Diploma certificate Program
Pharmacovigilance and Regulatory Guidelines
This certification course is designed to provide comprehensive knowledge of pharmacovigilance (PV) principles, drug safety monitoring, and regulatory requirements. It is ideal for professionals looking to build a career in drug safety, clinical research, or regulatory affairs.
Course Duration: 6 Months
Mode: Online/Hybrid
Key Features
Certificate of program completion from the Rapture Biotech International Pvt. Ltd.
Exclusive hackathons and “ask-me-anything” sessions by Rapture Biotech.
Curriculum delivered in live online classes by experienced field veterans.
It helps you get noticed by top hiring companies.
What you'll learn
Syllabus
- Understanding the role of pharmacovigilance (PV) in ensuring drug safety throughout its lifecycle.
- History and Evolution: From thalidomide disaster to the establishment of global PV frameworks.
- Importance: Impact on public health, drug market sustainability, and regulatory compliance.
- Pharmaceutical companies and their PV obligations.
- Role of healthcare professionals in ADR reporting.
- Contribution of patients and caregivers in drug safety.
- National and international regulatory bodies like FDA, EMA, CDSCO, and WHO.
- ADR vs. side effects, adverse events, and medication errors.
- Examples of ADRs and their consequences.
- Type A (Augmented): Dose-dependent reactions like hypoglycemia with insulin.
- Type B (Bizarre): Idiosyncratic or allergic reactions like anaphylaxis.
- Other types: chronic, delayed, end-of-use, and failure of efficacy.
- Mechanisms of ADRs: Immunological (allergic), non-immunological, dose-related, and drug-drug interactions.
- Detection Tools: Naranjo Algorithm for causality assessment.
- Severity and predictability scales.
- ICH Guidelines:
- E2E: Pharmacovigilance planning.
- E2D: Post-approval safety data management.
- M1: Standardized MedDRA terminology.
- WHO Framework: WHO Programme for International Drug Monitoring.
- VigiBase database managed by the Uppsala Monitoring Centre.
- National Systems:
- FDA (MedWatch and FAERS database).
- EMA (EudraVigilance and GVP modules).
- CDSCO (PvPI in India).
- International Agreements:
- CIOMS Working Groups: Standardization in ADR reporting.
- Good Pharmacovigilance Practices (GVP) in EU.
- Signal Detection:
- Quantitative: Disproportionality analysis (PRR, ROR).
- Qualitative: Case series review.
- Case study examples for signal identification.
- Risk Assessment: Tools for evaluating risk-benefit ratios.
- Techniques to minimize risks: Labeling changes, warnings, market withdrawal.
- Periodic Safety Update Reports (PSURs): Format, purpose, and submission requirements.
- Risk Management Plans (RMPs): Strategies to mitigate known and potential risks.
- Case Processing Workflow:
- ADR data collection: Sources like clinical trials, post-marketing surveillance, and spontaneous reports.
- Data entry and quality checks.
- Evaluation of seriousness, causality, and expectedness.
- Regulatory Timelines:
- Expedited reporting for serious ADRs (15 days for initial cases, follow-ups as required).
- Aggregate safety reports: Monthly and annual updates.
- ICSR Management: Importance of MedDRA coding for standardized ADR classification.
- Examples of well-documented ICSRs.
- Databases and Software: Argus, ArisGlobal, Oracle Safety Suite, VigiFlow, etc.
- Hands-on demonstration of ADR data entry and workflow automation.
- MedDRA: Use in coding ADRs, medical conditions, and lab results.
- Hierarchical structure: SOCs, HLGTs, PTs, and LLTs.
- Emerging Technologies:
- Role of AI in signal detection.
- Blockchain for data integrity and transparency.
- Digital health: Wearables and real-world evidence in ADR tracking.
- Pediatric Pharmacovigilance: Challenges in assessing ADRs due to developmental differences.
- Geriatric Pharmacovigilance: Risks due to polypharmacy and comorbidities.
- Pregnancy and Lactation: Teratogenicity studies and risk assessment.
- Rare Diseases and Orphan Drugs: Importance of pharmacovigilance in small patient populations.
- Career Opportunities:
- Roles: PV associates, case processors, signal analysts, and medical writers.
- Skillsets: Analytical thinking, regulatory knowledge, and software proficiency.
- Industry Trends:
- Personalized medicine and pharmacogenomics.
- Real-world evidence in PV (e.g., claims data, EHRs).
- Role of social media in ADR detection.
- Challenges: Underreporting and cultural barriers.
- Balancing Innovation with Regulatory Compliance.
Companies Hiring
Trainer’s Profile & Program Advisors
Dr. Vinod K Gupta
Dr. Vinod K Gupta is presently working as Technical Head (Life science Division) in Rapture Biotech. He is Ph.D. in Biotechnology from Visva-Bharati (A Central University), Santiniketan (WB). He has total 15 years of research experience in the field of natural product research and microbiology. He had published 5 Research paper in peer reviewed National/International Journals. He had presented poster in 5 National/International Conferences. He is also acting as the Review Member in The Indian Journal of Basic and Applied research, during his research period he had isolated 2 novel plant secondary metabolites for antifungal and antibacterial activity and also isolates and characterizes different bacteria and fungus. He has more than 5 years of experience in corporate sector. He had supervised more than 1500 students for Training in various field of Biotechnology (herbal drug formulation, microbiology, food technology, molecular biology, enzymology. Under his guidance 4+ Students awarded with Ph.D.
Ms. Priyanka Patel
Ms. Priyanka Patel is presently Center-Director, Rapture Biotech, Ahmedabad, Gujarat. She has her masters in Biotechnology from Barkatullah University, Bhopal. She has 10 years of research experience in development of molecular diagnostics and cardiology research with leading institutes of India. She has worked with National Institute of High Security Animal Diseases (NIHSAD) of Indian Council of Agriculture Research, which is a premier BSL-3+ bio-containment facility institute of India for research on exotic and emerging pathogens of animals. She was involved in the project for the development of molecular diagnostics of Nipah virus. She has experience in Research and development of molecular diagnostics, recombinant DNA technology, Gene expression, Protein purification, molecular biology and cell culture. She has also worked with U N Mehta Institute of Cardiology and Research Center (UNMICRC), Civil Hospital Campus, Ahmedabad, Gujarat. At UNMICRC, she has worked in Preventive Cardiology research projects aiming the study of risk factors for Myocardial infarction in young adults and its preventive measures. She has also worked in the projects for spreading social awareness regarding heart attack and its management. She has publications in journals of national and international repute.
Job Profiles
Pharmacovigilance Scientist
Pharmacovigilance Officer
Drug Safety Associate
Pharmacovigilance Specialist
Pharmacovigilance Manager
Medical Reviewer
Who can apply for this course?
Persons pursuing or passed out of M.B.B.S, BDS, B.Sc., M.Sc., B.Tech, M.Tech, Ph.D. in Biotechnology, Bioinformatics, Microbiology & other relevant qualifications and Corporate employees in the respective areas are eligible.
Course Fees
Duration | Indian | International |
6 month | 50,000 | 1000 USD |
Note:
Customized trainings are also available.
Special discounts are offered.
EVALUATION & AWARD OF CERTIFICATE
- Select Distance Learning Program of your choice.
- Fill online application form & Pay fees.
- Confirmation of admission & enrolment number.
- Transfer of Course material via E-mail.
- Download & submit Assignment.
- Evaluation.
- Award of Certificate based on performance in Assignment.
HOW TO APPLY
Step 1 – Click on “Apply Online Form from the website.
Step 2 – Completely fill the application form and submit online.
Step 3 – Submit application fee using:
For Indian students:
- NEFT from anywhere in India or Pay Via Phone Pay (9910181655).
- Name of the Account: Rapture Biotech International Pvt. Ltd.
- Account Number: 2612431210
- IFSC Code: KKBK0005033
For International Students:
- Bank to Bank Transfer by Swift Mode.
- Bank Name: Kotak Mahindra Bank, Sec-18, Noida
- Name of the Account: Rapture Biotech International Pvt Ltd
- Account Number: 2612431210
- Swift Code: KKBKINBB
- IFSC Code: KKBK0005033
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