Development

of risk assessment tools, Develop/risk

assessment questionnaire for diabetes, heart

disease, osteoporosis etc, Development of

patent education leaflets, Disease screening

exercise, Designing and implementation of

enlightenment programmes, Designing

lifestyle modification programmes.

Page 7: LAGOS UPDATE LECTURES · Marketing pharmaceutical care Tuesday 19th May, 2015 PCP 101 Pharmacy Practice & Regulation: Narcotic Laws Medicine Regulation Professional Ethics: National

FACULTY OF DRUG PRODUCTION & QUALITY ASSURANCE PHARMACY PART TWO (LEVEL 1) COURSE TIMETABLE

DATE 9.00 A.M. – 11.00 A.M. 11.00 A.M. – 1.00 P.M. 1-2 P.M. 2.00 P.M. – 4.00 P.M.

Monday 18th May, 2015

PCP 341 QUALITY ASSURANCE / QUALITY CONTROL Definition of Terms: QC, QA and TQM Quality Management Drug Information/Research Quality Control Lab-Release of Raw Materials, Products, Assay, etc. Environmental Control Quality Control within the Production Unit. Over viewing the importance of Documentation Analytical Methods and Validation Non-instrumental Methods- Titrimetry, Gravimetry

Instrumental Methods- Spectrophotometry,

Chromatography, Potentiometry, HPLC, GC MS, NMR

PCP 341: QUALITY ASSURANCE / QUALITY CONTROL Sampling Sampling Methods, Sample Retention, and

Sample Analysis: Chemical and Microbiological, Detection of impurities and Documentation

Self Inspection Why, When, How, Composition of Team,

Inspection Report, Follow up Action Complaints and Product Recall Product recall protocol/procedures (type of

recall) Response to consumer complaints Documentation Contract Manufacture and Analysis Description of the way in which the GMP

compliance of the contract-acceptor is assessed.

Assessment of the ability of the Contract Laboratory

Responsibilities of the Contract-Giver and Contract-Acceptor.

B

PCP 341 QUALITY ASSURANCE / QUALITY CONTROL WHO and Country-Specific Concepts and

Requirements Certification scheme, Site Master Files, Import/Export Control, Drug Registration, Counterfeit Medicines, Drug Donation, Orphan Drugs

Tuesday 19th May, 2015

PCP 342 Good Manufacturing Practice (GMP) Definition of Current Good

Manufacturing Practice (CGMP) Personnel Qualification,Experience, Responsibility Training Programmes/Seminars on GMP

Medical Examination for Communicable Diseases

Protective Clothing, Hygiene and Personal cleanliness

Prevention of eating and smoking within manufacturing area.

Premises and Equipment Suitability of site/ventilation/nature of

construction and finishes Handling of Wastes and Toxic Material

Group Discussions

R

PCP 342 Good Manufacturing Practice (GMP) Documentation Records of where

documentations are located 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 Standard Operative Procedures (SOPs) for all

processes that take place on the premises. Production Technology Standard Operative Procedures (SOPs), Process Validation

Packaging And Pharmaceutical

Page 8: LAGOS UPDATE LECTURES · Marketing pharmaceutical care Tuesday 19th May, 2015 PCP 101 Pharmacy Practice & Regulation: Narcotic Laws Medicine Regulation Professional Ethics: National

Water Supply: Source and Treatment Control of Microbial Contamination, Cross

and Gross Contamination Availability of Essential Equipment,

Production/Manufacturing Flow, Maintenance of Equipment

Calibration and Validation of recording system

E

Containers/Closures, Labelling Stability Studies (ICH Recommended Evaluation), Shelf-Life Calculation/Predictions and Product Dating

In-Process Control, Levels of Drug Production.

Wednesday 20th May, 2015

PCP 343 Total Quality Management (TQM) / Total Product Quality (TPQ) Introduction and Definition of TQM and

TPQ terms Characteristics of a TQM System,

Justification and Benefits of TQM, The Old Quality Philosophy

Validation and the Cost of Quality, Assuring Product Quality, Total Quality Culture

Residency Training

A

PCP 343 Total Quality Management (TQM) / Total Product Quality (TPQ) Quality Management Relationships,

Organisation for Quality Improvement, Quality Improvement Project Road Map

Training.

Thursday 21st May, 2015

PCP 301 Research Methodology – An Introduction (ALL FACULTIES in P2L1): Research process Literature Research Questionnaire Design Data Analysis Operational Research & Experimental

Design

PCP 301 Research Methodology – An Introduction (ALL FACULTIES in P2L1): Project Management (Planning, implementation, monitoring & evaluation) Conceiving the Research Study Characteristics of a good Research Question, Developing the Research Question and Study Design Choosing the Study Subjects Selection Criteria, Sampling and Recruitment Planning the Measurements Measurement Scales, Precision and Accuracy Estimating Sample Size;

Hypotheses and Underlying Principles

K

PCP 301 Research Methodology – An Introduction(ALL FACULTIES in P2L1): Estimating Sample Size and Power Sample Size Techniques for Analytical and

Descriptive Studies Study Designs Designing Observational Studies Enhancing Causal Inference in Observational

Studies Designing Experimental Studies Critical Appraisal of Scientific Literature Dissertation Execution and Writing

Page 9: LAGOS UPDATE LECTURES · Marketing pharmaceutical care Tuesday 19th May, 2015 PCP 101 Pharmacy Practice & Regulation: Narcotic Laws Medicine Regulation Professional Ethics: National

FACULTY OF DRUG PRODUCTION & QUALITY ASSURANCE PHARMACY PART TWO (LEVEL 3) COURSE TIMETABLE

DATE 9.00 A.M. – 11.00 A.M. 11.00 A.M. – 1.00 P.M. 1-2P.M. 2.00 P.M. – 4.00 P.M.

Monday

18th May, 2015

PCP 441: Product Registration, Licensing, and Patency

Dossier preparation

Allopathic Drugs,Herbal medicines and others

Overview of Drug Approval Process and Requirements

Clinical investigations, Clinical Trial Phases I -IV

Clinical Trial Planning and Design: Selecting Trial

Objectives and Design

Measure of Trial outcomes: Selecting the Trial Population, Sample

Size, Drug product design and blinding, Trial drug packaging.

Regulations governing the conduct of Clinical Trials.

Good Clinical Practice (GCP)

Monitoring: Monitoring and Reporting of Adverse Events during

Clinical Trials.

PCP 441: Product Registration, Licensing, and

Patency

The New Drug Application/ License

Post-Approval Activities

Safety Monitoring and Post Marketing Surveillance

Pharmacovigilance

Patents and Patents Rights

B R

Residency Reports

Tuesday

19th May, 2015

PCP 442 Microbial Quality Control of Sterile and Non Sterile

Drugs and Foods

Microbiological Assays

Introduction, definitions and Advantages

Factors influencing microbiological Essays

Types and principles of microbiological essays

Microbiological Essay methods for specific products (disinfectants,

antibiotics, vitamins and amino acids).

Particulate matter testing (clarity test)

Package integrity testing (leaker testing)

PCP 442 Microbial Quality Control of Sterile and

Non Sterile Drugs and Foods

Microbial quality control of sterile and non-sterile

products

Sterile products – tests for sterility, pyrogen test,

microbiological assays, clarity testing and

particulate analysis.

Non-sterile products – requirements of microbiological

purity, detection of pathogens – microbiological

unit test, sampling procedure and control of

microbial stability.

E

Dissertation Reports

Wednesday

20th May, 2015

PCP 434 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)

Case Studies

A

PCP 434 Management

Information System (MIS)

Computers in Drug MIS

Uses of Computers Specialized

softwares for Drug Management

and Control

Building a Drug Master file in

a database

Thursday

21st May, 2015

PCP 443 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, combinati products

Intended Use

Product information for the consumer Promotion

PCP 443 Quality Assurance of Herbal

Medicines

Assessment of efficacy

Activity, Evidence to support indications, combination

products

Intended Use

Product information for the consumer

Promotion

K

Class Discussions

Page 10: LAGOS UPDATE LECTURES · Marketing pharmaceutical care Tuesday 19th May, 2015 PCP 101 Pharmacy Practice & Regulation: Narcotic Laws Medicine Regulation Professional Ethics: National

FACULTY OF PUBLIC HEALTH PHARMACY PART TWO (LEVEL 1) COURSE TIMETABLE

DATE 9.00 A.M. – 11.00 A.M. 11.00 A.M. – 1.00 P.M. 1-2 P.M. 2.00 P.M. – 4.00 P.M.

Monday

18th May, 2015

PCP 351 Evolution of Public and

International Health

National and International efforts to

control: Narcotic

and Psychotropic Drug Substances

PCP 352 Healthcare Organization, Policy

and Finance

Health Care- Primary, Secondary and

Tertiary levels

Essential Drugs Concept

B

Class Discussions

Tuesday

19th May, 2015

PCP 351 Evolution of Public and

International Health

Review of global trends in public

health;

Organization and functions

Regulation and Port Health services

Case Studies

R

PCP 351 Evolution of Public and

International Health

· Substance Abuse, Alcohol, narcotics and

psychotropic

Drug problems.

Wednesday

20th May, 2015

PCP 352 Healthcare Organization,

Policy and Finance

National Health Policy

National Drug Policy

Health Systems Reform globally and

in the West African region

Millennium Development Goals

PCP 352 Healthcare Organization, Policy

and Finance

Primary Health Care

E

Residency Training

Thursday

21st May, 2015

PCP 301 Research Methodology – An

Introduction : ( ALL FACULTIES in

P2L1)

Research process

Literature Research

Questionnaire Design

Data Analysis

Operational Research & Experimental

Design

PCP 301 Research Methodology – An

Introduction : (ALL FACULTIES in

P2L1)

Project Management (Planning,

implementation, monitoring & evaluation) Conceiving the Research Study

Characteristics of a good Research Question,

Developing the Research Question and Study

Design

Choosing the Study Subjects

Selection Criteria, Sampling and Recruitment

Planning the Measurements

Measurement Scales, Precision and Accuracy

Estimating Sample Size;

Hypotheses and Underlying Principles

A

K

PCP 301 Research Methodology – An

Introduction: (ALL FACULTIES in

P2L1)

Estimating Sample Size and Power

Sample Size Techniques for Analytical and

Descriptive Studies

Study Designs

Designing Observational Studies

Enhancing Causal Inference in

Observational Studies

Designing Experimental Studies

Critical Appraisal of Scientific Literature

Dissertation Execution and Writing

Page 11: LAGOS UPDATE LECTURES · Marketing pharmaceutical care Tuesday 19th May, 2015 PCP 101 Pharmacy Practice & Regulation: Narcotic Laws Medicine Regulation Professional Ethics: National

FACULTY OF PUBLIC HEALTH PHARMACY PART TWO (LEVEL 3) COURSE TIMETABLE

DATE 9.00 A.M. – 11.00 A.M. 11.00 A.M. – 1.00 P.M. 1-2 P.M 2.00 P.M. – 4.00 P.M.

Monday

18th May, 2015

PCP 453 Occupational Health and Safety

The work environment, work and health

An overview of occupational

health and safety

Occupational hazards and control

Group Discussions

B

R

E

A

K

PCP 453 Occupational Health and Safety

Specific occupational diseases and

management

Accidents (domestic, traffic and industrial)

Disability and workmen compensation

Ergonomics and safety designs

Tuesday

19th May, 2015

PCP 452 Nutrition and Health

Nutritional requirements of different age

groups

Challenges of obesity and non-

communicable diseases

Protein energy malnutrition

Micronutrient deficiency

Food supplementation

PCP 452 Nutrition and Health

Diagnosis of malnutrition

Management & Control of nutritional

deficiency etc

Dissertation Reports

Wednesday

20th May, 2015

Visits to sites of occupational health

interest such as factories for experiential

learning

Visits to sites of occupational health interest

such as factories for experiential learning

Residency Reports

Thursday

21st May, 2015

PCP 454 & 422 Health Promotion

Concept of health promotion

Health promotion models comprising:

Health protection, disease prevention, and

health education.

Health education and pharmacy practice:

the role of the pharmacist

Objectives of health

education

Methods/Techniques of

health education

Healthy people 2010 health target for

the 21st Century

PCP 454 & 422 Health Promotion

Specific health education themes

Health Screening/ Risk assessment Hypertension, Diabetes, Breast Cancer, Osteoporosis; Intervention Program: Hypertension, Diabetes, Oesteoporosis Folic acid supplementation, Low dose aspirin supplementation Smoking cessation program

PCP 454 & 422 Health Promotion

Practical Skills / Activities: Development of

risk assessment tools, Develop/risk assessment

questionnaire for diabetes, heart disease,

osteoporosis etc, Development of patent

education leaflets, Disease screening exercise,

Designing and implementation of enlightenment

programmes, Designing lifestyle modification

programmes.

Page 12: LAGOS UPDATE LECTURES · Marketing pharmaceutical care Tuesday 19th May, 2015 PCP 101 Pharmacy Practice & Regulation: Narcotic Laws Medicine Regulation Professional Ethics: National

FACULTY OF SOCIAL & ADMINISTRATIVE PHARMACY PART TWO (LEVEL 1) COURSE TIMETABLE

DATE 9.00 A.M. – 11.00 A.M. 11.00 A.M. – 1.00 P.M. 1-2 P.M 2.00 P.M. – 4.00 P.M.

Monday

18th May, 2015

PCP 331 Pharmacy Practice Regulation

Requirement for Pharmaceutical Registration

Market authorization and Parallel Imports

Pharmacy Premises Licensing

Registration of Pharmacists

Group Discussions

B PCP 331 Pharmacy Practice Regulation

Regulations of Pharmacy Practice

Pharmacy Education

Continuing Education and Continuing

Professional Development

Tuesday

19th May, 2015

PCP 331 Pharmacy Practice Regulation

Drug and Premises Inspection

Relevance and Implications of Laws and Ethics

Harmonization efforts: Training and Laws

Civil and criminal liabilities

PCP 332 Sociology and Psychology of Health

Social & Legal Concept of Pharmacy Practice

Personalities and Human Behaviour

Psychological Perspectives on Industrialization

Public image of pharmacy as a profession

R

PCP 332 Sociology and Psychology of

Health

Leadership, Teamwork and

Interdisciplinary healthcare

o Civic responsibility

Wednesday

20th May, 2015

PCP 332 Sociology and Psychology of Health

o Health beliefs

o Patient behavior to Health, Disease and medication

o Health and Wellness

o Provider - Patient Interactions

o Clinical, Economic and humanistic outcomes of care

Residency Training

E

Group Discussions

Thursday

21st May, 2015

PCP 301 Research Methodology – An Introduction:

(ALL FACULTIES in P2L1)

Research process

Literature Research

Questionnaire Design

Data Analysis

Operational Research & Experimental Design

PCP 301 Research Methodology – An

Introduction: (ALL FACULTIES in P2L1)

Project Management (Planning, implementation,

monitoring & evaluation)

Conceiving the Research Study

Characteristics of a good Research Question,

Developing the Research Question and Study Design

Choosing the Study Subjects

Selection Criteria, Sampling and Recruitment

Planning the Measurements

Measurement Scales, Precision and Accuracy

A

K

PCP 301 Research Methodology – An

Introduction: (ALL FACULTIES in

P2L1)

Estimating Sample Size and Power

Hypotheses and Underlying Principles

Sample Size Techniques for Analytical and

Descriptive Studies

Study Designs

Designing Observational Studies

Enhancing Causal Inference in

Observational Studies

Designing Experimental Studies

Critical Appraisal of Scientific Literature

Dissertation Execution and Writing

Page 13: LAGOS UPDATE LECTURES · Marketing pharmaceutical care Tuesday 19th May, 2015 PCP 101 Pharmacy Practice & Regulation: Narcotic Laws Medicine Regulation Professional Ethics: National

FACULTY OF SOCIAL & ADMINISTRATIVE PHARMACY PART TWO (LEVEL 3) COURSE TIMETABLE

DATE 9.00 A.M. – 11.00 A.M. 11.00 A.M. – 1.00 P.M. 1-2 P.M. 2.00 P.M. – 4.00 P.M.

Monday

18th May, 2015

PCP 434 Health and Drug Policy

Health Policy

National Drug Policy: Components of

National Drug Policy

Implementation and Monitoring

PCP 434 Health and Drug Policy

National and International (ECOWAS)

Health and Drug Policies

B

Group Discussions

Tuesday

19th May, 2015

PCP 431 Formulary Management

and Drug Utilization Studies

Drug Use Evaluation, Monitoring

effectiveness, Education and Evaluation

PCP 432 Pharmacoepidemiology

Risk Assessment

Screening and diagnotistic testing

Post-marketing surveillance

Data systems for

pharmacoepidemiology studies

R PCP 432 Pharmacoepidemiology

Principles of pharmacoepidemiology

Medical Surveillance and outbreak of

disease

Wednesday

20th May, 2015

PCP 434 Health and Drug Policy

Policy - overview

Policy formulation process

Policy Analysis

Law and Policy

Enactment Processes

Legal aspects

Group Discussions

E

A

PCP 432 Pharmacoepidemiology

Study designs in Epidemiology:

Observational and Experimental

Data identification and analysis

Thursday

21st May, 2015

PCP 412 & 431 Formulary Management & Drug Utilization Studies

Concepts in development and management of Formularies

Standard treatment Guidelines

PCP 412 & 431 Formulary Management & Drug Utilization Studies

Programme Medicine

Medicines and Therapeutic Committee

K

Group Discussions