Learn to create reports in the world’s most relied-upon aggregate reporting formats and provide a broader view of the safety profile of a drug.
Why Aggregate Reporting
Aggregate reporting involves the compilation of safety data for a drug over a prolonged period (months or years). The periodic reports play an important role in risk-benefit evaluation of the drug and involves collective analysis of cases in the database, monitoring regulatory actions, literature searches etc.
In This Course
Learn how to create Periodic Safety Update Reports – now known as the Periodic Benefit Risk Evaluation Report, Preapproval Reports including IND Annual Reports and Annual Safety Reports, and Post-approval Periodic Adverse Experience Reports.
The Sollers Advantage
The Aggregate Reporting short-term program by Sollers is taught by faculty experienced in the industry. The program is a great way to quickly develop the in-demand skills working with the aggregate reporting methodologies and gaining valuable hands-on experience.
- The procedure to generate line listings
- Summarize tabulation of ADR cases in Oracle Argus Safety Database
- Content and preparation of the reports
- Country specific requirements
- Guidelines governing periodic reports
- Extraction of NDA line listing from Argus Safety for preparation of PADERs
- Learn to perform the task of extracting the line listing which is step 1 in the preparation of the PADER
- Overview of PADERs and its preparation
- Various sections of PADER
- Collection of data from different sources
- Proper collation of the data
- Extraction of ICH line listing from Argus Safety for preparation of PSURs including Case Data Analysis
- Learn to modify inbuilt queries depending on the country specific requirement
- Learn to represent the data extracted from Argus Safety in forms other than line listings and its analysis
- Overview of PSURs and its preparation, Causality Assessment via Naranjo’s scale & Patient exposure calculation
- Preparation of important sections of the PBRER
- Perform causality assessment
- Calculation of patient exposure
- Literature search and identification of Potential Risks and Identified Risks
- Perform literature searches
- Identify the data relevant to PBRER preparation
- Extraction of Case listings for Aggregate reporting purposes
- Procedure to pull out the listings by creating different conditions Case data analysis
- CTPR line listing and Configuration of Clinical Studies in Argus Console
- Work in the console environment of Argus Safety
- Products and Licenses Hierarchy and Configuration of Families, Products and Licenses in Argus Console
- Enter Products and licenses in the Argus Safety Database, gain practical experience
Our instructors are not just highly experienced in the industry, they give you the personal attention you need and guide you every step of the way.
Faculty of Clinical Research
Faculty of Drug Safety and Pharmacovigilance, Oracle Argus
OUR STUDENTS WORK AT
Sollers partners with industry-leading corporations and provides them with ready-on-day-one employees. We record an 82% placement rate within three months of graduation.
After the completion of program, we assist our students with interview coaching, resume building sessions, conduct mock interviews, job readiness training and make them competent to venture into the corporate world.
The Clinical Trial Management course is extensive, and the professors are thorough in delivering the course materials using real life experience and insight. Career Services helped me throughout the interview process, and I landed my dream job with the very first interview after graduating from Sollers.
Thanks to the academic team at Sollers, I was able to gain quick admission with financial options to pay tuition. Career Services was very helpful with resume and interview prep. They sent me job postings with major hospitals and pharma companies which helped me land my current job as Data Manager in cancer clinical trials.