- On demand course!
iLearn Institution for Learning and Development
An initiative in imparting education with the mission of achieving high impact among learners, and scholars through continuing
collaboration between Academic Institutions and Industries.
This initiative will ensure latest updates and practices through healthy networking and up-skilling courses which create awareness and confidence among talent forces of future society.
Through iLearn courses, academic institutions can leverage their standards and confidence among the society by providing up-skilling courses, latest practices through Industry expertise, facilitation of career opportunities, streams to choose after their graduations, which is win-win approach for scholars and academic institutions.
Key Collaborative Elements
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Curriculum Development:
Co-create curriculum content that seamlessly integrates academic theories with practical applications, ensuring a well-rounded and industry-aligned learning experience.
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Global Faculty Engagement:
Facilitate cross-institutional collaboration between faculty members to encourage knowledge exchange, joint research initiatives, and the infusion of real-world examples into academic discourse. Experts across globally will be identified and engaged for the courses.
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Technology Integration:
Implement state-of-art online learning platforms, to enhance the overall learning experience and facilitate seamless interaction between students and course content.
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Promotion and Outreach:
Develop joint initiatives to promote the online courses, tapping into the combined networks and resources of both institutions to reach a global audience of learners.
On Demand Course
- Featured Course
Pharmacovigilance
Academic Course Recommended by Pharmacy Council of India for Bachelor of Pharmacy (B. Pharm) Course BP 805T
Duration 45 Hours.
Scope
This paper will provide an opportunity for the student to learn about development of Pharmacovigilance as a science, basic terminologies used in pharmacovigilance, global scenario of Pharmacovigilance, train students on establishing pharmacovigilance programme in an organisation, various methods that can be used to generate safety data and signal detection. This paper also develops the skills of classifying drugs, diseases and adverse drug reactions.
Objectives
At completion of this paper it is expected that students will be able to (know, do, and appreciate):
1. Why drug safety monitoring is important?
2. History and development of pharmacovigilance.
3. National and international scenario of Pharmacovigilance.
4. Dictionaries, coding and terminologies used in Pharmacovigilance.
5. Detection of new adverse drug reactions and their assessment.
6. International standards for classification of diseases and drugs.
7. Adverse drug reaction reporting systems and communication in pharmacovigilance.
8. Methods to generate safety data during pre clinical, clinical and post approval phases of drugs’ life cycle.
9. Drug safety evaluation in paediatrics, geriatrics, pregnancy and lactation.
10. Pharmacovigilance Program of India (PvPI) requirement for ADR reporting in India.
11. ICH guidelines for ICSR, PSUR, expedited reporting, pharmacovigilance planning.
12. CIOMS requirements for ADR reporting.
13. Writing case narratives of adverse events and their quality.
Module Details
Introduction to Pharmacovigilance
- History and development of Pharmacovigilance
- Importance of safety monitoring of Medicine
- WHO international drug monitoring programme
- Pharmacovigilance Program of India(PvPI)
Introduction to adverse drug reactions
- Definitions and classification of ADRs
- Detection and reporting
- Methods in Causality assessment
- Severity and seriousness assessment
- Predictability and preventability assessment
- Management of adverse drug reactions
Basic terminologies used in pharmacovigilance
- Terminologies of adverse medication related events
- Regulatory terminologies
Drug and disease classification
- Anatomical, therapeutic and chemical classification of drugs
- International classification of diseases
- Daily defined doses
- International Non proprietary Names for drugs
Drug dictionaries and coding in pharmacovigilance
- WHO adverse reaction terminologies
- MedDRA and Standardised MedDRA queries
- WHO drug dictionary
- Eudravigilance medicinal product dictionary
Information resources in pharmacovigilance
- Basic drug information resources
- Specialised resources for ADRs
Establishing pharmacovigilance programme
- Establishing in a hospital
- Establishment & operation of drug safety department in industry
- Contract Research Organisations (CROs)
Vaccine safety surveillance
- Vaccine Pharmacovigilance
- Vaccination failure
- Adverse events following immunization
Pharmacovigilance methods
- Passive surveillance – Spontaneous reports and case series
- Stimulated reporting
- Active surveillance – Sentinel sites, drug event monitoring and registries
- Comparative observational studies – Cross sectional study, case control study and
- cohort study
- Targeted clinical investigations
Communication in pharmacovigilance
- Effective communication in Pharmacovigilance
- Communication in Drug Safety Crisis management
Safety data generation
- Pre clinical phase
- Clinical phase
- Post approval phase (PMS)
ICH Guidelines for Pharmacovigilance
- Organization and objectives of ICH
- Expedited reporting
- Individual case safety reports
- Periodic safety update reports
- Post approval expedited reporting
- Pharmacovigilance planning
- Good clinical practice in pharmacovigilance studies
Pharmacogenomics of adverse drug reactions
- Genetics related ADR with example focusing PK parameters.
Drug safety evaluation in special population
- Paediatrics
- Pregnancy and lactation
- Geriatrics
CIOMS
- CIOMS Working Groups
- CIOMS Form
CDSCO (India) and Pharmacovigilance
- D&C Act and Schedule Y
- Differences in Indian and global pharmacovigilance requirements
Q & A Session after every module.
Assessment session after every module
Course Highlights
Domain Highlights
HEALTHCARE
Healthcare domain has been chosen as our first endeavour in this mission as preserving health in all aspects of life and living beings is crucial to keep the ecosystem intact against all adversities both natural and artificially.
Therefore, ensuring patient safety as the theme of first set of courses, we are partnering with universities and colleges in healthcare stream particularly for betterment of pharmacy graduates, as pharmacovigilance has been proposed by Pharmacy council of India to be imparted mandatorily to pharmacy graduates.
Key Collaborative Elements for Pharmacy and Medical Colleges
Training modules developed by domain experts, as per Pharmacy Council of India guidelines.
Additional trainings and guidance for soft
skill developments and continuous career
growth.
Career guidance, support in placement and internship opportunity for deserving candidates.
Value added courses for specialisation and
latest industry skill demand.