Introduction to Drug Safety and Pharmacovigilance
Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effectswithpharmaceuticalproducts.
The activity that is most commonly associated with pharmacovigilance and which consumes a significant amount of resources for regulatory authorities, is that of adverse event reporting. Adverse event (AE) reporting involves the receipt, triage, data entering, assessment, distribution, reporting (if appropriate), and archiving of AE data and documentation. The source of AE reports may include: spontaneous reports,solicited reports; reports from clinical or post-marketing studies; reports from literature sources; reports from the media and reports reported to drug regulatory authorities themselves. For pharmaceutical companies, AE reporting is a regulatory requirement in most countries. AE reporting also provides data to these companies and drug regulatory authorities that play a key role in assessing therisk-benefitprofileof agivendrug.
Course Highlights
Modules - 40
HRS of Learning- 500+
Months - 3
FAQs- 450+
Mock Interview FAQs- 150+
USP
Hands-on Advanced Drug Safety Training
from end to end case processing with narrative writing and MedDRA coding.
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Best online Drug Safety Training Modules
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Comprehensive Drug Safety Curriculum
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Professional Certification in Drug Safety and Pharmacovigilance
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Overview
The Advanced Drug Safety and Pharmacovigilance Certificate program is a very unique training program. The program provides a thorough understanding of the basic concepts of drug safety and risk management throughout the process of drug development and its life cycle in the open market either as a patent or generic drug. This exposure prepares students to understand and appreciate the various types and grades of Adverse Events.
Students are trained to correlate the Adverse Event with any vital and systemic abnormality resulting from this and understand the causal relation of the drug known as Adverse Drug Reaction (ADR). This further builds the analytical skills needed to differentiate between the progress of the disease and ADR as a signal. This program will focus on the regulatory issues across global governmental agencies like the FDA, EMA, ICH, and others that improve safety.
- Understand the FDA, EU-EMA, and ICH regulations for drug safety and pharmacovigilance.
- Develop advanced knowledge of the roles and responsibilities of various functionaries in Drug Safety departments, such as the Drug Safety Physician, Drug Safety Data Analyst, Drug Safety Associate or specialist, Drug Safety Data Entry Associate, Drug Safety Triage Officer, Drug Safety Scientist, Drug Safety Regulatory Associate, and etc.
- Practice the processes of triage, data entry, medical review, as well as reporting through the Oracle® Argus software.
- Detailed training in MedDRA coding and medical narrative writing for SAE reports.
- Expertise in narrative writing for various regulatory requirements.
- Capability for conducting end to end ICSR case management.
- Evolve and implement problem solving practices.
- Competency to handle pharmacovigilance audits.
- Working experience in Oracle Argus Software.
- Soft Skills development for interview success
- History and Why Pharmacovigilance
- Drug Development process
- ICH -GCP guidelines – PV perspective
- Oracle Argus suite training
- Adverse Drug Reactions (ADRs)
- ICSR – Work flow states and timelines
- Serious Adverse events (SAEs) & SUSARs
- MedDRA
- Drug coding
- Labelling Assessment
- Causality Assessment
- Narrative writing
- Query generation
- Follow up assessment
- Report generation and submission
- AOSE – Analysis of Similar events
- Reporting timelines
- Regulations and regulatory Databases
- Structure of Drug Safety department and cross functional teams.
- SOPS and working guidance in PV
- Medical devices
- Target medical events
- Vendor management
- Audits and Inspection
- Product quality complaints
- FAQs – Interview process
- Recent Updates to Drug Safety
- Future trends in Drug Safety
- Duration : 12 weeks
- Live webinars – twice weekly – 60 min each.
- 50 Self Paced online LMS Modules.
- 500 Hours of learning material – videos/ppts/assignments.
- Updated as per ICH/FDA guidelines.
- Recommended books provided.
- Hands-on Argus Safety database operation.
- Certification upon successful completion.
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