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.✓Currentissues and challenges for reporting ofADRs 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 [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]
