About the courses
Programme attendees will have the choice of acquiring various certifications which will portray the basic, yet comprehensive understanding the concepts of On The Job(OTJ)requirements.
The Mentees will have an opportunity to learn, understand and self-assess their skills and knowledge. Thus, the learning will be holistic in nature through scheduled live-virtual and offline classes by the subject matter experts for each of 5 modules.
The Assessment would be done on the following parameters:
EXAMINATION AND ASSESSMENT
Total Weightage :100
At the end of the course the attendee would earn: Certificate of Completion.
(6 Months Course)
Registration open : 11.11.2022
Last Date for Registration : 20.11.2022
Commencement of classes : 20.11.2022
Graduates/Master’s Degree Holders in Pharmacy/Nursing/Dental/or Any other equivalent medical degree from any recognized institute.
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.
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.
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.
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-4:Reports related to vaccines, herbals and specific situations.
Pharmacovigilance in Clinical Trials
Unit-1:Characteristics of pharmacovigilance in clinical trials.
Unit-2:Collection of hazard data: planning and practical realization.
Unit-4:Guidance and regulatory framework.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
MASTERS PHARMACY ACADEMY (Head Office)
4th floor, Just For You showroom building, Dilsukhnagar, Hyderabad, Telangana - 500060 IN ; Email ID: firstname.lastname@example.org
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