PADER (Periodic Adverse Drug Experience Report) is one of the critical components of pharmacovigilance. It is a part of the post approval safety report submitted to the US-FDA. It contributes to updating the global medical data and adds to the safety information of the drug.
What Is Periodic Adverse Drug Experience Report?
PADER is referred to as a safety report that comprises of all the safety aspects of the drug and adverse reactions observed. This report is submitted after the market approval of the drug. This report provides an insight into changes required to be made in the drug product in terms of safety.
Why Is PADER Important For Drug Safety?
PADER serves as an important aspect of drug safety as it provides complete information about the safety aspects, adverse events, etc. Which needs to be addressed to increase the safety of drug products on human use.
Here are some key points to prove the importance of PADER in drug safety:
It helps the drug to prove its safety and gain customer trust and satisfaction.
It signals any safety parameters immediately which need to be addressed.
Overall public health remains protected with the help of PADER.
It helps in surveillance of safety parameters after marketing of drug products.
It also helps in meeting the safety requirements of the drug regulatory bodies.
The drug safety data keeps on constantly updating with the help of PADER.
PADER Regulatory Requirements:
Below are some of the key regulatory requirements of PADER discussed:
PADER is to be submitted to the US-FDA, which is to be submitted quarterly for the first three years and after three years the report should be submitted annually.
PADER should contain in the report all the adverse events that occurred in patients consuming the drug product and a detailed report on serious adverse reactions that occurred.
It should be submitted in PDF format according to eCTD ICH format.
PADER should follow ICH E2 guidelines for content and format.
It must contain 5 sections that are less complex.
Components Of A PADER Report:
Introduction: It should contain a synopsis of all the adverse effects reported and the purpose of the report.
Summary: A summary of all the adverse effects should be summarized systematically.
Alert cases: All the unexpected and serious adverse effects of the last 15 days should be reported.
Risk Evaluation: It must contain the risk evaluation made according to the latest adverse effects reported.
Labelling review: It must contain detailed information about the labelling instructions regarding the safety parameters of the drug and any changes made to it.
Safety regulations: It comprises of all the regulatory actions taken based on the safety issues occurred.
Appendices: It consists of a list of all the adverse effects and related effects.
How To Prepare A PADER?
The image given below depicts the process of PADAR format and content preparation:
PADER Submission Timelines And Frequency:
PADER reporting frequency is quarterly for the initial three years of the new drug product.
After three years of time frame, it should be submitted annually.
For the initial three years PADAR has a time frame of 30 days and for drug products of more than three years it has a time frame of 60 days.
Challenges In PADER Preparation:
It is very difficult to manage bulk volume of drug reaction reports and compile them, especially for drugs that are in use on a large scale.
Sometimes it gets difficult to prepare complete PADER within given time frame,
Compliance with all the regulatory requirements is a tiring job.
It is difficult to calculate the cumulative benefit risk profile as it involves complex calculations.
Un-professional or under skilled staff may cause difficulty in the PADER preparation.
Sometimes trust issues are also faced by the staff collecting data on adverse events of drugs.
Another great task is merging lengthy and large volumes of safety and adverse reaction data.
At Artixio, we are committed to supporting pharmaceutical companies to meet the pharmacovigilance requirements like PADER preparation and submission. Our expect team ensures to meet the regulatory requirements. Partner with us to achieve the drug safety standards. Contact Artixio today!
FAQ’s About PADER
What is the PADER submission evaluation process of regulatory authorities?
The regulatory authorities check for accuracy, completeness, details, format of the document, inclusion of safety parameters and adverse effects, new safety measures in the PADER.
What are the consequences of PADER submissions not meeting regulatory requirements?
If PADER does not meet the regulatory requirements, it can cause delay in review time and may also penalty and suspension of drug product approval.
Who confirms PADER lines up with the global regulatory requirements?
This is ensured by pharmacovigilance staff and medical writers.
What software is available for automating PADER preparation?
Yes, software like Argus safety, Veeva vault, Aris global, Empirica signal, AB Cube, etc. are used for PADER automation.
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