Advanced Program in Pharmacovigilance
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Instructor: Dr Devprakash
Validity Period: 180 days
Advanced Program in Pharmacovigilance
Advanced Pharmacovigilance course is an integrated training program that clarifies the clinical research methodologies, clinical trials, drug development, and pharmacovigilance systems. You can strengthen your knowledge base and refine your skills to become a Pharmacovigilance and clinical research professional.
The advanced program enables trainees to analyze and organize data about the drugs’ side effort. Thus, trainees can apply their knowledge to make the right regulatory decisions on the available drugs.
By learning pharmacovigilance audit processes, a company can find out risks and gaps in their methodologies and systems. Thus, it becomes easy for an organization to establish compliance and define priorities.
As one of the participants of the training program, you will learn the technique for preparing the audit. Moreover, you can apply the best practices to get the desired result from the auditing process.
Scope of Pharmacovigilance training
You can find different trends in the drug development sector. However, the most important thing is that drug safety must not be separated from innovations. The newly developed business models are getting more mature, and they can help in developing new-generation therapies. Thus, the healthcare sector constitutes both qualified products and newer drugs.
Pharmacovigilance is now one of the major factors of healthcare products’ lifecycle. It is has become increasingly important to manufacturing more effective and safer drugs based on the latestregulations. The development, research, and marketing must also be compliant with these regulations.
Pharmacology curricula give higher importance to the need for learning about the safety of different medications. It will make the trainee aware of the pros and cons of medicines. It is a systematic approach to decision-making for therapeutic purposes. Irrational use of medicines results in adverse effects. Low-quality drugs and inaccessibility of the relevant drug details are the major problems. To avoid these issues, Pharmacovigilance is highly valuable.
Some global pharmaceutical companies have already created their pharmacovigilance centers. Local drug manufacturers also have stepped up their efforts with Pharmacovigilance. Thus, you can benefit your company by undergoing pharmacovigilance training.
What is included in the course?
Module 1- Basic concepts- Introduction and revision- You will learn about PV terminologies and get an overview of Pharmacovigilance.
Module 2- It includes a database about PV reporting, signal detection, quality systems in PV, and several other things.
Module 3- Aggregate Reports - PSUR, PBRER, PADER, and DSUR
Module 4- Signal and RMP
Module 5- PV for pharmaceutical industry and regulators
Module 6- Partners in Pharmacovigilance, analysis of the adverse case in medical fields, Active and passive surveillance
Module 7- Learn about the software used in the Pharmacovigilance field
Who are eligible forthe Advanced Pharmacovigilance training course?
To be eligible for the course, you must haveAdvanced Post-Graduate Diploma in Pharmacovigilance and Clinical Research. Moreover, you need to have a degree in any of the following fields-
Bioscience/Life Sciences- Microbiology, Biochemistry, Genetics, Botany, Biotechnology, and Zoology
Medicine- BDS, MBBS, BPT, BHMS, BAMS, and BUMS
Pharmaceutical Sciences/ Pharmacy
Bioformatics / Chemistry / Biostatistics
Allied Health / Nursing
When you are pursuing the final year of your graduation, you can apply for the Advanced Pharmacovigilance program.
Why to attend the course?
- Increase your knowledge about the global drug safety
- Make your team more capable and compliant with regulations
- Build a proper pharmacovigilance department for your drug manufacturing company
- Participate in workshop sessions to know the way of applying legislation and ensuring compliance
Who has to attend the Advanced Pharmacovigilance training course?
The comprehensive course on Pharmacovigilance will be highly beneficial to safety professionals working in the post–marketing safety field of the clinical sector. Professionals who need to deal with QA for auditing can make their career brighter with this training program. The course includes different types of activities in the clinical safety department. Moreover, those who have multifunction responsibilities (like medical directors) in the healthcare industry can undergo this course.
What will you learn from the course?
At the end of the training program, trainees will gain the skill-
- To do pharmacovigilance audit by analyzing risks
- Check a range of aspects with system audit
- Manage the process audit
- Evaluate the audit documentation
- Manage complicated characters and missing documentation
- Follow-ups and reviews for the corrective actions
- Solve disagreements based on the audit result
Is it a self-learning training program?
Advanced pharmacovigilance course is available as a virtual training program. You can learn each of the modules at your own pace. We have designed every lesson carefully to make the content easily understandable.
Is there any technical requirement for the pharmacovigilancecourse?
|Module 1:Introduction and revision of the basic concepts|
|PV Module 1 Class-1_20-Jun-2020|
|PV Module 1 - Class 2_20Jun|
|Module 1- Class 3 - 21-Jun-2020|
|Brief Overview of Product Lifecycle in a Glance (Example from Health Canada)|
|PV Overview - Part1|
|Pharmacovigilance - Overview Complete|
|Module 2 Pharmacovigilance Reporting Database, Signal Detection,Managements and Risk Assessments & Evaluation (I) -Quality System In PV, Expedited Reporting Criteria|
|PV Module 2 - Class 4 - 21Jun2020|
|E2D_Guideline_POST-APPROVAL SAFETY DATA MANAGEMENT|
|ICSR Case Assignment#1|
|ICSR Case - Assignment#2|
|Module 2 and Module 7 - Week2 - Class1- Session 1- 27Jun2020|
|Module 2 - ICSR - Case Processing|
|Narrative Writing Course|
|Quality System in PV|
|ICSR Case# 4 - Report and Narrative Writing with updated template|
|ICSR Case#5 - Practice ADR form filling and Narrative writing|
|ICSR Case#6 Baby Boy case|
|ICSR Case#4 - Complete ADR form|
|ICSR Case#5 - Complete ADR form|
|Module 3 : Pharmacovigilance Reporting Database, Signal Detection, Managements and Risk Assessments & Evaluation (II) -PSUR & PBRER, PV Database, and Signal Detection, Risk Assessments & Managements|
|Module 3 - Week 2 - Day 2 - Class 1- 28Jun2020|
|Aggregate Reports - PSUR, PADER, PBRER, DSUR, ASR, SMR|
|Software or PV Database in Pharmacovigilance|
|Module 4 : Pharmacovigilance for healthcare practitioners|
|Module 4 - Week 2 - Day 2 - Class 2- 28Jun2020|
|Module 4 Signal and RMP|
|Module 5 Pharmacovigilance for regulators and the pharmaceutical industry|
|Module 5 - KSH in PV and Reg Authorities|
|Module 6 Medical evaluation of adverse events, Partners in pharmacovigilance, Pharmacovigilance Methods e.g. passive surveillance, stimulating reporting, active surveillance|
|Module 6 - Day 5 - Session 1|
|Module 6 - Day 5 - Session 2|
|Module 6 -ICH MedDRA|
|Module 6-Passive and Active Survelliance|
|Module 7 Softwares in Pharmacovigilance|
|Module 7 - Week2 - Class1- Session 2- 27Jun2020|
|Module 7 - Software used in Pharmacovigilance|
|Module 8 Recent developments, Development Safety Update Reports, job prospects in India and abroad|
|Module 8 - Week 3 - Day2 - Session 1|
|Module 8 - Week 3 - Day 2- Session 2|
|Module 8 -Pharmacovigilance Job in India|
|PvPI CDSCO - Link to reach to PvPI CDSCO website|
|Advance Program in PV - Final assessment|
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