Instructor: Dr Dev
Validity Period: Lifetime
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
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.
Who are Eligible For 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?
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-
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|
|Brief Overview of Product Lifecycle in a Glance (Example from Health Canada)|
|PV Overview - Part1|
|Pharmacovigilance - Overview Complete|
|PV Module 1 Class-1|
|PV Module 1 - Class 2_|
|Module 2 Pharmacovigilance Reporting Database, Signal Detection,Managements and Risk Assessments & Evaluation (I) -Quality System In PV, Expedited Reporting Criteria|
|Recording - Module 1- Class 3|
|Recording - PV Module 2 - Class 4 -|
|E2D_Guideline_POST-APPROVAL SAFETY DATA MANAGEMENT|
|ICSR Case Assignment#1|
|ICSR Case - Assignment#2|
|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|
|Recording - Module 2 and Module 7 - Week2 - Class1- Session 1- 23rd Jan|
|Module 3 : Pharmacovigilance Reporting Database, Signal Detection, Managements and Risk Assessments & Evaluation (II) -PSUR & PBRER, PV Database, and Signal Detection, Risk Assessments & Managements|
|Aggregate Reports - PSUR, PADER, PBRER, DSUR, ASR, SMR|
|Software or PV Database in Pharmacovigilance|
|Recording - Module 3 - Week 2 - Day 2 - Class 1- 24th Jan|
|Module 4 : Pharmacovigilance for healthcare practitioners|
|Module 4 Signal and RMP|
|Recording - Module 4 - Week 2 - Day 2 - Class 2- 24th jan|
|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 -ICH MedDRA|
|Module 6-Passive and Active Survelliance|
|Recording - Module 6 - Day 5 - Session 1|
|Recording - Module 6 - Day 5 - Session 2|
|Module 7 Softwares in Pharmacovigilance|
|Module 7 - Software used in Pharmacovigilance|
|Recording - Module 7 - Week2 - Class1- Session 2- 23rd Jan 2021|
|Module 8 Recent developments, Development Safety Update Reports, job prospects in India and abroad|
|Module 8 -Pharmacovigilance Job in India|
|PvPI CDSCO - Link to reach to PvPI CDSCO website|
|Recording - Module 8 - Week 3 - Day2 - Session 1|
|Recording - Module 8 - Week 3 - Day 2- Session 2|
|Advance Program in PV - Final assessment|
After successful purchase, this item would be added to your courses.
You can access your courses in the following ways :