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MASTER YOUR PADER WORKSHOP
Date: 14th and 15th Sept, 2024,
Duration: 2.5 hours/day
Time: 6:00 PM – 8.30 PM IST |
08:30 AM – 11:00AM GMT |
01:30 PM – 04:00 PM EST
About Mentor
About Mentor
Nisha Saini
What we are delivering in workshop?
Overview of PADER
Purpose of PADER
Components of PADER
PADER regulatory requirements
PADER submission
process
Key points while drafting PADER.
What is PADER?
- A Periodic Adverse Drug Experience Report (PADER) is an essential and mandated safety report for the pharmaceutical industry. It is a comprehensive assessment of a drug’s safety profile based on the information gathered during the post-marketing safety monitoring of a product.
Which countries PADER is used?
- PADERs are required by the United States Food and Drug Administration (FDA) to ensure continuous examination of drug safety and efficacy throughout its life cycle. When it comes to international regulations for drug safety reporting, PADERs are primarily applicable to the United States.
- The FDA requires PADERs to be presented periodically for the first three years after approval and annually thereafter.
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Benefits of Knowing PADER.
- The main benefit of learning PADER is to update and evaluate a medicine's global data and provide information about drug safety.
- It provides a brief summary of changing post-approval information of a drug along with the benefit-risk profile evaluation.
How this workshop will help you?
- PADERs are essential for monitoring the safety and efficacy of approved drugs, by reporting adverse events and lack-of-efficacy experiences.
- These reports must be submitted regularly to regulatory authorities following country-specific guidelines and requirements.
- After the PADER report is made, the Stakeholders such as healthcare professionals, regulatory authorities, and pharmaceutical companies collaborate to ensure patient safety through the PADER process.
As a fresher who graduated a couple of months back, Pharmamentor's Pharmacovigilance program for Beginners was nothing less than a boon for my career life! This training didn't only give me insight & trained me for PV. Infact I found this curious side as an individual in me during this training. The mentors, Ajay Sir & Nisha Mam, full of knowledge & experience were just commendable & perfect for a fresher like me. A big thank you to Ajay Sir, Nisha Mam & of course Pharmamentors! A highly recommended program for everyone out there in their dilemma if they should go for it or not. Go for it! It's worth it!
Pharmacovigilance courses at Pharmamentors are well structured. The instructors are industry experts with rich and varied experience who explain concepts in ways that are easy to understand. Mock assignments given to students provides them with hands on experience and the valuable feedback provided by instructors helps them improve their knowledge. I would highly recommend their services.
Pharmacovigilance courses at Pharmamentors are well structured. The instructors are industry experts with rich and varied experience who explain concepts in ways that are easy to understand. Mock assignments given to students provides them with hands on experience and the valuable feedback provided by instructors helps them improve their knowledge. I would highly recommend their services.
I have had a wonderful experience, learning with PharmaMentors. The tutors/mentors were personable, experienced professionals and worked with us to make the concepts understandable with examples from the real world work environment. We got to work on mock assignments, which made us put all that we learnt into real world based reports and assessments. I highly recommend their tutoring service to everyone. Thank you Swapnil, Ajay and Nisha!
The Pharmamentor's pharmacovigilance program was my best discovery of the year 2021. Their tutors were knowledgeable of the principles and concepts of clinical research in general. During my training, I found their teaching skills very interactive and excellent. Their experience, sound knowledge of the material, and the resources shared were helpful for anyone new to the pharmacovigilance field.
Training given at Pharmamentors with extreme care at individual particularly aggregate report preparation training and the way trainer prepare for the interview.. Trainer put immense effort to make your query solve and trainer over here are extremely knowledgeable and professional.. I recommend everyone who are looking to shift their career to aggregate report from icsr can take up course at Pharmamentors
One of the trusted Training Institutes if you want to gain knowledge in Aggregate Reporting, SD. All topics were extensively covered with hands-on experience. They teach in small group so that individual attention is provided. Mock assignments will make you a pro if you are looking out for a job Change. I truly recommend Pharmamentors.
I highly recommend pharmamentors for those who are looking for career advancement into signal detection, risk management and aggregate reporting. The course curiculum was well articulated and covered all topics with hands on experience. The instructor was awesome, and incredibly knowledgeable. Over all the training met my needs.
Pharmamentors aggregate program is quite good. The program is well designed and gives practical knowledge. Their mock assignments gives in depth knowledge of real time scenarios. I found this program very helpful and would highly recommend to anyone who wants to learn about aggregate reports. Thank you Nisha.
Pharmamentors is great institute for all PV related trainings.The signal detection course is designed so that it covers practical aspects along with hands on training on documents.Trainer Nisha has good technical and industrial knowledge of subject and has good patience in teachingDr Sowmya Pharmamentors is great institute for all PV related trainings.The signal detection course is designed so that it covers practical aspects along with hands on training on documents. Trainer Nisha has good technical and industrial knowledge of subject and has good patience in teaching
Why Choose Us?
Pharmamentors provides a complete online PADER Workshop with certification!
