VigiServe Academy for Patient Safety
VigiServe Academy for Patient Safety
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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

Pharmacovigilance System Master File
Переглядів 3,3 тис.Рік тому
PSMF
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
Need for a Safety Data Exchange Agreement
Переглядів 8212 роки тому
Why is an SDEA required?
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
Causality Assessment
Переглядів 8 тис.2 роки тому
Causality Assessment
Sources of Adverse Event Reports
Переглядів 2,8 тис.2 роки тому
Sources of Adverse Event Reports
Four Minimum Criteria for Validity
Переглядів 1,8 тис.2 роки тому
Four Minimum Criteria for Validity
Day Zero in Pharmacovigilance
Переглядів 4,2 тис.2 роки тому
Day Zero in Pharmacovigilance
Seriousness Assessment in Pharmacovigilance
Переглядів 2,4 тис.2 роки тому
Seriousness Assessment in Pharmacovigilance
Medical Coding in Pharmacovigilance
Переглядів 10 тис.2 роки тому
Medical Coding in Pharmacovigilance
Pharmacovigilance Training - Company Personnel
Переглядів 9152 роки тому
Pharmacovigilance Training - Company Personnel
Need for Pharmacovigilance Audits
Переглядів 1642 роки тому
Need for Pharmacovigilance Audits
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
WHO Pharmacovigilance Resources
Переглядів 1,4 тис.2 роки тому
WHO Pharmacovigilance Resources
IME and DME list in Pharmacovigilance
Переглядів 3,3 тис.2 роки тому
IME and DME list in Pharmacovigilance

КОМЕНТАРІ

  • @zaGn123
    @zaGn123 11 днів тому

    pls do the one video about aggregate reports ..

    • @VigiServeAcademy
      @VigiServeAcademy 11 днів тому

      @@zaGn123 ua-cam.com/video/axhWM8SHxms/v-deo.htmlsi=KKbCn_JqR_L1wJUz

  • @drmanivannan18
    @drmanivannan18 18 днів тому

    Will this course help me to get a job in USA ??

    • @VigiServeAcademy
      @VigiServeAcademy 18 днів тому

      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.

  • @lavakishor-k8i
    @lavakishor-k8i 22 дні тому

    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.

  • @MyHome-p7o
    @MyHome-p7o 28 днів тому

    Thanks 🙏❤

  • @hajranaashkar2103
    @hajranaashkar2103 Місяць тому

    Thanks for your insightful session.when a PV officer has to do causality assessment

    • @VigiServeAcademy
      @VigiServeAcademy 21 день тому

      It is a concept that's worth to know. Primarily medics would use it.

  • @snanamcharla
    @snanamcharla Місяць тому

    Won't they ask adr of any particular drug🫣🫣

  • @bellyinparis4582
    @bellyinparis4582 Місяць тому

    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

    • @VigiServeAcademy
      @VigiServeAcademy Місяць тому

      Yes, if the ICSR was not reported by any other company

    • @bellyinparis4582
      @bellyinparis4582 Місяць тому

      ​@@VigiServeAcademy How can I determine if it was reported by another company?

    • @VigiServeAcademy
      @VigiServeAcademy Місяць тому

      @@bellyinparis4582 - that is the way Eudravigilance portal works

  • @bellyinparis4582
    @bellyinparis4582 2 місяці тому

    I would also add patient predispositions factors to AEFI causes , such immunodeficiency or autoimmune disorder.

  • @bellyinparis4582
    @bellyinparis4582 2 місяці тому

    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

    • @VigiServeAcademy
      @VigiServeAcademy 2 місяці тому

      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

  • @bellyinparis4582
    @bellyinparis4582 2 місяці тому

    Hello Sir, what is the difference between off label use and indications in product usage ?

    • @VigiServeAcademy
      @VigiServeAcademy 2 місяці тому

      indication is what is approved by the regulatory agency (? based on clinical trial data) and the rest are off-label

  • @pratyaychatterjee7055
    @pratyaychatterjee7055 2 місяці тому

    Can you please tell me, what to study? what subjects and topics should I cover?

    • @VigiServeAcademy
      @VigiServeAcademy 2 місяці тому

      Could you please elaborate?

    • @pratyaychatterjee7055
      @pratyaychatterjee7055 2 місяці тому

      @VigiServeAcademy what should I supposed to study from b.pharm or M.pharm syllabus?

    • @VigiServeAcademy
      @VigiServeAcademy 2 місяці тому

      @@pratyaychatterjee7055 - at the most, someone might ask you regarding the classification of drugs

  • @AVKBA
    @AVKBA 2 місяці тому

    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.

  • @Kl9-120
    @Kl9-120 2 місяці тому

    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!

  • @ThingsbyNeha
    @ThingsbyNeha 3 місяці тому

    🙏

  • @nehadas7456
    @nehadas7456 3 місяці тому

    Very very useful 😊

  • @drsuryasnair5061
    @drsuryasnair5061 3 місяці тому

    Hello sir, could you please tell me from where do we get RA cases? I was asked this in one of the interview

    • @VigiServeAcademy
      @VigiServeAcademy 3 місяці тому

      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.

    • @drsuryasnair5061
      @drsuryasnair5061 3 місяці тому

      @@VigiServeAcademy : Thank you so much sir for the reply

  • @kedarkathale6922
    @kedarkathale6922 3 місяці тому

    Nice explanation sir thank you

  • @keerthis125
    @keerthis125 4 місяці тому

    Sir plz do a video for med document specialist plz

  • @Sherlynforegard
    @Sherlynforegard 4 місяці тому

    Can a btech (EEE) get into pharmacovigilence What role does the IT ppl play in oharmacovigilence do

  • @chopparisrivalli1674
    @chopparisrivalli1674 4 місяці тому

    very useful and clear many doubts sir for freshers thank you sir

  • @sandysandip4428
    @sandysandip4428 4 місяці тому

    Thank You sir

  • @Revealed2705
    @Revealed2705 4 місяці тому

    Would the certification course provided by UMC do it?

    • @VigiServeAcademy
      @VigiServeAcademy 4 місяці тому

      yes; these courses are indeed valuable for gaining knowledge

  • @vivekrakha5295
    @vivekrakha5295 4 місяці тому

    Clear and concise explanation

  • @drdinakarkr
    @drdinakarkr 4 місяці тому

    Thank you

  • @haritharanjith6484
    @haritharanjith6484 4 місяці тому

    sir difference between medical coding and pv

    • @VigiServeAcademy
      @VigiServeAcademy 4 місяці тому

      Medical coding is only one of the aspects of Pharmacovigilance. Besides, there is medical coding even in medical transcription.

  • @shraddhadubey996
    @shraddhadubey996 5 місяців тому

    Sir make same video for qc interview

  • @EstherSHEN-u3y
    @EstherSHEN-u3y 5 місяців тому

    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.

  • @SwatiWanj
    @SwatiWanj 5 місяців тому

    Sir, from where I can do this course

  • @phoenixtv.307
    @phoenixtv.307 6 місяців тому

    Can you suggest me some project ideas for pharmacovigilance

    • @VigiServeAcademy
      @VigiServeAcademy 5 місяців тому

      You can consider analyzing the freely available safety data (regulatory agencies)

  • @chessgold8768
    @chessgold8768 6 місяців тому

    thanks a lot sir

  • @chessgold8768
    @chessgold8768 6 місяців тому

    great and very instructive sir.. thanks a lot..

  • @jeetcollection
    @jeetcollection 6 місяців тому

    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. ❤❤❤❤❤

  • @Vijaykumar-gt1pr
    @Vijaykumar-gt1pr 6 місяців тому

    What is the starting salary in Pv? After 5yrs of exp what would be the salary?

  • @user-lw8bw3es6t
    @user-lw8bw3es6t 6 місяців тому

    Thanks for the thorough explanation. May I know the updated link to download IME list?

    • @VigiServeAcademy
      @VigiServeAcademy 5 місяців тому

      www.ema.europa.eu/en/human-regulatory-overview/research-development/pharmacovigilance-research-development/eudravigilance/eudravigilance-system-overview

  • @English_Yoga_Studio
    @English_Yoga_Studio 6 місяців тому

    Thanks

  • @bharathj4615
    @bharathj4615 7 місяців тому

    Nice video

  • @hindt.al-manea1606
    @hindt.al-manea1606 7 місяців тому

    Thank you for this video. can you add the reference please.

  • @nimet5242
    @nimet5242 7 місяців тому

    very useful, thank you! Looking forward to see more videos like this :)

  • @nitinpawar9182
    @nitinpawar9182 7 місяців тому

    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

    • @VigiServeAcademy
      @VigiServeAcademy 7 місяців тому

      There is no point if these are indexed journals. Look for grey literature or journals published by various organizations (e.g., colleges)

  • @keerthis125
    @keerthis125 7 місяців тому

    Sir we need Ans for a ques Many interviewer asking wt is the use of isep certification course

  • @svsantoshkumar
    @svsantoshkumar 8 місяців тому

    This is so well and simply explained session. Thank you

  • @sreedharreddypochana2892
    @sreedharreddypochana2892 8 місяців тому

    Excellent Explanation Sir.I want your Mobile number...

  • @yuvarajraj6579
    @yuvarajraj6579 9 місяців тому

    Sir how to collect the case... It means the origin.....the first source...how and where....and when

    • @VigiServeAcademy
      @VigiServeAcademy 9 місяців тому

      Please check this: ua-cam.com/video/DtCATWo7Y_Q/v-deo.html

  • @sailaharicherukuthota4831
    @sailaharicherukuthota4831 9 місяців тому

    Hi sir I got job as Senior Pv associate I have answered all questions after attending all your Pv videos Thank you so Much

    • @VigiServeAcademy
      @VigiServeAcademy 9 місяців тому

      You made our day! Thanks a ton!

    • @vab5798
      @vab5798 2 місяці тому

      Could you please tell me what all questions were asked?

  • @Vivenvlog
    @Vivenvlog 9 місяців тому

    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

  • @haindhavil4238
    @haindhavil4238 9 місяців тому

    I have 1 question. … if company has 1000 cases, in this 1000 - 500 cases were unlisted aers… do does company do with this data?

    • @VigiServeAcademy
      @VigiServeAcademy 9 місяців тому

      they communicate to the regulatory agencies based on the country specific requirements

  • @deepshikha6647
    @deepshikha6647 10 місяців тому

    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

  • @anupreetkang3475
    @anupreetkang3475 10 місяців тому

    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?

    • @VigiServeAcademy
      @VigiServeAcademy 10 місяців тому

      Yes, you can consider Author's causality

  • @abhijitk5084
    @abhijitk5084 10 місяців тому

    Very good explanation

  • @kunjkomal
    @kunjkomal 10 місяців тому

    Very helpful