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.
