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Objective:
To sensitize Manufacturers, Importers, Distributors and other stakeholders to develop/
strengthen Pharmacovigilance system as per the Good Pharmacovigilance Practices (GVP).
Background:
Pharmacovigilance improve patient care and safety in relation to the use of medicines and
also play a major role in clinical practice and the development of public health policy. The
Ministry of Health & Family Welfare (MoHFW), Government of India, therefore launched a
Nationwide Pharmacovigilance Programme of India (PvPI) in Year 2010 to monitor Adverse
Drug Reactions ensuring the benefits of drugs outweighs the risks associated with its use.
Indian Pharmacopoeia Commission (IPC), autonomous institutes under the MoHFW has
been functioning as National Coordination Centre (NCC) for PvPI since April 15, 2011. To
monitor ADRs, Adverse Drug Reactions Monitoring Centres (AMCs) under PvPI have been
established across the country.
As per the recent amendment in Drugs & Cosmetic Rules 1945, Schedule Y and the
Gazette notification GSR 287 (E) dated March 8, 2016 the setting up of Pharmacovigilance
system is mandatory for all MAHs. In this regard, National Coordination Centre –
Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission, a WHO-
Collaborative Centre for Pharmacovigilance in collaboration with CDSCO has developed
“Pharmacovigilance Guidance Document for MAHs of Pharmaceutical Products”, which was
released by the then Secretary, Health, Govt. of India on September 29, 2017 and has been
effective from January 1, 2018.
About the Workshop:
The said workshop is organised by IPC, NCC-PvPI in collaboration with CDSCO aimed to;
✓ Discuss the setup/strengthen of Pharmacovigilance system at MAHs site.
✓ Current issues and challenges for reporting of ADRs by MAHs to IPC, NCC-PvPI.
Who will attend:
Professionals working in Pharmacovigilance, Quality Assurance and Regulatory Affairs in
Pharmaceutical Industry.
Expected Outcome:
Establishment/ strengthening of Pharmacovigilance system at MAHs, resolving queries/
doubts about reporting of ADRs by MAHs to IPC, NCC-PvPI.
Registration:
✓ Registration fee: Rs. 2500 /- (Including 18% GST) per participant.
✓ On-spot registration may also be considered (subject to availability of seats).
✓ Scanned copy of duly filled & signed Registration Form (available at www.ipc.gov.in)
may be sent to [email protected]
✓ Registration maximum for 50 participants will be accepted, based on “First come first
served basis”.
Contact Person:
Mr. Vipin Sharma: (09718329700), e-mail id: [email protected]
6th Regional Workshop
On
“Basics of Pharmacovigilance & Pharmacovigilance System in
Pharmaceutical Industries-A Way Forward” at Bengaluru.
Registration form
Name:- ....................................................................................................................
Organization:- .....................................................................................................................
Designation:- .....................................................................................................................
Address:- .....................................................................................................................
......................................................................................................................
Email:- ................................................................Mobile No:-.................................
Amount:- .....................................NEFT/DD No & Date...........................................
GST. No. .......................................................................................................................
Participant Signature
Terms and Conditions
❖ Payment can be made either by demand draft in favour of Indian Pharmacopoeia
Commission (IPC) payable at Ghaziabad or NEFT to Indian Pharmacopoeia
Commission, Sanjay Nagar, Ghaziabad, Bank Name: Bank of Baroda, Account
Number:- 21860100013540, Branch IFSC Code:-BARB0SANGHA (Fifth character is
Zero), Type of Bank Account:- Saving, GSTIN:-09AAATI7017F2ZR.
❖ Scanned copy of duly filled registration form may be send to email id: [email protected]
❖ Maximum 50 registrations will be accepted based on first come first served basis.
25th May 2018
