Drug
Information Association (DIA) is organizing a two-day Pharmacovigilance
conference in Bengaluru on March 3 and 4, 2012 The event will be held
at The Park hotel. The theme of the event is “Future Perspectives in Pharmacovigilance.’
The key
objective of the event is to explain the current global safety
reporting requirements for prescription and over the counter drugs.
There
is also need to discuss the new pragmatic approaches to
pharmacovigilance as proposed in the Council for International
Organizations of Medical Sciences (CIOMS) working group. Over the two
days, experts will deliberate and provide inspection program of
regulatory agencies in the area of clinical safety from US and Europe,
stated Kaushik Desai, director DIA India.
The key
note speakers are from India and abroad. They are Dr YK Gupta,
department of clinical pharmacology, All India Institute of Medical
Sciences, Moin Don, executive director PVCON, Pharmacovigilance
Consulting Services, Stewart Geary, vice president, and deputy director
of Corporate Regulatory Compliance, Safety & QA, Eisai Co. Ltd and
Dr Vivek Ahuja, director, Pharmacovigilance, Asia Pacific, Baxter
Healthcare.
While
Programme co-chairs are Moin Don and Dr Ahuja, the programme committee
members constitute Dr BR Jagashetty, Karnataka drugs controller, Dr
Gupta, Prof. Parathasarthy Gurumurthy, professor and head of the
department of clinical pharmacy, JSS College of Pharmacy Medical College
Hospital, Mysore, RK Giridhar, vice president, BPO Pharma Services,
Accenture, Dr Chitra Lele, chief scientific officer, Sciformix Corp.
International
speakers panel covers Dr Sidney Kahn, principal scientist, Sciformix
Pharmacovigilance Services, Dr Sumit Munjal, consultant, (oncology),
Global Medical Safety, Johnson & Johnson, a division of
Janseen-Cilag Ltd., Johnson & Johnson, UK and Angela Pitwood, VP,
Pharmacovigilance, Indipharm Inc. US.
Some of
the topics are safety and management during early drug development
programme, US &EU safety regulations upsides-New FDA Rule/ DSURs,
safety and regulatory writing, medical device vigilance, panel
discussion on Schedule Y and Empowerment to Ethics Committees(ECs) and
Institutional Review Boards (IRBs), India: as pharmacovigilance
outsourcing destination, safety during clinical trials through medical
monitoring, integrating pharmacovigilance in medical and para medical
curriculum., Utility of Cloud Computing in pharmacovigilance data base
domain.
The
organizers recommend that the conference should be attended by those
from clinical research, risk management, compliance, medical
information, regulatory affairs, academia and pharmacology.
