Aggregate reporting, also known as Periodic Reporting, plays a crucial role in assessing drug safety over extended periods. Unlike single-case reporting, which focuses on individual adverse event (AE) reports, aggregate reporting compiles safety data for a drug over months or years. These reports contribute significantly to risk-benefit evaluations by analyzing case data, monitoring regulatory actions, and conducting literature reviews. Regulatory agencies worldwide require these reports to ensure compliance with safety guidelines.
Among the most critical aggregate reports is the Periodic Safety Update Report (PSUR), submitted in regions such as Europe, the US, and Japan. The Periodic Benefit-Risk Evaluation Report (PBRER), an evolution of the PSUR introduced by ICH E2C (R2) guidelines, focuses on a drug’s cumulative benefit-risk profile. Other essential reports include IND Annual Reports and Annual Safety Reports (ASRs) during the pre-approval phase, as well as Periodic Adverse Drug Experience Reports (PADERs) post-approval in the US.
The Oracle Argus Safety Database facilitates the generation of ICH PSUR line listings, CTPRs, and NDA line listings, ensuring efficient and standardized reporting.
Course Duration
40-50 Hours
Next Enrollment
March 2025
Mode of Study
Hybrid Learning
Certification
Globally Accredited Certification
Program Highlights
- Comprehensive training on Argus Safety Database for extracting regulatory reports.
- Detailed insights into PADERs, PSURs, and PBRERs—their content, preparation, and regulatory requirements.
- Hands-on experience in causality assessment using Naranjo’s scale and patient exposure calculation.
- Understanding literature searches to identify potential and identified drug-related risks.
- Learning advanced techniques for case listing extraction and data analysis.
- Configuration of clinical studies, product hierarchies, and licenses in Argus Console to support regulatory compliance.
Learning Outcomes
- Generate line listings and summarize ADR cases in the Argus Safety Database.
- Prepare regulatory reports including PADERs, PSURs, and PBRERs.
- Understand and apply country-specific regulatory requirements.
- Conduct literature searches to identify and classify drug safety risks.
- Perform causality assessment and patient exposure calculations.
- Configure clinical studies, products, and licenses in Argus Console.
- Utilize advanced data extraction and analysis techniques for pharmacovigilance.
Why Choose Yes M Pharma?
Placement Assistance
Strong network of recruiters from the healthcare, pharmaceutical, and biotechnology industries and offer placement assistance to student
Industry Expert Trainers
Equip yourself with skills and knowledge under the mentorship of experienced faculties with over 17 years of experience in the field of healthcare research and training.
Internship Opportunities
Gain hands-on experience in safety reporting tools like Oracle Argus, systematic literature review, meta-analysis, and biostatistical analysis.
A Student’s Journey
Equip yourself with the skills and knowledge required to succeed in the healthcare, pharma, or healthcare-IT industry. Enhance your communication, personality, and technical expertise through hands-on training and real-world case studies.
Earn credentials through online or in-person programs that validate your expertise in the healthcare-IT and pharma sector. Our courses are designed to enhance your professional qualifications and provide industry-recognized certification.
Gain access to volunteer, internship, and placement opportunities in top healthcare settings like hospitals, CROs, and pharma companies. Apply real-world applications of your knowledge and kickstart your career with the right industry connections.
Receive continuous career guidance, resume-building assistance, and networking opportunities with industry professionals. Stay updated with the latest trends in healthcare, IT, and pharma to advance and grow in your career beyond placement.
Career Opportunities
Drug Safety Pharmacovigilance Career Opportunities
Regulatory Reporting SpecialistCareer Opportunities
Drug Safety Pharmacovigilance Career Opportunities
Got Questions?
We Have Answers!
Explore our FAQs to find quick solutions and helpful insights.
It involves compiling and analyzing safety data over time to assess a drug’s risk-benefit profile.
You’ll gain hands-on training in Argus Safety Database and other regulatory platforms.
Pharmaceutical companies, CROs, and regulatory bodies hire professionals for safety and compliance roles.
Not necessary, but having a basic understanding of drug safety is beneficial.
Absolutely! Many graduates have transitioned into high-paying regulatory roles.
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