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Master global drug-safety regulations and hands-on safety reporting. This program covers ICH E2 guidelines, CIOMS recommendations, FDA/EMA/Indian safety requirements, expedited and periodic reporting, EVMPD, FAERS/EudraVigilance submissions, and label-change tracking—exactly what PV teams do in industry.
“Master ICH E2A–E2F and CIOMS guidance, meet FDA/EMA/CDSCO reporting rules, and practice FAERS & EudraVigilance submissions, EVMPD updates, and CCDS/label-change tracking.”
This certification focuses on drug-safety regulations and real-world reporting. You’ll learn what/when/how to report in clinical and post-marketing/BA-BE studies, submission pathways (Gateways/FAERS/EudraVigilance and manual in India), and how to track innovator label updates and implement CCDS changes—all aligned to current PV expectations.
Join BCRI’s Certification in Advanced Pharmacovigilance Regulations—a job-oriented online course for drug-safety and PV-compliance roles in pharma and CROs. Learn ICH E2A–E2F & CIOMS, meet FDA/EMA/CDSCO reporting rules, and practice FAERS/EudraVigilance submissions, EVMPD updates, and CCDS/label-change tracking.
This course builds practical competence in applying ICH E2A–E2F and CIOMS guidance to real-world drug-safety work. You’ll learn what/when/how to report across clinical and post-marketing (including BA/BE), meet FDA, EMA (GVP), and India PvPI/Schedule-Y requirements, and practice end-to-end safety submissions.
You’ll practice preparing expedited and periodic reports (ICSR, PSUR/DSUR), submitting via FAERS/EudraVigilance, maintaining EVMPD entries, and tracking innovator label changes to update CCDS—exactly what PV teams deliver in industry.The regulatory Affair course will give you a good understanding of regulatory guidelines various regulatory authorities provide.
By the end, you’ll confidently interpret global PV rules and execute compliant safety reporting across major regions.
Master core PV terms and decisions: case intake, seriousness, expectedness, causality, MedDRA basics, and how ICH E2A/E2D/E2F drive daily safety work.
Apply ICH E2A–E2F and CIOMS recommendations; map requirements across FDA, EMA (GVP), and CDSCO/PvPI for clinical and post-marketing (incl. BA/BE).
Decide what/when/how to report; structure E2B(R3) data elements and narratives; understand PSUR vs DSUR and region-specific timelines & formats.
Practice Gateway/portal workflows, validation rules, and reconciliation; maintain EVMPD data; ensure 21 CFR Part 11 readiness and audit trails.
Track innovator label changes, update CCDS, and monitor FDA/EMA/HMA/Lareb sites; compile change justifications and impact assessments.
Pharmacovigilance (PV) is critical to patient safety and compliance. PV teams must detect, assess, and report safety events on strict timelines across clinical and post-marketing settings. That’s why employers need professionals who can apply ICH/CIOMS guidance and meet FDA, EMA, and CDSCO requirements—accurately and on time.
BCRI’s Certification in Advanced Pharmacovigilance Regulations builds hands-on skills in ICH E2A–E2F & CIOMS, region-specific rules (FDA/EMA/CDSCO), expedited and periodic reporting (ICSR, PSUR/DSUR), FAERS & EudraVigilance submissions, EVMPD, and CCDS/label-change tracking.
Map ICH E2A–E2F and CIOMS to daily safety work and align with FDA, EMA (GVP), and CDSCO/PvPI expectations for clinical and post-marketing (incl. BA/BE).
Practice Gateway/portal workflows, E2B(R3) data mapping and validation rules, duplicates/reconciliation, and submission readiness.
Decide what/when/how to report; craft narratives and key fields; meet region-specific timelines and formatting requirements.
Track innovator label updates and implement CCDS revisions; maintain EVMPD entries; monitor FDA/EMA/HMA/Lareb for safety changes.
Build hands-on competence in applying ICH E2A–E2F and CIOMS guidance, meeting FDA/EMA/CDSCO rules, and executing real safety submissions (FAERS/EudraVigilance), EVMPD maintenance, and CCDS/label-change tracking.
✅ Key Skills You’ll Develop:
Engage with industry experts through real-time discussions and Q&A.
Revisit lectures anytime with 3-month access to recorded sessions on the BCRI Class app.
Learn from experienced professionals working in clinical research.
Work on real-world scenarios to develop job-ready skills.
Get help with resume building, mock interviews, and job referrals.
Hands-on training with real-time tools
A practical, regulation-first curriculum covering ICH E2A–E2F & CIOMS, regional rules (FDA/EMA/CDSCO), expedited and periodic reporting, FAERS/EudraVigilance submissions, EVMPD, and CCDS/label-change tracking.
What is Pharmacovigilance; objectives and safety-monitoring importance
Global overview of PV regulations and governing guidelines
ICH, CIOMS and GVP at a glance; how they shape day-to-day safety work
ICH E2A, E2B, E2C, E2D, E2E, E2F: scope and practical use
CIOMS working groups and recommendations for safety operations
Mapping guidance to “what/when/how” reporting decisions
Safety reporting across pre-marketing, post-marketing and BA/BE studies
What, when, and how to report for the US
Submission methods and workflows: Gateway & FAERS portal
EU regulatory expectations for clinical and post-marketing/BA-BE
What, when, and how to report for the EU
Submission methods and workflows: Gateway & EudraVigilance
National Pharmacovigilance Programme & centres; Schedule-Y basics
What, when, and how to report for India
Submission methods: manual submission pathways and documentation
Ongoing screening: FDA, EMA/EMEA, HMA, Lareb (where/what to track)
Identifying report types: ICSR vs signal vs safety concern
Capturing safety updates and documenting risk/impact
Tracking innovator label changes; when a label update is required
Evidence gathering and justification notes
CCDS structure and preparing a change proposal
What is EVMPD and why it matters
Key regulations and data elements
Process and checklist for filing/maintenance
Build a “what/when/how” decision grid for US/EU/India
Mock FAERS/EudraVigilance submission pack
Label-change memo + EVMPD entry draft
Flexible Learning, Career-Focused Training
| Feature | Details |
|---|---|
| Course Name | Certification in Advanced Regulatory Affairs |
| Duration | 2 Months (Live Online Classes) |
| Mode of Delivery | Live Instructor-Led Online Sessions (with access to recordings & notes) |
| Focus Area | Drug Regulatory Affairs (Not medical devices) |
| Key Topics Covered | CTD/eCTD, IND, NDA, ANDA, ICH, US FDA, EMA, CDSCO guidelines |
| Tools/Formats Used | CTD Module Structures, Dossier Preparation Templates |
| Eligibility | B.Pharm, M.Pharm, B.Sc, M.Sc, MBBS, BDS, BHMS, BAMS, or professionals |
| Assessment | Assignment-based evaluation + Certification on successful completion |
| Certificate | BCRI Digital Course Completion Certificate |
| Placement Support | Resume prep, mock interviews, and job referrals |
Completing BCRI’s Certification in Advanced Pharmacovigilance Regulations prepares you for drug-safety and PV-compliance roles across pharma companies, CROs, MAHs and PV service providers. As global safety rules evolve, demand is strong in India and worldwide for professionals who can apply ICH/CIOMS and meet FDA/EMA/CDSCO reporting timelines with accuracy.
Whether you’re a fresher or an experienced professional, this program gives you the confidence to execute what/when/how reporting, submissions (FAERS/EudraVigilance), EVMPD upkeep and CCDS/label changes—skills PV teams hire for.
BCRI offers placement support in India and guidance for international applications—resume polishing, interview prep, and role-specific assignments that showcase PV skills (ICSR packages, FAERS/EudraVigilance mock runs, CCDS updates).
Take the next step in your career with our industry-recognized Online Regulatory Affairs Course. Secure your spot today!
The course spans 1.5 months and is delivered through live online sessions. Participants also receive access to class recordings and comprehensive study materials for flexible learning.
This program is specifically tailored to drug regulatory affairs. It does not cover medical device regulations, ensuring a concentrated and in-depth understanding of pharmaceutical regulatory processes.
The course requires candidates to be familiar with clinical trial fundamentals. There will be a brief discussion in class about Pharmacovigilance.
Recommend Course: Certification in Pharmacovigilance & Basics of Regulatory Affairs.
The course encompasses:
Graduates and postgraduates in Life Sciences, Pharmacy, Medicine (including BAMS, BHMS, BDS), Nursing, Biotechnology, or related fields are eligible. Working professionals aiming to transition into regulatory roles are also encouraged to apply.
Yes. The course content follows CTD/eCTD, IND, NDA, ANDA, ICH, US FDA, EMA, CDSCO guidelines — making it suitable for international roles in CROs, pharmaceutical companies, and research hospitals.
Yes! Our Online REgulatory Affairs Course is fully accessible to students across the United States, including major cities like New York, Los Angeles, Chicago, Houston, Boston, and San Francisco. Live sessions are scheduled to suit multiple time zones.
Absolutely. Students from Toronto, Vancouver, Montreal, Calgary, Ottawa, and other Canadian cities have successfully enrolled in our online program. We follow Health Canada and ICH-GCP guidelines, making the training relevant for Canadian job roles.
Yes, UK-based students from London, Manchester, Birmingham, Leeds, and Glasgow can enroll in this online course. The curriculum covers MHRA, EU EMA, and UK regulatory standards, making it ideal for jobs in the UK clinical trials industry.
Meet Aarthi P, a student of our Advanced Diploma in Clinical Research (ADCR) at BCRI. Even before completing the course, she landed a job at ICON PLC Clinical Research—a proud moment for her and for us!
In this short video, Aarthi shares how BCRI’s live online classes, practical training, and career support helped her achieve her dream job in the clinical research industry.
📢 Why Students Choose BCRI:
✔ Job-focused training with real-world projects
✔ Expert guidance from experienced faculty
✔ Internship and placement support that delivers results
Our Team would love to Guide you to select the right course here .
Recognized Training Partner under Life Sciences Sector Skill Development Council
Live mentor support • Internship & placement assistance*
