Conclusion - New discussion: PhV in medical research - XXXX

[Guest guest]

Dear members,With this little discussion of Pharmacovigilance in medical research we come to an end.I would like to conclude my discussion with one request to all especially clinicians and pharmacologist - Do report a single ADR which can contribute to the development of new signal. The robust pharmacovigilance system is the need of todays medicine because after all SAFETY Matters.I would like to highlight some of the ways to improve the ADR reporting. Members, your suggestions may add a worth information and can help to improve the safety of drugs.- Pharmacovigilance CME / Symposia / Training at frequent intervals in healthcare institutions- Encouraging patients prescribers and dispensers for their feedback on ADR- Establishing separate ADR

Monitoring Committee- Spreading awareness among all other professionals including Dentist, Pharmacist, Nurses,

that they could report ADRs- More collaborative and meaningful approach in concern to ADR with other healthcare

professionals- Providing information about reporting scheme through journals, meetings, symposia, etc.- Encouragement institutional head, from local authorities, from the ADR Monitoring Committee, from various head of departments, etc.- ADR specialist - nominated from each related department- On-line or telephone reporting encoraged- Educating patients to watch out for

possible ADR Your inputs to this are awaited.Finally, i would like to thank Divya, Dr. Vijay Thawani sir for their valuable contribution to the discussion.Also I am very grateful to Dr. Thawani sir for giving me such a great opportunity to moderate this topic. Thanks a lot sir.For further reading find the attached files.Regards,Dr. Vijay M. katekhayePostgraduate StudentDept. of Pharmacology,LTMMC & LTMGH,

Sion,Mumbai - 400 022 Ph - +919619313060

7 of 7 File(s)

E2D Post approval safety mang Def and Std.pdf

E2A ICH Definitions and standards for expedited reporting.pdf

USFDA guideline.pdf

E2E Pharmacovigilance planning.pdf

WHO-Imp of Pharmacovigilnace.pdf

E2E Pharamcovig planning.pdf

EMEA guideline.pdf

[Guest guest]

Hello Kaushik,Thanks for your valuable words. As far as our country concerned, pharmacovigilance has not grown yet so well.Read these lines...."Even though India started participating in the WHO Pharmacovigilance programme many years ago and has several professionals who have organized many pharmacovigilance workshops, adverse drug reaction monitoring in India is still in its infancy".As far as the Safety requirements in clinical trials is concerned, the investigator whosoever conducting the trial has to follow the protocol of Pharmacovigilance(SAFETY ISSUES).The complete framework of National

Pharmacovigilance Programme and Pharmacovigilance policy, you can find in the attached pdf.Again thank you and hope this will be of help. Regards,Dr. Vijay M. katekhayePostgraduate StudentDept. of Pharmacology,LTMMC & LTMGH, Sion,Mumbai - 400 022 Ph - +919619313060From: kaushik chakraborty <kaushik_chakr@...>netrum Cc: dr.vijaykatekhaye@...Sent: Sat, 30 October, 2010

11:21:57 PMSubject: Re: Conclusion - New discussion: PhV in medical research - XXXX

@ Dr. Vijay Katekhaye,It was a brain storming session on Pharmacovigilance by you. Congrates.Your last 7 attachments are of great help to the interested pharmacologists new to the field of Pharmacovigilance like me.Could you kindly share a few more lines on the recently lunched Pharmacovigilance Programme of India (PvPI) by Govt. of India?Also, I woud like to know about any upcoming Pharmacovigilance CME / Symposia / Training in India in near future?Regards,Dr. Kaushik Chakraborty,Tutor, Dept. of

Pharmacology,Agartala Govt. Medical College,Agartala, Tripura - 799006.From: Dr. vijay Katekhaye <dr.vijaykatekhaye@...>Subject: Conclusion - New

discussion: PhV in medical research - XXXX [7 Attachments]netrum Date: Saturday, 30 October, 2010, 11:05 PM

Dear members,With this little discussion of Pharmacovigilance in medical research we come to an end.I would like to conclude my discussion with one request to all especially clinicians and pharmacologist - Do report a single ADR which can contribute to the development of new signal. The robust pharmacovigilance system is the need of todays medicine because after all SAFETY Matters.I would like to highlight some of the ways to improve the ADR reporting. Members, your suggestions may add a worth information and can help to improve the safety of drugs.- Pharmacovigilance CME / Symposia / Training at frequent intervals in healthcare institutions- Encouraging patients prescribers and dispensers for their feedback on ADR- Establishing separate ADR

Monitoring Committee- Spreading awareness among all other professionals including Dentist, Pharmacist, Nurses,

that they could report ADRs- More collaborative and meaningful approach in concern to ADR with other healthcare

professionals- Providing information about reporting scheme through journals, meetings, symposia, etc.- Encouragement institutional head, from local authorities, from the ADR Monitoring Committee, from various head of departments, etc.- ADR specialist - nominated from each related department- On-line or telephone reporting encoraged- Educating patients to watch out for

possible ADR Your inputs to this are awaited.Finally, i would like to thank Divya, Dr. Vijay Thawani sir for their valuable contribution to the discussion.Also I am very grateful to Dr. Thawani sir for giving me such a great opportunity to moderate this topic. Thanks a lot sir.For further reading find the attached files.Regards,Dr. Vijay M. katekhayePostgraduate StudentDept. of Pharmacology,LTMMC & LTMGH,

Sion,Mumbai - 400 022 Ph - +919619313060

1 of 1 File(s)

Pharmacovigilance Protocol .pdf

[Guest guest]

Hello Kaushik,About upcoming Conference on pharmacovigilance.International conference on Pharmacovigilance and Rational Use of Medicine: An integrated approach26 - 28 Nov 2010 at LHMC, New Delhi.Details attached.Regards,Dr. Vijay M. katekhayePostgraduate StudentDept. of Pharmacology,LTMMC & LTMGH, Sion,Mumbai - 400 022 Ph -

+919619313060From: kaushik chakraborty <kaushik_chakr@...>netrum Cc: dr.vijaykatekhaye@...Sent: Sat, 30 October, 2010 11:21:57 PMSubject: Re: Conclusion - New discussion: PhV in medical research - XXXX

@ Dr. Vijay Katekhaye,It was a brain storming session on Pharmacovigilance by you. Congrates.Your last 7 attachments are of great help to the interested pharmacologists new to the field of Pharmacovigilance like me.Could you kindly share a few more lines on the recently lunched Pharmacovigilance Programme of India (PvPI) by Govt. of India?Also, I woud like to know about any upcoming Pharmacovigilance CME / Symposia / Training in India in near future?Regards,Dr. Kaushik Chakraborty,Tutor, Dept. of

Pharmacology,Agartala Govt. Medical College,Agartala, Tripura - 799006.From: Dr. vijay Katekhaye <dr.vijaykatekhaye@...>Subject: Conclusion - New

discussion: PhV in medical research - XXXX [7 Attachments]netrum Date: Saturday, 30 October, 2010, 11:05 PM

Dear members,With this little discussion of Pharmacovigilance in medical research we come to an end.I would like to conclude my discussion with one request to all especially clinicians and pharmacologist - Do report a single ADR which can contribute to the development of new signal. The robust pharmacovigilance system is the need of todays medicine because after all SAFETY Matters.I would like to highlight some of the ways to improve the ADR reporting. Members, your suggestions may add a worth information and can help to improve the safety of drugs.- Pharmacovigilance CME / Symposia / Training at frequent intervals in healthcare institutions- Encouraging patients prescribers and dispensers for their feedback on ADR- Establishing separate ADR

Monitoring Committee- Spreading awareness among all other professionals including Dentist, Pharmacist, Nurses,

that they could report ADRs- More collaborative and meaningful approach in concern to ADR with other healthcare

professionals- Providing information about reporting scheme through journals, meetings, symposia, etc.- Encouragement institutional head, from local authorities, from the ADR Monitoring Committee, from various head of departments, etc.- ADR specialist - nominated from each related department- On-line or telephone reporting encoraged- Educating patients to watch out for

possible ADR Your inputs to this are awaited.Finally, i would like to thank Divya, Dr. Vijay Thawani sir for their valuable contribution to the discussion.Also I am very grateful to Dr. Thawani sir for giving me such a great opportunity to moderate this topic. Thanks a lot sir.For further reading find the attached files.Regards,Dr. Vijay M. katekhayePostgraduate StudentDept. of Pharmacology,LTMMC & LTMGH,

Sion,Mumbai - 400 022 Ph - +919619313060

1 of 1 File(s)

brochure.doc

[Guest guest]

Dear Kaushik,

What you said is absolutely true.

Even i am searching for the details of new Pharmacovigilance Programme launched in July 2010.

Its my request to members, if they can provide any further details about the Pharmacovigilance Programme of India (PvPI).

Regards,Dr. Vijay M. KatekhayePostgraduate Student (JR II)Dept. of Pharmacology,LTMMC & LTMGH, Sion,Mumbai - 400 022 Ph - +919619313060

From: Dr. Kaushik Chakraborty <kaushik_chakr@...>"netrum " <netrum >Sent: Sun, 31 October, 2010 8:58:13 PMSubject: RE: Conclusion - New discussion: PhV in medical research - XXXX

Dear Sir,I think the attached file on Pharmacovigilance Protocol mentions about the old National Pharmacovigilance Programme which ran from 2005-2009 under CDSCO, Govt of India with WHO support/fund. After 5 yrs were over, WHO has withdrawn the financial support & also due to lack of ADR feedback from zonal & peripheral Pharmacovigilance Centres, the National Pharmacovigilance Programme got defunctional for some period.Now, as I have heard in different web based forums, the NPP has been relunched with the name of Pharmacovigilance Programme of India (PVPI), this time wholely funded by Govt. of India with Dr.Y.K.Gupta as the chief coordinator since July, 2010. Initially it has 10 ADR reporting centres in the 1st phase. The CDSCO website doesnt yet mention about the new programme but has issued a recruitment advertisement in the beginning of this year.Your attached article provides details & framework of the earlier

programme. The details about the new programme (PvPI), I could nt find anywhere. Regards,Kaushik Chakraborty MD (Pharmacology) Sent from my Nokia E63 Conclusion - New discussion: PhV in medical research - XXXX [7 >Attachments]>netrum >Date: Saturday, 30 October, 2010, 11:05 PM>>> >Dear members,>>With this little discussion of Pharmacovigilance in medical research we come to >an end.>>I would like to conclude my discussion with one request to all especially >clinicians and pharmacologist - Do report a single ADR which can contribute to >the development of new signal. >>>The robust pharmacovigilance system is the need of todays medicine because after

>all SAFETY Matters.>>I would like to highlight some of theways to improve the ADR reporting. Members, >your suggestions may add a worth information and can help to improve the safety >of drugs.>>- Pharmacovigilance CME / Symposia / Training at frequent intervals in >healthcare institutions>- Encouraging patients prescribers and dispensers for their feedback on ADR>- Establishing separate ADR Monitoring Committee>- Spreading awareness among all other professionals including Dentist, >Pharmacist, Nurses, that they could report ADRs>- More collaborative and meaningful approach in concern to ADR with other >healthcare professionals>- Providing information about reporting scheme through journals, meetings, >symposia, etc.>- Encouragement institutional head, from local authorities, from the ADR >Monitoring Committee, from various head

of departments, etc.>- ADR specialist - nominated from each related department>- On-line or telephone reporting encoraged>- Educating patients to watch out for possible ADR >>Your inputs to this are awaited.>>>Finally, i would like to thank Divya, Dr. Vijay Thawani sir for their valuable >contribution to the discussion.>>Also I am very grateful to Dr. Thawani sir for giving me such a great >opportunity to moderate this topic. Thanks a lot sir.>>For further reading find the attached files.>>Regards,>Dr. Vijay M. katekhaye>Postgraduate Student>Dept. of Pharmacology,>LTMMC & LTMGH, Sion,>Mumbai - 400 022 >Ph - +919619313060 >

[Guest guest]

Dear Friends,Here is an article entitled " Ensuring Patient Safety - Launching the New Pharmacovigilance Programme of India" by Dr. Y. K. Gupta, appeared in Pharma Times August 2010 issue.This gives a complete history as well as road map for future.With regards,Professor Guru Prasad Mohanta, M.Pharm., Ph.D.

Department of Pharmacy,

malai University,

malai Nagar- 608 002,

Tamil Nadu,

India

Tel: +914144238431 ®

+914144239738 (O)

Fax: +914144238080>From:

Dr. vijay Katekhaye <dr.vijaykatekhaye@...>>Subject: Conclusion - New discussion: PhV in medical research - XXXX [7 >Attachments]>netrum >Date: Saturday, 30 October, 2010, 11:05 PM>>> >Dear members,>>With this little discussion of Pharmacovigilance in medical research we come to >an end.>>I would like to conclude my discussion with one request to all especially >clinicians and pharmacologist - Do report a single ADR which can contribute to >the development of new signal. >>>The robust pharmacovigilance system is the need of todays

medicine because after

>all SAFETY Matters.>>I would like to highlight some of theways to improve the ADR reporting. Members, >your suggestions may add a worth information and can help to improve the safety >of drugs.>>- Pharmacovigilance CME / Symposia / Training at frequent intervals in >healthcare institutions>- Encouraging patients prescribers and dispensers for their feedback on ADR>- Establishing separate ADR Monitoring Committee>- Spreading awareness among all other professionals including Dentist, >Pharmacist, Nurses, that they could report ADRs>- More collaborative and meaningful approach in concern to ADR with other >healthcare professionals>- Providing information about reporting scheme through journals, meetings, >symposia, etc.>- Encouragement institutional head, from local authorities, from the ADR >Monitoring Committee, from various head

of departments, etc.>- ADR specialist - nominated from each related department>- On-line or telephone reporting encoraged>- Educating patients to watch out for possible ADR >>Your inputs to this are awaited.>>>Finally, i would like to thank Divya, Dr. Vijay Thawani sir for their valuable >contribution to the discussion.>>Also I am very grateful to Dr. Thawani sir for giving me such a great >opportunity to moderate this topic. Thanks a lot sir.>>For further reading find the attached files.>>Regards,>Dr. Vijay M. katekhaye>Postgraduate Student>Dept. of Pharmacology,>LTMMC & LTMGH, Sion,>Mumbai - 400 022 >Ph - +919619313060 >

[Guest guest]

Thank you sir for your help. I got the details of the programme.

Regards,Dr. Vijay M. KatekhayePostgraduate Student (JR II)Dept. of Pharmacology,LTMMC & LTMGH, Sion,Mumbai - 400 022 Ph - +919619313060

From: guruprasad mohanta <gpmohanta@...>netrum Sent: Tue, 2 November, 2010 8:15:22 AMSubject: Re: Conclusion - New discussion: PhV in medical research - XXXX

Dear Friends, Here is an article entitled " Ensuring Patient Safety - Launching the New Pharmacovigilance Programme of India" by Dr. Y. K. Gupta, appeared in Pharma Times August 2010 issue.

This gives a complete history as well as road map for future.

With regards,Professor Guru Prasad Mohanta, M.Pharm., Ph.D.Department of Pharmacy,malai University,malai Nagar- 608 002,Tamil Nadu,IndiaTel: +914144238431 ®+914144239738 (O)Fax: +914144238080>From: Dr. vijay Katekhaye <dr.vijaykatekhaye@...>>Subject: Conclusion - New discussion: PhV in medical research - XXXX [7 >Attachments]>netrum >Date: Saturday, 30 October, 2010, 11:05 PM>>> >Dear members,>>With this little discussion of Pharmacovigilance in medical

research we come to >an end.>>I would like to conclude my discussion with one request to all especially >clinicians and pharmacologist - Do report a single ADR which can contribute to >the development of new signal. >>>The robust pharmacovigilance system is the need of todays medicine because after >all SAFETY Matters.>>I would like to highlight some of theways to improve the ADR reporting. Members, >your suggestions may add a worth information and can help to improve the safety >of drugs.>>- Pharmacovigilance CME / Symposia / Training at frequent intervals in >healthcare institutions>- Encouraging patients prescribers and dispensers for their feedback on ADR>- Establishing separate ADR Monitoring Committee>- Spreading awareness among all other professionals including Dentist, >Pharmacist, Nurses, that they could

report ADRs>- More collaborative and meaningful approach in concern to ADR with other >healthcare professionals>- Providing information about reporting scheme through journals, meetings, >symposia, etc.>- Encouragement institutional head, from local authorities, from the ADR >Monitoring Committee, from various head of departments, etc.>- ADR specialist - nominated from each related department>- On-line or telephone reporting encoraged>- Educating patients to watch out for possible ADR >>Your inputs to this are awaited.>>>Finally, i would like to thank Divya, Dr. Vijay Thawani sir for their valuable >contribution to the discussion.>>Also I am very grateful to Dr. Thawani sir for giving me such a great >opportunity to moderate this topic. Thanks a lot sir.>>For further reading find the attached

files.>>Regards,>Dr. Vijay M. katekhaye>Postgraduate Student>Dept. of Pharmacology,>LTMMC & LTMGH, Sion,>Mumbai - 400 022 >Ph - +919619313060 >