M-PV (Pharmacovigilance) Certificate Course

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Module-1

Introduction to Pharmacovigilance

Unit-1:Subject and scope of PV.

Unit-2:History of PV.

Unit-3:ADRs and public health.

Unit-4:Limited risk prediction   from molecular analogy, pre-clinical studies and pre-marketing clinical   trials.

Module-2

Fundamental Clinical Aspects of ADRs

Unit-1:Types and mechanisms of   ADRs.

Unit-2:Pharmacogenetic causes   of inter-individual variability in the susceptibility to ADRs.

Unit-3:non-genetic risk   factors for ADRs and complex interactions.

Unit-4:Clinical management of   ADRs.

Module-3

Important ADRs and ‘Risk Driving’ ADRs of Important   Medicines

Unit-1:Serious ADRs at organ classes where ‘Type B’   reactions are important. Most involved drugs.

Unit-2:Important ADRs at organ classes where ‘Type A’   reactions are most important, and the mostly involved drugs.

Unit-3:Focus on ADRs of anti-infectives particularly   important in limited resource settings and of vaccines.

Unit-4:‘Risk drivers’ of important drugs for common illness   and chronic diseases, biologicals, herbals.

Module-4

Introduction to Individual Case Safety Reports   (ICSRs) Management.

Unit-1:Concerns about ADRs:   medical, psychological and regulatory background and reasons for reporting.

Unit-2:Contents, structure and   validity of reports and reporting procedures.

Unit-3:Case assessment.

Unit-4:Reports related to   vaccines, herbals and specific situations.

Module-5

Pharmacovigilance in Clinical Trials

Unit-1:Characteristics of pharmacovigilance in clinical   trials.

Unit-2:Collection of hazard data: planning and practical   realization.

Unit-3:Risk assessment.

Unit-4:Guidance and regulatory framework.

Module-6

Counterfeiting,   Quality Defects and Medication Errors

Unit-1:Counterfeiting,   demarcation against manufacturing-related quality defects.

Unit-2:Medication error (ME):   definition, impact, detection.

Unit-3:ME reports: description   and assessment.

Unit-4:Preventive measures.

Module-7

Spontaneous ICSR Reporting   Systems (SRS)

Unit-1:Definition, settings, potential and limitations of   SRS.

Unit-2:Computerised ICSR databases: requirements and   structure, administration.

Unit-3:Data transmission and entry.

Unit-4:Data retrieval, descriptive statistics, access and   confidentiality.

Module-8

Signal Detection   and Management

Unit-1:Definition of a signal;   sources, potentials, detection by non-statistical medical means.

Unit-2:Disproportionality   statistics for signal detection in spontaneous ISCR databases.

Unit-3:Special issues in   disproportionality approaches.

Unit-4:Prioritisation,   validation, assessment, risk confirmation or refusal, communication, further   action.

Module-9

Post-Authorization   Observational Studies and Clinical Trials in PV

Unit-1:Definition and objectives of post-authorization   studies, general requirements, specific studies.

Unit-2:Important observational studies and their strengths   and weaknesses.

Unit-3:Bias, confounding and effect modification in   observational studies.

Unit-4:Sources of study subjects and data.

Module-10

Benefit-Risk   Assessment

Unit-1:‘Benefit-risk’:   definitions, methodological approaches; disease as criterion of benefit.

Unit-2:Drug-related risks   (ADRs): analyzing, weighting and combining their components.

Unit-3:Balancing benefit/chance   vs. harm/risk and comparing different treatment options.

Unit-4:Taking into account   preferences of stakeholders, uncertainties and options for actions.

Module-11

Pharmacovigilance and Risk Management Systems, Risk Management Plans (RMPs), Inspections

Unit-1:Pharmacovigilance systems: definition, stakeholders   and operation.

Unit-2:Product-related risk management systems.

Unit-3:Specific product-related RMPs; other tools and   activities.

Unit-4:Pharmacovigilance inspections and audits, quality assessment.

Module-12

Industry and   Regulatory Authorities, Mandatory Procedures from Legislation

Unit-1:Facilities at   pharmaceutical companies, marketing authorization holders, wholesalers and   distributors.

Unit-2:Mandatory tasks and   procedures from legislation at industry.

Unit-3:Facilities at   regulatory authorities.

Unit-4:Mandatory tasks and   procedures from legislation at regulatory authorities.

Module-13

PV Organization and   Public Health

Unit-1:Detection, documentation and reporting of ADRs on   the local level.

Unit-2:PV capacity building and organization. on the   regional and national level.

Unit-3:Public Health Programmes (PHPs) with PV aspects and   other PV projects.

Unit-4:Co-operative international organizations, industry   associations.

Module-14

Communication

Unit-1:Context and guidance.

Unit-2:Communication with   patients and healthcare professionals: tools, channels and processes.

Unit-3:Communication with   patients and healthcare professionals: contents and presentation.

Unit-4:Interaction among stakeholders,   including the media.

Module-15

Sources of case   reports

Unit-1:Primary data: figures, facts, terms, cases.

Unit-2:Secondary information: assessments, judgements, decisions (hardcopy or electronic version).

Unit-3:Electronic/Internet methods for searching and   managing information.

Unit-4:Materials and training courses, where appropriate,   specific for regions or settings.