What is PADER?   Periodic Adverse Drug Experience Report (PADER/PAER) is aggregate safety reports required from MAH to be submitted consisting of ICSR submission and their analysis by FDA as per guidance 314.80 (c) and 600.80 (c) (2).  Why is it needed?   PADER serves the purpose of collating, updating, evaluating, and providing a summary of post-approval information of a product along with its benefit-risk profile evaluation.   The key difference is a detailed analysis is not required as per PBRER/PSUR format. Only mention about labelling changes already perform ..read more

 What skills are important in PV other than PV? Many of us who are SME (Subject matter experts) are always under impression than knowing my domain and being hardworking will help me in my career and i don't need anything else. I was under the same rock, being a nerd my whole life (off course i am doctor) i was huge believer of this myth at least for a year or two in my new job. Fortunately, i had great mentors, bosses, colleagues and leaders who bust my myth and helped me build whatever career i wanted to achieve one step, one skill and one learning and one t ..read more

ICH guidelines- Summary of E2F  DSUR Any PV professional aiming to work in or already working in PV has to be aware on how to navigate and use the ICH  guidance documents. The PV professional who has to write, review or compile a DSUR is supposed to know the DSUR guidance from ICH on finger tips. MAH (marketing authorization holder) are asked to prepare DSUR for a fixed period of time for each drug or active substance by health authorities for investigational products. A single DSUR from each investigational drug which should suffice to give complete information on evolving s ..read more

 ICH guidelines E2D  POST-APPROVAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING Any PV professional aiming to work in or already working in ICSR has to be aware on how to navigate and use the ICH E2D guidance. ICH E2D goes into details about the various scenario's a MAH has to navigate while processing, analyzing and submitting ICSR from post marketing scenario.  Below are generic timelines, format and content outlined from the guidance document with my interpretations. Reference:https://database.ich.org/sites/default/files/E2D_Guidelin ..read more

ICH guidelines- Summary of E2E                                                    Pharmacovigilance Planning  Any PV professional aiming to work in or already working in PV has to be aware on how to navigate and use the ICH  guidance documents. ICH E2E goes into details about a Safety Specification and Pharmacovigilance Plan that might be submitted at the time of license application.   This module describes two aspects i.e.  Safe ..read more

ICH guidelines  E2C PERIODIC BENEFIT-RISK EVALUATION REPORT (PBRER)   Any PV professional aiming to work in or already working in for aggregate reports like PSUR/PBRER has to be aware on how to navigate and use the ICH E2C guidance. ICH E2C goes into details about the various scenario's a MAH has to navigate while preparing the PBRER. It also breaks down each section in PBRER and how to write it and what are expectation in each section. Below are generic timelines, format and content outlined from the guidance document with my interpretations. 1. What ?    The ma ..read more

ICH guidelines- E2B Data elements for  Transmission of Individual Case Safety Reports (ICSRs)   As we talked about some pointers from ICH guidelines in my last post  E2A, in this post i will try my best to take out summary of E2B guidelines. Summarizing E2B guidelines is very difficult because it has multiple layers scattered over multiple documents.  This document describes the requirements of reporting ICSR in clinical trials.  Reference here https://admin.ich.org/sites/default/files/inline-files/E2B_R2_Guideline.pdf CLINICAL SAFETY DATA MANAGEMENT : DATA ELE ..read more

ICH Guideline- E2A CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING E2A  Anyone who starts working in PV or is working in PV has to know the ICH guidelines sooner than later. Knowing ICH guidance is must, as this guidance help you know requirements for US, EU and other countries. Although this documents are freely available on internet, we have to refer them on ongoing basis as per our questions rather than just reading it once. Also, despite reading them, they do appear overwhelming as its daunting to extrapolate what exactly is requirement. Hence my a ..read more

 Summary of CDSCO requirements and background Central Drugs Standard Control Organization (CDSCO) is an Indian regulatory authority which runs the PvPI program i.e. pharmacovigilance program of India. PvPI is run across country with the help of ADR monitoring centers that are attached in hospitals and medical colleges. This centers collect the adverse events and report to PvPI and PvPI reports to WHO database. MAH are also required to report the adverse events.  There is lot of good work and progress done by PvPi steadily over years contributing and achiveing their ob ..read more

 Module XVI Risk minimization measures: selection of tools and effectiveness indicators   Continuing the series on Guideline on good pharmacovigilance practices, in this blog i will jump right into module VI having covered module I , II, III, IV, V, VI VII, IX, X and XV in previous blogs. This module describes the measures taken for preventing or minimizing risks associated with product and their effectiveness. All products require routine risk minimization measures which are described in module module V and this module goes in details regarding additional risk minimization ..read more