Pharmacovigilance Notes and lectures

Pharmacovigilance Notes and lectures

Pharmacovigilance lectures with all four quadrants (Lecture + Questions + Notes + Discussion)

As per the B.Pharm VIII Semester Syllabus

Subject Code: BP 805ET

Pharmacovigilance lectures playlist

https://www.youtube.com/playlist?list=PLwijlZe7Cz3XlNydRqwWAxMOo8m3Jogk2 *pharmacovigilance lectures playlist*

Dr. Vivek Jain

Assistant Professor,

Department of Pharmaceutical Sciences

Mohan Lal Sukhadia University, Udaipur, Rajasthan, India

S. No. Topic Covered in Lecture Lecture + MCQ + Discussion Web Link Notes link
1 Introduction of Pharmacovigilance What is Pharmacovigilance? Purpose & Activity https://youtu.be/86-MT1m_rT0 https://drive.google.com/file/d/1i-syO2XjEte9116nczdKnc8Mmw0jcfrh/view?usp=share_link

 

2 History of Pharmacovigilance ; Development of Pharmacovigilance

MCQ

https://youtu.be/T_5BJ1rL4uw

 

https://drive.google.com/file/d/1ot3Cu4hX6HBi9vuevkfBLCmTgKUJQqy4/view?usp=share_link

 

3 Pharmacovigilance Programme of India; PVPI  Mission, https://youtu.be/GlF7tZrjLeg https://drive.google.com/file/d/1UYY88moxGAiHVDK5mhOW_pN9xmSHgQZx/view?usp=share_link

 

History ; Objective of PVPI; MCQ on PVPI https://youtu.be/T_5BJ1rL4uw https://drive.google.com/file/d/1ot3Cu4hX6HBi9vuevkfBLCmTgKUJQqy4/view?usp=share_link

 

Importance of safety monitoring of Medicine https://globalresearchonline.net/journalcontents/v70-1/02.pdf

 

4 WHO international drug monitoring Programme https://youtu.be/QedflWbRWdc https://drive.google.com/file/d/1oZkfDt-1ScwkkVzoOjrnZqLgL6Xxixd0/view?usp=share_link

 

5 Definitions and classification of ADR https://youtu.be/SzEYY33RcZI https://drive.google.com/file/d/1nEEWMCMux_2weJt8aS7_dzT4Bv28OqDi/view?usp=share_link

 

6 Classification of Adverse Drug Reaction | Mnemonic | TYPE of ADR | MCQ on ADR https://youtu.be/V1LGAEO83BU https://drive.google.com/file/d/1nEEWMCMux_2weJt8aS7_dzT4Bv28OqDi/view?usp=share_link

https://drive.google.com/file/d/1vELZExESWdIAIjT3I5ljoEbmjwrjN-k6/view?usp=share_link

 

7 Detection of ADR; MCQ https://youtu.be/C6cPFl4IIS8 https://drive.google.com/file/d/1Ix1Keog80O3qfHhcsu6eSO-cpcMD_hEx/view?usp=share_link

 

8 REPORTING OF ADVERSE DRUG REACTION | What, where, how and whom to report ADR ? PHARMACOVIGILANCE MCQ https://youtu.be/LbOu86w3EPw https://drive.google.com/file/d/1KrR1XI9G_s5e11x7mSxt97Y3Kq_YzmNa/view?usp=share_link

 

9 Severity and Seriousness of ADR | Hartwig Scale | MCQ on ADR | Classification of ADR Severity https://youtu.be/WUq64s0dNq4 https://drive.google.com/file/d/1MMHOJhRMnPeZYxRdYVgoVwFCBvmGBK9a/view?usp=share_link

 

10 Casualty Assessment Method | Naranjo Scale | Casualty Grading | Algorithm https://youtu.be/sTPLPH4EigA https://drive.google.com/file/d/1E-jim0XbI_2P6ftdPQgN54BYQ_hL2gKM/view?usp=share_link

 

11 Management of adverse drug reactions; MCQ https://youtu.be/ssyuqLf-qW4 https://drive.google.com/file/d/1WcEwxCCUOmI75ZBTbNi0Qqu0jHt8Uliu/view?usp=share_link

 

12 Naranjo Scale https://youtu.be/ayeywcC3ca0
13 Terminologies of adverse medication related events; Regulatory terminologies; WHO drug dictionary https://youtu.be/2Y2UGvXuDjo https://drive.google.com/file/d/1vwfqUWMnjJOYZL5dwuYEY14-blCESZQL/view?usp=share_link

 

14 Anatomical, Therapeutic and Chemical Classification of Drug | ATC classification https://youtu.be/TVYkp9jWBEM https://drive.google.com/file/d/1PMcOQssV2qpuDp54f_1fe_kUq3r-kk71/view?usp=share_link

 

15 International classification of diseases | https://youtu.be/LesA4hf1H4Y https://drive.google.com/file/d/1x0d0NKFsyIci7pq50B8_3v4Urn8WqyoA/view?usp=share_link

 

16 Daily defined doses https://youtu.be/y2cloulWU1Q https://drive.google.com/file/d/1LfOlr049bRISJNawB7K7b8W7Ouw-iYEL/view?usp=share_link

 

17 International Non proprietary Names for drugs https://youtu.be/Dfrj9Iv5nIg https://drive.google.com/file/d/1xXfes8wd4AGm0TBdY5abROEkEf-NUI6Z/view?usp=share_link

 

18 WHO adverse reaction terminologies; Basic drug information resources ; Specialized resources for A https://youtu.be/CjmL8uqf42k https://drive.google.com/file/d/1vwfqUWMnjJOYZL5dwuYEY14-blCESZQL/view?usp=share_link

 

19 MedDRA and Standardized MedDRA queries https://youtu.be/NxrvRheKpS8 https://drive.google.com/file/d/1yT0_mUH_0Dn0Jrdpx4oEhJfYr2vGyEJ_/view?usp=share_link

 

20 Establishing in a hospital https://youtu.be/Ua5zc0dTk00 https://drive.google.com/file/d/17NeyqZwfmRFxpQW8qs7wluQonmEjPoy6/view?usp=share_link

 

21 Establishing a national Programme https://youtu.be/3oG8nwupZ4g https://drive.google.com/file/d/1NxtFiR-ruF1K1QLURd6NSXNJbgOgYs8T/view?usp=share_link

 

22 Contract Research Organizations (CROs) https://youtu.be/JLOBp_K2ZV0 https://drive.google.com/file/d/1jOUPgSvWuzPd3b61Io7HxS_gH-gV_p8t/view?usp=share_link

 

23 Vaccine Pharmacovigilance https://youtu.be/HTJElrNyEbk https://drive.google.com/file/d/1iL5shpIsGF0kmixqCedfc7IRiR6_88ww/view?usp=share_link

 

24 Vaccination failure https://youtu.be/2gLzlTAtwm8 https://drive.google.com/file/d/1iL5shpIsGF0kmixqCedfc7IRiR6_88ww/view?usp=share_link

 

25 Adverse events following immunization https://youtu.be/W8iRw74Yzlc https://drive.google.com/file/d/1Djjc7F94VCIWL_33MY1nAtG8GZpuasw7/view?usp=share_link

 

https://drive.google.com/file/d/1T2k-IMgMX4J15tBmEzFX3_E7fShUdPwa/view?usp=share_link

 

26 Pharmacovigilance Methods | Classification of Pharmacovigilance Methods https://youtu.be/h56GU7FLYEI https://drive.google.com/file/d/1yfzUhAzJ4VZ5r5kEPd4kgcxHoUmS-696/view?usp=share_link

 

27 Passive Surveillance | Spontaneous reports and case series https://youtu.be/8gg8Fufidmk https://drive.google.com/file/d/18AmyqJ9RPH5AfxQQOkK_uNTQNecDKYiX/view?usp=share_link

 

28 Active surveillance | Sentinel Sites | Drug Event Monitoring | Registries | Cohort Study https://youtu.be/-8rFw0MpbJA https://drive.google.com/file/d/1Ir8tYfDGaAp2R1BFqavR1r4w9l3p3Ukw/view?usp=share_link

 

29 Comparative observational studies – Cross sectional study https://youtu.be/urX1ejgtYgA https://drive.google.com/file/d/1mG0k4em4l0kTV1M1FD0ixp8h9P9DBeXP/view?usp=share_link

 

30 Case Control Study https://youtu.be/YkzE7uzEZhg https://drive.google.com/file/d/14Dq8Tdwz14n25WLKTwz6o9TV5j40JHMY/view?usp=share_link

 

31 Cross Sectional Study | Pros & Cons of Cross Sectional https://youtu.be/9r3rl_RnFoo https://drive.google.com/file/d/1ExkVgLQ6ElibINXsEssEMmotk08W1wSR/view?usp=share_link

 

32 Targeted Clinical Investigation https://youtu.be/xB2PQSq-8qI https://drive.google.com/file/d/1hLjwSeO4wk0Am-gIzfvHvDAJK_tlN5yt/view?usp=share_link

 

33 Effective communication in Pharmacovigilance https://youtu.be/4LzZsUj_sN8 https://drive.google.com/file/d/11eMPyTTc6rTW1JM70tGD54Esan7sLQnX/view?usp=share_link

 

34 Communication in Drug Safety Crisis management https://youtu.be/EVkgkCNG5VE https://drive.google.com/file/d/14Dq8Tdwz14n25WLKTwz6o9TV5j40JHMY/view?usp=share_link

 

35 Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media https://youtu.be/_asH_s6431o https://drive.google.com/file/d/13R_dzqL7bD2csQaODSrunaDEHjZlukVW/view?usp=share_link

 

36 Safety data generation; Pre clinical phase https://youtu.be/sbm0ppPZCyk https://drive.google.com/file/d/1HmXXDaeG7lTM_i8OvsTBgo9-FSJlBXl1/view?usp=share_link

 

37 Clinical Trial Introduction | Phases of Clinical Trial; Post approval phase (PMS) https://youtu.be/UHGs411rMmw https://drive.google.com/file/d/1bXfkEZe3ktBIeMgtWnAE2lDqqp-d69g2/view?usp=share_link

 

38 Organization and objectives of ICH- part 1 https://youtu.be/WX-cUwtwcXg https://drive.google.com/file/d/1WMdnMGn1kO0BFfzj_VU2–NYtxfMkj64/view?usp=share_link

 

39 Organization and objectives of ICH | Series & Codes- Part 2 https://youtu.be/X12sxXr1un8 https://drive.google.com/file/d/1WMdnMGn1kO0BFfzj_VU2–NYtxfMkj64/view?usp=share_link

 

40 Expedited reporting & Post approval expedited reporting https://youtu.be/5HFoX_QtEeo https://drive.google.com/file/d/1zkqqrdUzx1WlcnQnUCRJQ_6IDAFEg50c/view?usp=share_link

 

41 Individual case safety reports- part 1 https://youtu.be/Lo-6BFanx8Y https://drive.google.com/file/d/1CiCPamSF4Q_OZIDT6JgbdSxPJe_R9lAO/view?usp=share_link

 

42 ICH ICSR E2B R3 Guideline | How to Fill ICSR | What Data Needed in Individual case safety reports- part 2 https://youtu.be/wH1X71Hc2hE https://drive.google.com/file/d/1CiCPamSF4Q_OZIDT6JgbdSxPJe_R9lAO/view?usp=share_link

 

43 Periodic safety update reports- Part 1 https://youtu.be/lSkpAGP1TSU https://drive.google.com/file/d/1wuWJJEaR2zFBY-OCdZcOKsOCxtBWNkrb/view?usp=share_link

 

44 Periodic safety update reports- Part 2 https://youtu.be/c8gEgCz2G9o https://drive.google.com/file/d/1wuWJJEaR2zFBY-OCdZcOKsOCxtBWNkrb/view?usp=share_link

 

45 Pharmacogenomics of adverse drug reactions; Genetics related ADR with example focusing PK parameters. https://youtu.be/uTxuygxnuWc https://drive.google.com/file/d/1T5c4GcKuJik5FRcD6a6vYQ9xH4J5wStH/view?usp=share_link

 

46 Drug safety evaluation in special population- Paediatrics- Part 1 https://youtu.be/Nhs9v3a2CFA https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4345950/

 

47 Drug safety evaluation in special population- Paediatrics- Part-2 https://youtu.be/jBFp_EaHpUk https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4345950/

 

48 Drug safety evaluation in Pregnancy and lactation https://youtu.be/TvL7Vr7CRpU https://drive.google.com/file/d/17ud6Ak9gcwSQ_7ZMS-ixsBiEML54b6gq/view?usp=share_link

 

49 Drug safety evaluation in Geriatrics https://youtu.be/EXBfqKTWN3I https://drive.google.com/file/d/15BvF9NCY_Ad-L-wqD-6ybCVe3GqAb1xJ/view?usp=share_link

 

50 CIOMS Working Group https://youtu.be/nDA1AnILdHA https://drive.google.com/file/d/1gwzItIfSgw1on9-CohLMAKGiMdEm89Oo/view?usp=share_link

 

51 CIOMS Forms https://youtu.be/oODTxRYGDpo https://drive.google.com/file/d/1nAp1syBZlOOq1idTxXrL_K867geIsL-T/view?usp=share_link

 

52 CDSCO (India) and Pharmacovigilance https://youtu.be/Hd_4CaOzfbI https://drive.google.com/file/d/1kFZL9IPnXPWw5X9OSJf5dRojuY-e5aW3/view?usp=share_link

 

53 D&C Act and Schedule Y https://youtu.be/C8A70Qd2I7I https://rajswasthya.nic.in/Drug%20Website%2021.01.11/12%20D%20&%20C%20Act%20amended%20upto%2026%20of%2008.pdf

 

54 Differences in Indian and global pharmacovigilance requirements https://youtu.be/8Ai_fq3XCPk https://drive.google.com/file/d/1AQP8kOJGxp5p8y3Ss1GDv4uDoiDNk6lF/view?usp=share_link

 

55 MCQ on Clinical Trials | Clinical Trials Question Answer https://youtu.be/7NNUMrdgQ9o
56 MCQ of Communication in Drug Safety Crisis management https://youtu.be/MUIGlvHJm44
57 MCQ on Effective communication in Pharmacovigilance https://youtu.be/6t0mzJ480BU
58 MCQ on Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media https://youtu.be/yBDu8DDZs2c
59 MCQ Case Control Study with Answer https://youtu.be/G6OHfXuNmFc
60 MCQ of Cross Sectional Study with Answer https://youtu.be/SYeQgxZVjM8
61 MCQ TARGETED CLINICAL ANSWER https://youtu.be/-cQXyulxZ3E
62 MCQ with Answer on ICH Guidelines for Pharmacovigilance | Part -1 https://youtu.be/U08epUnyfa4
63 ICH Guidelines for Pharmacovigilance | Part -2 | https://youtu.be/X12sxXr1un8
64

Schedule Y Explained in Hindi |

 

https://youtu.be/M2o1M4GB9Sg https://rgcb.res.in/documents/Schedule-Y.pdf

 

65

Amendments of Schedule Y |

https://youtu.be/sDrovcpUn_4 https://drive.google.com/file/d/12Nwf0n8OUCpWCPzA3MISCaFIuwYR17mj/view?usp=sharing

 

66

Eudravigilance

https://drive.google.com/file/d/1BtEWA8T66N_KFlIEGrJKvMRVf_PECLah/view?usp=share_link

 

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