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VigiServe Academy for Patient Safety
India
Приєднався 18 бер 2020
VigiServe Foundation is a registered NGO with no plans to monetize this UA-cam Channel so that the users encounter minimal or no advertisements.
These training videos are intended to assist the viewer in improving their understanding of the topic presented in the video. While we attempt to thoroughly address specific topics, it is not possible to include discussion of everything necessary and relevant to the given topic in a presentation of this nature. Thus, this information must be understood as a tool for a high-level introduction to the topic rather than exhaustive information about the said topic which is defined by directives, regulations, and other draft guidance by the respective regulatory agencies. Finally, over time, regulators may modify rules and interpretations in light of new technology, information, or circumstances; to keep apprised of such developments, or to review information on a wide range of patient safety, you should visit regulatory web sites.
These training videos are intended to assist the viewer in improving their understanding of the topic presented in the video. While we attempt to thoroughly address specific topics, it is not possible to include discussion of everything necessary and relevant to the given topic in a presentation of this nature. Thus, this information must be understood as a tool for a high-level introduction to the topic rather than exhaustive information about the said topic which is defined by directives, regulations, and other draft guidance by the respective regulatory agencies. Finally, over time, regulators may modify rules and interpretations in light of new technology, information, or circumstances; to keep apprised of such developments, or to review information on a wide range of patient safety, you should visit regulatory web sites.
EcoPharmacovigilance
Ecopharmacovigilance is be defined as science and activities concerning the detection, assessment, understanding, and prevention of adverse effects or other problems related to pharmaceuticals in the environment, which affect human and other animal species.
Переглядів: 331
Відео
Black Triangle Products and Black Box Warnings
Переглядів 530Рік тому
Caution / Additional Monitoring List of medicines under additional monitoring www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/medicines-under-additional-monitoring/list-medicines-under-additional-monitoring
Setting up a Pharmacovigilance System
Переглядів 1,4 тис.Рік тому
What resources are required for setting up a Pharmacovigilance System? www.whopvresources.org www.meddra.org/about-meddra/organisation/msso who-umc.org/whodrug/whodrug-global/
Country Specific Pharmacovigilance Requirements
Переглядів 1,1 тис.Рік тому
Variation in the Country Specific Pharmacovigilance Requirements
Effective Networking on LinkedIn - Pharmacovigilance Professionals
Переглядів 1,2 тис.Рік тому
Leveraging LinkedIn for searching jobs and effectively networking with peers.
Pharmacogenomics and its role in Patient Safety
Переглядів 1,2 тис.Рік тому
Personalized / Precision medicines
Role of the Regulatory Affairs in Pharmacovigilance
Переглядів 1,8 тис.2 роки тому
The Regulatory Affairs department plays a vital role in the smooth functioning of the Pharmacovigilance activities
Role of Legal Team in Pharmacovigilance
Переглядів 3442 роки тому
How can the legal team support the smooth functioning of the Pharmacovigilance department?
The Role of IT in Pharmacovigilance
Переглядів 4542 роки тому
The Information Technology team plays a very important role in the smooth functioning of the Pharmacovigilance department
Triage process in Pharmacovigilance
Переглядів 6 тис.2 роки тому
Book-In process for an adverse event report; assigning the priority.
Aggregate Safety Reporting - An Introduction
Переглядів 14 тис.2 роки тому
PSUR, PBRER, DSUR, PADER, etc
Medical Review in Pharmacovigilance
Переглядів 5 тис.2 роки тому
The role of a medical reviewer in Pharmacovigilance.
Literature Safety Monitoring
Переглядів 7 тис.2 роки тому
Learn about the literature search and review process in Pharmacovigilance. www.pubmed.gov Search String: DRUG NAME AND ('adverse drug reaction'/exp OR 'adverse drug reaction' OR 'drug overdose'/exp OR 'drug overdose' OR 'drug misuse'/exp OR 'drug misuse' OR 'drug abuse' OR 'substance abuse'/exp OR 'substance abuse' OR 'pregnancy'/exp OR 'pregnancy' OR 'drug efficacy'/exp OR 'drug efficacy' OR '...
Quality Management System in Pharmacovigilance
Переглядів 4,6 тис.2 роки тому
Quality Management System in Pharmacovigilance
Seriousness Assessment in Pharmacovigilance
Переглядів 2,4 тис.2 роки тому
Seriousness Assessment in Pharmacovigilance
Pharmacovigilance Training - Company Personnel
Переглядів 9152 роки тому
Pharmacovigilance Training - Company Personnel
Case Processing Lifecyle in Pharmacovigilance
Переглядів 17 тис.2 роки тому
Case Processing Lifecyle in Pharmacovigilance
Audit Vs Inspection in Pharmacovigilance
Переглядів 3,1 тис.2 роки тому
Audit Vs Inspection in Pharmacovigilance
Designing a good CV / Resume for the dream job in Pharmacovigilance
Переглядів 8 тис.2 роки тому
Designing a good CV / Resume for the dream job in Pharmacovigilance
Vaccine Adverse Event Reporting System in the United States
Переглядів 4072 роки тому
Vaccine Adverse Event Reporting System in the United States
IME and DME list in Pharmacovigilance
Переглядів 3,3 тис.2 роки тому
IME and DME list in Pharmacovigilance
pls do the one video about aggregate reports ..
@@zaGn123 ua-cam.com/video/axhWM8SHxms/v-deo.htmlsi=KKbCn_JqR_L1wJUz
Will this course help me to get a job in USA ??
There are a lot of opportunities in PHV, in the US. One needs to have authorization to work in the US, and the necessary experience in PHV.
i have a question based on covid 19 example lets say patient 1,patient 2 and patient 3 patient 1 is has no medical history and other 2 patient have medical history in safety database. now how could it works. can you please exaplain in detail.
Thanks 🙏❤
Thanks for your insightful session.when a PV officer has to do causality assessment
It is a concept that's worth to know. Primarily medics would use it.
Won't they ask adr of any particular drug🫣🫣
They may ask to give some examples
Thank you, Sir, for your video; I really appreciate it. I have a small question plz: As EMA provides medical literature monitoring using large databases including EMBASE, MEDLINE, IPA and AMED, does the MAH should conduct medical literature monitoring and report adverse events on Eudravigilance for those reported in local journals ? thank you
Yes, if the ICSR was not reported by any other company
@@VigiServeAcademy How can I determine if it was reported by another company?
@@bellyinparis4582 - that is the way Eudravigilance portal works
I would also add patient predispositions factors to AEFI causes , such immunodeficiency or autoimmune disorder.
Hello Sir, what is the difference between predisposing factors related to the drug and predisposing factors related to the patient ? Can you give some exemples ? Thank you
Predisposing factors related to patients include medical, familial/ personal history etc., while the predisposing factors related to medicine include the pharmacological profile of the drug eg.,contraindications special precautions etc
Hello Sir, what is the difference between off label use and indications in product usage ?
indication is what is approved by the regulatory agency (? based on clinical trial data) and the rest are off-label
Can you please tell me, what to study? what subjects and topics should I cover?
Could you please elaborate?
@VigiServeAcademy what should I supposed to study from b.pharm or M.pharm syllabus?
@@pratyaychatterjee7055 - at the most, someone might ask you regarding the classification of drugs
Thank you for sharing this valuable video content! 🌟 It’s incredibly helpful for those of us who may not have the formal qualifications for a Medical Reviewer role. 👩⚕️📚 I am An AI-POWERED BA in BA community and in a role of PV Domain consultant at workplace. My qualification is diverse, B.Pharmacy, International MBA (USU Russian Federation) PGDM-MM-HB, PCRSD (UK),Diploma in Business Communication.
Sir, I recently watched many of your videos regarding PV. It is very helpful. I'd like to thank you so much for sharing your knowledge. 🙂 I'd like to have a discussion with you because I'm looking for more intense personalized training in setting up a new PV system. I'm currently serving as QPPV for an MAH. Please let me know if you'd like to discuss further. Thank you!
🙏
Very very useful 😊
Hello sir, could you please tell me from where do we get RA cases? I was asked this in one of the interview
Some regulatory agencies proactively share adverse event reports with the companies, while some agencies have their portals from which companies need to search for potential adverse event reports associated with their products.
@@VigiServeAcademy : Thank you so much sir for the reply
Nice explanation sir thank you
Sir plz do a video for med document specialist plz
Can a btech (EEE) get into pharmacovigilence What role does the IT ppl play in oharmacovigilence do
ua-cam.com/video/jUXtEv91PoI/v-deo.html
very useful and clear many doubts sir for freshers thank you sir
Thank You sir
Would the certification course provided by UMC do it?
yes; these courses are indeed valuable for gaining knowledge
Clear and concise explanation
Thank you
sir difference between medical coding and pv
Medical coding is only one of the aspects of Pharmacovigilance. Besides, there is medical coding even in medical transcription.
Sir make same video for qc interview
China GPV has been officially released in 2021, in which, a qualified responsible PV is required. A remarkable change. The guidance document on PSMF was established in 2022.
yes, this is an old video
Sir, from where I can do this course
www.vigiservefoundation.org/courses/
Can you suggest me some project ideas for pharmacovigilance
You can consider analyzing the freely available safety data (regulatory agencies)
thanks a lot sir
great and very instructive sir.. thanks a lot..
I have an interview scheduled this Thursday. From my interview, I have gone through many pharmacovigilance materials, notes and videos to prepare myself fully. But trust me, this is the best video on UA-cam, which you can rely on. This video really summarise everything that I have studied in the past few weeks. It has all the necessary topics along with your personality improvement. How to deal with situations and impress the interviewers. This video is remarkable and insightful for every aspirant who wants to join the Pharmacovigilance field. Thank you, sir. Lots of love for you. ❤❤❤❤❤
Hey...did you got that job
@@jasmin__ameen_ unfortunately, NO!
What is the starting salary in Pv? After 5yrs of exp what would be the salary?
Thanks for the thorough explanation. May I know the updated link to download IME list?
www.ema.europa.eu/en/human-regulatory-overview/research-development/pharmacovigilance-research-development/eudravigilance/eudravigilance-system-overview
Thanks
Nice video
Thank you for this video. can you add the reference please.
very useful, thank you! Looking forward to see more videos like this :)
Need to understand the process for literature review for the product marketed in INDIA. We are doing literature review through 2 website Indian Pharmacology and Dermatology sites
There is no point if these are indexed journals. Look for grey literature or journals published by various organizations (e.g., colleges)
Sir we need Ans for a ques Many interviewer asking wt is the use of isep certification course
isep? Could you please clarify?
This is so well and simply explained session. Thank you
Excellent Explanation Sir.I want your Mobile number...
www.linkedin.com/in/drmanojswaminathan/
Sir how to collect the case... It means the origin.....the first source...how and where....and when
Please check this: ua-cam.com/video/DtCATWo7Y_Q/v-deo.html
Hi sir I got job as Senior Pv associate I have answered all questions after attending all your Pv videos Thank you so Much
You made our day! Thanks a ton!
Could you please tell me what all questions were asked?
Sir i m Master's in pharmacology And 13 year experience pharmacist work at mornings shift from 7 am to 1 pm Sir i wanted to do part time jobs?? What course is best for me To work from home Please suggested me something good
You can look at medical prescription
I have 1 question. … if company has 1000 cases, in this 1000 - 500 cases were unlisted aers… do does company do with this data?
they communicate to the regulatory agencies based on the country specific requirements
Sir I wana pursue certification course in pharamacovigilance. I am serching alot and confusef to pick a appropriate instuite. Now I am stuck between 2 instuite, IBRI- 6months certification course Or igmpi - 6 months executive diploma . Plz help
Join the one that assures you of a job!
Thanks so much for a detailed video on lit screening for ICSRs. Don't we consider a related/possible causality for a literature article to be valid along with the 4 min criteria?
Yes, you can consider Author's causality
Very good explanation
Very helpful