Complying with Regulations, Reviewing RMPs for Asia, and Improving Audits and ADR Reporting
The Asia Pacific region has seen the introduction of stringent local and global regulations which have forced the concept of pharmacovigilance to expand beyond just identifying adverse events to incorporating risk management plans. Today pharmacovigilance is on the minds of every pharma and bio executive, and starts earlier in the drug development process. And rightly so, considering the startling fact that 200,000 patients die each year from Adverse Drug Reactions.
Pharma/Biotech companies are faced with the challenge of finding solutions that can improve the quality and analysis of safety data, while managing the increase in the quantity of data and the need to satisfy regulatory requirements.
It is this developing threat environment and the challenges facing pharmacovigilance professionals that the 5th Annual Pharmacovigilance Asia Summit 25th-27th November will be addressing:
DAY 1: 25th November 2014
Complying with multiple regulations for PV: significant recent and impending regulatory changes in Asia
Reviewing risk management plans for Asia
DAY 2: 26th November 2014
Effective audit planning and being well prepared for inspections
ADR capturing and reporting
Join us in November 2014 and be part of our growing Pharmacovigilance community to discuss the latest challenges and solutions in the PV field for ensuring drug safety in Asia.
Find solutions in 6 key areas of concern for pharmacovigilance professionals.
Join us to learn to:
- Comply with multiple regulations: Significant recent and impending regulatory changes in Asia and EMA
- Develop risk management plans for Asia
- Improve your Quality management systems for PV 4
- Comply with the latest regulatory standards for audits/inspections
- Author PBRERs as against PSURs
- Review PSMF structure and Medical Review of ICSRs
Interactive Learning at expert-led workshops
- Workshop 1: Establishing an effective strategy for operating social media and mobile technology platforms to monitor drug safety
- Workshop 2: Overcoming the challenges of the PV-QA role to ensure good pharmacovigilance practice
- Workshop 3: Signal Management: Overcoming the challenges in applying the basic concepts and principles of signal detection in Pharmacovigilance, including the role and differences of classical and statistical signal detection in the on-going safety surveillance of medicinal products
The IQPC Pharmacovigilance conference in Singapore, which is becoming an annual event is, to my knowledge, the most comprehensive information exchange and discussion forum dedicated to pharmacovigilance held in Asia so far!- Head of Pharmacovigilance Asia-Pacific, Bayer Healthcare Global R&D Centre
Had an overall understanding of pharmacovigilance running in Asia, particularly in ASEAN. It is helpful for me to make a plan locally and accelerate a pharmacovigilance strategy locally.- Director of Regulatory Affairs, Nycomed China
The topics discussed in this conference are simple enough for a beginner and complex enough for the experienced. Brilliant!- Senior Safety Officer, GSK
Very well organised conference! Attendee mix was nice – including industry and regulators! Well done!- Head, Lifesciences EU & APAC, Cognizant
This conference offers the opportunity for those working in pharmacovigilance to share expertise and learn about best practices and challenge the way they do things.- Pharmacovigilance manager, MSD
Good discussions and good comments from all representatives and speakers!- CPM, EPS International