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.
Key Features:
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.
Registration:
(6 Months Course)
Registration open : 11.11.2022
Last Date for Registration : 20.11.2022
Commencement of classes : 20.11.2022
Eligibility:
Graduates/Masterβs Degree Holders in Pharmacy/Nursing/Dental/or Any other equivalent medical degree from any recognized institute.
(B.Pharm/M.Pharm/Pharm D)
Course Advantages:Β·
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 βRisk Drivingβ ADRs of Important Medicines
Unit-1:Serious ADRs at organ classes where βType Bβ reactions are important. Most involved drugs.
Unit-2:Important ADRs at organ classes where βType Aβ 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:βRisk driversβ 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:βBenefit-riskβ: 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.
MASTERS PHARMACY ACADEMY (Head Office)
4th floor, Just For You showroom building, Dilsukhnagar, Hyderabad, Telangana - 500060 IN ; Email ID: admin@matserspharma.in
Copyright Β© 2020 Masters Pharma Academy - All Rights Reserved.
Powered by GoDaddy Website Builder
This website uses cookies. By continuing to use this site, you accept our use of cookies.