Advanced Certification · Drug Safety Regulations
Certification in Regulatory Affairs
A 1.5-month live online regulatory affairs course in drug safety. Learn global safety rules and practise real safety reporting and FAERS and EudraVigilance submissions — the work PV teams do every day.
- Duration
- 1.5 months
- Mode
- Live Online
- Next batch
- Every month
- Certificate
- BCRI certificate
Course fee₹22,500₹25,500
- LSSSDC · NSDC · Skill India training partner
At a glance
What is drug-safety regulatory affairs — and why learn it at BCRI?
BCRI’s Certification in Advanced Regulatory Affairs is a 1.5-month live online regulatory affairs course in drug safety. You learn what, when and how to report safety events under ICH, CIOMS, FDA, EMA and CDSCO rules. You also practise FAERS and EudraVigilance submissions, EVMPD entries and label changes. It suits pharmacy and life science graduates who know clinical trial basics.
Drug-safety regulatory affairs makes sure side effects are reported correctly and on time. Pharma companies must find, check and report side effects under strict rules in every country where they sell a medicine.
This course teaches those rules and the real reporting work. You learn what to report, when and how, for trials, post-marketing and BA/BE studies. You learn to submit reports through FAERS, EudraVigilance and India’s manual route. You also learn to track label updates and make CCDS changes.
The course covers drug regulations only, not medical devices. It is taught live online by industry professionals, with recordings and notes for revision.
Last updated
Why BCRI
Why choose BCRI for your regulatory affairs course?
Global PV rules
Map ICH E2A–E2F and CIOMS to daily safety work for FDA, EMA and CDSCO.
Hands-on submissions
Practise FAERS and EudraVigilance gateway workflows and E2B(R3) data mapping.
Recorded classes
3-month access to recorded sessions on the BCRI class app.
Expedited & periodic reports
Prepare ICSRs, PSURs and DSURs to region-specific timelines.
Labeling & EVMPD
Track label updates, revise the CCDS and maintain EVMPD entries.
Placement assistance
Resume help, mock interviews and job referrals from the placement team.
Skills you will gain
- Apply ICH E2A–E2F and CIOMS guidance in day-to-day safety work
- Decide what, when and how to report for pre-marketing, post-marketing and BA/BE studies in the USA, EU and India
- Prepare expedited ICSRs and periodic reports (PSUR/DSUR) to ICH E2 guidelines
- Build and validate FAERS (US) and EudraVigilance (EU) submission packages
- Maintain EVMPD entries and understand the filing process
- Track innovator label updates and carry out CCDS changes with evidence
- Scan FDA, EMA/HMA and Lareb for regulatory updates and document changes
- Work to 21 CFR Part 11 expectations for data integrity and audit trails
Curriculum
Regulatory affairs course syllabus
Eight units and a capstone — a regulation-first course in global drug-safety reporting.
- Modules
- 9
- Topics
- 27
- Duration
- 1.5 months
Want the detailed syllabus?
An advisor will share the full module plan on WhatsApp or email.
Get the syllabus1
Introduction to PV Regulations
3 topics- What pharmacovigilance is and why safety monitoring matters
- Global overview of PV regulations and guidelines
- ICH, CIOMS and GVP at a glance, and how they shape daily safety work
2
Global PV Framework: ICH & CIOMS (E2A–E2F)
3 topics- ICH E2A, E2B, E2C, E2D, E2E and E2F: scope and practical use
- CIOMS working groups and recommendations
- Turning guidance into “what, when and how” reporting decisions
3
United States (FDA) Requirements & FAERS
3 topics- Safety reporting for pre-marketing, post-marketing and BA/BE studies
- What, when and how to report in the US
- Submission workflows: Gateway and the FAERS portal
4
Europe (EMA) Requirements & EudraVigilance
3 topics- EU expectations for clinical, post-marketing and BA/BE studies
- What, when and how to report in the EU
- Submission workflows: Gateway and EudraVigilance
5
India (CDSCO / PvPI) Requirements
3 topics- The Pharmacovigilance Programme of India (PvPI) and its centres; New Drugs and Clinical Trials Rules 2019 basics (which replaced Schedule Y)
- What, when and how to report in India
- Manual submission routes and documentation
6
Regulatory Screening & Intelligence (hands-on)
3 topics- Ongoing screening of FDA, EMA, HMA and Lareb
- Telling ICSRs, signals and safety concerns apart
- Recording safety updates and their risk and impact
7
Labeling & CCDS (hands-on)
3 topics- Tracking innovator label changes and when an update is needed
- Gathering evidence and writing justification notes
- CCDS structure and preparing a change proposal
8
EVMPD Essentials & Filing
3 topics- What EVMPD is and why it matters
- Key regulations and data elements
- Process and checklist for filing and maintenance
9
Capstone & Assessment
3 topics- Build a “what, when and how” decision grid for the US, EU and India
- Prepare a mock FAERS/EudraVigilance submission pack
- Write a label-change memo and an EVMPD entry draft
Fees & batches
Advanced Regulatory Affairs fees and upcoming batches
Course fee
₹22,500₹25,500Save ₹3,000
1.5 months · Live online, with recordings and notes
What’s included
- Live interactive online classes
- Industry-expert trainers
- ICH E2 and CIOMS safety guidelines
- Hands-on FAERS and EudraVigilance practice
- Class recordings and notes
- Resume, interview and placement assistance
Paying the full fee online? Choose “Pay in full online” when you apply and get 5% off. Instalment options are available — ask an advisor.
Compare all course fees →Upcoming batches
New batches start every month — online and at HSR Layout.
Classes run Monday to Friday. Ask an advisor for the next start date.
- Monday–Friday classes
- Recordings for online batches
- Online or HSR Layout, Bengaluru
- Instalment options available
Certification
Regulatory affairs certification
On completion you receive the BCRI Certification in Advanced Regulatory Affairs. Assessment is assignment-based, and the certificate is awarded on successful completion.
This course is not part of BCRI’s Dual Certification. For a programme that includes the LSSSDC certificate, see the Pharmacovigilance & Basics of Regulatory Affairs certification.
What your certificate shows
- Certificate of CompletionIssued by Bangalore Clinical Research Institute
- Core modules completedICH & CIOMS · FDA, EMA & CDSCO reporting · Labeling & EVMPD
- Registration numberUnique to you and verifiable online
Recognition marksISO 9001:2015
Careers & salary
Career opportunities after the regulatory affairs course
This course prepares you for drug safety and PV compliance jobs in pharma companies, CROs and PV service firms. Safety rules keep changing, so employers in India and abroad need people who can meet FDA, EMA and CDSCO deadlines.
Job roles you can apply for
- Drug Safety Associate / ICSR Case Processor
- Pharmacovigilance Associate / Executive
- Regulatory Affairs Associate (drug safety)
- Narrative Writer (ICSR)
- Aggregate Reports Writer (PSUR/DSUR/PBRER)
- FAERS / EudraVigilance Submission Specialist
- E2B(R3) Data Manager / Safety Database Coordinator
- Signal Detection & Risk Management Analyst (entry level)
Where you can work
- Pharmaceutical companies and MAHs
- Contract research organisations (CROs)
- PV service providers
- Regulatory consultancies
Hiring locations
- Bengaluru
- Hyderabad
- Mumbai
- Pune
- Chennai
- Remote global safety teams
Typical career progression
- 1
Entry
Drug Safety Associate · RA / PV Associate
- 2
2–4 years
RA Executive · Submission Specialist
- 3
4–7 years
Aggregate Reports Writer · RA Specialist
- 4
Leadership
Regulatory Lead · PV Compliance Manager
Salary range — market data
| Role | Experience | Typical salary | Source |
|---|---|---|---|
| Regulatory Affairs Associate · Bengaluru | 1–6 years | ₹5.6 – 6.2 lakh per year | AmbitionBox, 320 salaries, updated 5 Oct 2026 |
| Regulatory Affairs Executive · Bengaluru | 1–6 years | ₹5 – 5.8 lakh per year | AmbitionBox, 64 salaries, updated 5 Oct 2026 |
| Regulatory Affairs Specialist · Bengaluru | 2–11 years | ₹8.7 – 9.7 lakh per year | AmbitionBox, 239 salaries, updated 30 Sep 2026 |
Figures are third-party market data for these roles, not BCRI placement outcomes. Actual pay depends on the employer, skills, certification and interview performance.
Student proof
Regulatory affairs course reviews, placements and student stories
4.6
BCRI is rated 4.6/5 from 987 Google reviews (as of Oct 2026)
I completed my Pharmacovigilance and Advanced Regulatory Affairs courses. It was a nice experience and I learned many new things. The trainer had strong knowledge and cleared all our doubts. I got placed in IQVIA as a safety associate.
Nikitha — Pharmacovigilance & Advanced Regulatory Affairs It was a wonderful experience learning PV and regulatory affairs with Mayuri ma’am and BCRI. The way she taught was amazing, clearing every doubt, even the simplest ones.
Abhishek Nemmaniwar — Pharmacovigilance & Regulatory Affairs It was a great experience with BCRI. They have a structured and well-organised curriculum. I am especially thankful to Mr. Devprakash, our course tutor, for his knowledge and teaching skills.
Krishna Dave — Pharmacovigilance & Regulatory Affairs
Recent BCRI placements & internships
Is this course right for you?
Talk to a BCRI advisor about eligibility, batches, fees and career paths. It’s free and there’s no obligation.
FAQs
Advanced Regulatory Affairs — frequently asked questions
What is the duration and mode of the regulatory affairs course?
The course runs for 1.5 months as live online sessions. You also get class recordings and study material, so you can learn at your own pace.
Does the course cover drug or device regulations?
This course covers drug regulations only — specifically drug-safety regulations and reporting. It does not cover medical device regulations.
What is the prerequisite for this course?
You should know the basics of clinical trials. Pharmacovigilance is discussed briefly in class. If you are new to drug safety, we recommend the Certification in Pharmacovigilance & Basics of Regulatory Affairs first.
What are the fees for the regulatory affairs course?
The course fee is ₹22,500 (list price ₹25,500). Paying the full fee online when you apply gives 5% off, and instalments are available.
Who is eligible to join?
Graduates and postgraduates in life sciences, pharmacy, medicine (including BAMS, BHMS and BDS), nursing and biotechnology can join. Working professionals moving into regulatory roles are also welcome.
What topics are covered?
ICH E2A–E2F and CIOMS guidance; FDA, EMA and CDSCO/PvPI safety reporting; expedited and periodic reports (ICSR, PSUR, DSUR); FAERS and EudraVigilance submissions; regulatory intelligence; labeling and CCDS changes; and EVMPD filing.
Is the content aligned with global standards?
Yes. The course follows ICH, CIOMS, US FDA, EU EMA (GVP) and CDSCO guidance, so it suits regulatory and drug-safety roles in CROs and pharma companies in India and abroad.
Can I join from the USA, Canada or the UK?
Yes. The course is live online, so students in the USA, Canada, the UK and elsewhere can join. Ask an advisor about batch timings for your time zone.
Is this course part of dual certification?
No. This course gives you the BCRI certificate only. The Pharmacovigilance & Basics of Regulatory Affairs certification includes BCRI’s Dual Certification with LSSSDC.
Does BCRI provide placement support?
Yes. Our placement team helps with resumes, mock interviews and job referrals in India, and guides you on international applications. The employer makes the final hiring decision, so a job is not guaranteed.